Patent Publication Number: US-2022219842-A1

Title: Closed convenience kits for sterilized medicine preparation

Description:
CONTINUATION-IN-PART 
     This Patent Application is a CONTINUATION-IN-PART of U.S. patent application Ser. No. 16/873,780, titled BAGGED BOTTLE FILLING AND CAPPING DEVICES AND METHODS submitted by Gale H. Thorne, Jr., et al., and contains information related to U.S. Pat. Nos. 10,555,872 B2, 10,800,556 B2 and 10,940,087 B2 but includes methods, applications and breadth of scope, unforeseen and not disclosed therein by the inventors. 
    
    
     FIELD OF INVENTION 
     Inventions disclosed herein relate generally to convenience kits and associated applications for medical procedures involving steps for mixing, sterilizing, transferring and capping medicine containers which require sterile conditions in processing, storage and pre-use. Of particular note, the convenience kits and methods of use are applied to steps which can occur in a potentially contaminating environment and still produce a sterile product. Therefore, the field of invention is particularly related to sterile kits (disposed within convenience kits) and to methods which employ preassembled parts provided sterilized within the protective enclosure of a closed and sealed apparatus having only a pathway or pathways into the apparatus through sterilizing assemblies which are primarily used for introducing medical product therein, thereby providing a protectively packaged sterile product without requiring employment of a laminar flow hood or other sterilization assurance level (SAL) product manipulating devices. Each convenience kit is a single use tool which is specifically designed and assembled to be used in preparation of a particular medicine. 
     BACKGROUND AND DESCRIPTION OF RELATED ART 
     U.S. Pat. No. 10,555,872 B1 (patent 872) discloses and claims a convenience kit for sterilizing and delivering liquids into the safety of a. sterile environment inside a plastic bag (which can be disposed in a potentially contaminating field environment) wherein a sterilized liquid is dispensed into a bottle which is capped and sealed before removal from the bag. The patent 872 convenience kit can be provided in a solitary format or, as a subkit, combined with other associated items in a more inclusive convenience kit. In short, convenience kits made, fin example, according to U.S. Pat. No. 10,555,872 B1, provide opportunity for accomplishing an aseptic liquid sterilizing transfer, a task which is commonly associated with capability of a laminar flow hood or other similar equipment, in field environments and other areas which are remote from facilities having such equipment, 
     Because kit items made and used according to the present inventive sterile kit cannot be removed or replaced without affecting sterility, a complete set of items required for sterile kit performance for a specific sterilizing and filling application must be provided as a closed system which is sealed and sterilized before use. Because particular kit applications are kit specific and have specific application and item requirements, methods and apparatus used for such applications often require novelty in selection and method of use, resulting in a special kit with novel features and uses being specifically designed for each such different application. 
     Thus, novel items disclosed and claimed hereafter provide means for performing unique kit single use functions which deviate and are not obvious from disclosures in prior related patents, published patent applications and other methods and apparatus in the public domain, while providing for quality kit prepared products using unique combinations of item design and selection for meeting each specific product application requirement. 
     As background mixing and compounding of medications, in a pharmacy or other medical facility, conventional techniques involve use of laminar flow hoods and other “closed” systems and strict aseptic technique and facilities to maintain sterility. Because of such, the United States Pharmacopeia Convention (USP) has found it necessary to establish standards, currently published in a Chapter titled (797) PHARMACEUTICAL COMPOUNDING—STERILE PREPARATIONS (referenced hereafter as Chapter 797), being a latest revised version dated 2021. The term “closed” has been italicized because equipment used is, in reality, open to the exterior environment, but employ various controls such as laminar flow to create as closed an environment as possible. Such systems permit a high variety of sterile preparation to occur within the same environment, but each substance or device to be manipulated within the sterile field must be introduced in a manner requiring special training, standards and precautions to assure maintenance of product sterility in multi-use systems. This requirement establishes the basis for a significant portion of the current, revised Chapter 797. In the second paragraph of the INTRODUCTION of Chapter 797, the following comment is made concerning touch contamination:
         Despite the extensive attention in this chapter to the provision, maintenance, and evaluation of air quality, the avoidance of direct or physical contact contamination is paramount. It is generally acknowledged that direct or physical contact of critical sites of CSPs with contaminants, especially microbial sources, poses the greatest probability of risk to patients. Therefore, compounding personnel must be meticulously conscientious in precluding contact contamination of CSPs both within and outside ISO Class 5 (see Table 1) areas.       

     It is well understood that standards for sterility and safety as disclosed in Chapter 797 are, at least, minimum and well worth abiding. However, providing a sterilizing pathway into the environment of a sterilized bag or other closed system containing pre-assembled and pre-sterilized components which can be filled with sterile product and manipulated external to the sterile environment, almost entirely, eliminates the possibility of contact contamination. As such, such a device renders moot many of the precautions recommended by 797 for manipulation of sterile product within the quasi-closed environment of a flow hood. 
     First, it should be recognized that the bag or container used for this invention and items therein represent a truly closed and continuously sterile system, because only matter sterilized by filtering can be delivered into the container permitting container contents to maintain a predetermined SAL. Such apparatus as this type of a closed system varies significantly from a quasi-closed system where sterile processing must be performed by highly skilled and extensively trained professionals using special techniques in scrupulously clean environments in order to maintain a desired sterilization assurance level (SAL). Unless the above disclosed closed container of the instant invention is damaged, concerns pertaining to the following items of Chapter 797 are significantly reduced or of no consequence:
         1. Garbing to maintain product sterility;   2. Training for proper use of laminar flow hoods and other like equipment which is not required by a sterile bag or other truly closed and sterilized system;   3. Protecting and sampling airborne contaminates; and   4. Monitoring and cleaning surface contaminates surrounding the production site. Of course, items used within the bags should not be pyrogenic.
 
Thus, it is considered a major object to define apparatus and methods for making and using truly closed and sterile kits into which all fluid, which is dispensed therein, is sterilized to preserve a desired in-container SAL which is an inventive aim of apparatus and methods disclosed hereafter.
       

     Convenience kits have become commonly used appliances in medicine for a number of reasons. First, each convenience kit is usually made for a specific application. Contents, of each such kits, are prepared and provided in a form which most often reduces procedure steps and improves efficiency. Second, such kits can provide effective safety such as the kit disclosed in U.S. Pat. No. 9,449,521, titled METHODS FOR MAKING AND USING A VIAL SHIELDING CONVENIENCE KIT, issued May 28, 2013, which proved effective in providing additional safety to technicians and patients by keeping hazardous drug liquid and fumes fully contained. 
     For reasons cited supra and because of Chapter 797&#39;s allowance for mixing and delivery of medical product within a short time limit indicates acceptance of all facets of product production except for maintaining a desired SAL (underlining for emphasis), preparing sterile product in pre-sterilized sealed bags or containers provides a novel opportunity for medical product preparation safety. Whereas aseptic production of CSPs using current methods depends on the training and technique of the personnel involved, the novel system presented here provides improved safety as aseptic production of CSPs is completely independent of the training or technique of the user. As such, garbing, training, facility management, cleaning and monitoring issues, as exemplified by USP Chapter 797 should be reconsidered for applications employing sterile kits made in accordance with the instant invention and provided as disclosed and referenced herein. 
     Terms and Definitions 
     Following is a list of terms and associated definitions which may be used herein, being provided for clarity and understanding, if and when used, to better disclose precepts of the instant invention: 
     Chapter &lt;797&gt; Terms and Definitions: 
     
         
         CSP (abbreviation) for: Compounded Sterile Preparation, a preparation intended to be sterile by combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug product or bulk drug substance. 
         Category 1 CSP: A CSP that is assigned a BUD (Beyond Use Date) of 12 hours or less at controlled room temperature or 24 hours or less refrigerated that is compounded in accordance with all requirements for Category 1 CSPs in Chapter &lt;797&gt;. 
         Category 2 CSP: A CSP that is assigned a BUD (Beyond Use Date) of greater than 12 hours at controlled room temperature or greater than 24 hours, refrigerated that is compounded in accordance with all requirements for Category 2 CSPs in Chapter &lt;797&gt;. 
         Immediate Use CSP: A CSP compounded for use within a four hour period and not subject to the requirements of Category 1 or Category 2 CSPs. (Must use aseptic processes performed in accordance with evidence based information, not involving more than 3 different products, discarding unused product, and appropriate labeling.) 
       
    
     Other Terms and Definitions: 
     
         
         at least one, n: one or more 
         apportioning device, n: a fluid dispensing instrument from which a measured quantity can be dispensed 
         bottle, n: a container for holding a quantity of medicine 
         chamber, n: an enclosed sterile space or cavity by which, according to the instant invention, liquid is displaced into containers, then capped within the sterile environment to prepare a sterile medicine for use outside the chamber. 
         convenience kit, n: (according to the instant invention) a self-contained, single-use convenience kit designed and assembled for preparing a specific medical product, each such kit comprising a sterile kit, a preparation (“prep”) kit providing any supporting items required exterior to the sterile kit, other parts associated with transport, instruction and packaging and waste disposal. 
         manifold connection, n, an interconnected channeling comprising four orthogonally disposed pathways with luer fittings affixed to each pathway 
         dead space, n: a volume of inaccessible fluid which is retained within a device after a procedure 
         digital, adj: relating to, or performance with thumb or fingers 
         ETO, n: acronym for ethylene oxide, a powerful sterilizing agent 
         field of use, n: a location in an uncontrolled environment in which potentially health-hazardous materials are present. 
         filter, n: a fluid transferring product using filtering material having a sufficiently small porous matrix to impede passage there through of a particulate of predetermined size; a medical grade sterilizing filter generally has a 0.2 micron pore size. 
         filter assembly, n: (a.k.a a sterilizing assembly) an apparatus which comprises a filter component whereby one of the opposing fittings is disposed for communicating fluid into a chamber which is closed and sterilized to a predetermined SAL, the filter assembly providing throughput for a fluid which is displaced therethrough into the chamber to ultimately fill a container with sterilized liquid. If the chamber is the inside of a bag, the communication pathway is via a hole in the bag, the hole being closed and sealed about the hole; if otherwise, the communication pathway is via fittings providing fluid flow into a chamber formed by the fittings and therefrom into receiving containers. 
         filter component, n: a component and housing having a pair of opposing fittings providing communicating conduits to and from a filter whereby a fluid is sterilized to a predetermined SAL when displaced therethrough. 
         fitting, n: a medical connector 
         formulate, v: to prepare a substance for use; when used for medicine preparation, it is understood preparation is according to a specific prescription 
         free plunger, n: a syringe plunger which is unattached to a plunger rod while the syringe is filled 
         insulated wrap, n: a flexible container which may be a bag or folded shield which is refused to provide a container in which enclosed parts can be maintained at a reduced temperature 
         interface gasket, n: an elongated hollow tube that is sized, shaped and disposed to be affixed along a filter component or other component conduit about a hole in a plastic bag and thereby provide a fluid tight seal about the hole in the bag 
         kit, n: a group of parts, provided within a single package for a particular, designated use 
         laminar flow hood, n: (a fume hood) a work-place enclosure in which micro-filtered air flow is directed to preclude, to a predetermined extent, contamination of sterile materials by airborne organisms 
         luer fitting, n: a medical connector having a frustoconically shaped connecting geometry which is in common use in medical practice 
         luer lock fitting, n: a luer fitting having a locking mechanism whereby a male and a female connector are securely, but releasably affixed one to the other 
         noninferior, adj: equal to or better than the object at hand 
         plastic bag, n: a sturdy container made of clear, pliant, sterilizable material which is sealed to provide a totally enclosed product shroud after displacing devices for use therein, the material being sufficiently pliant to permit digital product handling from outside the container 
         plate, n: a planar sheet of material comprising a pattern of holes in which caps are stored for capping containers, such as eye drop bottles 
         port or portal, n: an orifice site where through fluid is communicated (generally associated with a sealed conduit disposed there through) 
         prep kit, n: a part of a convenience kit, according to the present invention, which comprises items required exterior to a sterile kit for preparing a medical product 
         radiation, n: generally, gamma radiation imposed with sufficient intensity and time to sterilize a product to a desired SAL (sterility assurance level) 
         sterile chamber n: space within a sterile kit which is physically enshrouded, protected and maintained at a sufficiently low SAL to assure displacement of preparations there through, without undue contamination, the only fluid pathway for fluid entering into the chamber being a sterilizing device (e.g. a filter) by which all such fluid is sterilized to a predetermined SAL 
         sterile kit n: a separate kit which is part of a convenience kit prepared according to the present invention, the sterile kit comprising a closed chamber which is pre-sterilized, along with all devices provided therein and affixed thereto, to a predetermined SAL, and providing at least one pathway or into the chamber via sterilizing devices, such as a medical grade sterilizing filter; as an example, the closed chamber may be a plastic bag or a fluid pathway through a manifold. 
         tray, n: a convenience kit container, comprising a pattern of holes sized and shaped to securely hold liquid receiving vessels through filling, capping, and transporting 
         unitized, adj: a plurality of parts permanently joined to be handled and used as a single unit 
       
    
     BRIEF SUMMARY AND OBJECTS OF THE INVENTIONS 
     In brief summary, inventions disclosed herein broaden the scope of uses for convenience kits for sterilizing, capping and filling in manners not disclosed by related art by providing different, non-obvious and new uses for convenience kits related to mixing, dispensing and providing an enclosed sterile space (a sterile chamber) in which a sterile liquid medicine is prepared for use outside each kit in what may be a potentially contaminating field environment. 
     Currently, medical preparations that must be delivered sterile are produced under guidance of USP Chapter 797 within the confines of a fume or laminar flow hood in a pharmacy or laboratory facility. As such, current practice prohibits preparation and delivery of sterile products at any site remote from such Chapter 797 compliant facilities, greatly limiting access to such important sterile preparations to many medical professionals and their patients where such advanced facilities do not exist or are inadequate to fill the scope of need. It is for the purpose of fulfilling this need that the instant inventions comprising the methods and single-use convenience kit assemblies are disclosed and claimed herein. A summary comparison of sterile kit compliance with 797 standards is provided in Table 1 below: 
     
       
         
           
               
             
               
                 TABLE 1 
               
             
            
               
                   
               
               
                 Comparison of USP 797 Standards and Sterile Kit  
               
               
                 manufacture and use standards 
               
            
           
           
               
               
               
            
               
                   
                   
                 Sterile Kit Environment,  
               
               
                   
                 USP Standard  
                 according to present 
               
               
                 Description 
                 Environment 
                 invention 
               
               
                   
               
               
                 Filtration into  
                 HEPA Filters  
                 Syringe filters (0.2 micron) for  
               
               
                 environment 
                 (0.3 microns) 
                 entry into a sterile chamber 
               
               
                 Anteroom 
                 Required 
                 All Sterile Kits are manufactured  
               
               
                   
                   
                 using an anteroom and 
               
               
                   
                   
                 buffer room inside a certified  
               
               
                   
                   
                 clean room environment as 
               
               
                   
                   
                 required to minimize particulates.  
               
               
                   
                   
                 HEPA filters are used 
               
               
                   
                   
                 in these clean rooms with air  
               
               
                   
                   
                 flow controls. Regularly 
               
               
                   
                   
                 scheduled testing is performed  
               
               
                   
                   
                 to certify clean room 
               
               
                   
                   
                 standards. 
               
               
                 Buffer Room 
                 Required 
                 All Sterile Kits are assembled  
               
               
                   
                   
                 inside a certified buffer 
               
               
                   
                   
                 room as required to meet GMP  
               
               
                   
                   
                 standards for medical 
               
               
                   
                   
                 devices. 
               
               
                 Garbing 
                 Required for all  
                 Garbing requirements are met  
               
               
                   
                 clean room 
                 during manufacture of the 
               
               
                   
                 operations 
                 Sterile Kit. Use of the kit does  
               
               
                   
                   
                 not require garbing since 
               
               
                   
                   
                 all fluids must pass through  
               
               
                   
                   
                 a sterile filter into the filling 
               
               
                   
                   
                 environment of a sterile chamber. 
               
               
                 Terminal 
                 Drug/admixture  
                 Sterilized bag or other sterilized  
               
               
                 Sterilization 
                 dependent. 
                 container associated with 
               
               
                   
                 Not all drugs can  
                 the instant invention is sterilized  
               
               
                   
                 be terminally 
                 following kit assembly, 
               
               
                   
                 sterilized. 
                 All fluids are terminally sterilized  
               
               
                   
                   
                 upon injection through 
               
               
                   
                   
                 the .2 micron filter and  
               
               
                   
                   
                 delivery to a sterile filling 
               
               
                   
                   
                 chamber. 
               
               
                 Sterility testing 
                 Sampling  
                 Sterile Kit sterilization is  
               
               
                   
                 method—cannot  
                 confirmed in each  
               
               
                   
                 test 
                 bag or device 
               
               
                   
                 all finished  
                 using a marker. GMP practices  
               
               
                   
                 admixtures. 
                 assures product integrity 
               
               
                   
                 Sterility of all  
                 including low particulate  
               
               
                   
                 compounded 
                 requirements during assembly 
               
               
                   
                 solutions is based  
                 in a certified clean room. All  
               
               
                   
                 on statistical 
                 fluids delivered through the 
               
               
                   
                 analysis. 
                 filter assembly are filtered  
               
               
                   
                   
                 through .2 micron filters. 
               
               
                 Environmental 
                 Defined in  
                 As described supra, clean  
               
               
                 testing 
                 USP 797 
                 rooms used for Sterile Kit 
               
               
                   
                 documents,  
                 assembly meet all environmental  
               
               
                   
                 including but not 
                 testing requirements 
               
               
                   
                 limited to: 
                 associated with clean room  
               
               
                   
                 Glove testing 
                 assembly. Compounding 
               
               
                   
                 Air flow 
                 steps during use of Sterile  
               
               
                   
                 Surfaces 
                 Kits involve sterile technique- 
               
               
                   
                   
                 independent processing.  
               
               
                   
                   
                 A sterile, filtered environment 
               
               
                   
                   
                 during manufacture eliminates  
               
               
                   
                   
                 bacteria and particulates 
               
               
                   
                   
                 greater than .2 microns  
               
               
                   
                   
                 within the sterile chamber. 
               
               
                   
                   
                 Disposable, single use kits  
               
               
                   
                   
                 provide a new “facility” and 
               
               
                   
                   
                 new sterile “environment”  
               
               
                   
                   
                 for each compounding 
               
               
                   
                   
                 process. 
               
               
                 Regular 
                 Required and  
                 Each sterile chamber provides  
               
               
                 environment 
                 technique 
                 a new, clean environment 
               
               
                 cleaning 
                 dependent for  
                 that is guaranteed sterile 
               
               
                   
                 environment 
                   
               
               
                   
                 sterility 
                   
               
               
                 Environment 
                 Meets USP  
                 Meets and exceeds USP  
               
               
                 comparison 
                 Chapter 797 
                 Chapter 797 environment 
               
               
                 Summary 
                 environment  
                 requirements 
               
               
                   
                 requirements 
               
               
                   
               
            
           
         
       
     
     In summary, sterile kits made according to the present invention, meet or exceed all required USP 797 requirements for a sterile admixing environment. In effect, the sterile kit creates (via a sterile chamber) a smaller version of a clean room where all activities relative to compounding are completed within the “facility” and “environment” of the fluid filling system. 
     Thus, it is a major object of invention disclosed herein to provide examples of alternate ways and means for achieving the intent and purpose of USP Chapter 797 by ways not currently possible or available with contemporary convenience kits or other modes of production. 
     The core item of each inventive kit made according to basic inventive properties of kits for sterilizing, filling and capping under strictly sterile conditions is a sterile kit having a sterile chamber comprising either product preparation within a closed pre-sterilized bag assembly or other closed system wherein containers may be filled and capped or within a strictly closed pre-sterilized interior pathway formed by conventional medical devices and fittings for fluid delivery which is securely affixed in fluid tight relationship with recipient closed containers. If such an item is a bag, the bag should be made from material that is not only pliant, but also sufficiently thick and hardy to permit digital interfacing without breaching, transparent to permit visual feedback and sealable to assure maintenance of sterility until purposely opened for access to capped and sealed preparations. Strictly closed systems should be provided by proved bags, connectors, tubes and other commercial devices which have a long and successful history of being able to be sterilized and maintain sterility when used properly: 
     Generally, within the scope of each of the instant inventions, there is at least one fluid pathway into each sterile chamber through a sterilizing assembly whereby fluid is sterilized to a desired SAL by flowing therethrough. If there are multiple fluid pathways, each pathway is provided with a sterilizing input assembly. 
     Prior related art has disclosed methods and apparatus for achieving objectives of sterilizing, filling and capping bottles, such as eye drop bottles, which are filled by dispensing liquid through open, superiorly disposed orifices which, for example, are used for autologous serum eye drops. However, the need and opportunity for applying other novel forms of the closed sterilization and filling technology is much broader, as exemplified by the breadth and comprehensiveness of USP Chapter 797. It is, therefore, a major object to provide novel methods and apparatus for satisfying needs for broadening use and, yet, strictly meeting (being “noninferior” in meeting) sterility requirements in medical product genesis. 
     In all cases, each convenience kit, made according to the instant invention, will be provided with a sterile kit having a sterile chamber in some form. Each such kit will only be used just once. Other items within the convenience kit, but separate from the sterile kit, are provided as needed to meet auxiliary medication, transport, disposal and instruction requirements. In all cases, where bags form the truly closed system, consideration should be given to facilitating in-bag manipulations from the bag exterior. Novel apparatus and methods for various kinds of medicine preparation are provided in the following examples. 
     A tray is disclosed in the cited prior art which employs bottle holding wells which are closed at the bottom. It has been found, in some cases, that contact, through the bag, permitting digital access to the bottom of a container or bottle is useful and sometimes necessary, for example, in securely tightening a cap onto a. bottle to preserve out-of-bag sterility. For this reason, a tray which has a through hole for bottle assembly and rigid containment about the mid-portion of the bottle provides significant advantages. For this purpose, it is an object to provide a tray, having holes where through a bottle is displaced and still firmly held thereat, as disclosed and claimed herein. 
     Novel methods and kits for sterilizing, filling and capping containers within a closed sterile environment must be varied by the specific requirements for doing such for each medicine being prepared using a kit made according to the instant inventions. As an example, fortified antibiotic eye drops generally require only a limited number of eye drop bottles, usually two to four, but, because effective eye drop bottles are usually not sufficiently clear to permit a visual inspection of a compounded drug in all cases, a clear, preferably glass, spare additional bottle may he provided for quality assurance purposes. Thus, by example, it is another object to provide such a kit with a plurality of fillable and cap-able containers, including eye drop bottles and a quality assurance bottle. 
     Medical preparations associated with administering Avastin is an excellent example of need for a special convenience kit. Avastin is delivered by injection into the eye using a medical syringe and needle rather than by drops. Due to the physiologic attributes of the site of an Avastin injection, it is required to use syringes which are silicone-free with both syringes and medicine sterilized to a predetermined SAL. Such syringes should be filled and stored under strict conditions before use. Also, there is a range of kit requirements associated with the number of steps required for syringe filling which should be considered and reduced where possible. It is therefore another object to provide a sterile kit in which one or more syringes are filled with a sterile product delivered in a sterile environment. It is another object to provide a kit made according to the present invention by which multiple syringes are filled with a single dispensing stop. 
     Preparations of medicines involving oncology or other hazardous drugs require special care for safety in handling as well as need for sterility. As an example, mitomycin preparation, for pad soaking, may require reconstitution of a lyophilized form of the drug along with providing the drug sterile in a closed and exteriorly sterile container such that it can be manipulated on a sterile field; it is an object to provide such. 
     Also, there is a matter of hazardous drug fume release when a vial containing a hazardous drug vial is spiked for fluid withdrawal. For this purpose, it is an object to provide a closed dual bag system kit whereby an oncology drug vial is disposed within a first bag, septum pierced and drug withdrawn therefrom, and delivered to a second bag for container filling through a closed pathway, whereby all hazardous drug remains enclosed until packaged for safety for later distribution and use. It is therefore an object to provide a sterile kit comprising two basic functions of enclosing a hazardous drug vial when piercing the vial septum and delivering the drug to an enclosed receiving vessel which is capped and provided closed before delivery of the drug to a place of use. 
     In the case of medicine delivered via syringe and needle, there are needs for priming gas from the syringe, while maintaining needle coverage until bared for immediate use and for restricting spread of syringe contents when priming. It is, therefore, an object to provide a priming cap for a medical needle and use thereof as disclosed herein. 
     Because kits made according to the instant invention are designed and made for specific compounding purposes, different sterilizing methods can be employed for addressing sterilization in each kit within the scope of the instant invention. As an example, light sterilization can be used within the scope of the instant invention, wherein fluid flowing into a hag is sterilized by light of a sterilizing frequency upon being displaced into the pathway into the bag. When conditions allow, heat may also be used within the scope of the inventions. However, currently, the most convenient and effective means of fluid sterilization is a medical grade (i.e. 0.2 micron) filter as disclosed in all examples provided hereafter. In summary, for all examples, disclosed herein, it is an object to provide in-flow sterilization into a sterile filling chamber via a sterilizing filter assembly. 
     For reasons mentioned supra and for providing devices and convenience kits which can be used to prepare product which meets USP Compounding Standards, the following objects of invention are hereafter provided. 
     It is a major object to provide a plurality of kits wherein each kit, selectable from other kits, has an associated sterility producing design which is proved effective for formulating a pre-specified medicine and made according to the instant invention. Therefore, each such sterile kit is characterized by at least one totally closed sterile chamber, which is pre-sterilized to a predetermined SAL; each sterile kit comprising fluid access only through a medical grade sterilizing filter such that all fluid dispensed into the sterile chamber is sterilized to a predetermined SAL. Thus, medicine formulated therein is sterilized and fully enclosed in vessels provided as part of a sterile kit which are capped and closed until provided for use. Each convenience kit (and associated sterile kit) is understood to be used just once. 
     It is a primary object to provide a convenience kit which can safely and effectively provide a method for producing and providing a plurality of syringes filled with medicine sterilized to a desired SAL, closed until used, for example, for dispensing Avastin. 
     It is another primary object to provide a convenience kit which is effective in filling and capping eye drop dispensing containers with an inherently sterilized preparation of fortified topical antibiotics within closed and sterile conditions. 
     It is still another primary object to provide a sterile kit for reconstituting a lyophilized drug disposed in a medical vial and displacing the reconstituted drug into a container disposed in a sterile environment, which is thereafter closed, and which meets sterile conditions for being sterile, once filled and closed. As such, drugs may be classed as being hazardous, it is also an object that an associated sterile kit be closed for drug access from a vial and further closed for delivery and filling of drug into use containers. An example of such a drug being mitomycin. 
     It is an important object to provide a bottle holding tray with a pattern of through holes for containing open and cap-able eye drop bottles within closed, sealed and sterilized environs, the holes being sized and shaped to resist bottle rotation as caps are affixed to the bottles but sized and shaped to provide digital access to the bottom of each bottle for better assurance of securely affixing cap to bottle. 
     It is a very important object to provide a needle cap for a syringe needle which provides a closed chamber wherein fluid is dispensed and held when an attached syringe is primed, further, it is preferred that the needle cap should provide visual contact of both needle tip and dispensed matter for feedback control while priming. 
     Thus, it is a global object to disclose, provide and claim a variety of convenience kits, each of which is used but once to formulate a specific medical preparation, sterilized to a predetermined SAL and made to be used for accomplishing a preparation having assured sterility and purity, examples of such being preparations of autologous blood serum eye drops, avastin, mitomycin, hazardous drugs and antibiotic fortified eye drops and provided in closed and sealed containers which, for example, can be eye drop bottles, medical syringes (sized and selected for each specific preparation), IV bag spikes and cap-able medical cups. 
     These, and other objects and features of the present inventions, will be apparent from the detailed description taken with reference to accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a pre-assembly perspective of parts of a tray assembly for an eye drop processing kit. 
         FIG. 2  is an assembled perspective of the tray assembly seen in  FIG. 1  rotated to show access to bottoms of bottles. 
         FIG. 3  is a perspective of a four-bottle tray assembly. 
         FIG. 4  is an exploded pre-assembly perspective of a bottle-plate assembly. 
         FIG. 5  is a perspective of parts in  FIGS. 3 and 4  assembled. 
         FIG. 6  is a perspective of the assembly in  FIG. 5  rotated to permit viewing of exposed bottle bottoms. 
         FIG. 7  is a perspective of the assembly seen in  FIG. 6  disposed and sealed within a plastic bag according to the instant invention. 
         FIG. 8  is an exploded pre-assembly perspective of a bottle tray assembly with a bottle dedicated for quality assurance. 
       FIG,  8 A is an exploded pre-assembly perspective of a bottle plate assembly. 
         FIG. 9  is a perspective of parts in  FIGS. 8 and 8A  assembled. 
         FIG. 10  is a top elevation of an unfilled syringe and a priming needle cap disposed within a sealed plastic bag having a fluid interface with surrounding environment through a filter assembly, according to the instant invention, some items being seen in cross section. 
         FIG. 11  is a top elevation similar to that of  FIG. 10 , but with the syringe filled. 
         FIG. 11A  is a top elevation similar to that of  FIG. 11 , but with the syringe displaced from the filter assembly and affixed to the priming needle cap. 
         FIG. 12  is a top elevation schematic of a one-at-a-time syringe filling convenience kit wherein an array of frame-held syringes is seen with a first syringe freed from a medical needle and cap and displaced to connect with a filter assembly. 
         FIG. 13  is a top elevation schematic of the one-at-a-time syringe filling convenience kit seen in  FIG. 12 , but with the first freed syringe removed from the filter assembly and displaced to an attachment with an associated needle and needle cap. 
         FIG. 14  is a top elevation schematic of the one-at-a-time syringe filling convenience kit seen in  FIG. 13  with a second syringe displaced and affixed to the syringe assembly. 
         FIG. 15  is a top elevation schematic of a convenience kit made according to the instant invention, a kit assembly is mostly enclosed within a clam-shell tray and is seen to comprise a plurality of empty syringes affixed to a manifold with a sterilizing filter also affixed to the manifold at an inferior site in the figure and a pair of fluid flow controllers superiorly affixed to the manifold. 
         FIG. 16  is a top elevation schematic of the convenience kit seen in  FIG. 15A  with a cover of the tray removed for clarity of presentation. 
         FIG. 16A  is similar to  FIG. 16  except the kit assembly is seen removed from the clam-shell tray. 
         FIG. 16B  is similar to  FIG. 16A  except that a component has been interposed between each syringe and the manifold. 
         FIG. 17  is a top elevation schematic of the convenience kit seen in  FIG. 16  with a filled syringe containing liquid to be displaced into kit assembly syringes via the manifold affixed to the sterilizing filter. 
         FIG. 18  is a top elevation schematic of the convenience kit seen in  FIG. 17  wherefrom a portion of liquid disposed in the filled syringe is seen to be dispensed into the manifold. 
         FIG. 19  is a top elevation schematic of the convenience kit seen in  FIG. 18  wherein contents of the syringe affixed to the sterilizing filter have been displaced into the manifold and therefrom to fill the plurality of syringes. 
         FIG. 19A  is a top elevation schematic of the convenience kit seen in  FIG. 19  wherein the plunger rod of the syringe affixed to the sterilizing filter is withdrawn slightly to draw liquid from the manifold. 
         FIG. 20  is a top elevation schematic of the convenience kit seen in  FIG. 19A  with the filling syringe removed from the kit assembly. 
         FIG. 21  is a top elevation schematic of the convenience kit seen in  FIG. 20  with a top cover seen affixed to the bottom of the tray and displaced to provide access to filled syringes affixed to the manifold. 
         FIG. 22  is a perspective of a syringe used for communicating fluid through the vial spike assembly. 
         FIG. 23  is a top elevation schematic of an Avastin containing vial disposed within a plastic bag fitted with a vial spike assembly for spiking the vial and communicating fluid between the vial and the assembly. 
         FIG. 24  is a perspective of a hag with a filter assembly made according to the instant invention with a cup with a tethered cap affixed to a stabilizing tray disposed therein. 
         FIG. 24A  is perspective of a bag with a filter similar to  FIG. 24 , but with the cup cap closed. 
         FIG. 25  is a perspective of the cup and tray seen in  FIG. 24  disposed outside of the bag. 
         FIG. 25A  is an enlarged perspective of the cup seen in  FIG. 25  wherein a screen is seen supporting a pad away from the internal bottom of the vial. 
         FIG. 26  is similar to  FIG. 25 , but with the tethered cap disposed to close and seal the cup. 
         FIG. 27  is similar to  FIG. 26 , but with tray and cup turned upside down. 
         FIG. 28  is an open cup similar to the open cup seen in  FIG. 25A , but with the pad seen disposed upon the tethered cap. 
         FIG. 29  is a perspective of a hazardous drug assembly made according to the present invention, the assembly comprising a zip lock vial holding bag which is fitted with a vial spike and fluid communication assembly affixed to a stopcock which is affixed to a syringe and to a filter assembly through which liquid is dispensed into a container within a closed bag apparatus made according to the instant invention. 
         FIG. 30  is a side elevation perspective of a medical vial which may contain a hazardous drug. 
         FIG. 31  is a side elevation of a schematic for kit made according to the instant invention similar to the perspective seen in  FIG. 29  except that the vial, seen in  FIG. 30 , is disposed and spiked within the bag which has preferably been zip-locked prior to spiking of the vial. 
         FIG. 32  is similar to  FIG. 31 , but with the syringe being filled with liquid drawn from the vial. 
         FIG. 33  is similar to  FIG. 32 , but with the stopcock path controller displaced for liquid flow from the syringe to the filter assembly and thereby communicating liquid to the second syringe. 
         FIG. 34  is similar to  FIG. 33 , but with the second syringe disconnected from the filter assembly and with a priming needle cap, disposed within the associated bag affixed to the syringe. 
         FIG. 35  is a cross section of the needle cap seen in  FIG. 22 . 
         FIG. 36  is a cross section of the priming needle cap as seen in  FIG. 23  wherein a free plunger disposed about a needle is displaced by priming fluid from an attached source. 
         FIG. 37  is a side elevation of a priming needle cap with internal parts indicated by dashed lines. 
     
    
    
     DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS 
     In this description, the term proximal is used to indicate a segment of a device normally closest to an object of the sentence describing its position. The term distal refers a segment oppositely disposed. Reference is now made to embodiments illustrated in  FIGS. 1-40  wherein like numerals are used to designate like parts throughout. For parts which are similar but not the same as parts originally specified with a given number, a prime of the original numbers is used. 
     Kits disclosed herein are considered novel by specific application for use in preparing a particular medicine or medicine selected from a group of medicines. Reference is now made to  FIGS. 1-9  wherein trays which employ a pattern of through holes are seen with a plurality of applications. 
     Application: Autologous Blood Serum Eye Drops 
     As seen in  FIG. 1 , a tray  10  has a pattern of twelve through holes, each numbered  12 . Tray  10  is preferably made from a crosslinked, closed cell foam which is sufficiently elastic to permit a bottle  20  to he displaced into a hole  12  which is smaller in diameter than the exterior diameter of a bottle  20  such that each bottle  20  is held fast and resists rotation. It is recommended that such trays be made from cross linked, closed cell foam which deters problems associated with tray generated particulates. Note that each through hole  12  permits access to a bottom  21  of a corresponding bottle  20  for facile removal from tray  10  as seen in  FIG. 2 . 
     Application: Fortified Antibiotic Eye Drops 
     A more detailed example of a four bottle  20  and tray  10 ′ design is seen in  FIGS. 3-7  for an exemplary sterile kit  22  (see  FIG. 7 ). Similar to construction of plate  70  in U.S. patent application Ser. No. 16/873,780, a plate  30  (seen in FTG.  4 ) has two patterns of holes. A first pattern has holes, each numbered  32 , sized and shaped to hold bottle caps, each numbered  34 , for unitary cap displacement when displaced to cap bottles  20 . A second pattern of holes, generally numbered  36 , are disposed, sized and shaped to fit about bottles  20 , as seen in  FIG. 5 . As seen in  FIG. 6 , where filled tray  10 ′ and plate  30  are rotated to make bottoms  24  of bottles  20  visible, through holes  12  provide digital access to bottle  20  bottoms  24  for securing caps  34  to bottles  20  as well as facilely displacing bottles  20  from holes  12 . 
     The completed sterile kit  22 , seen in  FIG. 7 , comprises:
         1. A bag  40  containing a tray  10 ′ with bottles  20  affixed therein and plate  30 , the bag being sufficiently pliant and rugged to permit bottle  20  filling and capping via only outside bag contact without contamination from outside bag  40 ;   2. Bag  40  being closed, sealed and sterilized along with all components resident therein;   3. A sterilizing filter assembly  42  which provides the only fluid pathway into the bag, the sterilizing filter assembly  42  being constructed in a manner similar to filter assembly  40  of U.S. patent application Ser. No. 16/873,780 to, thereby, provide for sterilized product filling of bottles  20  and for capping and sealing bottles  20  with caps before removal from bag  40 . All sterilizing filter assemblies disclosed herein have similar construction.       

     As such, sterile kit  22  is specifically designed for use in filling and capping four eye drop bottles  20 ′ with fortified antibiotic eye drops. Each eye drop bottle  20 ′ for this application is recommended to have a volume of 10 mL. Various antibiotics can be effectively used, one at a time, in the general fortified antibiotic eye drop medication; examples of which are voriconazole, gentamicin, amikacin, cefuroxime, vancomycin and cyclosporine. 
     As the eye drop medication examples provided supra are simply examples and use can be much broader, it is understandable that a means for assuring quality of the resulting tears solution be quality assured. For this purpose, a clear material bottle  20 ″ provides opportunity for quality assurance testing, apart from bottles  20 ′ as seen in  FIGS. 8, 8A and 9 . 
     Referring to  FIGS. 8, 8A and 9 , a group of plates, trays, bottles and caps is seen to comprise: 
     1. Two eye drop bottles  20 ′ seen in  FIG. 8 . 
     2. A single clear, preferably clear glass bottle  20 ″ also seen in  FIG. 8 . Bottle  20 ″ is preferably cap-able to assure maintenance of purity. Such bottles are available commercially. 
     3. A plate  30 ′ which is similar in construction to plate  30 , but patterned for two types of eye drop bottles, i.e. bottle  20 ′, bottle  20 ″ and associated caps  34 ′ seen in  FIG. 8A . 
     4. A tray  10 ″ which is similar to tray  10 ′ but having a pattern for bottles  20 ′ and bottle  20 ″ delineated in item 3, above, is seen in  FIG. 8 . 
     Focus is now directed upon bottle  20 ″. Generally, eye drop bottles are not sufficiently clear for use in making visual quality assurance tests. As this kit may be used for a wide variety of antibiotic solutions, quality assurance of resulting tears solution and, therefore, clear bottle  20 ″, is worthy of note. An assembly  38  of of bottles  20 ′, caps  34 ′, bottle  20 ″, plate  30 ′ and tray  10 ″ is seen in  FIG. 9 . 
     Application: Sterile Single Syringe Filling and Capping 
     Reference is now made to  FIGS. 10, 11 and 11A  wherein, sterilized and enclosed within a closed and sterilized bag  40 ′ is a single syringe  43  securely, but releasably, affixed to a filter assembly  44  which provides the only fluid pathway into bag  40 ′ the interior of which provides an enclosed sterile chamber  41 . As well, an unattached priming needle cap  50  which covers and shields a medical needle  52  is disposed as a free part disposed within bag  40 ′. A more detailed disclosure of cap  50  is provided hereafter. 
     Filter assembly  44  is similar in construction and function to other filter assemblies disclosed herein and in related art (e.g. filter assembly  42  (see  FIG. 7 )), however, in this case, filter assembly  44  is affixed to a closed end of bag  40 ′. A grommet  60  is tightly affixed against inside surface  62  of bag  40 ′ to close and seal about a hole in bag  40 ′ through which a female luer fitting of a sterilizing medical filter  64  is displaced to permit sterilized fluid sterilized and displaced through filter  64  to be delivered to syringe  43 . The hole in bag  40 ′ and the female luer fitting are not shown in detail in  FIGS. 10, 11 and 11A , but one who is skilled in medical art would well understand construction as disclosed in the related art referenced supra and the fitting being a commercially available item. Thus, a female fitting of filter  64  is securely affixed to the female luer fitting (not shown) of filter  64  to provide a connecting force against grommet  60  to close and seal the hole in bag  40 ′. Syringe  43  is securely, but releasably, affixed to filter assembly  44  via fitting  66 . 
     As seen in  FIG. 10 , syringe  43  is affixed to female fitting  66  and provided empty within bag  40 ′. Once so affixed, hag  40 ′ is sealed and bag  40 ′ and all items disposed therein, including a priming cap  50 , are sterilized. It should be noted that bag  40 ′ should be made of pliant plastic material which is sufficiently supple to permit syringe  43  to be rotated to become free of fitting  66  by only exterior contact with bag  40 ′. Such material should also be sufficiently hardy to permit such rotation without tearing the material. 
     As seen in  FIG. 11 , barrel  67  of syringe  43  is filled with a liquid medicine  68 , sterilized when, as provided and delivered through filter assembly  44 . However, once filled with a predetermined dose of liquid medicine  68 , it is often preferable to cap syringe  43  before breaching hag  40 ′. Also, it is common to prime such a syringe before use. As seen in  FIG. 11A , cap  50  provides capacity for priming without spilling syringe  43  contents into bag  40 ′ or other areas when syringe  43  is displaced from bag  40 ′. Further, disclosure concerning cap  50  is provided hereafter (see  FIGS. 39-40A ). 
     Application: Multiple Syringe Filling and Capping 
     Reference is now made to  FIGS. 12-14  wherein a multiple syringe kit  70  provided for a wide variety of uses, made according to the instant invention is seen. A plurality of medical syringes, generally numbered  72 , are seen disposed and sterilized within a bag  74 , which encloses a sterile chamber  75 , as noted in  FIG. 12 , and therein affixed to priming caps  50  held firmly by a rack  76  with a single exception. This example is provided to show attachment of a priming cap, in those cases where each syringe is simply capped, rack  76  would provide a plurality of caps rather than priming needle caps. 
     The exception, a single syringe, also numbered  72 ′, is affixed to a filter assembly  78  made and affixed to bag  74  by a grommet  78  in the same manner syringe  43  is affixed to filter assembly (see  FIG. 10 ). Note that bag  74  should have the same material character and quality as bag  40 ′, also seen in  FIG. 10  and he formed with sufficient space for all activity disclosed herenin within sterile chamber  75 . Other caps may be used within the scope of the instant invention but being able to prime syringes without spilling liquid therefrom is considered preferable. Also, plunger rods are not shown, as such can be affixed to displace each plunger after a syringe, generally numbered  72 , is removed from bag  74  and bag  74  would have to be enlarged if plunger rods were initially so affixed. It should be noted that plunger rods can be affixed each associated plunger, generally numbered  82 , and used without affecting the sterility state of each syringe  72  content. Such plunger rods and plungers  82  with accepting interfaces are well known in syringe art. 
     By example, kit  70  is seen to comprise eight syringes  82 . Effectively, any number of syringes which will fit into bag  74  can be made part of kit  70 . In  FIG. 12 , the single syringe  72 , also numbered  72 ′, is removed from a cap  50  and affixed to filter assembly  44 ′ which is constructed similarly to filter assembly  44 . Note, that all syringe handling is effected by syringe contact via hag  74  to maintain product sterility. So affixed, syringe  72 ′ is filled with a predetermined volume of liquid  78  as seen in  FIG. 13 . 
     Thereafter, filled syringe  72 ′ is removed and reaffixed to an available cap  50 . A second syringe numbered  72 ″ is then removed from a cap  50  and digitally affixed to filter assembly  44 ′ and thereat filled with a predetermined volume of liquid. This process is continued until all syringes have been filled with a desired volume of sterilized liquid  78  in the same manner syringe  72 ′ was filled. Once such has been accomplished, bag  74  (i.e. sterile chamber  75 ) can be breached for access to capped syringes  72  filled with a sterilized product. 
     Application: Sterile Single Step, Multiple Syringe Filling 
     Method and convenience kit for filling multiple syringes in a single step is provided, by example, using a convenience kit  80  (see  FIG. 15 ) made according to the instant invention as se in  FIGS. 15-21A . As seen in  FIG. 15 , a core portion  82  (the “sterile kit assembly”) is disposed within a porting tray  84 , contents of which are seen as dashed lines. Portion  82 , being a closed filtering and dispensing portion of kit  80 , is seen separate from tray  84  in  FIG. 21A . Portion  82  comprises a medially disposed manifold  90  made up of one cross connection fitting  92  for each pair of syringes (each syringe being numbered  94 ) affixed thereto. In this example, fittings (commonly numbered  92 ) of manifold  90  are interconnected by male/male luer fittings (commonly numbered  96 ). One connecting fitting  97  of an inferiorly disposed cross connection fitting  92  is interconnected with a filter  64 ′, functionally the same as filter  64 , disclosed supra. In this case, the interior pathway of manifold  90  is the sterile chamber, not shown, but well understood by those who are skilled in medical device art. 
     On an end  98  of manifold  90 , a female fitting  98 ′ (not shown) is affixed to a “T” connector  99  providing a first pathway to a one-way valve  100  which is permissive to flow out of manifold  90  to an air release/liquid retaining valve  102 . Such valves are commercially available. One skilled in manifold design would understand character of a pathway through manifold  90  tracing a pattern from filter  64 ′ to each syringe  94  and to pathway end “T” connector  99 , also available commercially. An ascending leg  104  of “T” connector  99  is affixed to another one-way valve  106  which is disposed to only permit fluid flow into manifold  90 . Another filter  64 ″, similar in form and function to filter  64 ′ is affixed to one-way valve  106  to provide a filtered pathway for air entry into manifold  90  when pressure gradients within manifold  90  are appropriate. 
     Each syringe  94  has a barrel (commonly numbered  110 ) and a plunger (commonly numbered  112 ) securely affixed to a plunger rod (commonly numbered  114 ). Also, each barrel  110  has a bulbous open end (commonly numbered  116 ). As well, each plunger rod  114  has an end pad (commonly numbered  118 ). Bulbous end  116  and pad  118  are commonly used for digital displacement of plunger rod  114  relative to barrel  110 . On fluid communication dispensing end  119  of filter  64 ′, is a male luer fitting  119  (not completely shown, but well understood by those skilled in medical syringe art). In core portion  82 , syringe associated luer fittings are seen to be luer-slip (as opposed to “luer-lock”), as is commonly the case for small syringes, such as those used for Avastin. Due to the size and function of each syringe in an Avastin medical treatment it is often preferable that such fittings be luer slip. For Avastin, syringes use a generally small (i.e. about  1  mL and must be non-siliconized. Note that when core portion  82  is sterilized, the manifold pathway remains sterile due to the only inflow pathway openings being by interconnecting filters  64 ′ and  64 ″. As such, core portion is pre-sterilized and provided sterile with empty syringes  94  affixed at the time of sterilization, as seen in  FIG. 17 . It should be noted that in the case of core portion  82 , a filling chamber is not a bag, but the pathway through manifold  90 . 
     The filling process is as follows: 
     As seen in  FIG. 17 , a source syringe  140 , filled with liquid medicine  142  to be displaced into syringes  94  is affixed to filter  64 ′. To minimize gas dispensed into syringes  94 , the first liquid displaced from syringe  140  fills manifold with gas being driven outward through valve  102  (the lowest resistance pathway) until liquid reaches  102  which requires delivery of a very small amount of liquid as seen by limited displacement of plunger  112  in  FIG. 18 . Once air flow is complete and fluid flow is thereby prohibited by valve  192 , syringe  94  filling begins. Continued displacement of liquid  142  from syringe  140  fills syringes  94 , as seen in  FIG. 19 . 
     As seen in  FIG. 21 , tray  84  is preferably of “clam shell” design with having a bottom  84 ′ and a top  84 ″ (see  FIG. 21 ). As seen in  FIG. 17 , syringes  94  are provided empty. When liquid is introduced into manifold  90  through filter  64 ′, stiction in one or more plungers  102  may result in a higher dispensing pressure than retention force, between manifold  90  and an associated syringe  92  than the connection to associated manifold  92  fitting can withstand, resulting in syringe  94  and fitting  92  separation. Such separation is not acceptable. 
     To obstruct such separation, restraints in the form of strips of firm, but impressionable material can be used if each syringe  94  is not fitted with a luer lock fitting. As an example, four strips (commonly numbered  150 ) of closed cell foam having thickness adequate to be indented by bulbous end  116  and thereby be restrained from being displaced when covered and compressively restrained by top  84 ″ and bottom  84 ′ of tray  84 . 
     Further to impede overfilling of syringes  94 , a raised inside edge  152  is sized and shaped to provide a stop for each plunger rod  118 . Using strips  150  and inside edges  152 , syringes can be filled without incident. Completion of a filling cycle, with syringe  140  emptied is seen in  FIG. 19A . 
     In summary, kit  80  is provided as seen in  FIG. 15  as a clam shell tray  84  with sore portion  82  disposed therein. A syringe  140  filled with medicine to be sterilized and displaced into syringes  94  is affixed to filter  64 ′ as seen in  FIG. 17 . The first liquid dispensed from syringe  140 , as seen in  FIG. 18  primes air from manifold  90 , as depicted in  FIG. 18 . Syringes a filled by displacing medicine from  142  syringe  140  into syringes  94 , as seen in  FIG. 19 . Liquid resident in manifold  90  is withdrawn therefrom by drawing liquid back into syringe  140  and replacing such liquid with air delivered through filter  64 ″ as seen in  FIG. 19A , such will allow unitized core portion  82  to be frozen as a unit for storing and maintaining quality of medicine  142  until thawed and used. Once syringe  94  filling is complete syringe  149  can be removed as seen in  FIG. 20 . Cover  84 ″ seen in  FIG. 21  is closed for storage if tray  84  is so used. However, core portion  82  can be displaced form tray  84  at any time after filling, being unitized as seen in  FIG. 21A . Thereby access is provided to each syringe  94  as needed. 
     As displacing a syringe  94  from portion  82  opens a pathway from a potentially contaminated environment into the sterile chamber, even though likelihood of contamination of remaining syringes  94  being resultingly contaminated is slight, though possible. By adding contamination blocking devices, generally numbered  130 , displaced between each syringe  94  and associate fitting  92  as seen in portion  82  in  FIG. 16B , such likelihood of remaining syringes being contaminated is eliminated. Such blocking devices may be needleless connectors or sterilizing grade filters. 
     Application: Mitomycin Sterilization and Pad Soaking 
     Reference is now made to a combination of kits seen in  FIGS. 23 and 24  and a syringe seen in  FIG. 22  which form a combination of kits and a syringe for being used for sterilizing mitomycin and soaking pads for applying sterilized mitomycin in surgical procedures according to the instant invention. U.S. Pat. No. 9,449,521, titled METHODS FOR MAKING AND USING A VIAL SHIELDING CONVENIENCE KIT discloses a plastic bag (which may be a Ziplock bag) for accessing a hazardous drug. While it is common practice to spike a mitomycin vial without protective cover, placing a cap-able cup in a sterilized plastic bag  201  with a liquid access assembly  202 , as seen in  FIG. 23 , provides two elements of safety by pre-sterilizing bag  201  and assembly  202  to reduce likelihood of drug contamination and by zip sealing bag  201  after placing a vial  204 , therein, after removing a septum cover and sterilizing the associated septum  205  thereafter, which assures maintenance of a sterile spiking interface. 
     Vial  204  is seen disposed within bag  201  in  FIG. 23 , whereby safety is increased by guarding against fumes released upon spiking and maintaining sterility of all spiking interfaces. Note that assembly  202  has a spike cap  206  which is displaced from covering a spike after vial  204  is disposed in bag  201 . As it is known that vial  204  can be spiked with only digital access from outside bag  201  and that assembly  202  comprises a vent  208  for a spike, vial  204  can be spiked for both introduction of liquid into vial  204  and for drawing liquid from vial  204 . 
     A syringe  210  seen in  FIG. 22  provides for introducing a diluent into vial  204  when mitomycin is provided as a lyophilized solid and for withdrawing liquid mitomycin from vial  204 . A second bagged kit  220  is seen in  FIG. 24 . Kit  220  comprises a closed bag  222  fitted with a filter assembly  261  whereby all fluid delivered into kit  220  is sterilized by a 0.20 micron filter. Any upstream contamination is thereby dispelled before dispensing the mitomycin into a delivery vessel disposed within a sterile chamber  223 , disposed within bag  222 . 
     In this example, mitomycin is dispensed through filter assembly  261  into a 3 ml cap-able cup  270 . As a normal dose of mitomycin is approximately 1 ml, the 3 ml cap-able cup  270  is well suited for this application. 
     Cap-able cup  270  has a tethered cover  272  which seals contents therein when cap-able cup  270  is closed. Such cap-able cups are available as medical cap-able cups commercially. Further, cap-able cup  270  is firmly disposed into a closed cell tray  280 , also disposed within sterile chamber  223 , as seen in  FIG. 24 . 
     Tray  280  acts as a stabilizer for facile interfacing between filter assembly  261  and cap-able cup  270 . As kit  220  is sterile along with contents therein, once cap-able cup  270  is provided with a dose of mitomycin, tethered cover  272  is displaced to cap and seal contents of cap-able cup  270  in place. With tray  280  also being sterilized, both cap-able cup  270  and tray  280  can be displaced from bag  222  onto a sterile surface without fear of contamination. Note that cap-able cup  270  is seen capped and ready for being accessed to a sterile surface in  FIG. 24A . 
     As mitomycin is provided within cap-able cup  270  for soaking one or more pads for a medical procedure, contents and use of cap-able cup  270  follows. As seen in  FIG. 25 , cap-able cup  270  has a liquid permeable screen  290  disposed above the interior bottom (not seen) of cap-able cup  270 . Screen  290  is preferably disposed sufficiently far above the interior bottom that the dose of mitomycin is fully disposed between screen  290  and vessel bottom. 
     To soak a pad, a pad  292  is placed upon screen  290  as seen in  FIG. 25A  and cover  272  is closed as seen in  FIG. 26 . Then tray  280  and cap-able cup  272  are turned upside down as seen in  FIG. 27  to soak pad  292 . After sufficient soak time has passed, tray  280  and cap-able cup  272  are turned again upright as seen in  FIG. 26 . When cover  272  is displaced to an open state, a soaked pad  292 ′ is likely found either on screen  290  of affixed to cover  272 , as seen in  FIG. 28 . Of course, within the scope of the instant invention, more than one pad  292  can be soaked at a time. 
     Application: Hazardous Drug Handling and Displacement 
     Reference is made to  FIGS. 30-34  wherein an example of a hazardous drug handling and displacement kit  300  made according to the present invention is seen. An example kit, made according to the instant invention and provided for use in hazardous drug handling and transferring for use is seen if  FIG. 30  where such a kit  300  is seen prepared for use. When preparing medicine using a hazardous drug, consideration must be given to both preparatory devices used in acquiring liquids from a drug source and to the purity and sterility of the final product. For this reason, two plastic bags, numbered  310  and  320  are provided as kit parts. 
     Both plastic bags are sufficiently pliant for manipulation of bag contents by contact with the bag exterior and made of sufficiently rugged material to endure such manipulation without being breached. Material of both bags is preferably sufficiently clear so contents can be viewed during manipulation. 
     Bag  310  is a source bag and provided for containment of spilled liquids and fumes resulting from access to a source container. A vial  340 , seen in  FIG. 34A , is provided as an example. Bag  310  is preferably a zip lock bag which is fully closed when zipped with only a single fluid pathway being provided into and out of bag  310  via a vial spike assembly  342  which is affixed through a hole in the bag (not shown), the hole being closed and sealed in a manner similar to closing a hole about a filter assembly as disclosed supra. Spike assembly  342  preferably has a conventional bag spike (not shown) which is covered and protected by a spike cover  344 . 
     Interconnection assembly  348  in this example, employs a stopcock  350  and a medical syringe  360  assembled and may be affixed to be unitized with the bag spike assembly  342 . However, if syringe  360  is employed to provide a diluent for contents of vial  340 , syringe  360  may be affixed at the time of use of kit  300 . It is important to note that, once affixed, syringe  360  should remain affixed and so held when kit  300  is disposed. Stopcock  350  is further unitized with a filter assembly  362 , associated with bag  320 . 
     Filter assembly  362  and bag  320  are similar in form and function to filter assembly  44  as seen in  FIG. 10 , except that a plunger rod  43 ′ is provided free from syringe  43 ″ within bag  320 . It is common in the medical syringe art to provide a plunger rod free from an associated syringe when extension of the plunger rod upon syringe filling would make an excessively long apparatus. Therefore, plunge rod  43 ′ is provided separate from the rest of syringe  43 ″ for later introduction and use. As well, a free cap, which is preferably a cap  50 , described and disclosed in detail hereafter, is enclosed within bag  320 . 
     As a first step following institutional protocol, vial  340  is displaced into bag  310 , bag  310  is zipped closed and vial  340  is spiked for liquid communication with stopcock  350  as seen in  FIG. 31 . Note that stopcock  350  is preset for communication between syringe  360  and vial  340 . As seen in  FIG. 32 , liquid  361  is drawn from vial  340  into syringe  360  as a truly closed system operation. 
     Stopcock  350  is then switched to direct flow between syringe  360  and syringe  43 ″ whereby liquid  361  is displaced into syringe  43 ″, as seen in  FIG. 33 . Once displacement is complete, syringe  43 ″ is displaced from filter assembly  362  through associated filter chamber  364  by only manipulations to the outside of bag  320 . Syringe is then capped with priming cap  50  as seen in  FIG. 34  and, with liquid  361  fully enclosed for sterility and safety, bag  320  may be breached with safety for access to filled syringe  43 ″. 
     Application: A Syringe Needle Cap for Spilless Syringe Priming 
     Reference is now made to  FIGS. 35-37  wherein apparatus and function of a priming needle cap  50  is seen. As seen in  FIG. 22 , cap  50  comprises a substantially constant exterior and interior diameter barrel  500  which has a standard needle hup and luer fitting interface (not shown) disposed for affixing cap  50  to a convention luer fitting syringe. As seen in  FIG. 35 , cap  50  further comprises a cylindrical internal barrel surface  502  which is similar, but diminished in size, to the barrel  500  exterior surface  502 ′. Disposed within and residing against surface  502  in a manner similar to the way a syringe plunger is held within a syringe barrel is a needle pierceable plunger  510 , best seen in  FIG. 36 . Plunger  510  is preferably made from material having the same piercing qualities as drug vial septa. Plunger  510  is sized and shaped to be displaced along surface  502  to a stop  512  molded with a reduced internal diameter at a predetermined place along surface  502  to provide an empty chamber  520  when disposed against stop  512 . Further, plunger  510  has a septum  514  which is pierced by a needle (sharpened cannula)  530  as best seen in  FIG. 36  with a needle point  532  disposed within chamber  520 . 
     With plunger  510  disposed as seen in  FIG. 36 , a syringe requiring priming is affixed to cap  50  (not shown, but similar practice occurs commonly daily in medical facilities). Generally, syringe priming is meant to rid a syringe of air, hut the process usually results in a bolus of liquid being uncontrollably dispensed. If such liquid is hazardous in any way, such action may be unsanitary, if not dangerous. 
     As seen in  FIG. 37  priming action displaces both dispensed gas and liquid  519  into chamber  520  where it is contained. Note that chamber  520  expands as fluid is displaced there into. For better control of priming action, cap  50  may be molded of clear plastic with a lens  550  disposed near a site of fluid ejection (i.e. needle point  532 ), as seen in  FIG. 37 , the focal point of the lens being needle point  532 .