Modular pharmacy system and pharmacy process
First Claim
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1. A pharmaceutical systemfor the admixture of ultra-high purity intravenous solutions and drugs, said system comprising:
- a plurality of work stations for completion of successive process flow steps in the admixture of intravenous solutions and drugs and comprising;
at least one work station for reception of patient prescriptions and generation of prescription labels comprising computer means for accessing and receiving a hospital'"'"'s prescription data files for prescription orders;
at least one work station for raw materials receiving and storage;
at least one work station for compounding of solutions, for sterile microfiltration of said solutions, and for unit filling of IV bags or syringes;
at least one work station for cleaning or sterilization of work station equipment;
at least one work station for analysis, control and testing of solutions and equipment;
at least one work station for double checking labeled product for release thereof; and
,environment control means comprising air filtration means to supply air in ultra-high purity form, at controlled pressure and temperature, to said plurality of work stations.
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Abstract
A modular pharmacy and a modular pharmacy system and process for the admixture of intravenous drugs and total parenteral nutrition solution which includes automatic daily computer download of hospital prescriptions and the daily compounding under controlled systematic aseptic conditions including individually controlled environments at each work station and following systematically controlled process steps.
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Citations
31 Claims
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1. A pharmaceutical system
for the admixture of ultra-high purity intravenous solutions and drugs, said system comprising: -
a plurality of work stations for completion of successive process flow steps in the admixture of intravenous solutions and drugs and comprising; at least one work station for reception of patient prescriptions and generation of prescription labels comprising computer means for accessing and receiving a hospital'"'"'s prescription data files for prescription orders; at least one work station for raw materials receiving and storage; at least one work station for compounding of solutions, for sterile microfiltration of said solutions, and for unit filling of IV bags or syringes; at least one work station for cleaning or sterilization of work station equipment; at least one work station for analysis, control and testing of solutions and equipment; at least one work station for double checking labeled product for release thereof; and
,environment control means comprising air filtration means to supply air in ultra-high purity form, at controlled pressure and temperature, to said plurality of work stations. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18)
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19. A pharmacy comprised of at least one modular structure divided interiorly into separate rooms and areas for performing specific activities for the admixture of ultrapure intravenous solutions and drugs comprising:
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at least one area for prescription order entry for receipt of prescriptions comprising computer means for accessing and receiving a hospital'"'"'s prescription data files for prescription orders; at least one changing area for donning sterile work garments; at least one control, analysis, and testing area for analysis of prescriptions and for testing for sterility of prescriptions and equipment; at least one process preparation area for washing and sterilizing of equipment; and
for weighing out and measuring raw materials;at least one area for extemporaneous compounding of prescription solutions; at least one area for wipe down of exterior portions of equipment prior to use in compounding and unit filling of prescriptions; at least one positive air pressure area for total parenteral nutrition compounding, sterile microfiltering and filling; at least one negative air pressure biohazard hood for general pharmacy, antibiotic and chemotherapy compounding and filling; and
,at least one area for product release. - View Dependent Claims (20, 21, 22)
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23. A pharmacy comprising:
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at least one structure divided interiorly into separate rooms for performing specific process flow activities for the production of ultrapure intravenous solutions and drugs comprising; at least one ambient air pressure room for raw materials receiving and storage, for receiving prescriptions, and for changing into scrubs; at least one positive air pressure room for control and testing of prescriptions, for process preparation, for cleaning and for sterilizing of equipment used in the preparation of prescriptions, for large scale compounding of solutions, for wipe down of equipment used in TPN compounding and filling, for changing into sterile gowns and related apparel, for TPN microcompounding, filtering and filling, for unit filling of antibiotic prescriptions, and for release of filled prescription products; and
,at least one separate negative air pressure room for compounding of general pharmacy and chemotherapy drugs and at least one separate negative air pressure room for compounding of antibiotics; and
,a biohazard hood disposed within each negative air pressure room for the compounding of the prescription drugs within each room. - View Dependent Claims (24, 25)
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26. A process for admixture of ultrapure intravenous solutions and drugs comprising:
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receiving prescription orders; analyzing each prescription order at least with respect to identity of ingredients and amounts thereof; preparing a list of needed materials, equipment and sterile prepared solutions; wiping down the exterior of each container of materials and prepared solutions, and equipment, attached equipment and transport equipment; transferring said wiped down containers, materials and equipment to form individual TPN prescriptions and extemporaneous solutions to a prescription compounding and filling room substantially free of pathogenic organisms and having a controlled air flow environment with positive air pressure and provided with a class 1000 or better standard; admixing at least one of the extemporaneous solutions and large scale batch TPN compounding solutions extemporaneously as needed wherein the steps comprise; analyzing each prescription order at least with respect to identity of ingredients and amounts thereof; preparing a list of needed raw materials and prepared solutions; transferring raw materials on said list to a process preparation area for weighing and measuring of said materials; mixing together needed raw materials and prepared solutions to form said extemporaneous and large scale batch solutions; sampling each solution batch; testing and analyzing each batch solution for quality; releasing each extemporaneous and batch solution for use in filling prescriptions; wiping down the exterior of each extemporaneous and large scale solution container, attached equipment and transport equipment; transferring each container of extemporaneous and large scale batch solutions to a prescription compounding and filling room substantially free of pathogenic organisms and having a controlled air flow environment with positive air pressure and a class 100 or better standard; checking each prescription at least as to identity of ingredients and amounts thereof; filtering each said extemporaneous and large scale batch solutions through a sterile micropore filter sized to exclude pathogenic organisms; metering prescription amounts of each said sterile prepared solutions and each filtered extemporaneous and large scale batch solution according to the prescription amounts into individual unit bags; checking for any prescription changes; adding individual sterile microadditives to each unit bag according to each individual prescription; rechecking for each prescription ingredient; and
,releasing the filled prescription product. - View Dependent Claims (27, 28, 29, 30)
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31. A process for admixture of ultrapure intravenous solutions and drugs comprising:
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receiving and accessing a hospital'"'"'s prescription data files for prescription orders by computer means; analyzing each prescription order at least with respect to identity of ingredients and amounts thereof by computer means; preparing a list of needed materials, equipment and sterile prepared solutions; wiping down the exterior of each container of materials and prepared solutions, and equipment, attached equipment and transport equipment; transferring said wiped down containers, materials and equipment to form said prescriptions to a prescription compounding and filling room substantially free of pathogenic organisms and having a controlled air flow environment with negative air pressure and provided with a class 1000 or better standard; checking each prescription at least as to identity of ingredients and amounts thereof; metering prescription amounts of each presterilized solution according to the prescription amounts into individual unit containers; checking for any prescription changes; rechecking for each prescription ingredient; and
,releasing the filled prescription product.
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Specification