Abstract:
An system and method for monitoring and evaluating solid and semi-solid materials. In an embodiment adapted for pharmaceutical manufacturing, a rotating platter is provided which contains a plurality of chutes. Manufactured items from an earlier section of the manufacturing process are deposited upon the rotating platter, and are separated for analysis by the plurality of chutes. Mounted near the edge radius of the platter is a Raman probe, which focuses photons from a laser onto each of the manufactured items. The manufactured items radiate photons according to Raman scattering principles, which are collected by the Raman probe and analyzed by a computer against a template file. The computer operates upon the chutes to sort and release the manufactured items according to a criteria. Thus, an in-process monitoring and evaluation system may be utilized to inspect and sort manufactured items in real time.

Description:
This application claims the benefit of U.S. Provisional Application No. 60/358,795, filed Feb. 22, 2002, the disclosure of which is incorporated herein by this reference. 

   BACKGROUND 
   Pharmaceutical manufacturers employ several forms for therapeutic compound delivery. For example, a liquid form may be used for injectable or ingestible therapeutic compounds. Ingestible compounds also may be delivered through tablets, capsules, and gelcaps. It is common in the manufacture of each of these forms of therapeutic compound delivery to require discrete analysis of samples of the therapeutic compound delivery form. This analysis is presently performed in a quality assurance laboratory located away from the manufacturing area. Such “off-line” analysis often is expensive and inefficient. 
   To illustrate the inefficiency of off-line quality assurance analysis, consider the manufacture of the tablet form of therapeutic compound delivery. During manufacture of tablets, a pharmaceutical tablet press operates on a therapeutic compound, normally in the form of a powder. The tablet press compresses the therapeutic compound into a tablet for subsequent ingestion and delivery of the therapeutic compound. Optionally, a binding agent may be added to the therapeutic compound during manufacturing to enhance tablet formation. Automated tablet presses may be employed to create tablets very quickly. Many automated tablet presses are capable of producing in excess of ten thousand tablets per minute. 
   After manufacture, it is typical that a representative sample of the tablets from each manufactured lot is taken to a separate quality assurance laboratory for analysis. Testing of the sample tablets ordinarily occurs after all tablets in a manufactured lot have been created, to permit a representative sample to be selected for analysis. The quality assurance laboratory conducts tests on the tablets to determine, for example, the chemical composition, variability, and other data from the sample tablets. The data collected from the tests is analyzed, and if the sample tablets are found to be within the manufacturer&#39;s specifications, the balance of the lot of manufactured tablets are released for packaging and use. If the sample tablets are not found to satisfy the manufacturer&#39;s specifications, it frequently is necessary to scrap the entire manufactured lot of the tablets. 
   During the time the sample tablets undergo testing in the quality assurance laboratory, the balance of the manufactured tablets from the lot are waiting in inventory storage. Without assurance that the tablets are within the manufacturer&#39;s specifications, releasing the balance of the manufactured tablets from the lot for packaging would present an unacceptable risk, as well as potentially wasting expensive packaging materials and labor. In addition, in some cases the manufacturing apparatus on which the tablets were produced may not be used again until a manufactured lot has received clearance from the quality assurance laboratory. Failure of the sample tablets to meet the manufacturer&#39;s specifications may be indicative of a problem with the manufacturing apparatus, or with the overall manufacturing process. 
   Unfortunately, off-line testing of pharmaceutical products in a quality assurance laboratory frequently introduces a bottleneck into the manufacturing process. The tests conducted by a quality assurance laboratory usually require the sample tablets to be prepared for testing with a great deal of human intervention. The time spent preparing the sample tablets for quality assurance testing may be several orders of magnitude longer than the time spent manufacturing the tablets. 
   At present, two methods are most commonly used for off-line sample testing, a spectroscopic method and a wet method. The spectroscopic method emits radiation onto a sample, and analyzes radiation emitted or reflected by the sample. The spectroscopic method may be non-destructive, or may destroy or degrade the tablet, depending on the wavelength and intensity of the radiation used. The wet method involves dissolving the sample in a solvent, or mixing the sample with other chemicals. The wet method is always destructive of the sample. 
   In addition to the sample preparation time required, the sample tablets may also wait in a queue while the off-line quality assurance laboratory conducts testing on other manufactured lots. Ultimately, the off-line testing process may add days or weeks to the manufacturing cycle time for each lot of tablets, through time directly spent testing the tablets, or time the sample tablets spend in queue. During this time, the balance of the manufactured tablets from the lots is held in storage, and the entire manufacturing process may be stopped, both of which can result in a significant loss of potential profit. 
   Further, even if the number of sample tablets selected for quality assurance testing is statistically appropriate, selectively testing only a subset of tablets taken from a larger group always incurs a risk that a problem may be overlooked. However, because the tests conducted on the sample tablets by the quality assurance laboratory ultimately results in the destruction of the tablets in many cases, it would be impossible to conduct testing on all of the manufactured tablets using common methods. The risk may be reduced by testing a greater number of the tablets, but the point at which destructive testing is economically infeasible is reached well before a one hundred percent sampling of the overall manufactured lot occurs. 
   Of course, the bottleneck presented by the off-line quality assurance laboratory is not limited to the manufacture of tablets. Gelatin capsules, topical ointments, and liquids are just a few possible forms of delivery of therapeutic compounds. In each case, representative samples are taken from the manufacturing process, and off-line testing is performed by a quality assurance laboratory. Therefore, it is possible that the manufacturing process for each method of therapeutic compound delivery suffers from the same or similar limitations as that experienced by the off-line analysis of tablets in a quality assurance laboratory. 
   For all the foregoing reasons, there is a need in the art for a system having the ability to analyze samples of pharmaceutical products in real time and in a way that is integrated with the manufacturing process. Such a system will conduct the analysis in a non-destructive manner, and will be adaptable to test each tablet produced by the manufacturing process, thereby reducing the statistical risk incurred by testing only a subset of the tablets. Alternatively, an enhanced statistical sampling could be conducted based on the information received by the system. By sampling “in-process” and in real time, process problems or manufacturing apparatus problems may be identified and fixed without requiring an entire lot to be created, thereby reducing costs. 
   Such a system may be used in conjunction with a traditional quality assurance laboratory. Routine testing could be done in real time using the desired system, and the quality assurance laboratory could be used to check smaller samples, to verify the correct operation of the system. Also, the desired system will provide a sufficient level of testing so that the balance of tablets from a manufactured lot may be more quickly released for packaging, and the manufacturing apparatus may be more quickly brought back into productive use, while previous lots wait in the queue or undergo analysis by the off-line quality assurance laboratory. Reducing cycle time in this critical stage of manufacturing results in less downtime, and an increase in productivity and profitability. 
   SUMMARY 
   The invention relates to a system for using spectroscopy to provide in-process quality assurance data for manufacturing processes. Such in-process data is advantageous for many reasons, and such a system would be useful for any industry producing non-metallic materials. The system is particularly advantageous for monitoring safety and quality of ingestible or injectable materials, such as those that are produced by the pharmaceutical industry. 
   In an embodiment, the present invention comprises a system for monitoring solid and semi-solid materials. The materials may comprise manufactured pharmaceuticals. A photon source is operable to produce substantially monochromatic photons of a predetermined wavelength. A Raman probe in communication with the photon source is operable to direct the substantially monochromatic photons produced by the photon source onto a target, thereby illuminating at least a portion of the target with the substantially monochromatic photons. The Raman probe is also operable to collect radiation emitted from the target following exposure of the target to the substantially monochromatic photons. A material handling apparatus is operable to receive a material and to consistently orient the material so that at least of portion of the material is in a position so that it will be illuminated by the substantially monochromatic photons directed by the Raman probe. The material handling device accomplishing the receipt and orientation of the material without the need for human contact with the material. An optical receiver in communication with the Raman probe is operable to receive information from the Raman probe and record a digital image of the information, the information comprising the radiation emitted from the target. A computer is in communication with the photon source, the Raman probe, the material handling apparatus, and digital image receiver, and the computer is operable to control the operation of the photon source, the Raman probe, the material handling apparatus, and the digital image receiver, and the communication therebetween. 
   In another embodiment, the present invention comprises a nondestructive material inspection system employing Raman spectroscopy in the inspection of a material. The material may comprise a manufactured pharmaceutical. A Raman probe is operable to direct substantially monochromatic photons onto a target thereby illuminating at least of portion of the target with the substantially monochromatic photons. The Raman probe also is operable to collect radiation emitted from the target following exposure of the target to the substantially monochromatic photons, the radiation being indicative of the target. A material handling apparatus is positioned to receive a plurality of discrete units of the material produced by a manufacturing apparatus and to orient each of the plurality of discrete units so that at least a portion of each of the plurality of discrete units will be illuminated individually by the substantially monochromatic photons directed by the Raman probe. The material handling device accomplishes the receipt and consistent orientation of the plurality of discrete units without the need for human contact with the plurality of discrete units. 
   In an aspect of this embodiment, a computer is in communication with the Raman probe and the material handling apparatus. The computer is adapted to control the operation of the Raman probe and the material handling apparatus, and the communication therebetween. A database is associated with the computer. The database comprises information about a desired radiation spectrum that is expected to be emitted from each of the plurality of discrete units of the material after illumination by the substantially monochromatic photons. Software is operating on the computer and is able to compare the information about the desired radiation spectrum retrieved from the database with information about an observed radiation spectrum that is emitted from a sample of the plurality of discrete units of the material that is exposed to the substantially monochromatic photons. 
   In still another embodiment, the present invention comprises a material handling apparatus for use in quality control application in a manufacturing system. The manufacturing system may comprise a pharmaceutical manufacturing system. A Raman probe is operable to direct substantially monochromatic photons onto a discrete unit of a target material, thereby illuminating at least of portion of the discrete unit of the target material with the substantially monochromatic photon. The Raman probe is further operable to collect radiation emitted from the discrete unit of the target material following exposure of the discrete unit of the target material to the substantially monochromatic photons, wherein the radiation is indicative of the discrete unit of the target material. A plurality of control gates automatically controls the positioning of a plurality of the discrete units of the target material produced in the manufacturing system. At least one of the plurality of control gates is operable to position each of the discrete units of the target material so that at least a portion of each of the discrete units of the target material will be illuminated individually by the substantially monochromatic photons directed by the Raman probe. At least two onward processing apparatuses are positioned to receive the discrete units of the target material after illumination of each of the discrete units of the target material by the substantially monochromatic photons directed by the Raman probe. Each of the discrete units of the target material is selectively delivered to one of the onward processing apparatuses by the control gates according to an evaluation of the radiation emitted from the discrete units of the target material. The selective delivery of each of the discrete units of the target material is accomplished without human contact with the plurality of discrete units of the target material. 
   In an aspect of this embodiment, a computer is in communication with the Raman probe and the material handling apparatus. The computer is adapted to control the operation of the Raman probe and the material handling apparatus, and the communication therebetween. A database is associated with the computer. The database contains information about a desired radiation spectrum that is expected to be emitted from a discrete unit of the target material after exposure of the discrete unit of the target material to the substantially monochromatic photons. Software operating on the computer is operable to compare the information about the desired radiation spectrum retrieved from the database with information about an observed radiation that is emitted from a sample of the target material that is exposed to the substantially monochromatic photons. 
   Yet another embodiment of the present invention comprises a computerized quality control system. A database associated with a computer contains information about a desired radiation spectrum that is expected to be emitted from a discrete unit of a material after exposure of the discrete unit of the material to monochromatic light of a predetermined wavelength. The material may comprise a manufactured pharmaceutical. Software operating on the computer is operable to compare the information about the desired radiation spectrum retrieved from the database with information about an observed radiation spectrum that is emitted from a sample of the material that is exposed to the monochromatic light of the predetermined wavelength. A Raman probe in communication with the computer is operable to collect the observed radiation emitted from the sample of the material after it is exposed to the monochromatic light of the predetermined wavelength, and to communicate an image of the observed radiation to the computer. A material handling apparatus in communication with the computer and operating cooperatively with the Raman probe automatically orients the sample of the material for exposure to the monochromatic light. 
   In an aspect of this embodiment of the present invention, the computerized quality control system also comprises at least two onward processing apparatuses positioned to receive the sample of the material from the material handling apparatus. The sample of the material is selectively delivered to one of the onward processing apparatuses by the material handling apparatus according to an evaluation of the observed radiation emitted from the sample of the material. The selective delivery of the sample of the material is accomplished without human contact with the sample of the material. 
   Still another embodiment of the present invention comprises a method for monitoring solid and semi-solid materials without the need for human contact with the materials. The method comprises the steps of receiving a plurality of materials to be monitored into a material handling apparatus; individually orienting each of the plurality of the materials; individually illuminating each of the plurality of the materials by substantially monochromatic photons; recording radiation emitted from each of the plurality of the materials after each of the plurality of the materials have been individually illuminated by the substantially monochromatic photons; comparing, with a computer, the recorded radiation with predetermined information previously stored in a memory of the computer, and selectively delivering each of the plurality of the materials from the material handling apparatus in accordance with the comparison. In an aspect of this embodiment, the materials comprise manufactured pharmaceuticals. 
   These and other features and advantages of the present invention, and the manner of attaing them, will be more apparent and better understood by reference to the following descriptions of embodiments of the invention taken in conjunction with the accompanying drawings and with the appended claims. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
       FIG. 1  shows a block diagram illustrating a portion of an exemplary manufacturing system, which includes an embodiment of the present invention; 
       FIG. 2  shows a side view illustrating a cross-section of a portion of a monitoring and evaluation system according to an embodiment of the present invention; 
       FIG. 3  shows a top view of a rotating platter of a monitoring and evaluation system according to an embodiment of the present invention; 
       FIG. 4  shows a top view of an exemplary chute of a monitoring and evaluation system according to an embodiment of the present invention; 
       FIG. 5  shows a schematic block diagram of the analysis components of a monitoring and evaluation system according to an embodiment of the present invention; 
       FIG. 6  shows a schematic diagram of a Raman probe as used in an embodiment of the present invention; and 
       FIG. 7  shows a flow chart of the detection and determination process according to an embodiment of the present invention. 
   

   DETAILED DESCRIPTION 
   The present invention comprises a system and method for monitoring and evaluating solid and semi-solid materials. For the purposes of promoting an understanding of the principles of the present invention, reference will now be made to the embodiment illustrated in the drawings, and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. 
   With reference to  FIG. 1 , there is shown a block diagram illustrating a portion of an exemplary manufacturing system, which may be a pharmaceutical manufacturing system, comprising first production process  12 , monitoring and evaluation system  18 , first and second quality control processes  20  and  22 , respectively, and second production process  24 . In operation of this exemplary manufacturing system, materials are received from first production process  12  by monitoring and evaluation system  18 , and then evaluated by monitoring and evaluation system  18  for conformance to quality assurance standards. It also is contemplated to be within the scope of the present invention that a cache of previously manufactured materials is provided to monitoring and evaluation system  18 , instead of such materials being received directly from first production process  12 . 
   Materials failing to satisfy the quality assurance standards according to the evaluation by monitoring and evaluation system  18  may be diverted to first quality control process  20  and/or second quality control process  22 . For example, where the quality assurance standards comprise a specified tolerance range for the materials, materials falling below the tolerance range may be diverted to first quality control process  20 , with other “under specification” materials. Similarly, materials exceeding the tolerance range may be diverted to second quality control process  22 , with other “over specification” materials. Materials meeting the quality assurance standards are allowed to proceed to second production process  24  for further processing. 
   In an implementation of the present invention, first production process  12  may comprise a pharmaceutical tablet press of a type known in the art that is capable of producing tablets at a high rate, and second production process  24  may comprise a packaging process wherein acceptable tablets are packaged for shipment. As discussed in more detail hereinafter, an embodiment of monitoring and evaluation system  18  employed in this implementation uses optical spectroscopy to obtain information about the therapeutic compound in each of the plurality of tablets. The information regarding the therapeutic compound in each of the plurality of tablets then is compared to a quality assurance standard that is automatically accessible by monitoring and evaluation system  18 . 
   The quality assurance standards used according to the present invention may contain information regarding a tolerance range for the amount of therapeutic compound in a tablet. If a manufactured tablet is found by monitoring and evaluation system  18  to contain an amount of therapeutic compound falling outside the specified tolerance range, further processing of the tablet is prevented. Conversely, tablets found by monitoring and evaluation system  18  to contain an amount of therapeutic compound falling within the tolerance range are allowed proceed to second production process  24 . Where the tolerance range has a specified lower limit and a tablet is found by monitoring and evaluation system  18  to contain an amount of therapeutic compound falling below the lower tolerance limit, monitoring and evaluation system  18  may be adaptable to move the tablet into first quality control process  20 , with other “under specification” tablets. Where a tablet is found by monitoring and evaluation system  18  to contain an amount of therapeutic compound falling above a specified upper tolerance limit, monitoring and evaluation system  18  may be adaptable to move the tablet into second quality control process  22 , with other “over specification” tablets. Of course, it is contemplated to be within the scope of the present invention that other manufacturing processes and quality control processes may be used, and it also should be noted that monitoring and evaluation system  18  is not limited to evaluating tablets in a pharmaceutical manufacturing process. Indeed, a monitoring and evaluation system according to the present invention may be employed to monitor and evaluate any nonmetallic material. Also, it is contemplated to be within the scope of the present invention that any number of quality control processes may be utilized to sort non-conformiing and conforming materials, or if no quality control processes are used, that the present invention may be used to monitor a production process without separating materials into non-conforming and conforming groups. 
   With reference to  FIG. 2 , there is shown a side view illustrating a cross-section of a portion of a monitoring and evaluation system  18  according to an embodiment of the present invention. As shown in  FIG. 2 , monitoring and evaluation system  18  comprises rotating platter  26 , Raman probe  34 , drive motor  46 , and platter radio transceiver  70 . 
   Rotating platter  26  is substantially circular, and may be sized according to the needs of a particular practitioner of the present invention. These needs may include, for example, the therapeutic delivery form, and the size and quantity thereof. Thus, for example, in an implementation of the present invention wherein monitoring and evaluation system  18  is used in the inspection of tablets, rotating platter  26  may be sized to hold tens or hundreds of tablets simultaneously. Rotating platter  26  comprises conical slide  45  and a plurality of substantially identical chutes  28  (for purposes of clarity, only one chute  28  is shown in FIG.  2 ). Conical slide  45  comprises apex  49  and base  51 . Each chute  28  comprises optical port  32 , exit gate  100 , and open end  116 . The open end  116  of each of the plurality of chutes  28  adjoins base  51  of conical slide  45 . The angular rotation of rotating platter  26 , the number of chutes  28 , and the size of chutes  28  may be adapted so that a continuous supply of tablets may be received for analysis by monitoring and evaluation system  18 . 
   Drive motor  46  is mounted below rotating platter  26  and is connected to rotating platter  26  by drive shaft  48 , such that rotation of drive shaft  48  by drive motor  46  translates into a rotation of rotating platter  26 . Drive motor  46  is in communication with computer  44  (not shown in FIG.  2 ), such that computer  44  may cause drive motor  46  to rotate drive shaft  48  at a variable angular speed and direction. It is envisioned that drive motor  46  may operate on drive shaft  48 , and thus on rotating platter  26 , to rotate rotating platter  26  with a substantially constant angular velocity. Drive motor  46  may be an electric motor of a type known in the art, or may be powered by another means as would occur to one of ordinary skill in the art. 
   Raman probe  34  comprises a spectroscopic probe of a type known in the art adapted for Raman spectroscopy. In the embodiment of monitoring and evaluation system  18  shown in  FIG. 2 , Raman probe  34  is mounted below rotating platter  26  such that the focusing lenses and radiation sensor(s) of Raman probe  34  are oriented in the direction of rotating platter  26 . It is contemplated to be within the scope of the present invention that Raman probe  34  is mounted above or beside rotating platter  26 . 
   Platter radio transceiver  70  is a radio transceiver of a type known in the art capable of transmitting and receiving data at one or more predetermined frequencies. Platter radio transceiver  70  is mounted to the underside of rotating platter  26 . Accordingly, platter radio transceiver  70  orbits drive shaft  48  as rotating platter  26  rotates. 
   With reference now to  FIG. 3 , there is shown a top view of rotating platter  26  of monitoring and evaluation system  18  according to an embodiment of the present invention. Shown in  FIG. 3  are conical slide  45  comprising apex  49  and base  51 , and a plurality of chutes  28  extending radially from base  51  of conical slide  45 . Each chute  28  comprises open end  116  adjacent to base  51 , and exit gate  100  that is substantially conterminous with the circumference of rotating platter  26 . The open ends  116  of the plurality of chutes  28  are arranged side-by-side wherein the end of the first radial wall  112  of a chute  28  abuts the end of the second radial wall  114  of an adjacent chute  28 . In this arrangement, materials moving down conical slide  45  (as discussed hereinafter) move into one of the plurality of chutes  28  through the plurality of side-by-side open ends  116 . In the embodiment shown in  FIG. 3 , substantially all of the circumference of base  51  adjoins the plurality of open ends  116  of the plurality of chutes  28 , but this adjoining arrangement is not required as long as the side-by-side arrangement of chutes  28  is provided. 
   Adjacent to rotating platter  26  are material handling devices  19 ,  21 , and  23 , which lead to first and second quality control processes  20  and  22 , and second production process  24 , respectively. Material handling devices  19 ,  21 , and  23  are stationary. Accordingly, once during each rotation of rotating platter  26 , each exit gate  100  passes by each of material handling devices  19 ,  21 , and  23 . It should be understood that although three material handling devices are shown in  FIG. 3 , the present invention is not so limited. Indeed, monitoring and evaluation system  18  may be used with any number of material handling devices, according to the need of a practitioner in a particular implementation of the present invention. 
   With reference now to  FIG. 4 , there is shown a top view of an exemplary chute  28  according to an embodiment of the present invention. As shown in  FIG. 4 , chute  28  comprises a first radial wall  112  and a second radial wall  114 , wherein the first radial wall  112  and the second radial wall  114  are substantially parallel and extend from base  51  of conical slide  45  to the circumference of rotating platter  26 . In an implementation of chute  28 , the distance between the first radial wall  112  and the second radial wall  114  may be adjustable, so as to accommodate many shapes and sizes of samples of materials submitted for evaluation. 
   In the embodiment of chute  28  shown in  FIG. 4 , chute  28  comprises open end  116 , exit gate  100 , first internal control gate  102 , and second internal control gate  104 . Exit gate  100 , first internal control gate  102 , and second internal control gate  104  operate to partition chute  28  into analysis section  106 , wait section  108 , and a queue section  110 . In the embodiment of chute  28  shown in  FIG. 4 , analysis section  106  and wait section  108  are sized to hold a single sample. Analysis section  106  comprises optical port  32 . When optical port  32  is aligned with Raman probe  34 , spectroscopic data may be obtained by Raman probe  34  from a sample that is in analysis section  106 . Alternatively, a hold down device may be utilized in place of second internal control gate  104 , so that a sample is restrained in queue section  110 . A hold down device utilized in this way would move down (relative to platter  26 ) to hold a sample in place between the hold down device and the floor of chute  28 . 
   In operation, exit gate  100 , first internal control gate  102 , and second internal control gate  104  move up (relative to platter  26 ) to close and down (relative to platter  26 ) to open, thereby enabling movement of items between queue section  110 , wait section  108 , and analysis section  106 . The movement of each of exit gate  100 , first internal control gate  102 , and second internal control gate  104  (or, alternatively, a hold down device as previously mentioned) and, thus, the movement of items between queue section  110 , wait section  108 , and analysis section  106 , is choreographed by computer  44  (not shown in FIG.  4 ). Exit gate  100 , first internal control gate  102 , and second internal control gate  104  may be pneumatically or electrically actuated into an open or closed position using techniques known in the art. Although the embodiment of chute  28  shown in  FIG. 4  comprises two internal control gates, the present invention is not so limited. Indeed, chute  28  may have any number of internal control gates, or may utilize one or more hold down devices, according to the need of a practitioner in a particular implementation of the present invention. 
   With reference now to  FIG. 5 , there is shown a schematic block diagram of the analysis components of a monitoring and evaluation system according to an embodiment of the present invention. Represented in  FIG. 5  are rotating platter  26 , Raman probe  34 , laser  36 , spectrograph  42 , computer  44 , drive motor  46 , platter radio transceiver  70 , and computer radio transceiver  72 . 
   Computer  44  is one or more computers, computing devices, or systems of a type known in the art, such as a personal computer, mainframe computer, workstation, notebook computer, laptop computer, programmable logic device, and the like. Computer  44  comprises such software, hardware, and componentry as would occur to one of skill of the art, such as, for example, one or more microprocessors, memory, input/output devices, device controllers, and the like. The configuration of computer  44  in a particular implementation of a monitoring and evaluation system comprising the present invention is left to the discretion of the practitioner. 
   Computer  44  is electronically interconnected with laser  36  via computer/laser communication link  37 ; with spectrograph  42  via computer/spectrograph communication link  41 ; with drive motor  46  via computer/drive motor communication link  47 ; and with computer radio transceiver  72  via computer/computer radio transceiver communication link  71 . Such electronic interconnections may be accomplished by any means known in the art for electronically interconnecting such devices and for enabling electronic communication therebetween. Thus, it will be appreciated by those of ordinary skill in the art that such electronic interconnection may be accomplished by copper cable, coaxial cable, fiber optic cable, twisted-pair cable, wireless communication, the Internet, the commercial telephone network, one or more local area networks, one or more wide area networks, one or more wireless communications networks, the equivalents of any of the foregoing, or the combination of any two or more of the foregoing. Communication over such electronic interconnections may be accomplished by communication protocols known in the art such as, for example, serial communications, parallel communications, USB, Ethernet, packet switched protocols, and/or other communication protocols known in the art. 
   It is known in the Raman spectroscopy art that a given material, when illuminated with monochromatic light of a known wavelength, will emit radiation having predictable spectral features such as wavelength and intensity. Resident in the memory of computer  44  or associated with computer  44  is a database (not shown) containing the predicted spectral features for the material(s) that will be evaluated using an embodiment of a monitoring and evaluation system according to the present invention. 
   Laser  36  is a laser of a type known in the art that is capable of producing substantially monochromatic photons of a wavelength selected from the range of wavelengths between about 266 and about 1064 nanometers, and may be tunable to provide monochromatic photons over this range. The wavelength of photons used in a particular implementation of the present invention may be selected from this range according to the needs of the practitioner in that implememtation. In one implementation of the present invention, laser  36  produces photons with a wavelength of about 355 nanometers. In another implementation, laser  36  produces photons with a wavelength of about 532 nanometers. Techniques for production of photons at these wavelengths using lasing activity is well known in the art. In an embodiment of the present invention, laser  36  comprises a diode laser, but other laser technologies are contemplated to be within the scope of the present invention. 
   The substantially monochromatic photons produced by laser  36  are carried to Raman probe  34  by a first fiber optic cable  38  or other light transmission device. Raman probe  34  is operable to focus the substantially monochromatic photons onto a target material, thereby illuminating at least of portion of the target material with the substantially monochromatic photons. Raman probe  34  also is operable to collect radiation emitted from the target material following exposure of the target material to the substantially monochromatic photons. 
   The emitted radiation collected by Raman probe  34  is carried to spectrograph  42  via second fiber optic cable  40  or other light transmission device. Spectrograph  42  comprises a charge-coupled device (“CCD”) of a type known in the art that is capable of recording a digital image of the radiation collected by Raman probe  34 . Second fiber optic cable  40  emits radiation onto the CCD, which records a digital image of the wavelength and intensity of the photons. The digital image then is transmitted to computer  44  via computer/spectrograph communication link  41 . 
   In an implementation of the present invention, spectrograph  42  comprises a CCD measuring 1×1024 pixels, wherein each pixel has a resolution of at least 16-bits. Other pixel ratios such as, for example, 64×2048 pixels, 64×512 pixels, 64×1024 pixels, and 1024×2048 pixels also may be successfully employed within the scope of the present invention. 
   Computer radio transceiver  72  is a radio transceiver of a type known in the art capable of transmitting and receiving data at one or more predetermined frequencies. In the embodiment of the present invention shown in  FIG. 5 , platter radio transceiver  70  and computer radio transceiver  72  communicate via radio frequency transmissions. Platter radio transceiver  70  and rotating platter  26  also are in communication regarding, for example, the angular position of rotating platter  26  and the status of each exit gate and control gate of each chute  28  as open or closed 
   Operation of an embodiment of monitoring and evaluation system  18  according to the present invention will now be described with reference to  FIGS. 1-6 . In this embodiment, monitoring and evaluation system  18  is adapted for use with pharmaceutical tablets. Accordingly, first production process  12  comprises a tablet press of a type known in the art. 
   Computer  44  controls and choreographs the operations of monitoring and evaluation system  18 . According to the present invention, computer  44  causes drive motor  46  to operate drive shaft  48  at a desired angular speed, which results in rotation of rotating platter  26 . While rotating platter  26  is rotating in the direction indicated in  FIG. 3 , a plurality of tablets are deposited on apex  49  of conical slide  45 . Gravity urges the plurality of tablets down the slope of conical slide  45  toward base  51  thereof At base  51  of conical slide  45 , the centrifugal force generated by the rotational rotating platter  26  urges the plurality of tablets through the plurality of open ends  116  and into the plurality of chutes  28 . Centrifugal force continues to act on the tablets within chutes  28 , causing tablets within a chute  28  to seek a position at the distal end of the chute  28 . 
   For purposes of clarity, the operation of chutes  28  in an embodiment of the present invention will be described with reference to only one of the plurality of chutes  28 , and to a first tablet, a second tablet, and a third tablet within the chute  28 , wherein the first tablet enters the chute  28  first, followed by the second tablet and then the third tablet. It will be understood that this example merely clarifies the operation of the present invention, and should not be interpreted as a limitation. It is within the scope of the present invention that tablets may be continuously received for evaluation by the present invention. 
   Initially, chute  28  is empty, exit gate  100  of chute  28  is closed, and first control gate  102  and second control gate  104  are open. As the first tablet fills analysis section  106 , sensors (not shown) on rotating platter  26  cause first control gate  102  to close behind the first tablet, thus creating a partition between wait section  108  and analysis section  106 . The first tablet is thus separated from subsequent tablets, and is positioned for analysis over optical port  32  of analysis section  106 . It should be noted that analysis section  106  should be sized to be slightly larger than the tablet, so that the size of analysis section  106  in combination with the centrifugal force provided by the rotating platter  26 , forces each tablet that enters analysis section  106  into consistent position within the analysis section  106 , thus improving the consistency of tablet analysis. 
   As the second tablet reaches wait section  108 , the second control gate  104  closes to create a partition between wait section  108  and queue section  110 . The second tablet is thus separated from the first tablet and from subsequent tablets. The third tablet is thus located in the queue section  110 , and subsequent tablets may be located in the queue section  110  as well. As described previously, second control gate  104  may alternatively comprise a hold down device used to restrain the tablets in queue section  110 . 
   Information regarding the angular position of rotating platter  26  and the open/closed status of each exit gate and control gate of each chute  28  is continually passed to the computer  44  via radio transmissions between platter radio transceiver  70  and computer radio transceiver  72 . As optical port  32  of chute  28  aligns with Raman probe  34 , computer  44  communicates with laser  36  to cause laser  36  to engage in lasing activity. Monochromatic photons then are produced by laser  36  and are transmitted to Raman probe  34  via first fiber optic cable  38 . 
   A schematic diagram of Raman probe  34  is shown in FIG.  6 . As shown therein, Raman probe  34  comprises a first turning mirror  150 , a long pass filter  152 , first focusing lens  154 , and a second focusing lens  156 . First turning mirror  150  reflects the photons received from the first fiber optic cable  38 , and is angled to reflect the photons toward long pass filter  152 . Long pass filter  152  is coated with a semi-reflective material. The long pass filter  152  coating is selected to reflect light with the wavelength generated by the laser  36 , and to allow radiation with a wavelength longer than the wavelength generated by the laser  36  to pass through without being reflected. The photons of the selected wavelength of the long pass filter coating are reflected by long pass filter  152  toward first focusing lens  154 . When first focusing lens  154  is aligned with optical port  32  of chute  28 , the photons are focused onto the tablet in analysis section  106 . Long pass filter  152  may also be a holographic notch filter selected in accordance with the wavelength of the monochromatic photons generated by laser  36  in the particular implementation of the present invention. 
   Photons emitted by the Raman probe  34  through first focusing lens  154  strike the surface of the tablet in analysis section  106 , and radiation is thereupon emitted from the tablet in a random and scattered manner. A portion of this radiation is collected and collimated by first focusing lens  154  and transmitted into the Raman probe  34 . A portion of the emitted radiation then is transmitted through the long pass filter coating of the long pass filter  152 , is focused by second focusing lens  156 , and is received by second fiber optic cable  40 , which communicates the radiation to spectrograph  42 . Some reflected laser light will also pass through the long pass filter coating and be collected by second fiber optic cable  40 . 
   Certain spectral features of the emitted radiation are recorded by the CCD of spectrograph  42 , which communicates the recorded spectral features to the computer  44  over computer/spectrograph communication link  41 . Residing in the memory of computer  44  is the predicted spectral feature information for a tablet of the type being analyzed. Computer  44  compares the spectral feature information recorded by spectrograph  42  to the predicted spectral feature information in the memory of computer  44 . As a result of the comparison, computer  44  determines if the first tablet contains a concentration of therapeutic compound that is within the specifications for a tablet of the type being analyzed. If the tablet is found to be outside of the specifications, in this embodiment of the present invention a further determination is made as to whether the tablet contains a concentration of therapeutic compound above the threshold specification concentration, or a concentration of therapeutic compound below the threshold specification concentration. It should be noted that while the computer  44  is analyzing the spectral feature information, rotating platter  26  continues to rotate so that the first tablet may no longer be over Raman probe  34 . 
   Based on positional information of the rotating platter  26 , and the information that the first tablet is above, below, or within specification, the computer  44  operates to cause exit gate  100  to open at an appropriate time so that the centrifugal force generated by the rotation of rotating platter  26  causes the first tablet to be released to one of material handling devices  19 ,  21 , or  23 . For example, if computer  44  determines the first tablet to be below specification, computer  44  causes exit gate  100  to open in conjunction with material handling device  19 , transferring the tablet to first quality control process  20 . If the computer  44  determines the first tablet to be above specification, the computer  44  causes exit gate  100  to open in conjunction with material handling device  21 , transferring the tablet to second quality control process  22 . If the computer  44  determines the first tablet to be within specification, the computer  44  causes exit gate  100  to open in conjunction with material handling device  23 , transferring the tablet to second production process  24 . 
   After the first tablet has moved off of rotating platter  26 , exit gate  100  closes. First control gate  102  then opens, and centrifugal force urges the second tablet into analysis section  106 . First control gate  102  then closes, and as the size of chute  28  is only slightly larger than the diameter of the tablet, the second tablet is oriented in analysis section  106  in the same fashion as was the first tablet. 
   After the second tablet has moved from wait section  108  into analysis section  106 , second control gate  104  closes, and centrifugal force urges the third tablet into wait section  108 . Second control gate  104  closes, and centrifugal force orients the third tablet in wait section  108  similarly to the second tablet in analysis section  106 . It should be noted that additional tablets maybe located in queue section  110 . 
   Second tablet is thus oriented properly for analysis, and rotating platter  26  continues to rotate. When chute  28  aligns with Raman probe  34 , spectral feature information from the second tablet will be collected, and a determination of the second tablet to be above, below, or within specification will be made similarly to the first tablet. 
     FIG. 7  shows a flow chart illustrating the detection and determination process as described above. Before the detection, the position of rotating platter must be checked (at block  50 ) to ensure that the tablet is properly aligned with Raman probe, then the spectral feature data is taken (at block  52 ). A determination of the content of the tablet based on the spectral features of the tablet, and whether the tablet is within or without specification is made (at block  54 ). If the tablet is within the specified tolerance range, then the tablet is released at the proper position for within specification product (at block  56 ). After the determination of being within or without specification, or even contemporaneously, a second determination of whether the out of specification tablets are above or below the tolerance range is made (at block  58 ) and the tablet then is routed accordingly (at blocks  60  and  62 ). In addition to the determinations made, the present invention may be utilized to plot statistical data (at block  64 ) regarding the process and the numbers of tablets which are within the specified tolerance range and the numbers which are outside the specified tolerance range. 
   It will be appreciated that the present invention provides significant advantages over the prior art. Specifically, the present invention provides the ability to analyze samples of pharmaceutical products in real time and in a way that is integrated with the manufacturing process. The present invention allows for analysis in a nondestructive manner, and is adaptable to evaluate every tablet produced by the manufacturing process, thereby reducing the statistical risk incurred by testing only a subset of the tablets. In addition, by evaluating materials “in-process” and in real time, the present invention enables process problems or manufacturing apparatus problems to be readily identified and fixed without requiring an entire lot of the material to be created, thereby reducing costs. 
   The present invention may be used in conjunction with a traditional quality assurance laboratory. For example, the present invention provides a sufficient level of testing so that the balance of tablets from a manufactured lot may be more quickly released for packaging, and the manufacturing apparatus may be more quickly brought back into productive use, while other lots wait in the queue or undergo analysis by the off-line quality assurance laboratory. Reducing cycle time in this critical stage of manufacturing results in less downtime, and an increase in productivity and profitability. 
   While this invention has been described as having an exemplary structure, the present invention can be further modified within the scope and spirit of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. For example, the methods disclosed herein and in the appended claims represent one possible sequence of performing the steps thereof. A practitioner of the present invention may determine in a particular implementation of the present invention that multiple steps of one or more of the disclosed methods may be combinable, or that a different sequence of steps may be employed to accomplish the same results. Each such implementation falls within the scope of the present invention as disclosed herein and in the appended claims. Furthermore, 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.