PATENT ABSTRACT
A semi-automated system ( 100 ) suitable for use in a hospital setting for filling patient-specific liquid medication prescriptions from balk medicine containers ( 104 ) into oral syringes (S) for administration on a just-in-time basis. The system enables hospital pharmacists to simplify and streamline their task, increasing the number of prescriptions mat can be filled in a day, improving patient safety and care by minimizing medication errors and the consequences that ensue. The present invention also includes a novel adapter cap for use in interfacing between bulk medicine containers ( 104 ) and syringes (S) having a Luer-lock fitting.

PATENT DESCRIPTION
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present application derives priority from U.S. provisional patent application Ser. No. 61/932,318, filed Jan. 28, 2014, which is a continuation-in-part of U.S. patent application Ser. No. 13/236,577, filed Sep. 19, 2011 (which derives priority from U.S. provisional patent application Ser. No. 61/384,217 filed Sep. 17, 2010, and U.S. provisional patent application Ser. No. 61/494,677 filed Jun. 8, 2011), all of which are incorporated herein by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The present invention relates generally to oral syringe packaging equipment and more specifically to a partially automated system for preparing patient-specific doses of selected pharmaceutical liquid medication for administration by oral syringe on a just-in-time basis, for use in a hospital pharmacy. 
         [0004]    2. Description of the Background 
         [0005]    Oral syringes are well known instruments in the medical fields and are used to administer liquid medicine into the mouth, as an alternative to pills which can present a choking hazard or be expectorated, typically for infants/children and uncooperative or geriatric adults. The oral syringe directs liquid medicine to the back of the throat prompting a swallowing response. Injectable syringes, on the other hand, are used to administer medication into the body by injecting its contents through the skin. Injectable syringes utilize a needle on the tip of the syringe. Injectable syringes must be manufactured and packaged in a sterile environment. Research has shown that the potential for adverse drug events within the pediatric inpatient population is about three times as high as among hospitalized adults. See, Joint Commission, Preventing Pediatric Medication Errors, Issue 39 (2008). According to the Commission Report, the most common types of harmful pediatric medication errors were improper dose/quantity (37.5 percent) and unauthorized/wrong drug (13.7 percent), followed by improper preparation or dosage form. Oral syringes help to minimize these problems and are considered the gold standard for delivering medicine to children. 
         [0006]    Oral syringes, which are relatively inexpensive and disposable, are comprised of a simple piston pump with a plunger that fits tightly in one end of a cylindrical tube (the barrel) and can be pushed or pulled along inside the barrel to create negative or positive relative pressure within the barrel that causes the syringe to take in or expel a liquid or gas through an orifice (nozzle) at the opposing end of the barrel. An annular flange partially or fully encircling the outside surface of the barrel is typically provided to facilitate compression of the plunger into the barrel. The barrel of an oral syringe is typically made of plastic and is at least partially transparent along its length with graduated markings to indicate the volume of fluid in the syringe based on the position of the plunger, which is thus visible within the barrel. Oral syringes are commonly marked in units of milliliters and come in standard sizes ranging from 0.5 to 60 milliliters. The plunger is also typically plastic as this provides a good seal within the barrel and is inexpensive to produce so as to be disposable, reducing the risk of contamination or transmission of communicable disease. Oral syringes come in a wide range of sizes and with some variation in configuration. For example, some oral syringes have the nozzle located along the central axis while others have the nozzle offset from the central axis. This variability makes it difficult to automate the filling process for oral syringes. 
         [0007]    Pharmacies at in-patient medical facilities and other medical institutions fill a large number of prescriptions on a daily basis including prescriptions for liquid or compounded suspension medicines to be administered by oral syringe, and must do so accurately for medical safety reasons. The volume of an oral pediatric prescription&#39;s dose is determined by the child&#39;s weight. This makes it impractical to stock pre-filled syringes due to the wide range of fill volumes required. As a result, pediatric oral liquid doses are prepared in the hospital pharmacy on a patient-specific, just-in-time basis. The process of filling numerous, variously sized single dose prescriptions for delivery by oral syringe is time consuming, labor intensive and prone to human error. To ensure that the medication is packaged error-free, the pharmacy technician must make sure that: (1) the syringe contains the correct medication; (2) the syringe contains the correct amount of medication; (3) the syringe is capped correctly; (4) the medication has not expired; (5) the medication has not been recalled; (6) the medication, when required, is shaken; (7) the medication, when required, has been properly refrigerated; (8) the medication, when required, has been properly protected from exposure to light; (9) the information on the syringe label is correct; (10) the syringe is placed into the correct bag; (11) the information on the bag containing the syringe is correct; (12) the bag is properly sealed; and (13) the syringe is protected from cross contamination from other medications. The process typically requires a pharmacist or pharmacy technician to retrieve the correct medication from a storage cabinet (with or without light protection) or refrigerated storage area. The liquid medications are typically stored in a container sealed with a safety cap or seal. After confirming the contents of the retrieved container and shaking the medication (if necessary), the technician manually opens the cap and inserts the tip of an oral syringe into the container which has previously been adapted to accept the syringe, inverts the container, and then withdraws the plunger to draw the medication into the barrel of the syringe. After filling with a proper amount, the syringe and medication container are rotated back to the original position, the syringe is removed from the container, the tip of the syringe is covered with a cap for transport to the patient and the syringe is labeled to indicate its content and the intended recipient, and then bagged. Prior to administering the dose, the nurse can determine the amount of the dose by observing where the tip of the plunger or piston is located in the barrel. 
         [0008]    Currently, the degree of automation in the hospital pharmacy for the packaging of oral syringes is very limited. Islands of automation exist, such as automatic labeling of the syringe and bagging of the filled and capped syringe to indicate to the administering nurse the content of the syringe. However, the filling and capping of oral syringes are done manually. Scanners, cameras, bar code readers and track-and-trace technology have not been applied on an integrated, comprehensive basis for the packaging of oral syringes in the hospital pharmacy. The potential to reduce medication errors using this technology is thus significant. Automated systems have been developed by Baxa, Inc., For Health Technologies, Inc., Intelligent Hospital Systems and others for the automated filling of injectable syringes. 
         [0009]    For example, U.S. Pat. Nos. 6,991,002; 7,017,622; 7,631,475 and 6,976,349 are all drawn to the automated removal of a tip cap from an empty syringe, the placement of the tip cap at a remote location, and the replacement of the tip cap on a filled syringe. U.S. Pat. Nos. 7,117,902 and 7,240,699 are drawn to automated transfer of a drug vial from storage to a fill station. U.S. Pat. No. 5,884,457 shows a method and apparatus for filling syringes using a pump connected by a hose to a fluid source. U.S. Pat. No. 7,610,115 and Application Publication 2010/0017031 show an Automated Pharmacy Admixture System (APAS). U.S. Application Publication 2009/0067973 shows a gripper device for handling syringes of different diameters with tapered or angled gripper fingers. U.S. Pat. No. 7,343,943 shows a medication dose under-fill detection system. U.S. Pat. No. 7,260,447 shows an automated system for fulfilling pharmaceutical prescriptions. U.S. Pat. No. 7,681,606 shows an automated system and process for filling syringes of multiple sizes. U.S. Pat. No. 6,877,530 shows an automated means for withdrawing a syringe plunger. U.S. Pat. No. 5,692,640 shows a system for establishing and maintaining the identity of medication in a vial using preprinted, pressure sensitive, syringe labels. 
         [0010]    The foregoing reference machines for packaging injectable syringes. The packaging process required for injectable syringes is significantly different than that for oral syringes. Injectable syringes must be packaged in a sterile environment, as the medication is injected into the body. This requirement adds cost and complexity to the machine. Injectable medications, when packaged on a just-in-time basis as with the Baxa, For Health Technologies, and Intelligent Hospital System machines, must typically be prepared by the machine before the medication is filled into the syringe. The medication preparation process involves diluting the medication or reconstituting the medication from a powdered state with water. This process adds expense and slows down the packaging process as well. The Intelligent Hospital Systems syringe packaging system is designed to be used to package cytotoxic medications which are hazardous. To avoid harm to the operator, this machine uses a robot located within an isolating barrier at considerable cost. The Baxa, For Health Technologies, and Intelligent Hospital System machines require the use of expensive disposable product contact parts when a different medication is to be filled. The foregoing machines are not suitable for packaging oral syringes due to their capital cost, complexity, slow production rates, inability to handle oral medication containers, the requirement of expensive disposable contact parts, and other features that add unnecessary cost and complexity to the process for filling and packaging oral syringes. Consequently, existing automation does not address the needs of medical institutions desiring an affordable pharmacy automation system for patient safety, prescription tracking and improved productivity in the filling and packaging of oral syringes. The present invention was developed to fill this void. 
         [0011]    Oral syringes are manufactured in a variety of sizes with differing tip and plunger configurations, as described in part above. Moreover, oral medications are commonly provided and/or stored in bulk form in variously sized, manufacturer-supplied (OEM) bottles or containers having threaded screw caps that must be removed and replaced between uses. Under the prior art, in order to fill an oral syringe from the manufacturer-supplied container, the original container cap must be replaced with a cap that allows insertion of an oral syringe nozzle. Baxa™ sells an “Adapta-Cap”™ bottle adapter in a variety of sizes that replaces the OEM caps to convert a standard prescription or manufacturer bottle into a filling device for oral syringes. These Adapta-Cap™ bottle adapters are screw-on caps with open center-holes capable of accepting an oral syringe nozzle, and a tethered closure. This enables an oral syringe to enter its center hole and withdraw an amount of liquid from the medication container while the medication container is positioned upside down. Unfortunately, the Adapta-Cap™ bottle adapters have no internal valves and are not self-sealing. Thus, for the syringe to be removed from the medication container, both syringe and medication bottle must be up-righted. Once up-righted, the syringe can be removed from the up-righted medication bottle with no leakage. If the medication bottle requires shaking at any given time, it must be done manually or in a separate shaker while upright when using the prior art Adapta-Cap™. 
         [0012]    It is known that an adapter cap can include a self-sealing valve for this purpose. For example, U.S. Pat. No. 8,459,312 to Manera et al. (Comar) issued Jun. 11, 2013 shows an adapter to be pressed into the neck of a bottle to receive a syringe for accessing the bottle contents by a syringe. The adapter has a normally closed valve located at that distal end to prevent the contents from leaking out of the bottle if the bottle is inverted. A very similar construct was shown in United States Patent Application 20110130740 by Levy (Baxa) published Jun. 2, 2011 (now abandoned). U.S. Pat. No. 4,493,348 shows a method and apparatus in which oral syringes can be filled using a screw-on adapter cap 12 for connecting the bulk medicine container 10 and a syringe 14 so that the liquid medication can be transferred from the bulk container 10 into the syringe barrel 20. The syringe is inserted into a nozzle 88 of the adapter cap 12 and displaces a detent valve 92 (see U.S. Pat. No. 4,493,348 FIG. 6) that allows medicine to flow through the nozzle 88 into the syringe. When not in use the nozzle 88 may be closed off by a plug 50 attached to a tether 48. The adapter cap 12 is well-suited for manual filling of oral syringes but is not suitable for automated filling. 
         [0013]    Additionally, all of the foregoing adapters allow a tapered tip oral syringe to enter a center hole and withdraw an amount of liquid from the medication container while the medication container is positioned upside down, allow an oral syringe be removed from the container while the container is inverted, without leaking, and allow the medication container to be shaken while it is positioned upside down without leaking. However, none can accommodate an oral syringe with a Luer-lock tip. The Luer-lock tip syringe, includes a circular hub about the oral syringe nozzle that screws into in a threaded sleeve on the medicine container cap (see  FIG. 39 ). As a result of a worldwide International Standards Organization directive ISO-80369, certain syringe types will be required to employ Luer-lock fittings to reduce the risk of misconnections between tubes, IV&#39;s, enteral devices, etc. In order to accommodate this change, any syringe fill automation system or semi-automatic system suitable for use in a hospital setting should be able to interface syringes with a Luer-lock fitting to a medicine container equipped with an adapter cap that preferably allows insertion, filling and withdrawal in any orientation without leaking, and which preferably enables the medication container to be shaken without leaking. Thus, preferably, a system of filling oral syringes should interface both Luer-lock and tapered tip oral syringes with medicine containers equipped with the appropriate adapter cap. A self-sealing adapter cap may accomplish these goals. 
         [0014]    Given the diversity of oral syringes and medicine containers available (and in use), any semi-automated (or fully-automated) system will need sufficient dexterity to manipulate all the myriad prescription bottles containing the pharmaceuticals to be dispensed as well as variously sized oral syringes with tapered and Luer-lock tips, bringing them together in a controlled environment to quickly and accurately fill and label each syringe and to verify its work as it proceeds in order to avoid errors in the process. Such a system would need to be reliably constructed so as to minimize downtime, quickly take and fill orders, be easy to clean and capable of maintaining an environment free from cross contamination. Such a system would also need to be able to interact with a human operator at multiple points in the operation. 
         [0015]    Additionally, in-patient medical facilities such as hospitals are moving toward electronic prescription (“e-prescription”) systems which use computer systems to create, modify, review, and/or transmit medication prescriptions from the healthcare provider to the pharmacy. While e-prescribing improves patient safety and saves money by eliminating the inefficiencies and inaccuracies of the manual, handwritten prescription process, any syringe fill automation system suitable for use in a hospital setting must interface with an existing e-prescription system (which records and transmits prescriptions to the pharmacy), and must be capable of filling prescription orders in a just-in-time environment. 
       SUMMARY OF THE INVENTION 
       [0016]    The present inventors herein provide a semi-automated system suitable for use in a hospital setting for filling patient-specific doses of liquid medications to be administered by oral syringes on a just-in-time basis. The system enables hospital pharmacists to simplify and streamline their task, increasing the number of prescriptions that can be filled in a day, and improving patient safety and care by minimizing medication errors and the consequences that ensue. 
         [0017]    The present invention also provides fourteen embodiments of a medication container adapter for oral syringe filling system. The preferred embodiment is a self-sealing valve which allows the container to remain in an inverted position for the entire time the syringes are being filled. In addition the container may be shaken without removal from the shake station. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0018]    The objects, features, and advantages of the present invention will become apparent from the following detailed description of the preferred embodiments and certain modifications thereof when taken together with the accompanying drawings in which like numbers represent like items throughout and in which: 
           [0019]      FIG. 1  is a flow chart of the overall method of the invention. 
           [0020]      FIG. 2  is a perspective view of the entire pharmacy automation system  100  according to an embodiment of the invention. 
           [0021]      FIG. 3  is a more detailed flowchart of the substeps of the batch fulfillment process  750  of  FIG. 1 . 
           [0022]      FIG. 4  is a more detailed block diagram of the medication container orientation and log-in process  720  of  FIG. 1 . 
           [0023]      FIG. 5  is a composite view of six of the embodiments of container/syringe interfaces according to the invention. The container/syringe interfaces include closures and neck inserts meant to facilitate the connection of an oral syringe to a medication container for the purpose of drawing fluid out of the container. 
           [0024]      FIGS. 6A and 68B  are perspective views of an exemplary vision inspection station  9 . 
           [0025]      FIG. 6C  shows an alternative articulating design for the backlight panel  97 . 
           [0026]      FIG. 6D  shows another alternative articulating design for the backlight panel  97 . 
           [0027]      FIG. 7A  is an enlarged perspective view of a semi-automated syringe fill station  5  for filling the syringes S. 
           [0028]      FIG. 7B  is a composite view of a self-centering spring loaded bottle gripper assembly  82 C used as an alternative to fixed yokes  82  of  FIG. 7A . 
           [0029]      FIG. 7C  I is an enlarged perspective view of fixed yoke  82 A illustrating how it is used. 
           [0030]      FIG. 7C  II is an enlarged perspective view of fixed yoke  82 B illustrating how it is used. 
           [0031]      FIG. 7C  III is an enlarged perspective view of self-centering jaws  82 C illustrating how they is used. 
           [0032]      FIG. 7C  IV is an enlarged perspective view of fixed yoke  82 D illustrating how it is used. 
           [0033]      FIG. 7D  is a further enlarged perspective view of the loading carriage  70  of  FIG. 7A . 
           [0034]      FIG. 8  is a composite view of the syringe gripping arms  110 ,  111  and  112  terminating in a pair of fork shaped fingers  120  that form a horizontally oriented “V” shaped opening. 
           [0035]      FIG. 9  illustrates an embodiment of the syringe gripping arms  111  and its drive mechanism. 
           [0036]      FIG. 10  is an enlarged perspective view of the semi-automated capping station  8 . 
           [0037]      FIGS. 11 and 12  illustrate an exemplary control system architecture for the system  100  of  FIGS. 2-10 . 
           [0038]      FIG. 13  is a perspective view of an exemplary capping/decapping station  93  resident at the Medication Container Orientation and Log-In Station. 
           [0039]      FIG. 14  is a perspective view of the optional label photographing station  98  resident at the Medication Container Orientation and Log-In Station. 
           [0040]      FIG. 15A  is a perspective view of an embodiment of the syringe size/color station  11 A which verifies that the correct syringe has been selected. 
           [0041]      FIG. 15B  is a perspective view of an alternate embodiment of the syringe size/color station  11 B which verifies that the correct syringe has been selected. 
           [0042]      FIG. 16A  illustrates an embodiment of a shaking mechanism  820  integral to the filling station  5 . 
           [0043]      FIG. 16B  is a composite operational diagram illustrating the operation of the integral shaking mechanism  820  of  FIG. 16A . 
           [0044]      FIG. 17  is a perspective view of an alternative, remote medication container shake station  6 . 
           [0045]      FIG. 18  is a sequential illustration of the process for filling a syringe S using a standard commercially available “Baxa” cap  214 ; 
           [0046]      FIG. 19  is a sequential illustration of the process for filling a syringe S using an OEM-Baxa™ Cap with self sealing valve  216 . 
           [0047]      FIG. 20  is a sequential illustration of the process for filling a syringe S using a press in bottle adapter (PIBA) (no valve)  210 ; 
           [0048]      FIG. 21  is a sequential illustration of the process for filling a syringe S using a PIBA (with valve)  212 . 
           [0049]      FIG. 22A  is a process drawing depicting grouped stations with a multiple syringe compartment tray (Option 3); 
           [0050]      FIG. 22B  is a process drawing with one operator and three and grouped stations (Option 2); 
           [0051]      FIG. 23  is a process drawing with three operators and three and three grouped stations (Option 3). 
           [0052]      FIG. 24  is a process drawing with two operators situated around a lazy Susan (carousel-like) disc  342 . 
           [0053]      FIG. 25  is a process drawing with three (3) operators situated around a lazy Susan (carousel-like) disc  342 . 
           [0054]      FIG. 26  illustrates an embodiment of a syringe gripping module having curvilinear distal ends. 
           [0055]      FIG. 27  is a composite view (A, B and C) of a press in tip  223  for a Baxa™ or Baxa™-equivalent manufacturer-supplied medication container cap to interface with a Luer lock oral syringe. 
           [0056]      FIG. 28  is a composite view (A, B and C) of a press in tip  223  for a PIBA to interface with a Luer lock oral syringe. 
           [0057]      FIG. 29  is composite view (A, B and C) of a push-pull cap  224  for a Baxa™ or Baxa™-equivalent manufacturer-supplied medication container cap to interface with a Luer lock oral syringe. 
           [0058]      FIG. 30  is composite view (A, B and C) of a push-pull cap  224  made integral with a Baxa™ or Baxa™-equivalent manufacturer-supplied medication container cap to interface with a Luer lock oral syringe. 
           [0059]      FIG. 31  is composite view (A, B, C and D) of a push-pull cap  224  for a PIBA cap to interface with a Luer lock oral syringe. 
           [0060]      FIG. 32  is composite view (A, B and C) made integral with a push-pull cap  224  for a PIBA cap to interface with a Luer lock oral syringe. 
           [0061]      FIG. 33  is a composite view (A and B) of a self-sealing press in bottle adapter (SSPIBA) for use with a tapered tip syringe. 
           [0062]      FIG. 34  is a composite view (A and B) of a threaded cap modified with a duckbill valve having automation grooves for use with a tapered tip syringe. 
           [0063]      FIG. 35  is  FIG. 29  is composite view (A and B) of a Baxa™ or Baxa™-equivalent manufacturer-supplied medication container cap modified with a duckbill valve to interface with a tapered tip oral syringe. 
           [0064]      FIG. 36A  illustrates a tethered protective cap for push-pull cap  224  for use in semi-automatic operations. 
           [0065]      FIG. 36B  illustrates a separate protective cap for push-pull cap  224  for use in fully automated operations. 
           [0066]      FIG. 37A  illustrates a tethered protective cap for modified Baxa™ or Baxa™-equivalent manufacturer-supplied medication container cap with duckbill valve for use in semi-automatic operations. 
           [0067]      FIG. 37B  illustrates a separate protective cap for modified Baxa™ or Baxa™-equivalent manufacturer-supplied medication container cap with duckbill valve for use in fully automated operations. 
           [0068]      FIG. 38  is a side view of a tapered tip oral syringe. 
           [0069]      FIG. 39  is a side view of a Luer lock oral syringe. 
           [0070]      FIG. 40  is a perspective view of filling station  5  according to another embodiment of the present invention comprising a grooved block  400  for actuating push-pull adapter cap  224 . 
           [0071]      FIG. 41  is an enlarged perspective view of the actuation mechanism for filling station  5  according to the embodiment shown in  FIG. 40 . 
           [0072]      FIG. 42  is an enlarged perspective view of the actuation mechanism for filling station  5  comprising a grooved block  400  for actuating push-pull adapter cap  224  according to another embodiment of the present invention 
           [0073]      FIG. 43  is a composite view (A and B) of the interaction between push-pull cap  224 , grooved block  400  and yoke  82  according to the embodiments illustrated in  FIGS. 40-42 . 
           [0074]      FIG. 44  is a composite view (A, B and C) of a valveless PIBA  210  retrofit to include an integral valve  225  (typically, a duckbill valve) for use with a tapered tip syringe. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0075]    For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the exemplary embodiment illustrated in the drawings and described below. The embodiment disclosed is not intended to be exhaustive or limit the invention to the precise form disclosed in the following detailed description. Rather, the embodiment is chosen and described so that others skilled in the art may utilize its teachings. It will be understood that no limitation of the scope of the invention is thereby intended. The invention includes any alterations and modifications in the illustrated device, the methods of operation, and further applications of the principles of the invention which would normally occur to one skilled in the art to which the invention relates. 
         [0076]    The present invention includes both the system hardware as well as the process for preparing and tracking prescriptions of oral syringes by a series of integrated manual and automated steps with respect to preparing the syringe and the bulk medicine, and subsequently bringing the series together for filling the former from the latter. The bulk medicine is typically supplied in manufacturer-supplied medicine containers with conventional screw-on caps. To facilitate processing the present system also envisions the use of one or more specialized adapter caps for interfacing with tapered or Luer lock type oral syringes; alternatively, another type of specialized cap may be provided to specification, or the OEM cap may be replaced or retrofitted with any available type of container/syringe interface to provide a penetrable orifice. As described more fully below, the retrofit may be accomplished in a number of ways. One solution is a press in bottle adapter (PIBA), e.g., a press-in plug inserted into the neck opening of a medication container which enables an oral syringe to enter its center hole and withdraw an amount of liquid from the medication container while the medication container is positioned up-side-down. Another is a modified manufacturer-supplied cap. Another is an adapter cap specially designed to modify a manufacturer-supplied cap to interface with a Luer lock oral syringe. Specifically, the present invention contemplates fourteen (14) container/syringe interface variations: (1) a valve-less press in bottle adapter (PIBA)  210  ( FIG. 5 ); (2) a self sealing PIBA (SSPIBA)  212  with an integral valve (typically, either a linear or a Z-shaped slit)  213  ( FIG. 5 ); (3) a standard manufacturer-supplied (Baxa™ or Baxa equivalent) valve-less medicine container cap  214  with opening ( FIG. 5 ); (4) a modified manufacturer-supplied (Baxa™ or Baxa equivalent) medicine container cap  216  that is retrofit to include an integral valve  225  (typically, a duckbill valve) ( FIG. 5 ); (5) a two-piece cap comprising an outer portion  220  with a common outer diameter for all standard sizes of medication container, and a self-sealing insert  212  ( FIG. 5 ); (6) a cap  221  comprising a common outer diameter for all standard sizes of medication container and having an integral self-sealing insert  212  ( FIG. 5 ); (7) a modified manufacturer-supplied (Baxa™ or Baxa equivalent) medicine container cap  214  that is retrofit to include a non-integral push-in tip  223  for interfacing with Luer lock oral syringes ( FIG. 27 ); (8) a modified PIBA  210  that is retrofit to include a non-integral push-in tip  223  for interfacing with Luer lock oral syringes ( FIG. 28 ); (9) a modified manufacturer-supplied (Baxa™ or Baxa equivalent) medicine container cap  214  that is fitted with a push-pull cap  224  for interfacing with Luer lock oral syringes ( FIG. 29 ); (10) a modified manufacturer-supplied (Baxa™ or Baxa equivalent) medicine container cap  214  that is retrofit with an integral push-pull cap  224  for interfacing with Luer lock oral syringes ( FIG. 30 ); (11) a modified PIBA  210  that is fitted with a push-pull cap  224  for interfacing with Luer lock oral syringes ( FIG. 31 ); (12) a modified PIBA  210  that is retrofit with an integral push-pull cap  224  for interfacing with Luer lock oral syringes ( FIG. 32 ); (13) a cap  226  comprising a common inner diameter for all standard sizes of medication container, fitted with an integral or separable valve  225  (typically, a duckbill valve), and having grooved rings to facilitate handling, positioning, etc. by the system according to the present invention ( FIG. 34 ); and/or (14) a valveless PIBA  210  that is retrofit to include an integral valve  225  (typically, a duckbill valve) ( FIG. 44 ). The chart below summarizes the fourteen (14) adapter cap variations according to the current invention: 
         [0000]    
       
         
               
               
               
               
             
               
               
               
               
             
           
               
                   
               
               
                 No. 
                 Description of adapter interface 
                 FIG. No. 
                 Reference No. 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                 1 
                 valve-less press in bottle adapter (PIBA) 
                 5 
                 210 
               
               
                 2 
                 self sealing PIBA (SSPIBA) with an integral valve 
                 5 
                 212/213 
               
               
                   
                 (typically, either a linear or a Z-shaped slit) 
               
               
                 3 
                 standard manufacturer-supplied (Baxa ™ or Baxa 
                 5 
                 214 
               
               
                   
                 equivalent) valve-less medicine container cap with 
               
               
                   
                 opening 
               
               
                 4 
                 modified manufacturer-supplied (Baxa ™ or Baxa 
                 5 
                 216/225 
               
               
                   
                 equivalent) medicine container cap that is retrofit to 
               
               
                   
                 include an integral valve (typically, a duckbill valve) 
               
               
                 5 
                 two-piece cap comprising an outer portion with a 
                 5 
                 220/212 
               
               
                   
                 common outer diameter for all standard sizes of 
               
               
                   
                 medication container, and a self-sealing insert 
               
               
                 6 
                 cap comprising a common outer diameter for all 
                 5 
                 221/212 
               
               
                   
                 standard sizes of medication container and having an 
               
               
                   
                 integral self-sealing insert 
               
               
                 7 
                 modified manufacturer-supplied (Baxa ™ or Baxa 
                 27 
                 214/223 
               
               
                   
                 equivalent) medicine container cap that is retrofit to 
               
               
                   
                 include a non-integral push-in tip for interfacing with 
               
               
                   
                 Luer lock oral syringes 
               
               
                 8 
                 modified PIBA that is retrofit to include a non- 
                 28 
                 210/223 
               
               
                   
                 integral push-in tip for interfacing with Luer lock oral 
               
               
                   
                 syringes 
               
               
                 9 
                 modified manufacturer-supplied (Baxa ™ or Baxa 
                 29 
                 214/224 
               
               
                   
                 equivalent) medicine container cap that is fitted with 
               
               
                   
                 a push-pull cap for interfacing with Luer lock oral 
               
               
                   
                 syringes 
               
               
                 10 
                 modified manufacturer-supplied (Baxa ™ or Baxa 
                 30 
                 214/224 
               
               
                   
                 equivalent) medicine container cap that is retrofit 
               
               
                   
                 with an integral push-pull cap for interfacing with 
               
               
                   
                 Luer lock oral syringes 
               
               
                 11 
                 modified PIBA that is fitted with a push-pull cap for 
                 31 
                 210/224 
               
               
                   
                 interfacing with Luer lock oral syringes 
               
               
                 12 
                 modified PIBA that is retrofit with an integral push- 
                 32 
                 210/224 
               
               
                   
                 pull cap for interfacing with Luer lock oral syringes 
               
               
                 13 
                 cap comprising a common inner diameter for all 
                 34 
                 225/226 
               
               
                   
                 standard sizes of medication container, fitted with an 
               
               
                   
                 integral or separable valve (typically, a duckbill 
               
               
                   
                 valve), and having grooved rings to facilitate 
               
               
                   
                 handling, positioning, etc. by the system according to 
               
               
                   
                 the present invention 
               
               
                 14 
                 valveless PIBA that is retrofit to include an integral 
                 44 
                 210/225 
               
               
                   
                 valve (typically, a duckbill valve) 
               
               
                   
               
             
          
         
       
     
         [0077]      FIG. 5  is a composite view of the first six of the embodiments of the container/syringe interfaces according to the invention. The embodiments shown in  FIG. 5  are suited for use with a tapered tip syringe S as shown in  FIG. 38 . The tapered syringe includes an annular, tapered or cylindrical nozzle through which liquid medication must pass to enter or exit the body of the syringe. The nozzle contains an open central channel. 
         [0078]    As shown in  FIG. 5 , two valveless embodiments include the PIBA  210  and OEM/Baxa Cap  214  at left, and four valved embodiments include the valved PIBA  212 , the valved self-sealing PIBA  212  integrally formed into, or combinable with, the common diameter outer portion  220  or  221 , and a modified/self-sealing OEM/Baxa Cap  216 . All may be adapted to fit a variety of medicine bottle types and sizes. 
         [0079]    The valved PIBA  212 , OEM/Baxa Cap  216  and common outer diameter caps  220 ,  221  all include a self-sealing valve that closes when the syringe nozzle is removed to prevent leakage when the medication container is in the inverted position at the fill station. 
         [0080]    Both PIBAs  210 ,  212  comprise a press-fitted open plug inserted into the neck opening of a medication container. This enables an oral syringe to enter its center hole and withdraw an amount of liquid from the medication container while the container is positioned up-side-down. This syringe filling procedure must be repeated for each syringe to be filled. If the medication container with open PIBA  210  requires shaking this must be done manually with the original screw cap replaced over the neck. The above procedure must be repeated every time shaking is required regardless of whether the same medication is being filled into multiple syringes. Also, the original cap must be placed over the Medication bottle and its press-in insert, during storage, to ensure cleanliness. 
         [0081]    OEM/Baxa Caps  214  (see  FIG. 5 ) are the commercially available “Baxa” screw on adapter caps which are applied to the necks of medication bottles to enable them to fill oral syringes. The standard commercially available “Baxa” cap consists of a female threaded cap to fit over medication bottles and is available in sizes to accommodate most medication containers. It enables an oral syringe to enter its center hole and withdraw an amount of liquid from the medication container while the medication container is positioned upside down. For the syringe to be removed from the medication container, both syringe and medication bottle must be up-righted. Once up-righted, the syringe can be removed from the up-righted medication bottle with no leakage. If the medication bottle requires shaking at any given time, it can be done manually or in a separate shaker by closing the tethered cap and fastening the bottle into the shaking mechanism (see  FIG. 17  below). 
         [0082]    The valved OEM/Baxa Cap  216  (see  FIG. 5 ) is preferably modified/constructed with an elastomeric check valve member  225  held captive in the plastic cap body  219 . Examples of self-sealing valves include check valves and simple diaphragms with a linear or a Z-shaped slit. Again, it is important to remember that valved interfaces  212 ,  216  can be left inverted at the filling station  5  ( FIG. 2  III  5 ) and even shaken without leaking, whereas valveless interfaces  210 ,  214  (see  FIG. 5 ) do not prevent leakage. Thus, valveless interfaces  210 ,  214  compel removal of the syringe/container combination from the filling station  5  after each filling operation. 
         [0083]    The elastomeric seal  225  (see  FIG. 5 ) of the valved OEM/Baxa Cap  216  is fitted within an aperture in the flange of cap  219 . In its simplest form the elastomeric seal  225  may be a resilient, penetrable membrane with a small hole or slot (such as a pinhole) punched at its center, and preferably formed of silicone or other rubber. The hole in the seal  225  expands as the tip of a syringe S is inserted to permit pressurization of the container  104  (see  FIG. 19 ) and/or filling of the syringe (by vacuum) as described below. On withdrawal of the syringe tip the resilient elastomeric seal  225  returns to its original shape closing the hole and preventing leakage of the fluid contents of the bottle  104 . 
         [0084]      FIG. 5  also shows cross-sections of alternative container/syringe interfaces  210 ,  212  which comprise a PIBA fitted as a plug-in insert into the neck of the medicine container. The PIBA is an annular body sized to conform to the inside of the medicine container neck and adapted for a friction fit therein, and may be formed with ribs as described above for this purpose. The interface  212  defines a central conduit, and the elastomeric seal  213  is fitted within interface  212  across this conduit to serve as a penetrable seal as described above. 
         [0085]    As still another option, any conventional cap, such as Baxa&#39;s AdaptaCap™ bottle adapter cap may be used (as shown in U.S. Pat. No. 4,493,348 referenced above) and simply modified or equipped by the manufacturer or aftermarket with a penetrable elastomeric seal such as check valve  225 , or other suitable self-sealing valve. In yet another embodiment of the present invention, a container/syringe interface includes an outer portion  220 ,  221  that will have the same outer circumference for use on any of the standard sizes of medication containers. It can be used with a purchased, self-sealing insert, such as valved PIBA  212 , or the insert can be integrally formed within the outer portion  221 . The interface between the medication container and the self-sealing insert will hold the outer portion  220 ,  221  securely onto the top of the medication container, locating the outer part on center with the opening of the medication container. The cap with outer portion  220 ,  221  may also include a tethered protective cap (to protect the contents of the medication container from contamination, such as, for example, from dust or other airborne particles) similar to the Baxa type cap, as shown in  FIG. 5 . In one preferred embodiment, the 2D bar code, described in further detail below, is affixed to the top of the tethered cap. The common outer diameter of outer portion  220 ,  221  for all standard sizes of medication container caps can serve as a common means of locating the medication container on center with the yoke at the fill station. The common size of the flange  222  of the outer portion  220 ,  221  of the instant cap embodiment may also facilitate transportation of the medication containers when used with a carousel designed to hold a single diameter syringe/container interface. 
         [0086]      FIG. 44  shows a composite view of another valved embodiment of the container/syringe interface for use with a tapered tip syringe: valveless PIBA  210  with integral or non-integral duckbill valve  225 . This embodiment also may be adapted to fit a variety of medicine bottle types and sizes. The valveless PIBA  210  with duckbill valve  225  comprises a press-fitted open plug inserted into the neck opening of a medication container. An elastomeric check valve member  225  is then inserted into the center hole of PIBA  210 . Examples of self-sealing valves include check valves and simple diaphragms with a linear or a Z-shaped slit. The hole in the seal  225  expands as the tip of a syringe S is inserted to permit pressurization of the container  104  (see  FIG. 19 ) and/or filling of the syringe (by vacuum) as described below. On withdrawal of the syringe tip the resilient elastomeric seal  225  returns to its original shape closing the hole and preventing leakage of the fluid contents of the bottle  104 . The presently described valved interface  210 / 225  can be left inverted at the filling station  5  ( FIG. 2  III  5 ) and even shaken without leaking. However, the original cap must be placed over the Medication bottle and its press-in insert, during storage, to ensure cleanliness. 
         [0087]    Additional preferred embodiments are illustrated with reference to  FIGS. 27-37 and 39 .  FIG. 39  depicts a Small Bore Luer Lock (also referred to herein as a “Luer-lock” syringe) syringe which has an inlet/outlet opening flush with the top edge of the syringe body and bordered by an annular flange which creates a female connection point for a male nozzle to fill the syringe body with liquid medication through the inlet/outlet point.  FIG. 27  is a composite view (A, B &amp; C) of a modified manufacturer-supplied (Baxa™ or Baxa equivalent) medicine container cap  214  that is retrofit to include a non-integral push-in tip  223  for interfacing with Luer lock oral syringes, shown in cross-section. Push-in tip  223  is preferably composed of an annular body having a tapered distal flange  223 A, flange  223 A having a diameter that decreases towards the distal end of tip  223  for insertion into the nozzle of the manufacturer-supplied medication container cap  214 . Tip  223  further comprises an annular flange  223 B (having a diameter slightly larger than the diameter of the nozzle opening for cap  214 ) at its midpoint to prevent tip  223  from sliding all the way into cap  214 . The end of tip  223  opposite tapered flange  223 A is sized to fit snugly within the outer flange of Luer Lock Syringe S, as shown in  FIG. 27C . This design requires the medication bottle to be upright while the syringe is inserted into the medication bottle nozzle. Then, both medication bottle and attached syringe are inverted as a unit and placed into the filler, as will be described. When syringe S is filled, both medication bottle and syringe are uprighted and the filled syringe is removed from the medication bottle. Tip  223  may use a separate cap  223 C to prevent spillage of the contents of the medication bottle when syringe S is not attached to tip  223 . 
         [0088]      FIG. 28  is a composite view (A, B &amp; C) of a modified PIBA  210  that is retrofit to include a non-integral push-in tip  223  for interfacing with Luer lock oral syringes. As in  FIG. 27 , tip  223  comprises a tapered distal flange  223 A, flange  223 A having a diameter that decreases towards the distal end of tip  223  for insertion into the nozzle of the PIBA cap  210 , while the opposite end of tip  223  is sized to fit snugly within the outer flange of Luer Lock Syringe S, as shown in  FIG. 28C . Tip  223  may use a separate cap  223 C to prevent spillage of the contents of the medication bottle when syringe S is not attached to tip  223 . 
         [0089]      FIG. 29  is a composite view (A, B &amp; C) of a modified manufacturer-supplied (Baxa™ or Baxa equivalent) medicine container cap  214  that is fitted with a push-pull cap  224  for interfacing with Luer lock oral syringes. Cap  224  comprises two separately formed nozzle sections that are slidably connected in a male-female link. A stationary portion  224 A for attachment to a medication bottle comprises an annular body with a central passage  80  therethrough, the central passage  80  being defined by an inner wall having a specific progression of diametric variations. At one end of the body of stationary portion  224 A, where stationary portion  224 A attaches to the top of a manufacturer-supplied (Baxa™ or Baxa equivalent) medicine container cap  214 , central passage  80  has a relatively large diameter sized to conform to and receive the conventional Baxa™ oral medication cap with syringe aperture  214  as shown in  FIG. 5 . It will be understood by one of ordinary skill in the art, however, that stationary portion  224 A may be sized to fit a Baxa™-equivalent manufacturer-supplied cap based on design preference. Central passage  80  continues through stationary portion  224 A at a diameter sized to accommodate the upper, smaller-diameter nozzle portion of the conventional Baxa™ oral medication cap  214 , wherein the two diameters of central passage  80  connect to define a shoulder  83  for press-fit anchoring of the conventional Baxa™ (or Baxa™-equivalent) oral medication cap  214 . At a midpoint of the smaller diameter portion of central passage  80 , a tapered elastomer poppet  84 , as will be described further herein, is anchored. The outer wall of stationary portion  224 A may further comprise annular grooves for alignment with the yoke of the filling station, as further described herein. 
         [0090]    At the distal end of stationary portion  224 A opposite its attachment with the manufacturer-supplied medication container cap  214 , stationary portion  224 A is slidably attached to a second, sliding portion  224 B of push-pull cap  224 . Sliding portion  224 B also comprises a generally annular body with a central passage  85  therethrough, the central passage  85  being defined by an inner wall having a specific progression of diametric variations. At a first end, proximate the connection point between stationary  224 A and sliding  224 B portions of cap  224 , channel  85  has a diameter sized to fit securely around the outer diameter of the distal end of stationary portion  224 A. Channel  85  continues through sliding portion  224 B to a shoulder  89  at the base of cap receiving chamber  60 . Past shoulder  89 , channel  85  progressively narrows in diameter, terminating in a nozzle  90  at the distal end of sliding portion  224 B. Nozzle  90  is sized to fit securely around the tip of poppet  84  when cap  224  is closed to provide a secure, water tight fit between nozzle  90  and poppet  84 . This configuration prevents any fluid medications from leaking from the medication bottle when inverted upon removal of the syringe from nozzle  90 . 
         [0091]    Cap  224  comprises a tab and groove locking mechanism to ensure positive locking between stationary  224 A and sliding  224 B portions of cap  224  in both open ( FIG. 29  at A) and closed ( FIG. 29  at B) positions. The locking mechanism comprises an annular tab  86  extending from the inner wall of channel  85  and flush with the distal end of sliding portion  224 B. Tab  86  corresponds in height and width to two grooves  87   a ,  87   b  in the outer wall of stationary portion  224 A. When cap  224  is open, as shown in  FIG. 29  (at A), tab  86  fits securely into groove  87   b , which is located proximate the distal end of stationary portion  224 A, creating a chamber  60  within channel  85  to allow liquid medication to flow from manufacturer-supplied medication container cap  214  through channel  80  and around poppet  84  into channel  85  and out through nozzle  90  into the oral syringe during filling. Poppet  84  is anchored within stationary portion  224 A using one or more anchor points (see  FIG. 29  at C, showing cross-section A-A through stationary portion  224 A) that allow liquid to flow past poppet  84  as indicated by the dotted line in  FIG. 29  (at A). Grooves  87   a ,  87   b  are spaced such that, when sliding portion  224 B is pushed towards stationary portion  224 A, tab  86  settles in groove  87   a  when the tip of poppet  84  is flush with the distal end of sliding portion  224 B forming a water tight seal with nozzle  90 . The exterior wall of sliding portion  224 B comprises an annular slide disc  91  to allow force to be applied along the main axis of sliding portion  224 B to open and close cap  224 . At the distal end of sliding portion  224 B proximate its connection with syringe S, the outer diameter of sliding portion  224 B is sized to fit inside the female nozzle of a Luer lock oral syringe. 
         [0092]    This design enables opening and closing the flow of medication to the Luer lock oral syringe while the medication container is inverted. As such, the time to load and unload, or upright and invert, the medication container between syringe fillings is eliminated. In addition, the medication container can also be shaken in an inverted position before, during or after a syringe filling operation, when the medication so requires, as will be described. The design also allows for placement of the medication container bearing cap  224  into the Syringe Filler (to be described) via a yoke in an automated or semi-automated process, and for slide disc  91 , which controls the opening and closing of cap  224 , to be automated for use in a fully or semi-automated process. Push-pull cap may further comprise a 2D barcode, as further describe herein, on a bottom edge of the slide disc  91  (facing up when medication container is inverted for filling operations) or elsewhere on cap  224  to enable easy tracking of the medication container bearing that cap. Alternately, the 2D barcode described herein may be placed on the base of the medication container. 
         [0093]      FIG. 30  illustrates the push and pull-cap  224  of  FIG. 29  wherein the distal end of stationary portion  224 A is made integral with medication container cap  214  by co-molding or like means known in the art. In this embodiment, the threaded portion of cap  214  may be provided in several standard sizes, such as 20 mm, 24 mm, 28 mm, 33 mm, etc., or in sizes which are chosen as a matter of design or operator preference. 
         [0094]      FIGS. 31 and 32  illustrate push-pull cap  224  which is made separate and integral, respectively, with a valveless PIBA cap. Instead of channel  80 , at its end proximate the medication bottle, being sized to fit over a Baxa™ or Baxa™-equivalent manufacturer-supplied medication container cap, it is instead sized to fit within outer wall of stationary portion  224 A, which in turn is sized to fit within the open channel of a PIBA cap as shown. In  FIG. 32 , outer wall of stationary portion  224 A is made integral with the inner channel of a PIBA cap, and/or is fitted with annular elastomeric rings to provide a press fit within the opening of a medication container. 
         [0095]      FIG. 34  depicts a cap  226  comprising nozzle fitted with an integral or separable valve  225  (typically, a duckbill valve, as shown in  FIG. 34 ). The threaded inner wall of cap  226  may be provided in several standard sizes, such as 20 mm, 24 mm, 28 mm, 33 mm, etc., or in sizes which are chosen as a matter of design or operator preference. The outer wall of cap  226  comprises two annular rings defining a groove to accept the fingers of the automated or semi-automated arms of the filling station, as will be described. Grooves provided on the outside of the medication container cap not only fit into the yoke of the syringe filling apparatus and hold the medication bottle securely, but also locate the medication container on a reference center line. Grooves may also serve as a means to handle, move and position the medication container during selection from a medication container library as will be described. 
         [0096]      FIGS. 36-37  depict protective caps for the medication container caps described herein. Each protective cap is designed to fit securely over and cover the nozzle of each of the medication container caps described herein such that the medication container may be inverted without the attached protective cap falling off. For automated or semi-automated systems, as described herein, a separable cap can be used (see  FIGS. 36B and 37B ). For semi-automated systems only, a tethered protective cap may be used (see  FIGS. 36A and 37A ). 
         [0097]    Each adapter cap may be barcoded with a unique identifier number. Where a tethered protective cap is used, the barcode may appear on the protective cap instead of or in addition to on the adapter cap itself. In addition, molded surface features or textures may be provided on the outer surface of each cap to provide a gripping surface. 
         [0098]    In addition, one skilled in the art should understand that the aftermarket valveless cap (e.g., Baxa Adapta-Cap™ bottle adapter) and the adapter  2  as described above and in other embodiments of the present invention may essentially be combined in a single unitary structure. Specifically, the press-on container cap  214  may, if desired, be co-molded with the valve adapter cap  2  to form a unitary adapter cap. In addition, the valve adapter cap  2  may include one or two flanges to enable the container to be mechanically-handled for storage or transport in a fully-automated filling system such as shown and described in Applicant&#39;s co-pending U.S. patent application Ser. No. 13/236,577 filed 19 Sep. 2011. 
         [0099]    A preferred embodiment of the invention is now described with reference to the PIBA with valve interface  212  of  FIG. 5 . Process and system configuration variations specific to each of the container/syringe interfaces are also described below. 
         [0100]    The support fixture illustrated in  FIG. 7A  comprises a fixed-position container holding yoke  82  that engages the container/syringe interface  210 ,  212 ,  214 ,  216  (see  FIG. 5 ) suspending the assembly. Note that the fourteen syringe-filling closure variations containe/syringe interfaces  210 ,  212 ,  214 ,  216 ,  220 ,  221 ,  226 , and the Baxa™-type or PIBA variations for caps  223  and  224 , both integral and separable, suitable for use with the present system necessitate differently sized/shaped container holding yokes  82 , and for this reason yoke  82  may be removably-mounted to filling station  5  by thumb-screws or the like, allowing replacement with different sizes and shapes. For example,  FIG. 7C  I shows a container holding yoke  82 A with aperture configured to seat the protruding stem of an interface  214 ,  216 , while  FIG. 7C  II shows a container holding yoke  82 B with aperture sized to seat the neck of a container in which an interface  210 ,  212  has been inserted. The platform thickness of yoke  82  is also important as valved versus valveless closures may require differing degrees of syringe nozzle insertion and so some yokes  82  may need to be very thin. The operator can choose the appropriately-configured yoke  82 , and in all such cases the yoke  82  facilitates easy frontal insertion of the container/syringe combination and stably supports the container. 
         [0101]      FIG. 7B  is a composite view of a self-centering spring loaded bottle gripper assembly  82 C used as an alternative to fixed yokes  82  of  FIG. 7A . The self-centering spring loaded bottle gripper assembly  82 C of  FIG. 7B  employs a pair of spring-loaded jaws  1002  slidably mounted on a ball-slide track  1003  for slidable separation. A pair of trammel arms  1004  are coupled from each jaw  1002  to a common pivot and thereby maintain symmetry of the jaws  1002  as they separate. The operator rests the container neck onto the lips of jaws  1002  and pushes the container straight back, separating the spring-loaded jaws, until the jaws spring tight about the container and it is gripped. Note that the jaws  1002  are formed to hook around the container and have a lowermost flange to serve as a reference to ensure that all syringes are uniformly located in the vertical dimension. Thus, gripping assembly  82 C is advantageously better able to withstand the shaking cycle and can fit into the limited space available. 
         [0102]    The following table maps the container/syringe interface variations to requisite variations in the filling station  5  ( FIG. 2  III  5 ) and points out the advantages of utilizing the self-sealing valve in the Baxa cap or PIBA for tapered tip syringes (as shown in  FIG. 38 ) and/or the push-pull adapter cap  224  for Luer lock oral syringes (as shown in  FIG. 39 ) according to one or more embodiments of the present invention: 
         [0000]    
       
         
               
               
               
               
               
               
             
               
               
               
               
               
               
             
           
               
                   
               
               
                   
                   
                   
                 Need to invert 
                   
                 Able to fill 
               
               
                   
                   
                 Filling station 
                 container and 
                   
                 multiple syringes 
               
               
                   
                   
                 5 container 
                 syringe 180° 
                   
                 at one time 
               
               
                   
                   
                 neck 
                 and then rotate 
                 Able to 
                 without removing 
               
               
                   
                 Container/Syringe 
                 positioning 
                 180° after 
                 shake at fill 
                 container from fill 
               
               
                 No. 
                 Interface 
                 device 
                 filling syringe? 
                 station? 
                 station? 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                 1 
                 valve-less press in 
                 Yoke 82B 
                 Yes 
                 No 
                 No 
               
               
                   
                 bottle adapter 
                 (FIG. 7C II) 
               
               
                   
                 (PIBA) 
               
               
                 2 
                 self sealing PIBA 
                 Yoke 82B 
                 No 
                 Yes 
                 Yes 
               
               
                   
                 (SSPIBA) with an 
                 (FIG. 7C II) 
               
               
                   
                 integral valve 
                 or self- 
               
               
                   
                   
                 centering jaws 
               
               
                   
                   
                 82C (FIG. 7C 
               
               
                   
                   
                 III) 
               
               
                 3 
                 valveless Baxa ™ 
                 Yoke 82A 
                 Yes 
                 No 
                 No 
               
               
                   
                 or Baxa 
                 (FIG. 7C I) 
               
               
                   
                 equivalent 
               
               
                 4 
                 valved Baxa ™ or 
                 Yoke 82A 
                 No 
                 Yes 
                 Yes 
               
               
                   
                 Baxa equivalent 
                 (FIG. 7C I) or 
               
               
                   
                   
                 self-centering 
               
               
                   
                   
                 jaws 82C 
               
               
                   
                   
                 (FIG. 7C III) 
               
               
                 5 
                 Valved self- 
                 Yoke 82D 
                 No 
                 Yes 
                 Yes 
               
               
                   
                 sealing two-piece 
                 (FIG. 7C IV) 
               
               
                   
                 220 
                 or self- 
               
               
                   
                   
                 centering jaws 
               
               
                   
                   
                 82C (FIG. 7C 
               
               
                   
                   
                 III) 
               
               
                 6 
                 Valved self- 
                 Yoke 82D 
                 No 
                 Yes 
                 Yes 
               
               
                   
                 sealing one-piece 
                 (FIG. 7C IV) 
               
               
                   
                 221 
                 or self- 
               
               
                   
                   
                 centering jaws 
               
               
                   
                   
                 82C (FIG. 7C 
               
               
                   
                   
                 III) 
               
               
                 7 
                 Baxa ™ or Baxa 
                 Yoke 82A 
                 Yes 
                 No 
                 No 
               
               
                   
                 equivalent 
                 (FIG. 7C I) 
               
               
                   
                 modified with 
               
               
                   
                 non-integral 
               
               
                   
                 push-in tip for 
               
               
                   
                 Luer lock oral 
               
               
                   
                 syringes 
               
               
                 8 
                 PIBA modified 
                 Yoke 82B 
                 Yes 
                 No 
                 No 
               
               
                   
                 with non-integral 
                 (FIG. 7C II) 
               
               
                   
                 push-in tip for 
               
               
                   
                 Luer lock oral 
               
               
                   
                 syringes 
               
               
                 9 
                 Baxa ™ or Baxa 
                 Yoke 82A 
                 No 
                 Yes 
                 Yes 
               
               
                   
                 equivalent 
                 with grooved 
               
               
                   
                 modified with 
                 block 400 
               
               
                   
                 non-integral 
                 (FIG. 41) 
               
               
                   
                 push-pull cap 
               
               
                 10 
                 Baxa ™ or Baxa 
                 Yoke 82A 
                 No 
                 Yes 
                 Yes 
               
               
                   
                 equivalent with 
                 with grooved 
               
               
                   
                 integral push-pull 
                 block 400 
               
               
                   
                 cap 
                 (FIG. 41) 
               
               
                 11 
                 PIBA modified 
                 Yoke 82B 
                 No 
                 Yes 
                 Yes 
               
               
                   
                 with non-integral 
                 with grooved 
               
               
                   
                 push-pull cap 
                 block 400 
               
               
                   
                   
                 (FIG. 41) 
               
               
                 12 
                 PIBA with 
                 Yoke 82B 
                 No 
                 Yes 
                 Yes 
               
               
                   
                 integral push-pull 
                 with grooved 
               
               
                   
                 cap 
                 block 400 
               
               
                   
                   
                 (FIG. 41) 
               
               
                 13 
                 Valved common 
                 (Not shown) 
                 No 
                 Yes 
                 Yes 
               
               
                   
                 inner diameter 
               
               
                   
                 cap with grooved 
               
               
                   
                 rings 
               
               
                 14 
                 PIBA retrofit with 
                 Yoke 82B 
                 No 
                 Yes 
                 Yes 
               
               
                   
                 integral valve 
                 (FIG. 7C II) 
               
               
                   
                   
                 or self- 
               
               
                   
                   
                 centering jaws 
               
               
                   
                   
                 82C (FIG. 7C III) 
               
               
                   
               
             
          
         
       
     
         [0103]    With reference to  FIGS. 7A and 7D , upper, middle, and lower syringe gripping arms  110 ,  111   i  and  112  are staged in a vertical orientation that will allow the selected syringe S to be easily slid into the fill zone, with plunger lifting arm  128  fully retracted. As different syringe sizes have different exterior dimensions, the vertical orientation of syringe gripping arms  110 ,  111  and  112  may be adjusted prior to syringe insertion to ensure that the syringe body can easily fit between the medication container and middle arm  111 , which, as will be described, rests below the hilt or flange of the syringe. The syringe S is connected to the medication container and both are held by yoke  82 . Once the medicine container and syringe S are in place, and the start button is pressed, a guard is closed around the filling station, or by some other signal from the processor, a pair of syringe finger grippers  78  close about the syringe S and hold it securely. Syringe finger grippers  78  are air operated for opening and closing, or may optionally be servo-driven, and have a servo-operated mount which moves the fingers to the center of the body of the syringe. This feature advantageously ensures that the syringe tip is exactly on center with the yoke, as syringe tip to body eccentricity varies on syringes sized from 10 mL to 60 mL. For syringe sizes between 0 mL and 60 mL, the tip of the syringe is eccentric to the body diameter, whereas on syringe sizes from 0.5 mL to 5 mL, the tip is concentric on the body diameter. The in and out motion of the servo mount locates the grippers  78  to grip the center of the syringe body so that the center of the tip is always on center with the yoke, regardless of its eccentricity to the body of the syringe. Additionally, a bottle holder platform  79  lowers to sandwich the medicine container against the container holding yoke  82 . The bottle holder platform  79  has an aperture  791  through it and a scanner  121  is mounted above the aperture  791  to read the machine readable label on the bottom of the container  104 . 
         [0104]    An articulating syringe locator guide  81  ( FIG. 7A ) comprises a pair of offset fingers on a bracket that push against syringe finger flanges, effectively rotating the syringe to a known orientation. This ensures that all offset-tip syringes (nozzle offset from center axis) are in proper orientation for filling. One skilled in the art should understand that the syringe locator collar  81  is not required for concentric tipped syringes and may be articulated out of the way. 
         [0105]    Once in the fill position in loading station  70  with syringe finger grippers  78  closed around it, the syringe S is engaged by the upper  110 , middle  111  and lower  112  arms, and a plunger lifting arm  128  that extends upward from below, all of which collectively grip and operate the syringe S in order to effectuate the filling process as described below. 
         [0106]    The syringe locator guide  81  withdraws to its home position. Upper arm  110  lowers and middle arm  111  raises to close on the syringe body hilt or flange (see  FIG. 19  for detailed view). This creates a sandwiching effect to hold the body of syringe S securely. Lower arm  112  then moves downward onto the upper side of the syringe plunger disc and plunger lifting arm  128  rises to a position just under the syringe plunger, thus working in concert with lower arm  112  to create a sandwiching effect on the syringe plunger disc captured between them. Upon command from the operator or programmer, arm  112  and arm  128  work in concert to perform priming and/or filling of the syringe S. The use of both arm  112  and arm  128  allow the filling station to exert both a pushing and a pulling effect on the syringe plunger as the program dictates, thus allowing better control of the plunger location during both priming and filling. Upper and middle arms  110  and  111  may also work in concert to push syringe S further upward towards the medication container as necessary to ensure that the closure of the medication container hasn&#39;t relaxed its fit with the tip of syringe S. The priming sequence is determined by syringe size and viscosity of medicine to be filled. After priming is complete and with the piston all the way up, the piston is then pulled downward to fill with the correct dose. 
         [0107]    As described in more detail below, in a preferred embodiment, arms  110 ,  111 ,  112  ( FIG. 26 ) protrude vertically from the horizontal base of the filling station  5  ( FIG. 2 ), at which point they are sealed with waterproof bushings, and terminate with at least one horizontally-oriented curvilinear jaw. The watertight seal between the vertically oriented syringe filling arms  110 ,  111 ,  112  and the horizontal base of the filling station  5  advantageously prevents liquids (such as medication from medication container  4 ) from being able to inter the interior of filling station  5 . This curvilinear embodiment is thus preferred over the herein described horizontal arms having straight fingers wherein the horizontal arms  110 ,  111  and  112  must articulate vertically through one or more open vertical slots in the vertical back of filling station  5  (see  FIG. 7A ). The watertight seal and vertical orientation of curvilinear arms  110 ,  111 ,  112  is accomplished via the horizontally-oriented curvilinear jaw, which is able to grip various portions of the syringe S through a rotational motion of syringe gripping arms  110 ,  111 ,  112  and withdraw the plunger of the syringe S with vertical motion of syringe gripping arms  10 ,  111 ,  112 . 
         [0108]    As stated in the foregoing Table the yoke  82  will vary depending on the syringe interface variation. Specifically, the OEM/Baxa cap  214  will require yoke  82 A ( FIG. 7C  I), the OEM/Baxa cap with self-sealing valve  216  will require Yoke  82 A ( FIG. 7C  I), the valveless PIBA  210  will require yoke  82 B ( FIG. 7C  II), the PIBA with self sealing valve  212  will require the adjustable clamping device  82 C ( FIG. 7C  III), the Luer-type syringe adapter tip  223  will require the adjustable clamping device  82 C ( FIG. 7C  III) or yoke  82 A ( FIG. 7C  I), push-pull cap  224  and the threaded cap with automation grooves and valve will both require the adjustable clamping device  82 C ( FIG. 7C  III). 
         [0109]    The invention relies on a conventional network architecture which includes a local OSPS (Oral Syringe Packaging System) computer. The OSPS computer is interfaced to a hospital host computer and receives oral syringe prescription instructions therefrom (however, the OSPS system may be used as a stand-alone unit independent of any interface with another computer). In the majority of circumstances, physicians submit prescriptions for oral syringes electronically to the hospital host computer and these prescriptions are communicated to the OSPS computer for fulfillment. The interface serves to parse/extract those oral medication prescriptions from all prescriptions submitted. 
         [0110]    The local OSPS computer is programmed to know what must occur at each station and monitors to ensure that each step of the process is completed satisfactorily and that all decision rules are complied with. The local OSPS computer software implements a Medication Container Orientation and Log-In Process for semi-automated preparation and storage of bulk medicine containers to be used in filling and packaging oral syringes, and a Batch Fulfillment Process for semi-automated filling and packaging of oral syringes using the stored bulk medicine containers. In general terms, the semi-automated Medication Container Orientation and Log-In Process comprises the following steps: 
         [0111]    a. Pharmacy technician (operator) removes the manufacturer&#39;s cap from the bulk medicine container received from the pharmaceutical manufacturer and installs one of several possible container/syringe interface variations (as described above and below), in all such cases facilitating insertion of an oral syringe nozzle into the container. The present system is adaptable to filling syringes with each interface variation. The system may include an optional motorized capper/decapper station to assist with the removal of the manufacturer&#39;s cap and the application of a threaded or PIBA interface. 
         [0112]    b. Variable information such as container fill size, manufacturer&#39;s expiration date, and product lot number are entered into the OSPS computer automatically as much as possible by bar code scan, or manually by the Pharmacy Technician under the supervision of the Pharmacist. First, the software guides the operator to scan the manufacturer&#39;s barcode label. However, the barcoded information is often incomplete. Any missing variable information such as container fill size, manufacturer&#39;s expiration date, and product lot number can be derived and manually entered into the OSPS computer by the Pharmacy Technician. 
         [0113]    c. If needed, the OSPS computer instructs the Pharmacy Technician which of the container/syringe interfaces to select for recapping the medication container. The OSPS obtains this information from the medication database. In addition, the OSPS may direct the storage location of the correct size container/syringe interface to illuminate, unlock, or the like, as described in further detail below. 
         [0114]    d. The OSPS computer auto-assigns an expiration date to the medication container based on either the manufacturer&#39;s expiration date or the expiration date defined by pharmacy policy. The pharmacy expiration date policy is determined by the date the container is opened at the medication container log in station plus the number of days the Pharmacist determines that the medication should expire. The OSPS computer uses the date that is the soonest to determine the effective medication container expiration date. 
         [0115]    e. Software automatically prints a new unique 2D barcode label. 
         [0116]    f. The 2D barcode label is placed on the center of the base of the container. 
         [0117]    g. Software guides the operator to rescan the manufacturer&#39;s barcode on the container label and the 2D barcode on the base of the container. 
         [0118]    h. If scanning checks, the software guides the operator to place the medication container in a particular (logged) storage facility location. 
         [0119]    The semi-automated Batch Fulfillment Process for any of the self-sealing caps described herein comprises the following steps: 
         [0120]    a. The software guides the operator to retrieve the medication container from a particular (logged) storage facility location (the medication container may previously be logged according to the method described herein with respect to the Medication Container Orientation and Login Station). 
         [0121]    b. The operator loads the medication container into the fill station. 
         [0122]    c. The 2D barcode on the medicine container bottom is scanned to make sure that all medication issues relating to that medicine container have been addressed, including correct medication, refrigeration, expiration and light-sensitive storage. 
         [0123]    d. The software guides the operator to pick a syringe of the proper color and size. 
         [0124]    e. The operator places the syringe in a syringe size/color station that verifies that the proper size and color syringe has been selected. 
         [0125]    f. If the syringe size/color inspection passes, the software automatically prints a label for the syringe, and the operator manually applies the label to the syringe. Alternatively, a semiautomatic flag labeler may be used, as described in more detail below. 
         [0126]    g. The label is rescanned to ensure that the information is readable and correct. 
         [0127]    h. The operator scans the 2D barcode on the syringe at the filling station. 
         [0128]    i. If needed, the medication container is shaken for the duration, intensity and interval(s) required by the shaking mechanism to which the container is attached. 
         [0129]    j. The operator positions the syringe at the filling station. 
         [0130]    k. The system/software automatically fills the syringe from medicine in medication container as described in more detail above and below. 
         [0131]    l. The operator caps filled syringe at optional semi-automatic capper. 
         [0132]    m. The operator scans the syringe at the optional fill inspection station. 
         [0133]    n. The system automatically inspects the syringe at an optional visual inspection station for proper weight and/or volume. 
         [0134]    o. The operator scans the syringe at the bagging station. 
         [0135]    p. The system/software automatically prints bag that the syringe will be packaged in. 
         [0136]    q. The software automatically scans the printing on the bag to make sure that it is correct. 
         [0137]    r. The operator places the syringe in the bag at the bagging station, and the system confirms that the syringe was placed in the bag and seals the bag with the syringe in it. 
         [0138]    All medication containers and medicines in those containers that have been logged in, each size syringe, each size container/syringe interface, the syringe labels, syringe bags, print media, etc. are automatically inventoried. As an item is used or consumed, an accounting of the amount of that item remaining is maintained. 
         [0139]    Via the 2D barcodes on each syringe and medication container and the scanning operations at each station, Track, Trace and Validation software monitors and documents the entire process from the prescription approval by the pharmacist, log-in of the medication container through each step of the packaging process to ensure that the syringe is filled and packaged correctly. The Track, Trace and Validation software also tracks the operation of the equipment used in the process to ensure that each piece of equipment is functioning properly, and provides error messages when any piece of equipment malfunctions. This aspect of the invention further results in the formation of an “audit” record of all machinery involved in the processes so that an operator, pharmacist, or technician may review a log of the machinery&#39;s operations to perform troubleshooting and/or quality checks. 
         [0140]      FIG. 1  is a high level flow chart of the overall method of the invention. The following method steps are performed semi-automatically with some manual intervention by or interaction with an operator for filling patient-specific oral syringes on a just-in-time basis. Note that “semi-automatic” necessarily entails manual intervention/interaction which has a propensity for introducing mistakes. The present method and apparatus is specifically designed to avoid mistakes and maintains comprehensive track-and-trace validation of each manual step: 
         [0141]    At step  705  a physician writes an oral medicine prescription which is electronically entered into existing hospital host computer (as all prescriptions are so logged). 
         [0142]    At step  710  the existing hospital host computer communicates the oral medicine prescription to the hospital pharmacy for approval. A pharmacist will typically review it. 
         [0143]    If approved by the pharmacist, then at step  715  the prescription is transmitted the local computer of the OSPS (Oral Syringe Packaging System) of the present invention. The oral syringe prescription is added to a batch fulfillment queue at the local OSPS computer. As described below the queue is multi-sorted so that all prescriptions for a particular type of medicine (e.g., Acetaminophen, cough syrup, etc.) can be fulfilled together, and at periods throughout the day an operator may run a batch fulfillment queue (typically batches are run a few times each day). 
         [0144]    At commencement of batch fulfillment, the OSPS system preferably guides the operator in retrieving the appropriate medication container from OSPS storage (as will be described). Such guidance presupposes that a library of medicine containers is maintained and that each such medicine container be logged into the OSPS system so that its location and contents are known to the local OSPS computer. Consequently, as a precursor to batch fulfillment each new medication container is logged into OSPS storage by a barcode, RFID scan or similar identification scan (e.g., of the manufacturer&#39;s barcode) as described above. The manufacturer-supplied medicine container cap must be replaced, retrofit, or supplied by the manufacturer in a form that enables an oral syringe to enter a center hole and withdraw an amount of liquid from the medication container while the medication container is positioned upside down, and the syringe S then removed from the container without leaking. There are fourteen container/syringe interface variations suitable for use with the present system (see  FIGS. 5, 27-34 and 44  and the detailed descriptions associated with them). All this occurs at step  720  ( FIG. 1 ). 
         [0145]    At step  725 , based on the medication container login, the OSPS system guides the operator in properly storing the new medication container. The OSPS system (as described below) includes separate storage locations for three types of medication containers: Location  1 —No Special Handling of container; Location  2 —Refrigeration Required; Location  3 —Light Sensitive medication container (refer to  FIG. 2  II, refs a-c). Each storage compartment within each location may be enclosed by a magnetically-actuable door so that access to each location may be electronically controlled by the local OSPS computer. Alternately, each storage compartment within each location may be illuminated by an LED light, so that access to the proper location may be electronically guided by illumination of the proper LED. As another alternative, each storage compartment within each location may be equipped with a light curtain so that the local OSPS computer can monitor access to the proper location. All these and other suitable forms of user-guidance/selection are considered to be within the scope and spirit of the present invention. In all such cases, the end result is an OSPS storage library of different oral medicines in their bulk containers, each properly logged in and stored in its corresponding storage location a-c. 
         [0146]    Similarly, at step  740  an inventory of packaging materials is maintained, including empty syringes in an array of sizes, syringe caps, labels (for barcodes), and ink foil printer ribbon. 
         [0147]    In support of the OSPS system, at step  730  a comprehensive medication database is maintained at the OSPS computer. The OSPS medication database includes the following: 
       1. Medication Information: 
       [0000]    
       
         
           
             a. Medication name. 
             b. Manufacturers barcode number. 
             c. Written information that corresponds to manufacturer&#39;s barcode number. 
             d. Whether medication needs to be shaken, if so, the frequency, intensity, and duration. 
             e. Whether the medication needs to be refrigerated, if so refrigeration policy required. 
             f. Whether the medication is light sensitive, if so light sensitive protection required.
 
2. Product information (pertaining to individualized medication containers logged in):
 
             a. The OSPS 2D barcode number assigned to that specific container. The label containing this information is placed on the base of the container. 
             b. Fill size of that container in cubic centimeters (cc) or milliliters (ml). 
             c. Current amount of product remaining in that container after deducting for previous fills extracted by the syringes. 
             d. Manufacturer&#39;s Expiration Date. 
             e. Date the medication container is logged-in at the Medication Container Log-In Orientation System. 
             f. Pharmacy Policy Expiration Date. This is the container open date plus number of days before container expires (determined by pharmacist). 
             g. Effective Expiration Date. This is the soonest of the manufacturer&#39;s expiration date or the date that the container is open plus the number of days that the open container will expire (i.e., Pharmacy Policy Expiration Date). 
           
         
       
     
         [0161]    Given all of the foregoing, at step  750  an operator may at any convenient time commence the batch fulfillment process. The detailed substeps of the batch fulfillment process  750  are described below and illustrated in the block diagram of  FIG. 3 . 
         [0162]    Referring back to  FIG. 1 , after each oral syringe has been filled and packaged during batch fulfillment  750 , it is inspected and either rejected at step  760  or approved at step  770 . 
         [0163]    The above-described method is herein implemented in several detailed embodiments of a system suitable for preparing patient-specific oral syringe doses. Various alternate embodiments of the invention may omit selected steps (and their performance station) where such is/are not required. The needs of the operating institution and the cost aspect of automating certain steps may direct which steps/stations (if any) are to be performed manually by an operator interfacing with the apparatus and which may be automated. 
         [0164]    A presently-preferred embodiment of the physical system componentry is described below with reference to  FIG. 2 . 
         [0165]    As seen in  FIG. 2 , the pharmacy automation system  100  for packaging oral syringes generally comprises a standalone Medication Container Login &amp; Orientation Station  11 , with an included array of container/syringe interface storage bins  12 . In addition, a proximate or remote Storage Facility II is provided for storing all logged in medication containers, with separate locations for the three types of medication containers: (a) Location  1 —No Special Handling of container; (b) Location  2 —Refrigeration Required; (c) Location  3 —Light Sensitive medication container. The final component of the system includes the syringe packaging line III. 
         [0166]    In an alternate embodiment of the present invention, Storage Facility II of  FIG. 2  may be substituted with an automated medication storage cabinet (AMSC) with rotary shelves, such as the commercially available MedCarousel® sold by McKesson Automation Solutions, or similar models sold by TALYST, OMNICELL, SAPIENT AND US MEZZANINES, AMSC units such as these are currently being utilized in hospital pharmacies. These systems automate the medication management process from ordering the medication, stocking the medication on the system&#39;s rotating shelves, and presenting the medication to the pharmacy technician at the time the medication needs to be utilized to fill the prescription on the OSPS. Therefore, the accuracy and efficiency of medication dispensing and inventory management is increased. Aided by rotating shelves, pick to-light, bar code scanning and comprehensive integrated workflow software, the AMSC systems guide the pharmacist to medication storage locations, improving picking speed and accuracy. AMSC systems such as the MedCarousel® can handle storage of refrigerated as well as non-refrigerated medicines. 
         [0167]    In conjunction with the OSPS, an AMSC system would operate as follows:
       1. Two AMSC systems would be utilized, one for non-refrigerated medications and the other for refrigerated medications. The containers that require light protection would be stored on the non-refrigerated AMSC system.   2. After the medication container was oriented and logged in to the OSPS, the AMSC would assign a location to store that medication.   3. The 2D bar code on the container would be scanned.   4. The shelf that the medication was to be stored on would be positioned in front of the pharmacy technician. A light would appear over the location on the shelf on which the medication was to be stored.   5. The pharmacy technician would place the medication at that location.   6. At the start of the next OSPS production run, the OSPS would list the prescriptions to be filled by medication. This information would be sent to the AMSC(s).   7. The pharmacy technician would then remove the medication containers that are presented and scan them. The medication containers would be kept in the same order in which they are removed by the technician. This order corresponds to the order in which the medication will be used to fill syringes on the OSPS.   8. After the production run, the medication containers would be returned to the AMSC(s) in the same order in which they were removed therefrom. The pharmacy technician would scan the medication containers. The AMSC(s) would present the pharmacy technician with the proper shelf and light the position to which the medication container should be returned. The pharmacy technician would return the medication container to the indicated location in the AMSC(s).       
 
         [0176]    A syringe storage bin  3  (see  FIG. 2  III) is provided for storage of empty syringes, and a syringe label printer and labeler station  4  (see  FIG. 2  III) is also provided. Next, a syringe size/color inspection station  11  is provided. These are followed by a syringe filling station  5  with integrated medication container shaker assembly  820  (as described below). An alternative embodiment is a stand-alone shaking station. 
         [0177]    At the filling station  5  the medication container with container/syringe interface  212  or  216  (see  FIG. 5 ) is manually inverted and inserted. An overhead clamp lowers against the topside base of the medicine container to clamp the container against its holder. This provides an opportunity to inspect the medication container&#39;s 2D barcode (located in the center of the container&#39;s bottom) via the Lexan™ disc found in platform  79  (see  FIG. 7A ) to verify that it is the correct medication. The medication container is shaken if necessary. The syringe&#39;s 2D barcode is inspected and, if correct, the syringe is inserted into the medication container via the container/syringe interface. A plurality of servo-driven fingers (to be described) grip and stabilize the syringe S. The fingers manipulate the syringe plunger to prime and fill the syringe. When all syringes have been filled with the medication, the medication container is returned to storage. This process continues until all syringes for that prescription production run have been filled. 
         [0178]    Next, a semi-automated capping station  8  is used to place a cap (fed from an inclined capping chute  149 ) on the open tip of the filled syringe. 
         [0179]    After each syringe S is filled and capped it is loaded into a vision inspection station  9  which verifies the presence of the cap, the piston position within the syringe, that the syringe is filled with medication, and that an excessive number of air bubbles are not present. 
         [0180]    Lastly a bag printing and sealing station  7  bags the filled syringe in a barcoded bag. 
         [0181]    The purpose and function of each of the foregoing stations  1 - 5 ,  7 - 9 , and  11  (see  FIG. 2  I, II, III) will become clearer in the context of a detailed description of the Medication Container Orientation and Log-In Process (step  720 ), and Batch Fulfillment Process (step  750 ). 
         [0000]    Medication Container Orientation and Log-in Process (step  720 ) 
         [0182]    The OSPS system guides the operator in properly equipping and storing each bulk medication container. As described above, the manufacturer-supplied medicine container cap must be replaced, retrofit, or supplied by the manufacturer in a form that enables an oral syringe to enter a center hole and withdraw an amount of liquid from the medication container while the medication container is positioned upside down, and the syringe S then removed from the container without leaking. Thus, at step  720  ( FIG. 1 ) the manufacturer-supplied medicine container cap may need to be provided to specification, or replaced or retrofitted with a container/syringe interface to provide a penetrable orifice. As described more fully below the retrofit may be accomplished in a number of ways. Thus, the present invention contemplates fourteen (14) container/syringe interface variations: (1) a valve-less press in bottle adapter (PIBA)  210 ; (2) a self sealing PIBA (SSPIBA)  212  with an integral valve (typically, either a linear or a Z-shaped slit)  213 ; (3) a standard manufacturer-supplied (Baxa™ or Baxa equivalent) valve-less medicine container cap  214  with opening; (4) a modified manufacturer-supplied (Baxa™ or Baxa equivalent) medicine container cap  216  that is retrofit to include an integral valve  225  (typically, a duckbill valve); (5) a two-piece cap comprising an outer portion  220  with a common outer diameter for all standard sizes of medication container, and a self-sealing insert  212 ; (6) a cap  221  comprising a common outer diameter for all standard sizes of medication container and having an integral self-sealing insert  212 ; (7) a modified manufacturer-supplied (Baxa™ or Baxa equivalent) medicine container cap  214  that is retrofit to include a non-integral push-in tip  223  for interfacing with Luer lock oral syringes; (8) a modified PIBA  210  that is retrofit to include a non-integral push-in tip  223  for interfacing with Luer lock oral syringes; (9) a modified manufacturer-supplied (Baxa™ or Baxa equivalent) medicine container cap  214  that is fitted with a push-pull cap  224  for interfacing with Luer lock oral syringes; (10) a modified manufacturer-supplied (Baxa™ or Baxa equivalent) medicine container cap  214  that is retrofit with an integral push-pull cap  224  for interfacing with Luer lock oral syringes; (11) a modified PIBA  210  that is fitted with a push-pull cap  224  for interfacing with Luer lock oral syringes; (12) a modified PIBA  210  that is retrofit with an integral push-pull cap  224  for interfacing with Luer lock oral syringes; (13) a cap  226  comprising a common inner diameter for all standard sizes of medication container, fitted with an integral or separable valve  225  (typically, a duckbill valve), and having grooved rings to facilitate handling, positioning, etc. by the system according to the present invention; and/or (14) a valveless PIBA that is retrofit to include an integral valve  225  (typically, a duckbill valve). Again, all fourteen variations as shown in  FIGS. 5, 27-32 and 34  and  44  are described below in detail above. 
         [0183]    It is envisioned that medication containers may be provided to the hospital pharmacy for use with the present system in such a way that will minimize or possibly eliminate any need for the Medication Container Orientation and Log-In Process (step  720 ). For example, medication containers may be provided for use with one or more of the following features:
       1) standardized caps with self-sealing valve (such as, for example, the above-referenced Baxa™ or Baxa-equivalent medicine container cap with penetrable opening);   2) standardized containers;   3) barcoded or RFID-coded containers that already contain the information that a pharmacy technician would otherwise need to input during the Medication Container Orientation and Log-In Process (step  720 ); and/or   4) any other means of providing the information that a pharmacy technician would otherwise need to input during the Medication Container Orientation and Log-In Process to the OSPS database and system, such as, i.e., via the Internet.       
 
         [0188]    A combination of all three features listed above would minimize or eliminate the need for the Medication Container Orientation and Log-In Process (step  720 ). However, for purposes of complete description it will be assumed that such features are lacking in OEM-supplied medication containers and so the Medication Container Orientation and Log-In Process (step  720 ) will herein be described in detail. 
         [0189]    Referring now to  FIG. 4  which is a flow diagram of the Log-In process for the valved PIBA  212  (see  FIG. 5 ), at step  900 , medication containers are received from a contract packager or pharmaceutical manufacturer. 
         [0190]    At step  910 , medication containers are delivered to the OSPS Medication Container Login &amp; Orientation Station  1  ( FIG. 2 ). 
         [0191]    At step  915  the pharmacist and operator logs into the local OSPS computer. 
         [0192]    At step  925  the manufacturer-provided medication container barcode is scanned. Variable information is entered into the system by the pharmacy technician. 
         [0193]    At step  935 , the labeler shown at the Medication Container Login &amp; Orientation Station  1  (see  FIG. 2  I) generates a 2D barcode label which includes the location that the medication container is to be stored at. The 2D bar code is manually placed on the bottom of the container (or on the container/syringe interface) at step  945 . 
         [0194]    At step  940 , the bar code label is automatically scanned/inspected immediately after printing to verify that its contents are correct and the bar code ID is stored in the OSPS database. 
         [0195]    At step  945 , the bar code label is adhered to the base (bottom) of the container. 
         [0196]    At step  950 , both the 2D bar code placed on the base of the container and the pharmaceutical manufacturer&#39;s barcode are scanned using a scanner resident at the Medication Container Login &amp; Orientation Station  1  and the manufacturer&#39;s bar code on the medication container label are scanned to verify that the correct 2D bar code was placed on the base of the container. 
         [0197]    At step  955  all general and container specific information, inclusive of Product Information and label photograph, is recorded in the local OSPS computer database, including the storage location of the bulk container. 
         [0198]    At step  960 , the OSPS local computer assigns an expiration date to the medication container. The expiration date is predetermined by pharmacy policy. The pharmacy policy expiration date is determined by the date the container is opened at the Medication Container Log In Station  1  plus some number of days after which the Pharmacist determines that the medication should expire. 
         [0199]    At step  961 , the medication container cap is removed from the container by the operator and is set aside for later reuse. 
         [0200]    At step  962 , the OSPS local computer instructs the pharmacy technician regarding which size adapter cap to obtain and insert into the container neck. To guide the operator, the box  12  containing the correct size adapter cap is preferably illuminated as shown in  FIG. 2 . 
         [0201]    At step  963 , the pharmacy technician inserts the adapter cap onto the medication container. In some embodiments, the original medication container cap from step  961  may be replaced on the medication container. 
         [0202]    At step  965 , the operator manually stores the medication container in the location specified by the OSPS local computer (see  FIG. 2  II). 
         [0203]    At step  970  if the container is to be stored in the refrigerator, an optional log-in/log-out control system and procedure is available to verify if the container was refrigerated satisfactorily (see  FIG. 2  II b). This way, if the container is outside of the refrigerated storage area more than a specific number of minutes the OSPS local computer will not permit the syringe to be filled from that container, and will alert the Pharmacy Technician to remove and discard that container. 
         [0204]    At step  975  if the container is to be stored in a light protected storage area, an optional log-in/log-out control system and procedure is available to verify if the container was stored appropriately (see  FIG. 2  II c). This way, if the container is outside of the light protected storage area more than a specific number of minutes the OSPS local computer will not permit the syringe to be filled from that container, and will alert the Pharmacy Technician to remove and discard that container. 
       Batch Fulfillment Process  750  (FIGS.  1 - 3 ) 
       [0205]    With reference both to  FIGS. 2-3 , at step  800  a pharmacist must log into the OSPS local computer to use the system. 
         [0206]    At step  810 , the pharmacist selects the desired OSPS operational mode. Currently four modes of operation are envisioned: 
         [0207]    1. Patient Specific—Hospital Directed
       a. The Doctor writes the prescription and enters it into the Hospital Host Computer System.   b. The prescription is reviewed by the Pharmacist. If it is okay, the prescription is sent to the Local OSPS Computer where it is batched. Batches will typically be run 2-3 times a day.   c. The Local OSPS Computer first sorts all the batched prescriptions by type of medication. The order of the queue may be in the discretion of the pharmacist (i.e., alphabetically by medication name).   d. The prescriptions are then sorted by size of fill from smallest to largest. The total amount of each medication required for that batch run is totaled. The Local OSPS Computer checks to ensure that there is a sufficient amount of product for each medication required to complete the batch.   e. If a doctor orders, for a single patient, multiple same doses of the same medication to be administered at different times, all doses can be filled together during a single production run or in separate production runs at the discretion of the Pharmacist. In a preferred embodiment, all prescriptions for one medication are filled at the same time, followed by all prescriptions for the next medication, etc.       
 
         [0213]    2. STAT (Rush Order)—Hospital Directed
       a. The Doctor writes the prescription and enters it into the Hospital Host Computer System.   b. The prescription is reviewed by the Pharmacist.   c. The prescription order indicates that the prescription needs to be administered soon to the patient.   d. If the OSPS System  100  is currently being used, the Pharmacist can decide to either stop all current prescriptions being packaged or wait until completion. Either way, the Local OSPS Computer processes the singular rush order.       
 
         [0218]    3. Medication Specific—Pharmacy Directed
       a. This mode allows production-scale filling of a large number of syringes with the same medicine and the same fill volume. Some medication will need to be inventoried in advance of the Doctor&#39;s prescription. This mode provides the pharmacist with the opportunity to package certain liquid oral products such as vitamins and popular standard dose medications on a more cost-effective basis than buying them already pre-packaged,   b. The Pharmacist will manually enter in a production order for the medication into the Local OSPS Computer.   c. The Pharmacist will specify the medication name, size of fill, the information that will go onto the syringe label, the information that will go onto the bag that the syringe is packaged in, and the amount of syringes that are to be packaged for that production run.       
 
         [0222]    4. Manual—Pharmacy Directed
       a. Not all hospitals have an existing electronic prescription system installed that permits the electronic transmission of the Doctor&#39;s prescription to the hospital pharmacy. Consequently, the OSPS can be operated on a manual basis whereby the prescriptions are entered into the system under the Pharmacist&#39;s supervision.       
 
         [0224]    One skilled in the art should understand that other operational modes are possible, for example, a Patient Priority mode in which all medications/oral prescriptions for a specific patient are processed sequentially before moving on to the next patient. The invention is herein described in the context of Patient Specific—Hospital Directed Mode which is the most typical mode of operation. 
         [0225]    At step  811 , by way of example, Patient Specific—Hospital Directed is selected and the process is herein described accordingly. 
         [0226]    At step  815  an operator (pharmacy technician) logs in. 
         [0227]    At step  820  the OSPS local computer directs the operator to select the appropriate medicine container from Storage Facility  2  (see  FIG. 2  II), and an appropriate syringe from storage bin  3  ( FIG. 2  III). 
         [0228]    At step  825 , the operator retrieves the appropriate medicine container from Storage Facility  2  (see  FIG. 2  II) (under system guidance) and inverts and installs it at the syringe filling station  5  (see  FIG. 2  III). 
         [0229]    At step  826 , the barcode on the bottom of the container is scanned to make sure that all medication-related issues have been satisfied (refrigeration, shaking, light-sensitive storage, expiration, etc.). 
         [0230]    At step  830 , the pharmacy technician places the syringe S on the inspection station cradle (see  FIG. 2 , ref.  11 ). Alternatively, the inspection station may be omitted and the syringe may be inspected at the labeling station  4 . 
         [0231]    At step  835 , the system automatically inspects the syringe for proper size based on a syringe body measurement (described below), to verify that the correct syringe has been selected. Proper color of color-coded syringes is also verified. 
         [0232]    At step  837 , the operator prints a syringe label at syringe label printer and labeler station  4  indicating in both human and machine readable forms (i.e. text, barcode or RFID tag) the type, concentration, expiration, etc. of the medication it will contain. The label includes a bar code (preferably a 2D barcode though other labels such as RFID may be used. The label is adhered to the syringe barrel. Alternatively, a semi-automatic flag labeler is used as described below. 
         [0233]    After printing the label per step  837 , at step  838  the label is inspected to ensure that its content is correct. 
         [0234]    At step  839 , the label is affixed to the syringe S (where a semi-automatic flag labeler is used, the flag is adhered to the syringe S automatically by the labeler). 
         [0235]    At step  840 , the operator manually places the syringe at the syringe filling station  5  ( FIG. 2 ). 
         [0236]    At step  841  (if required), the shaking mechanism  820  ( FIG. 2  III) shakes the medication container before any medication is drawn from it into the syringe. 
         [0237]    At step  845 , the syringe is filled at the filling station  5 . The OSPS system automatically primes and fills the syringe with the medicine by insertion and withdrawal of the plunger. 
         [0238]    At step  848 , the syringe is capped at the semi-automatic capping station  8 . The capping station caps the syringe and presents it to the operator. 
         [0239]    At step  850 , the operator positions the filled syringe S at the vision inspection station  9  ( FIG. 2 , III) and at step  855  the syringe is inspected for correct vision metrics. These actions are logged. 
         [0240]    At step  860  a syringe bag is printed/barcoded at bag printing and sealing station  7  ( FIG. 2 , III), and at step  861  the system verifies the bag is printed correctly. If so, the operator is permitted to insert the filled/capped syringe S into the barcoded/labeled bag. 
         [0241]    At step  865  the pharmacy technician inserts the syringe S into the bag ( FIG. 2 , III). 
         [0242]    At step  870  the syringe bag is sealed at the bag printing/sealing station  7 . The packaged syringe can then be distributed to the patient. 
         [0243]    As mentioned at Note  1  ( FIG. 3 ), at each step of the above-described process the OSPS system employs comprehensive track-and-trace inspection/validation of the syringe and, when required, the bulk medication container, to insure that the packaging process is occurring correctly and to compile an audit trail of the current and past locations (and other information) for each syringe. If all process steps  800 - 870  occur correctly, the syringe S is approved and made available for distribution to the patient (see  FIG. 1 , step  770 ). 
         [0244]    If a process step fails then as seen at step  760  of  FIG. 1  the syringe or medicine container is rejected (and barred from distribution to the patient). 
         [0245]    The core method and possible variations are herein implemented in several detailed embodiments of a system suitable for preparing patient-specific doses of liquid medications into oral syringes on a just-in-time basis. Various alternate embodiments of the invention may omit selected steps (and their performance station) where such is/are not required. The needs of the operating institution and the cost aspect of automating certain steps may direct which steps/stations (if any) are to be performed manually by an operator interfacing with the apparatus and which may be automated. For example, the syringe S handling can be accomplished in numerous ways, the simplest option being described above in regard to  FIGS. 2-3 . In this instance, one operator packages one syringe at a time sequentially from syringe selection through bagging that syringe S until each of the syringes S that need to be filled with a specific medication are packaged (see  FIG. 2 ). However, several syringe handling variations are given below. 
       Alternative Syringe Handling Options 
       [0246]    As mentioned above the handling of the syringes S on the packaging line can be accomplished in numerous ways, the simplest option (Option 1) being described above with regard to  FIG. 3 . However, productivity of the packaging line can be increased using other syringe handling variations. Some of the alternate syringe handling options are as follows: 
         [0247]    Option 2—Similar to Option 1 but two operators process/package some or all of the syringes S at one time as a group, at each of three grouped stations, wherein a first operator processes/packages some or all of the syringes S at one time at station  1 , then moves to station  3  while a second operator processes/packages some or all of the syringes S at one time at station  2 . As shown in  FIG. 22B , for Option 2 a first group of stations includes syringe selection from the syringe storage location  3 , inspecting the syringe for size and color, and labeling the syringe. A second group of stations comprises filling and capping the syringe at syringe filling station  5  and capping station  8 . A third group of stations comprises inspecting and bagging the syringe at vision inspection station  9  and bagging station  7 . All of the syringes S that are to be filled with the same medication would be processed collectively at the first group of stations by operator  1  and then placed in a first receptacle to be picked up by the second operator. While this is taking place, operator  2  may begin to process some or all of the syringes from the first receptacle at the second group of stations, placing processed syringes in a second receptacle. When operator  1  has completed the tasks of selecting a syringe, verifying that it is correct, labeling the syringe and verifying that it was labeled correctly, he or she may move to the third group of stations to process some or all of the syringes in the second receptacle until all of the syringes are packaged with the specific medication. Then the next medication would be packaged. To facilitate this grouped approach, as an alternative,  FIG. 22A  shows a multiple syringe compartment tray which slides along a track to shuttle multiple syringes S back and forth to successive grouped stations and may be used in place of first and second receptacles. 
         [0248]    Option 3—Similar to Option 1 but one operator processes/packages some or all of the syringes S at one time as a group, at each of three grouped stations before proceeding to the next grouped station. Similarly to Option 2, in Option 3 a first group of stations includes syringe selection from the syringe storage location  3 , inspecting the syringe for size and color, and labeling the syringe. A second group of stations comprises filling and capping the syringe at syringe filling station  5  and capping station  8 . A third group of stations comprises inspecting and bagging the syringe at vision inspection station  9  and bagging station  7 . All of the syringes S that are to be filled with the same medication would be processed collectively at the first group of stations  3 ,  4 , then all of the syringes would be processed at the second group of stations  5 ,  8 , and then all of the syringes would be processed at the third group of stations  7 ,  9  until all of the syringes are packaged with the specific medication. Then the next medication would be packaged. 
         [0249]    Option 4—Similar to Option 2 but three operators are utilized, one at the first group of stations  3 ,  4 , one at the second group of stations  5 ,  8 , and one at the third group of stations  7 ,  9 . To facilitate this, a carousel conveyor  325  is shown in  FIG. 23  with multiple trays  327 , each containing 3-5 syringe compartments per tray. The trays  327  rotate around the carousel  325  past three operators positioned one per each group of stations. 
         [0250]    Option 5—Similar to Options 1, 2 and 3 but two operators are situated around a lazy Susan (carousel-like) disc  342 , as shown in  FIG. 24 . Operator  1  selects, labels and inspects empty syringes S for size and color and places them in trays  343  located radially arranged on the disc  342 . Additionally Operator  1  collects the medication bottles and either stages them, or an upper tier  345  of the disc  342  retains them for the second operator. 
         [0251]    Operator Two receives the syringes S and medication bottles via the rotating disc  342  and performs the filling and capping at stations  5 ,  8 , respectively. Operator Two may also do the filled syringe inspection at station  9 . At this point it may be necessary to opt for an Operator Three to do the filled syringe inspection at station  9 . Operator Two or Operator Three may then place the Filled, Capped and Inspected syringe S onto the rotary disc  342  to be indexed back to Operator One for bagging at station  7 . 
         [0252]    Option 6—Similar to Option 4 however this system utilizes (3) operators. As seen in  FIG. 25 , Operator One inspects empty Syringes for size and color, applies a flag label to syringe S and places it on the lazy Susan disc  342  in trays  343 . Operator Two, places the empty inspected syringe S into the filling station  5  and fills, caps and places them onto the disc  342  for transport to Operator Three. Operator Three inspects the filled syringe for correct dosage. The syringes S are then conveyed back to Operator One for bagging at station  7 . 
         [0253]    Referring back to  FIG. 2 , each station of the pharmacy automation system  100  for oral syringes is described below in more detail. 
       Medication Container Login &amp; Orientation Station  1   
       [0254]    The first station in the process of the present invention is Medication Container Login &amp; Orientation Station  1  (see  FIG. 2  I) at which the bulk medicine is prepared for use in the overall system  100 . Medication Container Login &amp; Orientation (MCLO) Station  1  is a standalone desk unit that provides a facility for inputting needed information into the OSPS database via scanner  95  and data entry terminal  96 , apply barcodes as needed via label printer  97 , decap bulk containers  104  at optional capping/decapping station  93 , refit and/or retrofit them as necessary with a container/syringe interface (as will be described) at capping/decapping station  93 , and optionally photograph them using a label photographing station  98 . All of the scanner  95 , data entry terminal  96 , and label printer  97  are commercially available components. MCLO Station  1  is standalone so that it can be positioned as desired. Medicine for oral syringes is provided in liquid form in a container with a manufacturer-applied safety cap. An object of the present invention is to be able to insert a syringe nozzle into the containers to withdraw a proper dose of medicine into the syringe. To be able to do this, manufacturers must supply a specialized cap or insert, or the pharmacy technician must replace or supplement the manufacturer-supplied cap with a container/syringe interface. 
         [0255]    Referring back to  FIG. 2  I, at MCLO Station  1  a number of bins  12  are provided for storing various sizes and configurations of container/syringe interfaces  210 ,  212 ,  214 ,  216 ,  220 ,  221 ,  226 , and the Baxa™-type or PIBA variations for caps  223  and  224 , both integral and separable, (see  FIGS. 5, 27-34 and 44 ) as needed to fit all standard container sizes. As described above in steps  910  through  965  ( FIG. 4 ), OSPS system  100  guidance for the manual container  104  selection process and return process (along with the container/syringe interface  210 ,  212 ,  214 ,  216 ,  220 ,  221 ,  226 ,  223  and  224  and syringe S selections) may be “system-guided” as described above. Each container/syringe interface storage compartment  12  (see  FIG. 2  I) may be enclosed by a magnetically-actuable door so that access to each location may be electronically controlled by the local OSPS computer, or illuminated by an LED light, or equipped with a light curtain so that the local OSPS computer can monitor access to the proper location. 
         [0256]    OSPS system  100  guidance for the manual container  104  selection process employs a software module that relies on all three of the information components stored in the OSPS system database: 1) product information from the manufacturer or other external sources describing the medicines and their containers (size, dose, handling requirements, etc.); 2) prescription-specific information from the hospital identifying the prescription details and patient to receive it; and 3) OSPS runtime information such as the amount of medicine previously taken from a given bulk container. The exact container  104  location is provided to the operator via OSPS system  100  guidance who retrieves the container from the Storage facility  2 . Again the Storage facility  2  may be fitted with magnetic doors, LED lamps or light curtains either to compel the proper selection, draw the operator&#39;s attention to it, or provide an alarm in case of a wrong selection. 
         [0257]    In operation, and as described above with regard to  FIG. 4  (medication container orientation and log-in process steps  961 - 963 ), the OEM caps on medication containers  104  are manually removed and replaced with an applicable adapter cap, i.e., a valved PIBA  212  (see  FIG. 5 ). The OSPS local computer instructs the operator which of the valved adapter cap sizes in storage bins  12  ( FIG. 2 ) to select for insertion into the medication container  104  (step  963 ). The labeler  97  generates a 2D barcode label which includes the location of Storage facility  2  (see  FIG. 2  II) that the medication container  104  (see  FIG. 2  I) is to be stored at. The operator places the 2D bar code on the bottom of the medicine container, and the 2D barcode is scanned by scanner  95 , and optionally photographed using a label photographing station  98 . All general and container specific information derived by scanning or supplemental data entry at data entry station  96  is recorded in the local OSPS computer database, including the storage location of the bulk container  104  in Storage facility  2  and the expiration date of the medication container. The operator then manually stores the container in the Storage facility  2  assigned by the OSPS computer. If the container is to be stored in light protected storage  2  II c or refrigerated storage  2  II b the track-and-trace software ensures compliance. Later, when needed to fulfill a batch of oral syringe prescriptions an operator will select (with system guidance) a container  104  of the desired medicine from the Storage facility  2  with container/syringe interface  210 ,  212 ,  214 ,  216 ,  220 ,  221 ,  226 ,  223  and  224 , (see  FIGS. 5, 27-34 and 44 ) applied and load it into the filling station  5  where the 2D bar code label on its base is automatically scanned by scanner  121  at the filling station  5 . The medicine is verified by the scanning as to proper content, available fluid volume and other attributes before being filled at filling station  5 . 
         [0258]    A second station in the packaging process according to the present invention is a storage bin  3  (see  FIG. 2  III) for storage of empty syringes. The syringe storage  3  preferably incorporates a separate syringe compartment for each size of syringe that the system anticipates needing in the course of a production run. Again, this manual selection process (along with other manual selections) is “system-guided” as defined above in respect to syringe S selection as well. As with medicine container  104  selection, the software module ascertains from the patient-specific information the appropriate dose of medicine to determine the specific syringe S size to retrieve. The location of that syringe S is ascertained from the database, and the exact syringe S location in syringe storage  3  is presented to the operator who retrieves it from the syringe storage  3 . Again the syringe storage  3  may be fitted with magnetic doors, LED lamps or light curtains either to compel the proper selection, draw the operator&#39;s attention to it, or provide an alarm in case of a wrong selection. In still other embodiments the syringe storage  3  selection may be semi-automated so that the appropriate syringe S is ejected to the operator under control of the local OSPS computer. The selection software module calculates the most appropriate syringe S size based on the required prescription information dosage, the known volume of the syringe selections (the following standardized oral syringe sizes: 0.5 ml, 1 ml, 3 ml, 5 ml, 10 ml, 20 ml, 35 ml, 60 ml), identifies the syringe size to accommodate the fill volume of the prescription, and presents the syringe storage  3  location to the operator who retrieves the syringe from the proper magazine (with help of LED indicator, magnetic door, light curtain, ejection mechanism or otherwise). 
         [0259]    A third station in the filling and packaging process is the syringe size/color inspection station  11  which verifies that the correct syringe S has been selected. The syringe size/color inspection station  11  is described more fully below with regard to  FIG. 15A . 
         [0260]    The fourth station is a flag label printer/applicator  4 . After determining that the syringe S is the proper size and color, the operator inserts the syringe into syringe label printer/applicator  4 . As described above relative to  FIG. 3  (step  837 ), the operator prints a syringe label at syringe label printer  4 . The labeler is in communication with the local OSPS computer and automatically prints self-adhesive labels bearing information regarding the prescription such as the eventual contents of the syringe (medicine type, concentration, dosage, expiration, scheduled administration, etc.) and its intended recipient (name, room number, etc.) along with a bar code identifying a central record of this information in the OSPS database. The label includes a 2D barcode though other labels such as RFID may be used. The label is inspected to verify the accuracy of the printed information before it is attached to the syringe S. The label is supported by hinged arms of the applicator and held by vacuum pressure while the applicator advances to envelope the syringe barrel with the hinged arms coming together to join the label as a flag to the barrel of syringe S. Alternatively, the flag label may be applied manually by the operator. A portion of the label around the barrel must be transparent to permit dosage markings of the syringe to be clearly visible. 
         [0261]    As an alternative to the flag label printer/applicator  4 , an on-demand label printer may be used which prints a patient-specific label on demand. This arrangement would require the operator to manually apply the label to the syringe. After the label is printed, the operator will verify that the syringe was labeled correctly. This option is less expensive than the use of a semi-automatic flag label printer/applicator  4  and will be offered as an option for substitution of same. 
         [0262]    A fifth (optional) station is a medication container shake station for automatically shaking the medicine container when necessary (see  FIGS. 16A and 16B ). A shaking mechanism  820  integral to the filling station  5  is described below. An alternative, remotely-positioned medication container shake station  6  is described more fully below with regard to  FIG. 17  while a standalone or integral shaker module is described more fully below with regard to  FIG. 16A . 
         [0263]    For certain medications, such as those in the form of emulsions, liquids containing particulates or other non-homogeneous liquids, shaking is required prior to filling to render the mixture homogeneous. Within this category of medications, certain medications need to be shaken at more frequent intervals, and with a greater intensity, than other medications based on the unique characteristics of each medication. Embodiments of the instant invention comprise an electronic medication database accessible by the OSPS-S system. Information about any required shaking protocols for each medication may be stored in the medication database in association with the relevant medication(s). At the Medication Container Orientation and Login Station ( FIG. 2  (I)) described herein, the method according to the present invention may involve the printing of a 2D barcode for each medication bottle which, when scanned at the filling station  5 , provides the OSPS-S system with the required shaking protocol, if any, for the scanned medication. This will then prompt the OSPS-S system to cause the integral shake station  820  to shake the medication container before or after the filling operation with the frequency, intensity and in the intervals as required for the given medication. This process advantageously prevents medication that is prone to settling or separating from doing so such that each syringe contains the proper composition of medication. 
         [0264]    The sixth station is the syringe filling station  5  for filling the syringes S. The operator positions the empty syringe S (step  840 ) at the syringe filling station  5 . A scanner  121  is resident at the syringe filling station  5  to automatically scan the machine readable label on the bottom of the container  104  to again verify that the selected item is correct. The hand-held scanner at the fill station  5  scans the label attached to the syringe to verify that the appropriate syringe is being used. The medicine container  104  and the syringe S are loaded into the filling station  5  in various ways dependent upon the container/syringe interface that is used. The fourteen container/syringe interfaces and associated procedures for use are discussed in more detail above and below. The system automatically fills the syringe S with the medicine by calibrated withdrawal of the plunger. 
         [0265]    The seventh station is a visual inspection station  9  which comprises optical inspection to optically determine if the syringe is filled correctly. On this basis the System  100  accepts or rejects the weighed/inspected syringe. 
         [0266]      FIG. 6A  is a perspective view of an exemplary vision inspection station  9  in which syringe fill volume is inspected by a CCD imager  330  that optically detects by image analysis if the syringe S plunger is at the correct location, the volume above the plunger and below the syringe tip is filled with product, and also checks for bubbles in the product. 
         [0267]    With respect to  FIGS. 6A and 6B , the illustrated embodiment of the vision inspection station  9  generally comprises a flat base  92  with vertical syringe-mounting plate  93  at one end, caddy-corner to a vertical camera mounting plate  94 . CCD imager  330  is mounted overhead on a camera-mounting bracket  95  extending upward from the camera mounting plate  94 . A syringe holder  96  protrudes from the vertical syringe-mounting plate  93  and suspends a syringe by its cap (two yoke fingers under the cap). An optional syringe clamp  99  may be provided opposite the syringe holder  96  for clamping the syringe therein. In its simplest form (shown), syringe clamp  99  is a spring-biased jaw that clamps against holder  96  to secure the syringe. A backlight panel  97  resides directly behind the syringe S (beneath syringe holder  96 ). Two side-mounted lights  98  provide frontal illumination. 
         [0268]    In operation, the vision inspection station  9  establishes and maintains a “Reference Point” on each syringe which is consistent for all syringes despite size, nozzle offset and other variables. In accordance with the invention the reference point is selected to be just below the syringe tip at its intersection with the top of the syringe body. Since the syringe cap covers most of the syringe tip, and that tip volume is never dispensed, the tip can be ignored from any vision reading taken. The filled and capped syringe S is preferably held stationary in the spring-loaded yoke fingers of syringe holder  96  by its cap, while the backlit camera CCD  330  measures from a reference point to the seal ring of the syringe S plunger. Since the syringes are hung by their caps within a common yoke they will all have the same zero reference point, despite varying sizes. The reading from the “Reference Point” downward to the seal ring of the plunger comprises a numerical dimension for the specific syringe S size relative to the prescribed dose (the size selected being the next larger size in excess of the dose). Once taken, the OSPS computer compares the reading to a predetermined value associated with that syringe size and every increment on the syringe. For example, if a 10 ml dose is prescribed the OSPS computer will recommend a 20 ml syringe, in which case the distance from the “Reference Point” downward to the seal ring of the plunger (when fully inserted) should be 32.75 mm or 1.289″. This way, given knowledge of the prescribed dose and the syringe size, the system can accurately determine if the fill dose is correct. Otherwise it will be rejected. The accuracy of fill should be +−5% of target. In addition, the vision inspection may also include phase-contrast imaging to measure bubbles in the syringe. Phase contrast imaging exploits differences in the refractive index of the contents to differentiate bubbles. Some bubbles are tolerable, but too many are not. The vision inspection may employ phase-contrast imaging as a bubble check. This same process is used to determine if the syringe is “short filled” based on differences in shading. Any voids or bubbles are interpreted as a mixed pixel count in either light or dark depending on the opacity of the medication derived from the OSPS computer database. If the syringe volume inspection device  9  determines that the syringe S is filled to the correct volume with an acceptable amount of bubbles and no voids, it will be accepted. An acceptable bubble/void percentage is +/−2%. Optionally, a digital photograph of the filled syringe may be taken and archived for track and trace purposes. In a preferred embodiment, the color of the light may be changed to give the greatest possible contrast over liquids of different colors and opacities. The lighting color may be determined by the vision inspection station  9  based on a scan of the 2D barcode on the syringe to be inspected. 
         [0269]    The illustrated embodiment reduces the footprint (size) of the vision inspection system  9  using a mirror to break up focal distance into shorter lengths (here two, though additional mirrors may be used). Specifically, the overhead camera  330  view is reflected off a mirror  333  mounted to wall  94 , and is then focused on the syringe S being inspected. 
         [0270]      FIGS. 6C and 6D  show two alternative articulating designs for the backlight panel  97  which resides directly behind the syringe S (beneath syringe-holder  96 ), both perspective sequential views, which facilitate easier loading of the syringe S from behind. In  FIG. 6C , the syringe-holder  96  is mounted from a suspension or other non-obtrusive bracket to facilitate rearward access. The backlight panel  97  is mounted behind the syringe-holder  96  on hinges or pivots  198  as shown, to allow the backlight panel  97  to be opened or closed like a door. As shown in the sequence, the operator places the filled, capped syringe S into the syringe-holder  96  at (1), closes the backlight panel  97  at (2), the CCD imager  330  images the syringe S against the backlight panel  97  at (3), and the backlight panel  97  is reopened at (4) and the syringe S removed. 
         [0271]      FIG. 6D  shows a guillotine-style backlight panel  97  slidably mounted on a pair of spaced-apart vertical rails  195 . Backlight panel  97  moves up and/or down within rails  195 . As shown in the sequence, the operator places the filled, capped syringe S into the syringe-holder  96  at (1), and closes the backlight panel  97  whereupon the CCD imager  330  images the syringe S against the backlight panel  97  at (2). The backlight panel  97  is then reopened and the syringe S removed. 
         [0272]    As still another alternative, the inspection may be accomplished with a check-weigh scale to weigh and/or inspect the filled syringe S to verify the syringe is as labeled. In this case, the OSPS software calculates target weight based on the fill size in cc&#39;s and multiplies by the specific gravity to derive weight. The specific gravity of each medication is stored in the OSPS database along with the percentage +/−% deviation that is acceptable for the actual fill weight. If the actual fill weight is in the target range, it is accepted. If not, it is rejected. 
         [0273]    The OSPS software calculates the target weight based on the fill size in cc&#39;s and multiplies by the specific gravity to derive weight. The specific gravity of each medication is stored in the OSPS database along with the percentage (+/−%) deviation that is acceptable for the actual fill weight. If the actual fill weight is in the target range, it is accepted. If not, it is rejected. 
         [0274]    An eighth station  8  is the semi-automatic syringe capping station described below in detail with regard to  FIG. 10 . The syringe capping station  8  facilitates accurate placement of syringe caps onto filled syringes S. 
         [0275]    The ninth station is a bag printing and sealing station  7  (see  FIG. 2  III). The bagging station  7  is a commercially available Hand Load Printer/Bagger for hand load labeling and bagging applications. It is networked to the local OSPS computer to automatically print the bag that the syringe S will be packaged in. The bag is printed with information regarding the prescription such as the eventual contents of the syringe (medicine type, concentration, dosage, expiration, scheduled administration, etc.) and its intended recipient (name, room number, etc.) along with a bar code identifying the same content. After printing a bag the system inspects the print on the bag to make sure that it is correct. If so, the operator is permitted to place the filled/capped syringe S in the bag, the system confirms that the syringe was placed in the bag, and the bag is then sealed. 
         [0276]    If all the steps are completed correctly the syringes are distributed for administration to the patient. 
         [0277]    One skilled in the art will recognize that certain steps may be completed in various alternate sequences to achieve the same result, and features may be modified or eliminated as a matter of design choice. 
         [0278]    At initial MCLO Station  1  an operator prepares bulk medicine containers for use at the automated syringe filling station  5 . Preparation entails applying one of the above-described container/syringe interfaces. Again, each medicine container is pre-labeled with a unique identifying number, for example, in barcode format adhered to the bottom of the container. Preparation of the container  104  also includes scanning, verification, optional photographing, and recordation of container  104  label information including content information (name, manufacturer, full volume, concentration, etc.), batch or production information, and expiration information with its assigned container  104  in a medication track and trace database. Various other parameters for each medicine can be associated with each record in the database such as the maximum flow rate at which a certain medicine can be withdrawn from its storage container (i.e. to prevent cavitation/inaccurate fills), the storage temperature (ambient or refrigerated), the required frequency of shaking/agitation of each medicine to keep any particulate matter properly suspended/distributed (e.g. between each syringe fill dispense cycle or only at the start of a series of syringe fill dispense cycles). 
         [0279]    Each barcode (or possibly RFID tag or other label) preferably references the following information:
       Batch number   Expiry date   Storage instructions   Product name   Strength   Name of the active ingredient(s)   Dose form   Warning statements   FDA number   Des product need to be shaken before use? If so, how often?   Does product need to be refrigerated before use? If so, temp?   Does product need to be protected from light?   Volume of original bulk medication container?       
 
         [0293]    The information available from the pharmaceutical manufacturer&#39;s barcode on the medication container varies from manufacturer to manufacturer. The operator is prompted to enter any missing data directly into the computer data entry terminal  96  at MCLO Station  1 . The information from the pharmaceutical manufacturer&#39;s barcode label plus the variable information is stored in the medication container database which is linked to the medication container by the barcode label on the base of the container, which includes the container identifying number assigned to the container  104  in the medication track and trace database. It is also important that each container  104  is marked in both human and machine readable forms (i.e. text, barcode or RFID tag) as to the type and concentration of the medication it contains along with various other information, to enable visual inspection. 
         [0294]    The containers/bottles  104  are typically manufacturer-supplied although custom containers/bottles may be used for purposes of the present system. If the storage containers or bottles  104  are provided by the manufacturer, 20 mm, 24 mm, and 28 mm neck diameters are typical. The bulk containers may be provided in a specified, standardized format by the manufacturer, or the medicines may be refilled into standardized containers onsite. 
         [0295]    With regard to filling station  5  in  FIG. 2 , the oral syringe may be entirely evacuated such that its plunger is advanced all the way into its barrel or the oral syringe may have a calibrated amount of a gas (such as air) in front of the plunger in the barrel. The syringe plunger may be withdrawn to draw the fluid into the barrel. Where a gas is present in the syringe, the plunger may be first advanced so as to force the gas into the container  104 . The plunger is then withdrawn to draw the fluid into the syringe. Introduction of the gas into the container  104  slightly pressurizes the container initially and prevents the development of negative pressure within the container which would inhibit fluid flow. When the syringe is filled to the proper volume it is withdrawn. 
         [0296]    Referring back to  FIG. 2 , the operator returns the prepared medicine container  104  with its container/syringe interface  210 ,  212 ,  214 ,  216 ,  220 ,  221 ,  226 ,  223  and  224  in the medicine Storage Facility  2  where it remains until called for. The system software monitors the contents of the medicine Storage facility  2  in terms of both identity of the prepared medicines available to be dispensed and the quantity of each medicine. The content of the Storage facility  2  is continually updated as the medicine is dispensed and the system is able to predict based on current pending prescription and historical dispensing information when the current available container of any given medication will be empty so as to advise the operator to prepare a replacement quantity of such medicine prior to emptying the existing container. Medicines exceeding their expiry dates are also identified by the system to be discarded by the operator. 
         [0297]    After retrieving the syringe from syringe store  3  (see  FIG. 2  III) of empty syringes S to be filled as described above, the operator inserts the syringe into a station that includes a syringe color/size inspection device  11  and a syringe label printer/applicator  4 . 
         [0298]      FIG. 15A  is a perspective view of an embodiment of the syringe size/color station  11 A which verifies that the correct syringe size (0.5 ml, 1 ml, 3 ml, 5 ml, 10 ml, 20 ml, 35 ml, and 60 ml)) has been selected by the operator. One skilled in the art should understand that syringe size/color inspection station  11 A may be placed anywhere but is best placed proximate the filling station  5 . The illustrated syringe size/color inspection station  11 A essentially comprises a set of automatic electronic calipers connected to the OSPS Computer. More specifically, a support surface  1101  is formed with a pair of aligned slots  1103 ,  1104 . A stationary cradle comprises a pair of spaced-apart yokes  1102   a ,  1102   b  fixedly mounted on the support surface  1101  on opposite sides of the slots  1103 ,  1104  for supporting the syringe S in a horizontal position. A pair of articulating caliper fingers  1105  protrude upward through the slots  1103 ,  1104  to embrace the syringe S on both sides. Caliper fingers  1105  are driven by an underlying caliper drive mechanism connected to the OSPS Computer which moves fingers  1105  into contact with the syringe S after the shuttle  5   s  has deposited the syringe S onto the yokes  1102   a ,  1102   b . The caliper fingers  1105  rise to a height higher than the center of the largest syringe size, and in operation the fingers  1105  close around the body of the syringe S until a force is sensed (indicating contact with the syringe). At this point a measurement of the syringe body is taken (the distance between fingers  1105  is calculated) to verify that the correct syringe S has been selected. Oral syringes are often color coded in translucent colors for ease of identification. For example, oral syringes may be a highly visible amber color to distinguish its contents as an orally administered medication. To verify color, a color inspection camera  1107  is also connected to the OSPS computer and may be mounted in either of yokes  1102   a ,  1102   b  to image the color of the syringe S. A 3-CMOS imager is preferred for this application to capture RGB pixel data, which is compared by OSPS Computer to a color lookup table or subjected to another color-matching algorithm to verify the proper syringe color. If size and/or color are correct, labeling and/or further processing of the syringe S will take place. 
         [0299]      FIG. 15B  is a perspective view of an alternate embodiment of a syringe size/color station  11 B which verifies that the correct syringe has been selected. Embodiment  11 B comprises a parallel pneumatic gripper  1201  fixedly mounted at a downward incline within a supporting structure here comprising opposing vertical plates  1210 ,  1212  connected by a cross-bar  1214 . There are a variety of commercially-available pneumatic grippers available in parallel, angular, radial and concentric versions, and in this instance a parallel version is used, such as a Rexroth™ GSP precision parallel pneumatic gripper. Opposing syringe gripper jaws  1220  are attached to the existing gripper  1210  arms, each jaw  1220  comprising a downward extension to a horizontally-disposed finger. The opposed horizontal fingers  1220  are formed with inwardly-disposed vertical grooves to provide a proper grip on the syringe barrel, while holding it vertically. A linear variable differential transformer (LVDT)  1225  (also called a differential transformer) is mounted in plate  1210 , and its sensing piston is threaded into a collar  1227  secured to the opposing jaw  1220  for measuring linear displacement (position). The LVDT  1225  is connected to the OSPS Computer and measures the distance traveled by the jaw  1220  as it closes around a syringe S. The LVDT  1225  takes monitors an input voltage differential from a starting position to a final position after gripping the syringe S, and calculates syringe size from distance traveled by the jaw  1220 . As above, to verify color a color inspection camera  1107  may be mounted in either of plates  1210 ,  1212  to image the color of the syringe S and thereby ensure that size and color are correct, such that labeling and/or further processing of the syringe S may take place. One skilled in the art should understand that the syringe measurement system  11 B may be integrated as part of the syringe filling station  5  (see  FIG. 2  III) rather than as a standalone station as shown in  FIG. 15B , thereby consolidating the size/color inspection function with the filling operation. 
         [0300]    The labeler  4  is in communication with the central controller and prints self-adhesive labels bearing information regarding the prescription such as the eventual contents of the syringe (medicine, dosage, scheduled administration, etc.) and its intended recipient (name, room number, etc.) along with a bar code identifying a central record of this information. The label is printed, scanned (inspected) and, if approved, applied to the syringe using known application methods. In one such method the label is supported by the hinged arms of the applicator by vacuum pressure while the applicator advances to envelop the syringe barrel with the hinged arms coming together to join the label as a flag to the barrel. A portion of the label around the barrel must be transparent to permit dosage markings of the syringe to be clearly visible. Alternatively, an on-demand label printer, for manual application of the label to the syringe, may be used in place of labeler  4 . 
         [0301]      FIG. 7A  is an enlarged perspective view of a semi-automated syringe fill station  5  for filling the syringes S. Prior to inserting the syringe into the syringe filling station  5 , the operator will have selected from the Storage facility  2  the appropriate, prepared container  104  with a valved PIBA (see  FIG. 5 ) from which to dispense the proper medicine into the syringe S. The operator first inverts and then inserts the prepared container  104  into yoke  82 C (see  FIG. 7C  III). The syringe S is then manually loaded by the operator into the syringe filling station  5 , preferably with the plunger partially withdrawn from the barrel. The syringe S/plunger combination is inserted into the medicine container. Several support fixture/yoke variations are envisioned. 
         [0302]    As seen in  FIG. 8 , each arm terminates in a pair of fork shaped fingers  120  that form a horizontally oriented “V” shaped opening to engage the syringe barrel and plunger cross sections regardless of the size of these elements. Each arm is independently servo controlled and slideable in both an up-down direction and a horizontal forward-back direction to facilitate engagement with and operation of the syringe and plunger. The upper and middle arms  110 ,  111  grip above and below the syringe barrel flange, while the lower arm  112  grips the plunger flange. The local OSPS computer calculates the distance to move the lower arm  112 , plunger lifting arm  128  and plunger flange to extract the appropriate dose of medicine based on the prescribed dose volume V and known radius or diameter of the syringe S size retrieved. The linear travel distance H equals V/nr 2 , where the radius r is stored in the database. The linear travel distance H constitutes the distance that the lower arm  112  needs to travel to pull the correct amount of medicine into the syringe S. The local OSPS computer then controls the movement of fill arms  110 ,  111 ,  112  and plunger lifting arm  128  in accordance with the calculated distance H, and may also account for other variables such as medicine viscosity, volume of fill, etc. to optimize either the linear travel distance H or the filling force exerted or filling time taken along that distance. 
         [0303]    With reference to  FIG. 9 , a preferred embodiment of the present invention provides the upper, middle and lower arms  110 ,  111  and  112 , respectively, in a single stacked configuration each having a horizontally fixed base member  129  riding on a pair of ball slides  122  on a set of guide rails  123  vertically oriented with the housing  895  (of  FIG. 7A ). Vertical movement of each base member  129  on the guide rails  123  is controlled by a linear servo  124  situated below and extending into the housing  895 . Each arm  110 ,  111 ,  112  is also provided with a horizontal reaching element  127  slideably mounted horizontally to each base member  129  so as to ride up or down the guide rails  123  with the base member  129  while being extendable or retractable in the horizontal to engage the syringe S. Horizontal extension and retraction of the reaching members  127  is controlled by a horizontally oriented linear servo  125  fixedly mounted to each base member  129  and engaged to the proximate reaching element  127 , each which is itself mounted via a horizontally oriented ball slide assembly  126  affixed to the base member  129 . The forked fingers  120  are horizontally disposed at the distal ends of the reaching elements  127 . In this way the horizontal and vertical motion of each arm  110 ,  111 ,  112  is individually controllable in two dimensions. 
         [0304]    Referring back to  FIG. 7A , in addition to the upper, middle and lower arms  110 ,  111 ,  112 , a plunger lifting arm  128  extends upward from below to depress the plunger of the syringe S into the barrel as will be described. The plunger lifting arm  128  is controlled by a linear servo and is vertically oriented. In certain embodiments the lower arm  112  may serve both the plunger pull-down (withdraw) and plunger lift (depress) operations. 
         [0305]    In an alternate embodiment, as shown in  FIGS. 26 and 27 , instead of horizontally extending syringe gripping arms with two-dimensional horizontal and vertical motion of each arm  110 ,  111 ,  112 , vertically extending syringe gripping arms are implemented with vertical and rotational motion of each arm  110 ,  111 ,  112 . This is made possible by replacing the laterally-extended fork-shaped fingers each with standard “V” shaped openings with one or more right-angle plates each having a transverse curvilinear notch or “curvilinear jaw.” This way, each syringe gripping arm  110 ,  111  and  112  terminates with at least one horizontally-oriented curvilinear jaw, wherein the notch forms an overall curved shape along the horizontal plane of the gripping arms  110 ,  111  and  112  which lessens in width towards its closed end. The advantage of this configuration is that the syringe gripping arms  110 ,  111 ,  112  extend vertically from the horizontal base member of the filling station and may enter the filling station through fluid-sealed bushings, whereas the above-described two-dimensional embodiment requires elongate slots to permit vertical movement of the arms, but which are difficult to seal to prevent liquid medication and other materials from infiltrating into the interior of the filling station. Where the filling station is expected to operate in a clean-room environment, the ability to environmentally seal the external filling area is an absolute requirement, and the use of vertical/rotational syringe gripping arms  110 ,  111 ,  112  rotating within sealed rotary bushings makes this possible. Additionally, in this embodiment, the sealed interface between the vertical rotating mounting elements for arms  110 ,  111 ,  112  and  128  and the base plate of the filling station prevents any liquids or other materials spilled during the filling process or otherwise from leaking into the interior of the filling station. In this embodiment, arms  110 ,  111  and  112  may be mounted through a horizontal base member of the filling station, extending through rotary shaft seals, and attached to linear and rotational servo motors mounted underneath the filling station base that control the motion of the arms  110 ,  111 ,  112  (as well as plunger lifting arm  128 ) as will be described. The servo motors thus control vertical position and axial rotation of the vertical mounting elements and therefore the arms  110 ,  111 ,  112  and  128  mounted thereon, with plunger lifting arm requiring only the capacity to raise and lower vertically, and not to rotate. Thus, as vertical mounting elements and arms  110 ,  111  and  112  rotate, they close on the various portions of syringe S corresponding to their vertical orientation. Arms  110 ,  111  and  112  may rotate as far as possible to grasp syringe S until the curvilinear gap between the fingers matches the width of the portion of syringe S upon which it closes; thus, arms  110 ,  111  and  112  will rotate under control of the servo motors until syringe S is snugly positioned within the gap between the fingers. In addition, upper and middle arms  110  and  111  may rest on the same vertical mounting element spaced vertically from one another, with a clamping cylinder incorporated there between to control their relative vertical orientation. Clamping cylinder may pull upper arm  110  down on top of middle arm  111  to sandwich the syringe hilt or flange between them as described. Advantageously, the use of a low cost clamping cylinder eliminates a more costly servo motor to independently operate arm  110  and/or  111 . In all other respects, arms  110 ,  111 ,  112  and  128  may perform the same functions as described herein. 
         [0306]    Prior to filling, the scanner  121  at the syringe filling station  5  reads the machine readable label on the bottom surface of the container  104  to again verify that the selected container contains the correct medicine. 
         [0307]    Once verified to be the correct, the upper arm  110  lowers to contact the upper surface of the syringe S finger flange, and the middle arm  111  raises to contact the lower surface of the syringe S finger flange. Initially, plunger lifting arm  128  pushes the syringe piston all the way up and the lower arm  112  lowers to clamp the syringe piston downward against the plunger lifting arm  128 . Priming of the syringe S takes place as lower arm  112  and plunger lifting arm  128  move up and down in concert with each other to perform the syringe priming sequence. After priming is complete and with the syringe piston fully retracted, the syringe can be filled. 
         [0308]    During fill operations the upper, middle and lower arms  110 ,  111  and  112  are initially in a horizontally retracted state. The lower arm  112  engages the plunger above the plunger flange in a similar manner while the lift arm  128  extends upward to engage the distal end of the plunger. The lower and lift arms  112 ,  128  are brought together to engage trap the plunger flange between them, and the syringe S is entirely evacuated by fully depressing the plunger within the barrel. If the syringe S is entirely evacuated (i.e. the plunger is fully depressed within the barrel), the lower arm  112  is initially dropped, withdrawing the plunger from the barrel and drawing the medicine into the syringe. As noted, in certain embodiments the syringe may have a predetermined amount of air in the barrel to pre-pressurize the container  104 . In such a situation the position of the plunger (and hence the volume of air in the barrel to be injected into the container) is determined by the system based on known parameters of the medicine, the container volume and its current fill level, and the plunger is positioned accordingly prior to insertion into the container/syringe interface by relative movement of the upper, middle, lower and lifting arms  110 ,  111 ,  112  and  128 . Upon insertion of the tip in the container/syringe interface the plunger is first fully depressed by the lift arm  128  to pressurize the container and subsequently withdrawn by the lower arm  112  at a predetermined rate to fill the syringe S with desired amount of medicine without cavitation. 
         [0309]    When the syringe is filled to the desired level, the arms  110 ,  111 ,  112  and  128  are lowered in unison and the syringe S is withdrawn from the container/syringe interface  210 ,  212 ,  214 ,  216  and where an elastomeric insert  225  is present it returns to it closed/sealed position. If desired, the syringe plunger may be further withdrawn from the barrel slightly by relative movement of the lower arm  112  as the nozzle is withdrawn to draw in any medicine left in the elastomeric insert  225  so as to avoid drippage. 
         [0310]    With reference to  FIGS. 40-43 , where a push-pull cap  224  is used as the syringe-medication container interface to enable the medication container to interface with a Luer lock oral syringe, syringe filling station  5  additionally comprises a grooved block  400  for actuating slide disc  91  to open and close push-pull cap  224  between each syringe fill. As shown in  FIG. 43  (at A), grooved block  400  comprises a horizontal block having a cutout through the entire height thereof to accommodate the exterior diameter of push-pull cap  224  above and below slide disc  91 . At a height-wise midpoint of the inner wall of the cutout is a groove corresponding to the outer diameter of slide disc  91  such that slide disc may be captured within the groove when the medication container is properly positioned in yoke  82 . Grooved block  400  is positioned a given distance below yoke  82  such that it captures slide disc  91  within its groove when push-pull cap  224  is in a closed position (with slide disc  91  raised and tab  86  in upper groove  87   a ; see  FIG. 29  at B) and is movable vertically relative to stationary yoke  82 . 
         [0311]    In a first embodiment, shown in  FIG. 41 , grooved block  400  is operatively connected to a horizontal air cylinder  401  via two cams  404  comprising cam slots  402 . Air cylinder  401  is in turn connected to OSPS software for controlling the operation of air cylinder  401  based on one or more programmed syringe filling sequences. When air cylinder  401  is retracted, cams  404  move inward towards air cylinder  401  and away from the syringe and medication container. Two cam followers  405  each have a horizontal arm, a portion of which is disposed in one of the two cam slots, and a vertical arm connected to the horizontal arm and extending downward through yoke  82  to connect to grooved block  400 . Cam followers  405  are held stationary within the horizontal plane but movable within the vertical plane, such that when cams  404  move inward, cam followers  405  are pushed downward following the downward incline of the cam slots  402  in the direction opposite that in which cams  404  are moving. By their attachment to grooved block  400 , cam followers  405  in turn push grooved block  400  downward which forces the slide disc  91  held within grooved block  400  downward, opening push-pull cap  224 . Likewise, when air cylinder  401  is extended, cams  404  move outward away from air cylinder  401 , cam followers  405  are pulled upward following the upward incline of the cam slots  402 , grooved block  400  is pulled upward and slide disc  91  is pulled upward, closing push-pull cap  224 . Syringe gripping arms  78  are also mounted to grooved block  400  such that the syringe body is pulled upward or downward in the same magnitude as slide disc  91  and nozzle  90  of push-pull cap  224  such that a connection between the syringe S and nozzle  90  is constantly maintained until push-pull cap  224  is closed and the syringe S is removed from the filler. For filling operations not involving a push-pull cap  224 , grooved block can be articulated out of the way and air cylinder  401  will hold syringe gripping fingers  78  in a stationary position relative to yoke  82 . 
         [0000]    In a second embodiment, shown in  FIG. 42 , the operation of grooved block  400  and its interface with slide disc  91  and syringe gripping fingers  78  is the same as described above. However, horizontal air cylinder  401  is replaced by vertical air cylinder  403  which moves grooved block  400  in a vertical direction directly without the need to utilize cam slots  402 . 
         [0312]    To enable the conversion between the use of tapered tip syringes ( FIG. 38 ) and Luer lock syringes ( FIG. 39 ) as is expected in the future for safety reasons, the entire system described herein may be modular to allow replacement of those modules designed specifically for tapered tip syringes as the Luer lock syringe rollout takes place. 
         [0313]      FIG. 16A  illustrates an shaker mechanism  820 , which may be either integral to filling station  5  or a standalone unit, in which a single-speed motor  823  operates through an electronic clutch  827  to rotate cam wheel  824 . In a preferred embodiment, filling station  5  comprises a base module containing syringe gripping fingers and a top module for supporting the medication container in an inverted position for filling the syringe. The top module may be shaker mechanism  820 , or may be a module comprising medication container yoke  82 A,  82 B and/or self-centering jaws  82 C and medication container platform  79  without any integral shaking mechanism, such as when a separate shaking mechanism  6  is used. Preferably, either of these top modules may be interchangeable based on design preference to allow for, i.e., an upgrade of the system from comprising an independent shaker mechanism  6  to integral shaking mechanism  820  or to allow the system to be adaptable to different needs. The top module and base module may be connected by a series of screws or any other non-permanent connection means known in the art. 
         [0314]    For shaking mechanism  820 , an eccentric pin  829  protruding from cam wheel  824  slidably engages a slotted block  830  as shown, and block  830  directly engages plate  821 . When the motor  823  is activated it reciprocates plate  821 , again shaking it and mixing the contents of medicine container  104  held therein. 
         [0315]      FIG. 16B  is a composite operational diagram illustrating the operation of the integral shaking mechanism  820  of  FIG. 16A  external of the syringe filling station  5 . The plate  821  which supports the medicine container platform and syringe yoke is mounted on vertical slides  831 . A slotted driven block  832  mounted on the plate  821  is engaged by eccentric pin  829 . As the pin  829  rotates within the slot of block  832  the block  832  oscillates up and down. A single position clutch is mounted to the motor so that the slotted driven block as well as the entire platform stops at the same downward position all the time. The insets at top illustrate eccentric pin  829  engaging slotted driven plate  832  at top dead center (left), 90 degrees rotation, and bottom dead center. 
         [0316]      FIG. 17  is a perspective view of an alternative remote medication container shake station  6  (i.e. not an integral part of the filling station  5  as seen in  FIG. 2 ) for shaking the medicine container when required. The shake station  6  comprises a motor  62  with an offset trough  64  coupled to the rotary shaft  63 . The trough  64  is an elongate arched platform for seating and centering medicine containers of various sizes. An upright post  65  abuts the base of the medicine container and self-centers it, allowing tightening of restraining straps  66 . The straps  66  secure the medicine container along an oblique offset axis relative to that of the shaft  63 . This particular configuration makes loading of the medicine container on the trough  64  very easy as seen in  FIG. 17 . When the motor  62  is activated the oblique rotation of the medicine container causes a centrifugal force that keeps the container against the stop post  64 . Constrained by the bands  66  and post  65  the medicine container is effectively and efficiently shaken. 
         [0317]    The (optional) semi-automated capping station  8  (see  FIG. 2 ) facilitates syringe cap placement on the open tip of the filled syringe S, fed from an inclined capping chute  149  (see  FIG. 10 ). Referring back,  FIG. 10  is an enlarged perspective view of the semi-automated capping station  8  with feeder bowl  147  and inclined capping chute  149 . Feeder bowl  147  may be a centrifugal or vibratory bowl feeder as known in the art, sized for sorting and feeding syringe S caps single-file down inclined chute  149 . A transparent plastic chute cover  145  may be provided overtop chute  149  to prevent access to all but the leading syringe S cap. It is rather common for pharmacy technicians to improperly cap filled syringes prior to administration, and this leads to leaking, contamination and other problems. A mechanism is herein provided to prevent this. When the leading syringe caps reach the bottom of chute  149  they come to bear against a cylinder rod  146  in a position directly overhead an electronic pressure transducer  148 . Pressure transducer  148  is in communication with the OSPS central controller and registers the pressure of the syringe S nozzle pressing against transducer  148 . A threshold pressure indicator LED  144  is mounted proximate transducer  148 . To cap a syringe S the operator merely presses it down onto the leading cap until an acceptable threshold pressure is attained, and this is signaled by an LED indicator  144 . At this point the cylinder rod  146  retracts allowing the operator to pull the capped syringe S out and free. The OSPS central controller preferably logs this in its track and trace database to provide an audit trail. This mechanism avoids any issues with improperly capped syringes. 
         [0318]    During batch operation a series of syringes S to be filled with the same medicine may be queued and loaded in sequence by the operator for filling. When no more syringes are to be filled with the particular medicine, the local container  104  is returned to the medicine Storage facility  2  by the operator, who may retrieve another medicine and replace it in the syringe filling station  5  for the next medicine to be dispensed. 
         [0319]    In a preferred embodiment, a 2D barcode on the syringe, medication container or cap may be scanned at each station described herein, and red/green lights or another visual or audible alert may indicate to the operator and/or to the software that a required protocol has not been followed for a given syringe, medication, or the like. For instance, a red light may be used to indicate, when a medication container is scanned at filling station  5 , that the medication has expired, or to indicate, at the visual inspection station  9 , that syringe S has not been filled to the proper fill volume as required for a given prescription. Scanning a 2D barcode at each station described herein would also permit the pharmacist or other operator to process medication or syringe/cap/container recalls more promptly and prevent any recalled items or medication from being provided to a patient. Recall information may be entered directly into the OSPS system when received by the hospital or pharmacy and the software may check every scanned item against the database of recalled medications and/or devices. 
         [0320]    The 2D barcode described herein is preferably generated for syringe S at the syringe labeling station, and for the medication container at the Medication Container Orientation and Login Station ( FIG. 2  (I)). Thus, in a preferred embodiment, the 2D barcode on the medication container is scanned at the Medication Container Orientation and Login Station (after it is generated) and the filling station  5 , and the 2D barcode on the syringe S is scanned at the syringe labeling station (after it is generated), the filling station  5 , syringe capping station  8 , filled syringe inspection station  9 , and bagging station  7 . 
         [0321]    Referring back to  FIG. 2 , after retrieval from the syringe filling station  5  and capping at syringe capping station  8 , the operator places the syringe on inspection system  9  to cross check the weight and/or volume of the filled syringe against the expected weight/volume. The tare weight check is based on the known weight of the empty syringe and the volume of the prescribed medicine. The vision inspection entails an optical inspection (described above) based on the location of the syringe S plunger, the volume above the plunger and below the syringe tip, and bubble check. If the inspection station  9  determines that the syringe is filled to the correct volume and/or weight with an acceptable amount of bubbles, it will be accepted. Otherwise it will be rejected. 
         [0322]    The labeled, filled and capped syringe is then bagged at bagger  7  for distribution to the patient, the bag itself being labeled in a similar manner as to the syringe. Bagger  7  may be any suitable commercially-available bagger with a network-capable bag printer, bag storage/dispenser, and heat seal assembly. A variety of automatic “tabletop bagger/printers” are available for this purpose. 
         [0323]    With reference to  FIGS. 11 and 12 , a control system architecture for the system  100  is disclosed in which a main controller  300  is provided in communication with a series of sub-controllers for one or more station steps via a communications backbone  310 , in the depicted case, via Ethernet and local digital inputs and outputs. The main controller  300  is preferably a microprocessor based microcontroller or PC containing a processor core, memory, and programmable input/output peripherals. The controller contains a system safety controller, logic controller, top level motion controller and human-machine interface for interaction with a system operator. The main controller  300  further incorporates a database read/write module for interaction with a local or remote customer (patient) records database and local event database for managing downstream component operation. An order listener/parser module is provided for receiving orders from an external pharmacy/prescription entry and management system maintained by the institution. The parser can be custom formatted to discern and populate order information based on a user specified data stream and structure. 
         [0324]    Sub-controllers are provided for all downstream machine sections such as Syringe Storage  320 , Inspector/Labeler/verifier  330 , and Medicine Library  350 . The sub-controllers are each provided with a local input/output system and local motion controller integrated with the main controller  300  via the communications backbone  310 . The main controller orchestrates the integration and operation of the downstream machine elements as described above and controls the overall operational mode of the system  100 . 
         [0325]    The local OSPS Computer may incorporate fill weight/volume adjustment software. Specifically, the vision inspection station  9  ( FIG. 2 ) is networked to the Local OSPS Computer and may provide weight or volume feedback to automatically adjust the amount of liquid transferred into the oral syringe at servo-operated syringe filling station  5 . The software determines if a syringe has too much or too little medicine in it. Any out-of-spec syringe will be rejected and the system will automatically queue a replacement utilizing information from the previously-rejected syringe. 
         [0326]      FIG. 13  is a perspective view of an exemplary capping/decapping station  93 , which comprises an elevated platform support surface  952  for stabilizing the medicine container. An optional container clamp (not shown) may be mounted on the support surface  952  for centering and constraining the medicine container. The container clamp may comprise a pair of opposing V-shaped clamps. An operator presses a “clamp” button and the opposing V-shaped clamps close around the container bottle. The V-shaped clamps may be mounted on low-friction slides so that any size bottle can be slid toward the center of the chuck. Although the clamps are mounted on low friction slides, they remain stationary to rotation. An articulating spindle assembly extends upward from a base  953  mounted on the support surface  952 , the spindle assembly including a vertical piston  954  extendable/retractable from base  953  and a horizontal mast  955  extending from piston  954 . The mast  955  contains a motor which drives a vertical spindle  959 . A manual lowering arm  956  is geared to the piston  954  for piston extension/retraction from base  953 , thereby allowing an operator to raise or lower spindle  959  manually. A pressure sensor  957  is mounted to the spindle  959  (or internal to the mast  955  for sensing the downward pressure. A chuck  958  is mounted at the lower end of the spindle  959 . As seen in the inset (at left), the chuck  958  is preferably formed with a hard outer shell (e.g., stainless steel) and a molded plastic core placed inside, the core defined by a conical interior surface with an elastomeric inner lining. An elastomer such as polyurethane or equivalent resin can be poured around the interior of the core to form the elastomeric lining. A lateral slot enters the interior of the chuck  958 . This chuck  958  is designed to fit all caps ranging from 18 mm to 38 mm in diameter. Due to its conical interior and elastomeric inner lining, downward pressure onto the container cap causes a non-slip, gripping action. The slot accommodates certain container caps which have a tethered closure feature. The tether is free to protrude and will not cause interference between the chuck  958  and cap. This capping/decapping station  93  enables the medicine caps to be loosened from their containers mechanically without the need for an operator to exert strong hand pressure. The system is capable of loosening caps as well as applying torque to seat them. In operation, the medicine container is placed on the support surface  952 , and the operator centers the container either with the optional holding clamp or by hand, and if to cap a pre-labeled container/syringe interface is placed on the container. Upon moving the manual lowering arm  956  forward, the piston  954  extends from base  953 , thereby a lowering spindle  959 . The chuck  958  descends into contact with the container/syringe interface to tighten it, or into contact with the manufacturer cap if decapping is desired. Once the chuck  958  descends onto the cap and downward force is applied the pressure sensor  957  begins to compress and in doing so, signals the motor to start. This avoids inadvertent rotation of the elastomeric chuck  958  in advance of contacting the cap which may cause abrasion and emit particles of the elastomer in the vicinity of the work area. The scanner  95 A may be mounted beneath the platform support  952  to read the medicine container&#39;s 2D barcode from beneath. Preferably, the scanner  95 A is synchronized via the OSPS computer such that the first time it reads a particular barcode the spindle  959 /motor turn in the counter-clockwise (cap removal) direction. Conversely, the second time scanner  95 A reads that particular barcode the spindle  959 /motor turn in the clockwise (cap tightening) direction. The assembled medicine container and container/syringe interface can be slid out and removed. 
         [0327]      FIG. 14  is a perspective view of the label photographing station  98  resident at the Medication Container Orientation and Log-In Station. The label photographing station  98  is employed for the purpose of photographing the entire medicine container&#39;s label for archival purposes (to retain a record of the medication used to fill a specific prescription). In some cases, the barcode scan from scanner  95 A alone will be insufficient to identify details such as medicine concentration, expiration, handling and other precautions relative to the medication. The label photographing station  98  comprises a circular table  984  rotatably seated atop a support surface  982 . A camera  988  is oriented directly toward a focal point centrally atop the table  984 , and a pair of opposing sensors  986   a .  986   b  is indirectly aimed from the sides toward that same focal point. The camera  988  and sensors  986   a ,  986   b  are all mounted on a common undercarriage via struts that pass through tracks in the table  984 . This allows the camera  988  and sensors  986   a ,  986   b  to translate in unison along the tracks in the table  984 . The undercarriage is servo-driven (or otherwise adapted for controlled translation) under control on the OSPS Computer, in accordance with feedback from sensors  986   a ,  986   b . The medicine container may be manually placed anywhere atop the table  984 , and the OSPS Computer will drive the undercarriage until the sensors  986   a ,  986   b  align with the surface of the medicine container. The sensors  986   a ,  986   b  track the surface of the container and travel with that focal surface, along with the camera  988 . This positions the camera  988  at exactly the proper focal distance regardless of container position, and maintains the optimum focal distance from label to camera  988  despite a variety of sizes and shapes of medicine containers. 
       Process and System Configuration Variations Specific to Container/Syringe Interfaces 
       [0328]    Filling a Syringe Using a Standard Commercially Available “Baxa” Cap  214  (See  FIG. 5 ) 
         [0329]    The standard commercially available Baxa™ cap  214  comprises a female threaded cap to fit over medication containers and is available in sizes to accommodate most medication containers. Baxa™ cap  214  enables an oral syringe to enter its center hole and withdraw an amount of liquid from the medication container while the medication container is positioned upside down. For the syringe to be removed from the medication, both syringe and medication container must be up-righted. Once up-righted, the syringe S can be removed from the up-righted medication bottle with no leakage. If the medication bottle requires shaking at any given time, it can be done manually or in a separate shaker ( FIG. 17 ) by closing the tethered cap and fastening the bottle into the shaker tray. The sequence of operation is as follows:
       a. Remove original cap ( FIG. 18A ).   b. The Baxa™_cap  214  is applied onto the neck of the container ( FIG. 18B ).   c. The syringe S is inserted into the Baxa™ cap  214 . ( FIG. 18C ).   d. The medication container and the syringe S combination are rotated up-side-down. ( FIG. 18D ).   e. Both the medication container and the inserted syringe S are then inverted and placed into the yoke  82 A ( FIG. 18E ) of the filling station  5  (see  FIG. 7A ).   f. The Syringe is clamped by the filler finger grippers  78  and a platform  79  ( FIG. 18F ) lowers to the bottom of the over turned medication bottle and applies downward pressure to the bottle as it is supported by the yoke  82  (see  FIG. 7D ).   g. Now the syringe gripping arms  110 ,  111  and  112  engage the syringe S plunger, prime and pull the plunger to the exact fill dose (see  FIG. 7A ).   h. Remove medication container and the syringe S combination and extract syringe S.       
 
         [0338]    Filling an Oral Syringe Using an OEM-Baxa™ Cap with Self Sealing Valve  216  (See  FIG. 5 ) 
         [0339]    As described above the standard Baxa™ cap is modified to incorporate a self-sealing valve  216  which enables an oral syringe S to enter its center hole while the medication container is positioned upside down without leaking. The Baxa™ Cap with Self Sealing Valve  216  also allows for syringes to be removed after filling without removing the medication container from the filing station  5  (see  FIG. 2  III) and repeat the filling of subsequent syringes S when a quantity of syringes are to be filled with the same medication. In the event of a scheduled shaking requirement, after a specified amount of time, the system can shake the medication without removing it from the filling station (see  FIG. 16A ). Frequency and strokes per minute are pre-programmed into the system. The sequence of operation is as follows:
       a. Remove original cap ( FIG. 19A ).   b. Baxa™ Cap with Self Sealing Valve  216  is tightened onto the neck of the container ( FIG. 19B ).   c. Medication container is turned upside down (see  FIG. 19C ). The neck of the container is placed into a slotted yoke  82 B or the self-centering spring loaded jaws  82 C ( FIG. 7B ). Since the neck of the container is held on center by the slotted yoke  82 B, or the self-centering spring loaded jaws  82 C the opening to the Baxa Cap with Self Sealing valve  216  will be properly aligned with the syringe S and the mechanism for filling the syringe S by pulling the syringe plunger downward. (see  FIG. 19C ).   d. The medication container platform  79  is lowered to securely hold the medication container in place onto either the Yoke  82 A (see  FIG. 19C ).   e. If the medication container needs to be shaken, it is shaken at the programmed speed, duration and frequency (see  FIG. 16A ).   f. The syringe S tip is inserted up, into the Baxa Cap with Self Sealing Valve opening  216 .   g. The syringe S is filled by the syringe gripping arms  110 ,  111  and  112  which engage the syringe S plunger, prime and pull the plunger to the exact fill dose (see  FIG. 19D ).   h. The syringe is unclamped by the filler finger grippers  78  and the syringe is removed from the Medication container ( FIG. 19D ).   i. If additional syringes S need to be filled with the same medication, the process is repeated.   j. When all syringes have been filled with the medication, the platform  79  rises and the medication bottle is removed.   k. This process continues until all syringes for that prescription production run have been filled.       
 
         [0351]    Filling a Syringe Using a PIBA (No Valve)  210  (See  FIG. 5 ) 
         [0352]    If a medication container with valveless PIBA  210  requires shaking, this must be done either manually or with the optional free standing shaker ( FIG. 17 ). This must be repeated every time shaking is required regardless of whether the same medication is being filled into multiple syringes. The original cap must be placed over the Medication bottle and its press-in insert, during storage, to ensure cleanliness. The sequence of operation is as follows:
       a. Remove medicine bottle cap ( FIG. 20A ).   b. The valveless PIBA  210  is inserted into the neck of the container ( FIG. 20B ).   c. The syringe S is inserted into the valveless PIBA  210  ( FIG. 20C ).   d. The medication container and the syringe S combination are rotated up-side-down. ( FIG. 20D ).   e. The medication container and syringe S combination are placed into the filling station  5  via Yoke  82 B or Self-Centering jaws  82 C ( FIG. 20E ).   f. After filling, the medication container and syringe S combination are removed from the filling station  5 .   g. The medication container and syringe S combination are then up-righted ( FIG. 20C ), and the filled syringe is then removed from the medication container.       
 
         [0360]    Filling a Syringe S Using a PIBA (with Valve)  212 / 225  (See  FIGS. 5 and 44 ) 
         [0361]    The Self Sealing PIBA Insert  212  is pressed into the neck opening of a medication container and enables an oral syringe S to enter its center hole and withdraw an amount of liquid from the medication container while the medication container is positioned upside down. In addition, it also enables the syringe to be removed without leaking and the medication container to be shaken at the fill station  5  ( FIG. 2  III), while it is positioned upside down and without leaking. The self sealing PIBA insert  212  also allows for syringes S to be removed after filling without removing the medication bottle and repeat the filling of subsequent syringes S in cases where a quantity of syringes S are to be filled with the same medication. In the event of a scheduled shaking requirement, after a specified amount of time, the system can shake the medication without removing it from the filling station (see  FIG. 16A ). Frequency and strokes per minute are pre-programmed into the system. The sequence of operation is as follows:
       a. Remove medicine bottle cap ( FIG. 21A ).   b. The self sealing PIBA insert  212  is inserted into the neck of the container ( FIG. 21B ).   c. The medication container is turned upside down ( FIG. 21C ).   d. The neck of the container is placed into the Self Centering Jaws  82 C or Yoke  82 B ( FIG. 21D ) Since the neck of the container is held on center by the yoke  82 B or Self Centering Jaws  82 C, the opening to the self sealing PIBA insert  212  will be properly aligned with the syringe S and the mechanism for filling the syringe.   e. The medication container platform  79  is lowered to securely hold the medication container in place on the Self Centering Jaws  82 C (see  FIG. 21D ).   f. If the medication container needs to be shaken, it is shaken at the programmed speed, duration and frequency (see  FIG. 16A ) while still held in the filling station  5 .   g. The syringe S is inserted into the self sealing PIBA insert  212  opening ( FIG. 21E ).   h. The syringe is filled.   i. The syringe is removed from the medication container.   j. If additional syringes need to be filled with the same medication, the process is repeated while the medication bottle remains held within the filler.   k. When all syringes S have been filled with the medication, the medication container is removed.   l. This process continues until all syringes for that prescription production run have been filled.       
 
         [0374]    Filling an Oral Swine Using a Valved Self-Sealing Two Piece Cap with Common Outer Diameter  220 ,  221  (See  FIG. 5 ) 
         [0375]    As described above, the cap comprises a common outer diameter portion and either an insertable or integrally-formed self-sealing insert which enables an oral syringe S to enter its center hole while the Medication container is positioned upside down without leaking. The valved self-sealing one or two-piece cap  220 ,  221  also allow syringes to be removed after filling without removing the medication container from the filing station  5  (see  FIG. 2  III) and repeat the filling of subsequent syringes S when a quantity of syringes are to be filled with the same medication. In the event of a scheduled shaking requirement, after a specified amount of time, the system can shake the medication without removing it from the filling station (see  FIG. 16A ). Frequency and strokes per minute are pre-programmed into the system. The sequence of operation is as follows:
       a. Remove original cap ( FIG. 19A ).   b. Valved self-sealing one or two piece cap  220 ,  221  is tightened onto the neck of the container ( FIG. 19B ).   c. Medication container is turned upside down (see  FIG. 19C ). The neck of the container is placed into a slotted yoke  82 B or the self-centering spring loaded jaws  82 C ( FIG. 7B ). Since the neck of the container is held on center by the slotted yoke  82 B, or the self-centering spring loaded jaws  82 C the opening to the cap  220 ,  221  will be properly aligned with the syringe S and the mechanism for filling the syringe S by pulling the syringe plunger downward (see  FIG. 19C ).   d. The medication container platform  79  is lowered to securely hold the medication container in place onto either the Yoke  82 A (see  FIG. 19C ).   e. If the medication container needs to be shaken, it is shaken at the programmed speed, duration and frequency (see  FIG. 16A ).   f. The syringe S tip is inserted up, into the cap opening  220 ,  221 .   g. The syringe S is filled by the syringe gripping arms  110 ,  111  and  112  which, in concert with arm  128 , engage the syringe S plunger, prime and pull the plunger to the exact fill dose (see  FIG. 19D ).   h. The syringe is unclamped by the filler finger grippers  78  and the syringe is removed from the Medication container ( FIG. 19D ).   i. If additional syringes S need to be filled with the same medication, the process is repeated.   j. When all syringes have been filled with the medication, the platform  79  rises and the medication bottle is removed.   k. This process continues until all syringes for that prescription production run have been filled.       
 
         [0387]    Filling a Syringe S Using a Push-in Tip  223  for Interfacing with Luer Lock Oral Syringes (See  FIGS. 27-28 ) 
         [0388]    The push-in tip  223  is pressed into the nozzle opening of a Baxa™ or Baxa™-equivalent manufacturer-supplied medication container cap ( FIG. 27 ) or PIBA cap ( FIG. 28 ). If a medication container with push-in tip  223  requires shaking, this must be done either manually or with the optional free standing shaker ( FIG. 17 ). This must be repeated every time shaking is required regardless of whether the same medication is being filled into multiple syringes. A protective cap  223 C must be placed over the Medication bottle during storage, to ensure cleanliness. The sequence of operation is as follows:
       a. The push-in tip  223  is inserted into the nozzle opening of a Baxa™ or Baxa™-equivalent manufacturer-supplied medication container cap ( FIG. 27 ) or PIBA cap ( FIG. 28 ).   b. The syringe S is inserted into the push-in tip  223  ( FIGS. 27C and 28C ).   c. The medication container and the syringe S combination are rotated up-side-down.   d. The medication container and syringe S combination are placed into the filling station  5  via Yoke  82 A, Yoke  82 B or Self-Centering jaws  82 C.   e. After filling, the medication container and syringe S combination are removed from the filling station  5 .   f. The medication container and syringe S combination are then up-righted and the filled syringe is then removed from the medication container.       
 
         [0395]    Filling a Syringe S Using a Push-Pull Cap  224  for Use with a PIBA or Baxa™ or Baxa™-Equivalent Medication Container Cap and Luer Lock Oral Syringe ( FIGS. 29-32 ) 
         [0396]    The push-pull cap  224  is inserted over the nozzle of a Baxa™ or Baxa™-equivalent manufacturer-supplied medication container cap ( FIG. 29 ) or into the nozzle of a PIBA ( FIG. 31 ). Alternately, push-pull cap  224  is made integral with either a Baxa™ or Baxa™-equivalent manufacturer-supplied medication container cap ( FIG. 30 ) or a PIBA ( FIG. 32 ) enabling the integral cap to be screwed directly onto or pushed directly into the neck opening of a medication container, respectively. All of these arrangements enable an oral syringe S to enter the center hole of cap  224  and withdraw an amount of liquid from the medication container while the medication container is positioned upside down. In addition, they also enables the syringe to be removed without leaking and the medication container to be shaken at the fill station  5 , while it is positioned upside down and without leaking. The push-pull cap  224  also allows for syringes S to be removed after filling without removing the medication bottle and repeat the filling of subsequent syringes S in cases where a quantity of syringes S are to be filled with the same medication. In the event of a scheduled shaking requirement, after a specified amount of time, the system can shake the medication without removing it from the filling station (see  FIG. 16A ). Frequency and strokes per minute are pre-programmed into the system. The sequence of operation is as follows:
       a. For integral push-pull caps  224 , remove medicine bottle cap; for separable push-pull caps  224 , insert push-pull cap  224  directly over or into a Baxa™ or Baxa™-equivalent manufacturer-supplied medication container cap, respectively.   b. The medication container is turned upside down.   c. The neck of the container is placed into the filling station.   d. The medication container platform  79  is lowered to securely hold the medication container in place at the filling station  5 .   e. If the medication container needs to be shaken, it is shaken at the programmed speed, duration and frequency (see  FIG. 16A ) while still held in the filling station  5 .   f. The syringe S is inserted into the nozzle  90  of push-pull cap  224 .   g. The syringe is filled.   h. The syringe is removed from the medication container.   i. If additional syringes need to be filled with the same medication, the process is repeated while the medication bottle remains held within the filler.   j. When all syringes S have been filled with the medication, the medication container is removed.   k. This process continues until all syringes for that prescription production run have been filled.       
 
         [0408]    In the future, for drug anti-counterfeiting purposes, medication containers may include 2D barcodes applied to them by the manufacturers with unique ID numbers and other data. Consequently, medication containers may be supplied to the pharmacies with a pre-applied 2D barcode providing a unique ID number and other medication-related data. When this is the case, the system does not require that a special barcode label with information on the medication be generated and attached to the base of the medicine container. The medication Container Login &amp; Orientation Station  1  may be bypassed and/or omitted entirely, and the manufacturer&#39;s barcode on the container is utilized. A track, trace and control system is similar to the OSPS previously described is provided. The objective of the simplified syringe filling and labeling system is to ensure that the proper medication is filled into the syringe and that the syringe is labeled correctly. If an optional weight check or volume check station is utilized, the proper amount of fill can be verified. The system minimizes downtime as well as processing time to take and fill orders, and is easy to clean and capable of maintaining an environment free from cross contamination. The system is open and accessible and allows interaction and oversight by a human operator at multiple points in the operation. Moreover, it is modular and permits a differing and upgradeable level of operator participation (from a syringe filling device only to a semi-automated combination of labeling, filling, inspection, capping, and/or bagging functionality) based on the need of the individual institution. 
         [0409]    It should now be apparent that the above-described system is driven by prescription orders in a just-in-time environment, manages all the various prescription containers containing the pharmaceuticals to be dispensed, as well as variously-sized oral syringes, to automatically converge them and orient, fill, label and cap each syringe and fully verify its work as it proceeds in order to avoid medication errors in the process. The pharmacy automation system for oral syringes substantially improves the pharmacist and technician productivity and maintains an environment free from cross contamination. 
         [0410]    In all the above-described embodiments, the entire system is modular and permits an upgradeable core based on the need of the individual institution. Optional system components such as the label photographing station  98  resident at the Medication Container Orientation and Log-In Station may be purchase and added to the system subsequent to the original purchase. 
         [0411]    Having now fully set forth the preferred embodiment and certain modifications of the concept underlying the present invention, various other embodiments as well as certain variations and modifications of the embodiments herein shown and described will obviously occur to those skilled in the art upon becoming familiar with said underlying concept. It is to be understood, therefore, that the invention may be practiced otherwise than as specifically set forth in the appended claims and may be used with a variety of materials and components. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains. 
       STATEMENT OF INDUSTRIAL APPLICABILITY 
       [0412]    In hospitals around the world, many types of liquid medications are necessarily administered orally to patients who cannot or are unwilling to receive the same medications by injection. Thus, for a typical hospital, it may be necessary to fill hundreds or thousands of oral prescriptions each year by removing the prescribed amount of liquid medication from a bulk liquid medication container and placing it into an oral syringe in a clean environment. Filling an oral syringe prescription incorrectly, by placing the wrong medication, the wrong dosage, by mislabeling the syringe such that it is received by the wrong patient, etc., can be harmful or even fatal to the patient who receives the medication (and to the patient who does not receive the proper medication). In addition, it is often necessary to rapidly fill prescriptions for oral syringes to promptly treat patients needing the liquid medication. A system for quickly and accurately filling several oral syringes in a hospital setting would greatly increase patient safety and treatment quality. The present invention is a system and methods for the semi-automated filling, bagging, and labeling of several oral syringe prescriptions, wherein each step in the filling, bagging and labeling procedure is performed at least in part by, and monitored and tracked by, a device controlled by a programmable controller which may interface with a hospital prescription database to further eliminate errors in filling oral syringes.