CN1352570A - 在有效的灭菌场内处理预先灭菌的部件的方法和设备 - Google Patents

在有效的灭菌场内处理预先灭菌的部件的方法和设备 Download PDF

Info

Publication number
CN1352570A
CN1352570A CN00806371A CN00806371A CN1352570A CN 1352570 A CN1352570 A CN 1352570A CN 00806371 A CN00806371 A CN 00806371A CN 00806371 A CN00806371 A CN 00806371A CN 1352570 A CN1352570 A CN 1352570A
Authority
CN
China
Prior art keywords
sterilization
field
electron beam
forms
parts
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN00806371A
Other languages
English (en)
Inventor
阿诺德·C·比尔施泰德
布拉德利·H·布坎南
艾伦·W·马蒂拉
阿奇·伍德沃思
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Baxter International Inc
Original Assignee
Baxter International Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=23135674&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CN1352570(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Baxter International Inc filed Critical Baxter International Inc
Publication of CN1352570A publication Critical patent/CN1352570A/zh
Pending legal-status Critical Current

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/08Radiation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/08Radiation
    • A61L2/087Particle radiation, e.g. electron-beam, alpha or beta radiation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/14Plasma, i.e. ionised gases
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20Gaseous substances, e.g. vapours
    • A61L2/208Hydrogen peroxide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • A61M39/16Tube connectors; Tube couplings having provision for disinfection or sterilisation
    • A61M39/18Methods or apparatus for making the connection under sterile conditions, i.e. sterile docking
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/02Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/02Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • B29C65/10Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using hot gases (e.g. combustion gases) or flames coming in contact with at least one of the parts to be joined
    • B29C65/103Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using hot gases (e.g. combustion gases) or flames coming in contact with at least one of the parts to be joined direct heating both surfaces to be joined
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/001Joining in special atmospheres
    • B29C66/0012Joining in special atmospheres characterised by the type of environment
    • B29C66/0018Joining in special atmospheres characterised by the type of environment being sterile
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/01General aspects dealing with the joint area or with the area to be joined
    • B29C66/02Preparation of the material, in the area to be joined, prior to joining or welding
    • B29C66/028Non-mechanical surface pre-treatments, i.e. by flame treatment, electric discharge treatment, plasma treatment, wave energy or particle radiation
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/01General aspects dealing with the joint area or with the area to be joined
    • B29C66/05Particular design of joint configurations
    • B29C66/10Particular design of joint configurations particular design of the joint cross-sections
    • B29C66/11Joint cross-sections comprising a single joint-segment, i.e. one of the parts to be joined comprising a single joint-segment in the joint cross-section
    • B29C66/114Single butt joints
    • B29C66/1142Single butt to butt joints
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/01General aspects dealing with the joint area or with the area to be joined
    • B29C66/05Particular design of joint configurations
    • B29C66/10Particular design of joint configurations particular design of the joint cross-sections
    • B29C66/12Joint cross-sections combining only two joint-segments; Tongue and groove joints; Tenon and mortise joints; Stepped joint cross-sections
    • B29C66/122Joint cross-sections combining only two joint-segments, i.e. one of the parts to be joined comprising only two joint-segments in the joint cross-section
    • B29C66/1222Joint cross-sections combining only two joint-segments, i.e. one of the parts to be joined comprising only two joint-segments in the joint cross-section comprising at least a lapped joint-segment
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/01General aspects dealing with the joint area or with the area to be joined
    • B29C66/05Particular design of joint configurations
    • B29C66/10Particular design of joint configurations particular design of the joint cross-sections
    • B29C66/12Joint cross-sections combining only two joint-segments; Tongue and groove joints; Tenon and mortise joints; Stepped joint cross-sections
    • B29C66/122Joint cross-sections combining only two joint-segments, i.e. one of the parts to be joined comprising only two joint-segments in the joint cross-section
    • B29C66/1224Joint cross-sections combining only two joint-segments, i.e. one of the parts to be joined comprising only two joint-segments in the joint cross-section comprising at least a butt joint-segment
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/50General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
    • B29C66/51Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles
    • B29C66/52Joining tubular articles, bars or profiled elements
    • B29C66/522Joining tubular articles
    • B29C66/5221Joining tubular articles for forming coaxial connections, i.e. the tubular articles to be joined forming a zero angle relative to each other
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/50General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
    • B29C66/51Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles
    • B29C66/52Joining tubular articles, bars or profiled elements
    • B29C66/522Joining tubular articles
    • B29C66/5229Joining tubular articles involving the use of a socket
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/80General aspects of machine operations or constructions and parts thereof
    • B29C66/81General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps
    • B29C66/814General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps
    • B29C66/8141General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the surface geometry of the part of the pressing elements, e.g. welding jaws or clamps, coming into contact with the parts to be joined
    • B29C66/81431General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the surface geometry of the part of the pressing elements, e.g. welding jaws or clamps, coming into contact with the parts to be joined comprising a single cavity, e.g. a groove
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/80General aspects of machine operations or constructions and parts thereof
    • B29C66/83General aspects of machine operations or constructions and parts thereof characterised by the movement of the joining or pressing tools
    • B29C66/832Reciprocating joining or pressing tools
    • B29C66/8322Joining or pressing tools reciprocating along one axis
    • B29C66/83221Joining or pressing tools reciprocating along one axis cooperating reciprocating tools, each tool reciprocating along one axis
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/80General aspects of machine operations or constructions and parts thereof
    • B29C66/84Specific machine types or machines suitable for specific applications
    • B29C66/857Medical tube welding machines
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B67OPENING, CLOSING OR CLEANING BOTTLES, JARS OR SIMILAR CONTAINERS; LIQUID HANDLING
    • B67CCLEANING, FILLING WITH LIQUIDS OR SEMILIQUIDS, OR EMPTYING, OF BOTTLES, JARS, CANS, CASKS, BARRELS, OR SIMILAR CONTAINERS, NOT OTHERWISE PROVIDED FOR; FUNNELS
    • B67C7/00Concurrent cleaning, filling, and closing of bottles; Processes or devices for at least two of these operations
    • B67C7/0073Sterilising, aseptic filling and closing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20Targets to be treated
    • A61L2202/23Containers, e.g. vials, bottles, syringes, mail
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20Targets to be treated
    • A61L2202/24Medical instruments, e.g. endoscopes, catheters, sharps
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/02Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • B29C65/04Dielectric heating, e.g. high-frequency welding, i.e. radio frequency welding of plastic materials having dielectric properties, e.g. PVC
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/48Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor using adhesives, i.e. using supplementary joining material; solvent bonding
    • B29C65/4895Solvent bonding, i.e. the surfaces of the parts to be joined being treated with solvents, swelling or softening agents, without adhesives
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/50General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
    • B29C66/51Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles
    • B29C66/52Joining tubular articles, bars or profiled elements
    • B29C66/522Joining tubular articles
    • B29C66/5229Joining tubular articles involving the use of a socket
    • B29C66/52291Joining tubular articles involving the use of a socket said socket comprising a stop
    • B29C66/52293Joining tubular articles involving the use of a socket said socket comprising a stop said stop being external
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/50General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
    • B29C66/51Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles
    • B29C66/52Joining tubular articles, bars or profiled elements
    • B29C66/522Joining tubular articles
    • B29C66/5229Joining tubular articles involving the use of a socket
    • B29C66/52298Joining tubular articles involving the use of a socket said socket being composed by several elements
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/70General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/73General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset
    • B29C66/739General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of the parts to be joined being a thermoplastic or a thermoset
    • B29C66/7392General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of at least one of the parts being a thermoplastic
    • B29C66/73921General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of at least one of the parts being a thermoplastic characterised by the materials of both parts being thermoplastics
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29LINDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2023/00Tubular articles
    • B29L2023/005Hoses, i.e. flexible
    • B29L2023/007Medical tubes other than catheters

Landscapes

  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Mechanical Engineering (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Plasma & Fusion (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Combustion & Propulsion (AREA)
  • Toxicology (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)
  • External Artificial Organs (AREA)
  • Basic Packing Technique (AREA)
  • Filling Of Jars Or Cans And Processes For Cleaning And Sealing Jars (AREA)

Abstract

本发明公开了在维持部件的无菌状态的同时,对两个或多个预先灭菌的部件进行连接、装配或灌装的方法以及实现此类连接的设备,其中所述部件的每个带有至少一个与另一部件相连接的末端。使用溶剂粘合技术、射频密封机、热封机或任何其他适当的方法通过将接触的部件粘合在一起实现部件的永久连接。优选在有效的灭菌场内完成连接。使用一种低电压电子束仪器,例如MIN-EBTM,能够形成一种合适的灭菌场范围。多个部件的末端保持在灭菌场范围内,直至在密封的部件内发生污染的可能性被显著降低至工业上可以接受的标准。

Description

在有效的灭菌场内处理预先灭菌的部件的方法和设备
技术领域
本发明总体上涉及在灭菌场内连接、装配和灌装预先灭菌医疗部件的方法和设备。更具体地说,本发明涉及使用低电压电子束场形成一种灭菌气氛,在其中可以进行诸如溶液输送装置、医疗管线、药瓶、医疗容器等预先灭菌的医疗部件的连接、装配或灌装,从而使产品的无菌性得以连续维持。
背景技术
在美国和世界范围的其他国家,预先灭菌的、一次性的医疗产品是常见的。对此类产品的设计、开发和制造的一个重要的限制是所需要的特定产品可能包括在灭菌的角度上相互间不相容的部件或成分。例如,可能需要提供一种包括封装的液体或粉末药品成分以及例如一种管线或流动控制装置的塑料设备部件的整体的、预先灭菌的产品。
然而,由于不是所有的组成部件都能够进行同等形式的灭菌操作,因此,整体产品不能在装配后进行灭菌。也就是说,塑料设备部件(例如管线或流动控制装置)仅能够使用射线或气体灭菌。另一方面,药品部件不能使用气体或射线灭菌——气体灭菌对于封装的药品是没有灭菌效果的,而将药品置于射线之下可能会导致药品的分解或者在药品中产生其他有害的影响。
相应地,人们一直在努力设计一种以无菌的方式连接已经分别预先灭菌的组成部件的方法或手段。这些努力包括使用电子束加速器用于装配部件组成部分的灭菌。电子束灭菌法是用于一次性医疗装置最终灭菌的一项众所周知并被接受的技术。现有的电子束系统是电子完全穿透被灭菌物质的高压装置。此类装置和方法在美国专利No.5,009,654和5,496,302中公开,二者的发明人均为Minshall等人,并均已转让给巴克斯特国际公司。
Minshall等人所使用的电子束来自一种高能(>0.3MeV或300KeV)仪器以“实现在管线中心灭菌”。公开了用于灭菌的1.1MeV,0.9MeV,0.75MeV和0.6MeV的能量水平。高能方法包括在接近其末端的位置使待连接的管线夹在一起。然后截断其末端并将末端开口的管线粘合或焊接到一起。在新的流体通路被打通前,在两个夹钳之间施加高能电子束进行有效地灭菌。虽然这些类型的高能系统运行良好,但与本发明相比,它们可以被视为体积过大(有时要求一个具有铅屏蔽厚墙的单独房间)、更加昂贵以及具有产品特异性。
实现灭菌连接的另外一个例子在Granzow等人的美国专利No.4,157,723及Reissure No.32,056中公开,每项专利均已转让给本发明的受让人。Granzow等人的发明以一种含有一个完整的黑色TPX(掺杂碳)圆盘的透明TPX(甲基戊烯聚合物)单一连接器机座(unisexconnector housing)为基础。连接器与来自例如一种经过蒸汽灭菌的溶液容器的管线相接,溶液容器与来自经过环氧乙烷(EtO)或伽马射线灭菌的溶液输送装置的类似管线连接。将两个连接器迅速咬合在一起并在黑色圆盘上施加强烈聚焦的光线,迅速将其融合在一起形成一个完整的灭菌流体通路的环形环并完成无菌连接。在连接后,溶液被转移至空的溶液容器中,而包括最初的溶液容器的无菌连接器被移开并抛弃。虽然实用,但本发明提供了一种能够改进本方法的效率和成本的方法。
E.I.DuPont开发并获得了一种“热刀”管线与管线连接系统的专利,如授予Benin等人的美国专利No.4,521,263所示。在这一系统中,两个带有彼此相对的封好的末端的热塑管被并排放置在一个带有一种特殊的热刀片的固定装置中。连接通过下列步骤实现:(1)使用热刀片切穿两个管,(2)反复移动两个管,使其在热刀片的两侧成一条直线连接,以及(3)在移去热刀片的同时将两个管推进到一起。这一系统比本发明所使用的方法可能更昂贵,因为它要求在每一次连接时使用一个新的一次性的刀片。
本发明的设备和方法克服了其他现有技术的缺点。本发明专注于在装配、连接和灌装的过程中维持预先灭菌的部件的无菌性,而不是象本领域的技术人员所广泛使用的方法那样在完成这些操作后再试图有效地灭菌。此外,本发明专注于比使用一次性部件便宜得多的方法。
本发明概述
本发明公开了一种用于在两个或多个预先灭菌的部件之间形成连接,特别是无菌连接的新的设备和方法。优选每个部件具有至少一个适于与另一个部件连接的封闭末端。本发明方法和设备的一个实施方案要求使用一种有效的灭菌场将待连接的每个部件的末端进行灭菌,然后在有效的灭菌场内打开每个部件的封闭末端。通过在有效的灭菌场内将打开的末端连接在一起完成无菌连接。
本发明的一个方面还提供了一种在两个或多个预先灭菌的部件之间形成无菌装配的设备和方法。优选每个部件具有至少一个适于与另一个部件连接的封闭末端。本发明方法和设备的一个实施方案要求使用一种有效的灭菌场将待装配的每个部件的末端进行灭菌,然后仍然在有效的灭菌场内将末端装配到一起。
本发明的一个方面还进一步提供了一种实现将来自散装容器的预先灭菌的液体成分灌装至预先灭菌的容器的设备和方法。优选空容器带有至少一个适于接受液体成分的末端,散装容器带有至少一个适于输出液体的末端。本发明设备和方法的一个实施方案要求使用一种有效的灭菌场对每个部件的末端进行灭菌,然后在末端仍然在有效的灭菌场的情况下完成来自散装容器的液体向空容器的灌装。
特别地,在本发明的一个实施方案中,通过形成一种产生有效灭菌场的电子束场而实现对每个部件末端的灭菌,然后在电子束场的范围内处置末端。本发明的方法优选使用在低于300KeV电压下形成的电子束场。特别地,电子束场在大约30至大约300KeV范围的电压下形成。
在本发明的另一个实施方案中,通过制造一种化学蒸汽气氛以形成有效的灭菌场而实现对每个部件末端的灭菌,然后,在无菌的化学蒸汽气氛下处理末端。化学蒸汽气氛可以由过氧化氢、过乙酸、二氧化氯或任何其他适当的化学蒸汽形成。
仍然是本发明的另一个实施方案,通过使用一种具有大量紫外线成分的高能脉冲光以形成有效的灭菌场而实现对每个部件末端的灭菌,然后在该脉冲光范围内处理末端。
仍然是另一个实施方案,通过制造一种等离子体气氛以形成有效的灭菌场而实现对每个部件末端的灭菌,然后在该等离子体气氛范围内处理末端。
关于本发明的设备,公开了一种使用至少两个预先灭菌部件实现无菌连接、无菌装配或无菌灌装的装置,优选每个部件具有至少一个与至少另一个部件连接的末端。本发明的一个实施方案包括一种用于包围待连接、装配或灌装的部件的末端的有效的灭菌场,同时还包括一个支持预先灭菌部件的末端在有效的灭菌场范围内的表面。
一个实施方案可以带有一个在有效的灭菌场内在表面的支持下切断预先灭菌部件的末端以形成开放末端的机械结构,同时还包括在有效的灭菌场内在表面的支持下使开放的末端排成相互接触的一列的机械结构。该设备还包括一个使开放的末端密封在一起的装置。
在阅读了下文对本发明的详细描述后,本发明的其他优点和方面将是明显的。
对附图的说明
图1表示两个部件的位置,在进行灭菌场连接前一个是被装满的湿容器,另一个是空的干容器;
图2表示本发明一个实施方案的装配线结构;
图3A至3D表示用于在一个有效的灭菌场内实现两个部件的无菌连接的本发明方法的一个实施方案;
图4表示用于本发明的一个实施方案的一种电子束电子管;
图5A表示在一个有效的灭菌场内支撑多个部件末端的机械结构的实施方案;
图5B表示当多个部件的末端在有效的灭菌场内开始相互接触时图5A的机械结构;
图6A至6D表示将本发明用于预先灭菌的管形瓶与预先灭菌的装置进行灭菌装配的不同应用;
图7A至7E表示尖管和膜式管构形末端的不同实施方案和变体;
图8A至8D表示使用热空气流软化膜式管,然后随着膜式管的冷却将其连接到一起的一种不同的连接方式;
图9表示本发明的无菌灌装过程。
对优选实施方案的详细描述
虽然本发明可以用于许多不同形式的实施方案,但这里公开的内容将详细地描述本发明的优选实施方案,应当理解的是,这里所公开的内容应被理解为对本发明原则的例证而不是欲将本发明广泛的方面限定在所说明的实施方案范围之内。
本发明涉及以无菌的方式接合塑料部件的方法和设备。在本申请中所使用的术语“接合”包括下列过程:1)连接部件,在连接过程中形成流体通路;2)装配部件,其中在接合时没有形成流体通路但可能在以后形成;以及3)从散装容器中灌装至少一个部件。特别地,本发明允许在无菌场中将管-容器,管-管,管-连接器,管形瓶-连接器,容器-连接器,甚至于片/膜料与自身接合在一起。
附图及下文的讨论中引用了分别作为空的干容器和装满的湿容器的部件10和12。这些部件是典型的以其他方法,例如伽马射线、蒸汽灭菌、化学蒸汽、高压电子束射线等预先灭菌的。
优选低压电子束仪器作为有效的灭菌场的来源。此类装置适当的实例在Wakalopulos的美国专利No.4,910,435和5,612,588中有详细的讨论,上述专利均已转让给American International Technologies,Inc.ofTorrance,California。这些Wakalopulos的每项专利所公开的内容在此引入作为参考。特别地,一种适当的低压电子束来源是由AmericanInternational Technologies,Inc.制造的、商品名为MIN-EBTM的产品。MIN-EBTM能够在一个相对较低的电压下运转,电压的范围是大约30KeV至大约100KeV。这是本发明优选的运转范围,包括该范围内的所有组合和次组合。
参照附图,部件10和12更易于在图1中理解。优选每个部件带有一个与其相连接的封闭的末端14。部件10和12封闭的末端14可以是相同的或者如图7A至7E所表示,也可以是几种不同的构形。封闭末端14的其他变体(没有表示)也是可能的。可以针对每种类型有区别地将末端类型连接在一起,但那些相关领域中的技术人员能够理解配合此类设计变化所需要的修改。
图2表示一种常见的用于无菌接合系统20的装配生产线的概念。据预计,此类批量生产系统能够在整个产业范围内产生许多收益。部件10和12在无菌接合系统20流程的不同位置分开表示。图2表明无菌接合系统20包括一个延伸至整个系统长度的支撑面22。当以纵向划分时,这一支撑面包括左半部分(L)和右半部分(R)。部件10和12被表示成在支撑面22上面成对排列,其中部件10在支撑面22的左侧(L),部件12在右侧(R)。支撑面22可以是一条传送带或类似的移动表面,自动传送部件10和12通过系统20。使用散装容器的无菌灌装可以仅使用一列空部件,这在下文的描述中将更加清楚。
排列好的部件10和12可以首先选择性地被传送至帖标签的位置40,在这里将贴上容量、批号以及日期等重要的信息。然后将部件10和12传送至有效的灭菌场位置50,在这里将实现在预先灭菌的部件之间的无菌连接。图3A至3D对这一过程进行了更好的表示。
图3A至3D表示在50位置产生的一个电子束(e-beam)场60。电子束场60由如图4所表示的电子管54产生。电子管54包括一个真空管55,该真空管除底边57以外在所有侧面上罩住灯丝56。底边57上有用于插入低压电源的不同的电连接器58。在底边57对面是一个向预定的位置发射电子束的薄膜窗口59。窗口59大约3微米厚,通过该窗口发射出一束面积为大约2mm×25mm(0.08英寸×1英寸)的电子束。电子管54的排列可以是竖立的以提高对所发射电子束的收集面积。此种排列的一个实例在授予Wakalopulos的美国专利No.5,414,267(或Re.35,203)中说明,在此引入该专利的公开内容作为参考。
优选电子管54与所期望的有效的灭菌场区域的距离为5cm(2英寸)并在60KeV下运转。电压越高可以允许的间隔越大,电压越低要求的间隔越小。图3A表示在连接前排列好的预先灭菌的部件10和12。电子管54产生直径大约为2英寸的球形电子束场60。其他直径的灭菌场无疑也是可能的,然而,接合部件的操作要求非常小的空间。当要求使用更大的空间时,可以通过传统的方法使场60更大。
参照图3B,部件10和12的末端14被传送到灭菌电子束场60中。在维持于范围60内的期间,部件10和12的各个末端14可以如图3C所示被截断,形成开口的末端。用于打开这些末端的机械结构可以是长期存放于电子束场60以维持其无菌性的机械刀片,或者是任何适当的截断或开口机械结构。图3D表示一旦末端14被截断,所得到的开口末端仍然在场60范围内时被连接在一起。
虽然使用电子束场是形成有效的灭菌场的优选来源,本发明的申请人也预先考虑到了使用不同的来源,例如化学蒸汽气氛。化学蒸汽气氛可以通过已知的方法形成,化学物质可以选自含有过氧化氢、过乙酸、二氧化氯或任何其他适当化合物的组中。类似地,也可以使用任何通常已知的方法制造等离子体气氛,例如臭氧(未表示),形成灭菌场。脉冲的高能光也适用于形成所要求的有效的灭菌场。然而,这些不同的来源可能不会提供与优选的电子束来源相同的尺寸和成本上的优点。
可以以不同的方式实现将开口的末端在电子束场60范围内连接起来。图5A和5B表示将开口的末端形成相互间对准的接触的一种机械结构。该机械结构使用了一对自动夹钳70和71,如图5A所示,它们分别夹住部件10和12末端14后面的一部分。通过向箭头(A,B)所示方向的驱动使夹钳70和71包围部件10和12。夹钳70和71带有一对可转动的翼片72和73,调整翼片帮助维持部件10和12末端14的对准状态。通过按照箭头(C,D)的方向转动调整翼片72和73,部件10和12的末端14被置于来自电子管54的电子束场(见图3B)内。大约2-3秒短时间的停留允许电子束在末端14被打开前对其表面进行灭菌。
连接的类型将决定部件10和12打开的末端相互间如何开始接触。图5A和5B表示尖管和膜式管的使用。在尖管和膜式管构形中,不需要截断末端14。在允许对表面进行灭菌的短暂停留后,夹钳70和71可以被向着箭头(E,F)的方向驱动。尖管被设计用于刺穿膜式管并继续进入膜式管直至驱动完成。
图6A至6D表示一种使用所公开方法的变体进行管形瓶灭菌装配(如灭菌连接相对)的装置。此种装配在未授权的美国专利申请序列号No.09/153,569中公开,在此引入该专利申请的公开内容作为参考。很明显,对于尖和膜式构形的部件,在处理过程中不需要截断这些部件的末端。
如上文所述,两个部件的“装配”与两个部件的“连接”区别在于在装配中没有立即形成流体通路。当两种药品成分被结合在一起时,有时候会出现单独的成分比结合在一起形成最终产品具有更长的保存期限的情况。在这种情况下,需要将不同药品成分的容器装配在一起而不是连接在一起,特别是在装配好的部件被预期能够储存一定期间时。适当的连接(即,形成流体通路)可以由本领域(例如医院、门诊部等)内接受过培训的人员在使用时轻易地实现。
图5B所表示以及本发明的优选实施方案所使用的尖管和膜式管的不同类型和变体在本领域中是丰富的。图7A-7E表示了一些不需要截断末端的这些不同类型的管。例如,图7A表示带有尖头保护器的尖末端。图7B表示在每个末端可移去的塞子。这些塞子可以插入到末端的内径中,或者如图所示插在末端外径上。图7C表示作为末端密封塞所使用的密封接头。图7D表示尖头和膜式构形的另一种变体。图7E也是尖头和膜式构形的一种变体,引入了一种双重尖末端的部件。通常,图示的构形可以有变化,可能一个部件密封末端的内直径比另一个部件密封末端的外直径大,这样小直径部件的末端可以密合地插入大直径部件的末端。同样,末端14的直径可以是一致的,但在一个接头(未表示)内被相互连接到一起。只要此类不同的设计(太多以致于无法一一列举)允许预先灭菌的末端在一个灭菌场内被连接,形成在末端之间的无菌连接,此类不同的设计就应视为落入了本
发明的范围之内。
不论末端14的设计构形如何,都需要在接触末端之间实现长期的密封。优选在灭菌场之外完成最终的长期连接,但是如果有必要,也可以在接触末端在电子束场范围60之内完成。这些连接可以通过射频密封器(例如HEMATRONTM),热封机,溶剂粘合技术等完成。
在图8A-8D所表示的一种不同的方法中,表示了与上文所述方法有一些区别的一种管形瓶配件(类似图6D中所表示的装配)连接装置。图8A表示带有膜式管114的装置110和管形瓶配件112为进行灭菌连接彼此对准。如图8B所示,每个部件的膜式管114都处于热空气流中。每个管114的膜变成半-无定形的状态,如图8C所示,管114向着彼此的方向移动并处于电子束场范围60之内。图8D表示最终的连接,其中膜式管被连接在一起直至充分冷却形成完全密封。
图9的系列图示表示另一种不同的方案,其中本发明被用于灭菌灌装过程。优选散装液体容器(未表示)带有某种类型的刺穿阀门,以92表示,用于容器内所灌装的预先灭菌液体的分装。在保持阀门92在有效的灭菌场范围60之内期间,可以放置好带有以优选的薄膜(未表示)覆盖其入口97的空的预先灭菌容器的位置,如位点(A)和(B)所示,使空容器向着容器分装阀门92的方向运动,接受一份无菌液体。在到达分装阀门92以后,如在位点(C)所示,入口97和膜被保持在灭菌场60范围内并与分装阀门92排成一列,完成对外表面的灭菌。然后,带有尖末端的分装阀门92在灭菌场60范围内被移动刺入或打破入口97的膜,然后可以开始灌装。入口97维持在灭菌场60范围内,直至预先灭菌的容器96被充满。然后可以通过密封器98密封入口97并从灭菌场60移走,如图位点(D)所示。
然而,重新回到图2,作为选择,在通过将部件10和12各自的末端相互接触完成连接后,部件10和12也可以被输送至密封位置80。正如现有技术已知的,在这里可以使用现有的技术将接触的末端密封形成焊接。例如,两个末端的材料均发生熔化。然后可以通过夹钳70,71的驱动将末端压在一起并冷却形成密封。在密封后,连接好的部件10,12可以进行包装用于运输、储存、立即使用或其他目的。
虽然描述和图示了特定的实施方案,仍然可能进行许多修改而不会偏离本发明的精神,本发明的保护范围仅由所附的权利要求的范围限定。

Claims (56)

1.一种灭菌接合两个或多个预先灭菌的部件的方法,包括下列过程:
a.在一个有效的灭菌场内将待接合在一起的每个部件的末端灭菌;
b.在待接合的每个部件的末端处于有效的灭菌场内时对其进行准备;以及
c.在末端处于有效的灭菌场内时将准备好的末端接合在一起。
2.权利要求1的方法,其中准备过程包括打开待接合的每个部件末端的步骤。
3.权利要求1的方法,其中灭菌过程包括下列阶段:
a.形成一种电子束场以产生有效的灭菌场;以及
b.将末端置于电子束场内。
4.权利要求3的方法,其中形成电子束场的阶段包括在低于300KeV的电压下形成场的步骤。
5.权利要求4的方法,其中电子束场在大约30KeV至大约300KeV的范围内形成。
6.权利要求4的方法,其中电子束场在大约30KeV至大约100KeV的范围内形成。
7.权利要求6的方法,其中电子束场在约60KeV下形成。
8.权利要求1的方法,其中灭菌过程包括下列阶段:
a.形成一种化学蒸汽气氛以产生有效的灭菌场;以及
b.将末端置于化学蒸汽气氛内。
9.权利要求8的方法,其中形成化学蒸汽气氛的阶段包括从由过氧化氢、过乙酸和二氧化氯所组成的组中选择出一种适当的化合物的步骤。
10.权利要求1的方法,其中灭菌过程包括下列阶段:
a.脉冲一种具有大量紫外成分的高能光以产生有效的灭菌场;以及
b.将末端置于该脉冲高能光范围内。
11.权利要求1的方法,其中灭菌过程包括下列阶段:
a.形成一种等离子体气氛以产生有效的灭菌场;以及
b.将终端封闭的末端置于该等离子体气氛范围之内。
12.权利要求11的方法,其中形成等离子体气氛的阶段由使用臭氧实现。
13.权利要求1的方法,其中灭菌、准备和接合的过程是自动的。
14.权利要求2的方法,其中接合过程包括下列步骤:
a.将一个部件的开口末端插入另一个部件的开口末端以形成重叠区;以及
b.将重叠区粘合在一起。
15.权利要求2的方法,其中接合过程包括下列步骤:
a.将一个部件的开口末端与另一个部件的开口末端邻接;以及
b.将邻接的末端焊接在一起。
16.权利要求1的方法,其中准备过程包括切断至少一个部件末端的步骤。
17.权利要求1的方法,其中准备过程包括打开至少一个部件的末端的步骤。
18.一种用散装灭菌液体灭菌灌装带有灌装口的预先灭菌容器的方法,包括下列过程:
a.形成一种有效的灭菌场;
b.将预先灭菌的容器灌装口引入到该有效的灭菌场内;
c.将一份散装的灭菌液体从供应容器中通过灌装口转移至预先灭菌的容器中;以及
d.将预先灭菌的容器灌装口从有效的灭菌场中移走。
19.权利要求18的方法,还包括将一份散装的灭菌液体转移后,密封预先灭菌的容器灌装口的过程。
20.权利要求18的方法,其中转移过程包括下列步骤:
a.将连接于散装灭菌液体供应容器的分装末端置于有效的灭菌场内;
b.使用分装末端打破密封的灌装口;
c.将散装的灭菌液体输送至预先灭菌的容器中;以及
d.密封打破的灌装口。
21.权利要求18的方法,其中引入、转移和移走的过程是自动的。
22.权利要求18的方法,其中形成灭菌场的过程包括使用低于300KeV的电压形成电子束场以产生有效的灭菌场的步骤。
23.权利要求22的方法,其中电子束场在大约30至大约300KeV的范围内形成。
24.权利要求22的方法,其中电子束场在大约30至大约100KeV的范围内形成。
25.权利要求24的方法,其中电子束场在大约60KeV下形成。
26.权利要求18的方法,其中形成灭菌场的过程包括形成等离子体气氛以产生有效灭菌场的步骤。
27.权利要求18的方法,其中形成灭菌场的过程包括使用带有大量紫外成分的高能脉冲光产生有效灭菌场的步骤。
28.权利要求18的方法,其中形成灭菌场的过程包括形成化学蒸汽气氛以产生有效灭菌场的步骤。
29.权利要求18的方法,还包括防止散装灭菌液体受到有效的灭菌场影响的过程。
30.权利要求18的方法,还包括对另一个带有灌装口的预先灭菌容器重复(b)至(d)的过程。
31.权利要求30的方法,还包括在相邻的预先灭菌容器之间维持有效灭菌场的步骤。
32.权利要求20的方法,还包括将另一个带有灌装口的预先灭菌容器重复引入灌装口、转移一份液体和移走灌装口的过程。
33.权利要求32的方法,还包括在相邻的预先灭菌容器之间维持灌装末端无菌性的步骤。
34.一种将两个或多个预先灭菌的部件灭菌装配在一起的方法,包括下列过程:
a.准备每个部件的至少一个末端用于装配;
b.在有效灭菌场内将待装配在一起的准备好的每个部件的末端进行灭菌;
c.在有效灭菌场的范围内,将准备好的末端彼此相互接触;以及
d.在有效灭菌场内将准备好的末端装配在一起。
35.权利要求34的方法,其中准备末端的过程包括从至少一个末端移去盖子的步骤。
36.权利要求34的方法,其中灭菌过程包括下列阶段:
a.形成一个电子束场以产生一个有效的灭菌场;以及
b.将末端置于电子束场。
37.权利要求36的方法,其中形成电子束场的阶段包括在不高于300KeV的电压下形成场的步骤。
38.权利要求37的方法,其中电子束场在大约30KeV至大约300KeV的范围内形成。
39.权利要求38的方法,其中电子束场在大约30KeV至大约100KeV的范围内形成。
40.权利要求39的方法,其中电子束场在大约60KeV下形成。
41.权利要求34的方法,其中灭菌过程包括下列阶段:
a.形成化学蒸汽气氛以产生有效的灭菌场;以及
b.将末端置于化学蒸汽气氛范围内。
42.权利要求38的方法,其中形成化学蒸汽气氛的阶段包括从由过氧化氢、过乙酸和二氧化氯所组成的组中选择适当的化合物的步骤。
43.权利要求34的方法,其中灭菌过程包括下列阶段:
a.脉冲一种具有大量紫外成分的高能光以产生有效的灭菌场;以及
b.将末端置于脉冲的高能光范围内。
44.权利要求34的方法,其中灭菌过程包括下列阶段:
a.形成一种等离子体气氛以产生有效的灭菌场;以及
b.将末端置于等离子体气氛范围内。
45.权利要求41的方法,其中形成等离子体气氛的阶段通过使用臭氧实现。
46.一种实现将至少两个预先灭菌的部件灭菌接合在一起的系统,包括:
a.一种包围待接合在一起的每个部件的至少一个末端的有效灭菌场;
b.在有效灭菌场内支撑预先灭菌部件末端的表面;
c.一种在有效灭菌场内在表面的支撑下打开预先灭菌部件末端的机械结构;
d.一种在有效灭菌场内将开口的末端排成相互接触的一列的机械结构;以及
e.一种将开口的末端粘合在一起的密封装置。
47.权利要求46的系统,其中有效的灭菌场由低电压电子束仪器形成。
48.权利要求47的系统,其中低电压电子束仪器在大约30KeV至大约300KeV的范围内运转。
49.权利要求47的系统,其中低电压电子束仪器在大约60KeV至大约100KeV的范围内运转。
50.权利要求46的系统,其中有效的灭菌场由化学蒸汽气氛形成。
51.权利要求50的系统,其中化学蒸汽气氛由从包括过氧化氢、过乙酸和二氧化氯的组中所选择出的化合物形成。
52.权利要求46的系统,其中有效的灭菌场由含有大量紫外成分的脉冲的高能光形成。
53.权利要求46的系统,其中有效的灭菌场由等离子体气氛形成。
54.权利要求46的系统,其中使开口的末端相互接触的机械结构包括至少一个机械驱动器。
55.权利要求54的系统,其中至少一个机械驱动器是自动的。
56.权利要求46的系统,其中的支撑表面是自动的。
CN00806371A 1999-04-20 2000-04-12 在有效的灭菌场内处理预先灭菌的部件的方法和设备 Pending CN1352570A (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/294,964 1999-04-20
US09/294,964 US7264771B2 (en) 1999-04-20 1999-04-20 Method and apparatus for manipulating pre-sterilized components in an active sterile field

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CNA2008102149369A Division CN101391107A (zh) 1999-04-20 2000-04-12 在有效的灭菌场内处理预先灭菌的部件的方法和设备

Publications (1)

Publication Number Publication Date
CN1352570A true CN1352570A (zh) 2002-06-05

Family

ID=23135674

Family Applications (2)

Application Number Title Priority Date Filing Date
CN00806371A Pending CN1352570A (zh) 1999-04-20 2000-04-12 在有效的灭菌场内处理预先灭菌的部件的方法和设备
CNA2008102149369A Pending CN101391107A (zh) 1999-04-20 2000-04-12 在有效的灭菌场内处理预先灭菌的部件的方法和设备

Family Applications After (1)

Application Number Title Priority Date Filing Date
CNA2008102149369A Pending CN101391107A (zh) 1999-04-20 2000-04-12 在有效的灭菌场内处理预先灭菌的部件的方法和设备

Country Status (14)

Country Link
US (5) US7264771B2 (zh)
EP (1) EP1171167B1 (zh)
JP (1) JP2002541922A (zh)
KR (1) KR100675710B1 (zh)
CN (2) CN1352570A (zh)
AT (1) ATE457184T1 (zh)
AU (1) AU760376B2 (zh)
BR (1) BR0009908A (zh)
CA (2) CA2649673C (zh)
DE (1) DE60043813D1 (zh)
HK (1) HK1045469A1 (zh)
IL (2) IL145784A0 (zh)
NZ (1) NZ514683A (zh)
WO (1) WO2000062820A2 (zh)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103316388A (zh) * 2012-03-19 2013-09-25 董东生 由穿刺连通的一体式输液容器
CN106456812A (zh) * 2014-06-11 2017-02-22 西德尔合作公司 通过脉冲电子轰击去污容器的盖件或颈部的方法和系统
CN108367113A (zh) * 2015-11-19 2018-08-03 豪夫迈·罗氏有限公司 一种用于多部件医疗装置的无菌组装的方法及其套件

Families Citing this family (39)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7264771B2 (en) * 1999-04-20 2007-09-04 Baxter International Inc. Method and apparatus for manipulating pre-sterilized components in an active sterile field
US7358505B2 (en) * 1998-09-15 2008-04-15 Baxter International Inc. Apparatus for fabricating a reconstitution assembly
US7243689B2 (en) * 2000-02-11 2007-07-17 Medical Instill Technologies, Inc. Device with needle penetrable and laser resealable portion and related method
US7331944B2 (en) 2000-10-23 2008-02-19 Medical Instill Technologies, Inc. Ophthalmic dispenser and associated method
SG160186A1 (en) 2000-10-23 2010-04-29 Medical Instill Tech Inc Fluid dispenser having a rigid vial and flexible inner bladder
WO2003028785A2 (en) * 2001-10-03 2003-04-10 Medical Instill Technologies, Inc. Syringe and reconstitution syringe
US7798185B2 (en) 2005-08-01 2010-09-21 Medical Instill Technologies, Inc. Dispenser and method for storing and dispensing sterile food product
US6957752B2 (en) * 2001-10-16 2005-10-25 Medical Instill Technologies, Inc. Dispenser with sealed chamber and one-way valve for providing metered amounts of substances
US6696018B2 (en) * 2001-11-14 2004-02-24 Electron Process Company, Llc System and method for sterilization of biological connections
US6913056B2 (en) * 2002-01-31 2005-07-05 Baxter International Inc. Apparatus and method for connecting and disconnecting flexible tubing
EP2433871A3 (en) 2002-06-19 2012-07-11 Medical Instill Technologies, Inc. Sterile filling machine having needle filling station within e-beam chamber
ES2543009T3 (es) * 2002-08-13 2015-08-13 Medical Instill Technologies, Inc. Recipiente y ensamblaje de válvula para almacenar y distribuir sustancias y método relacionado
AU2003299041B2 (en) 2002-09-03 2008-06-05 Medical Instill Technologies, Inc. Sealed containers and methods of making and filling same
EP1594749B1 (en) * 2003-01-28 2013-05-29 Medical Instill Technologies, Inc. Combination of a thermoplastic stopper and a needle, and method of filling a vial using said combination
WO2004096113A2 (en) * 2003-04-28 2004-11-11 Medical Instill Technologies, Inc. Container with valve assembly for filling and dispensing substances, and apparatus and method for filling
US6997219B2 (en) * 2003-05-12 2006-02-14 Medical Instill Technologies, Inc. Dispenser and apparatus and method for filling a dispenser
FR2856004B1 (fr) * 2003-06-11 2005-08-05 Maco Pharma Sa Procede de connexion sterile de deux tubulures
US7264142B2 (en) 2004-01-27 2007-09-04 Medical Instill Technologies, Inc. Dispenser having variable-volume storage chamber and depressible one-way valve assembly for dispensing creams and other substances
US7722733B2 (en) * 2004-03-29 2010-05-25 Baxter International Inc. Method for sterile connection of tubing
DE102004024175A1 (de) * 2004-05-13 2005-12-01 Gesellschaft für Ingenieur- und Unternehmensberatung mbH Verfahren zum hygienischen Aufbereiten von Beatmungsgeräten sowie Verfahren zum hygienischen Aufbereiten von medizinischen Gegenständen und Vorrichtung mit einem Plasmasterilisator sowie Verwendung eines Niedertemperatur-Plasmasterilisators
WO2007062226A1 (en) * 2005-11-28 2007-05-31 Pdc Facilities, Inc. Filling machine
CA2682650A1 (en) * 2007-04-24 2008-10-30 Hyclone Laboratories, Inc. Sterile connector systems
US7938454B2 (en) 2007-04-24 2011-05-10 Hyclone Laboratories, Inc. Sterile connector systems
US8448992B2 (en) * 2011-02-16 2013-05-28 Fenwal, Inc. Sterile docking device, medical fluid flow system with sterile docking device and method of using same
EP2819708B1 (en) 2012-02-28 2017-08-02 Life Technologies Corporation Systems and containers for sterilizing a fluid
US20150056095A1 (en) * 2012-04-12 2015-02-26 Electronworks Holdings Llc Low energy electron sterilization
JP5934577B2 (ja) * 2012-05-21 2016-06-15 株式会社エアレックス 電子線照射装置
IL247301B (en) 2014-02-20 2022-07-01 Vaxart Inc Formulations for administration to the small intestine
US9839582B2 (en) 2014-12-02 2017-12-12 Fenwal, Inc. Sterile connection syringe assemblies
KR20240031420A (ko) 2015-06-12 2024-03-07 박사르트, 인크. Rsv 및 노로바이러스 항원들의 소장 내의 전달을 위한 제형들
US20180322817A1 (en) * 2016-09-16 2018-11-08 Shawn Gibson Fabric cover for concealing a rigid structure
AU2017404183B2 (en) 2017-03-15 2023-08-10 Grifols Engineering, S.A. Device for the sterilisation of flexible bags by irradiation with an electron beam and method for sterilising flexible bags
CN107297904A (zh) * 2017-05-26 2017-10-27 武汉佰美斯医疗科技有限公司 一种无菌管接驳装置
CN111132729A (zh) * 2017-09-26 2020-05-08 心脏器械股份有限公司 使用柔性人造皮肤紫外(uv)光发射器的传动系感染预防
EP3958949A4 (en) * 2019-04-26 2023-01-11 Neuma LLC DEVICE AND PROCEDURE FOR STERILE CONNECTIONS OR LINES
WO2021003243A1 (en) * 2019-07-01 2021-01-07 Saint-Gobain Performance Plastics Corporation Profile connection
EP4072832A4 (en) * 2019-12-12 2024-01-31 Saint-Gobain Performance Plastics Corporation DEVICE FOR STERILIZED WELDING
US20220134461A1 (en) * 2020-10-30 2022-05-05 Saint-Gobain Performance Plastics Corporation Apparatus for welding
EP4424330A1 (de) * 2023-03-02 2024-09-04 SKAN Stein AG Verfahren zum seriellen transfer von gebinden durch eine prozesskammer zur weiterverarbeitung in einem containment unter aseptischen bedingungen und produktionsanlage dazu

Family Cites Families (44)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2098974A5 (zh) 1970-07-31 1972-03-10 Remy & Cie E P
US3780308A (en) 1971-06-07 1973-12-18 Energy Sciences Inc Process and apparatus for surface sterilization of materials
US4014158A (en) * 1973-08-24 1977-03-29 Ab Ziristor Apparatus for filling and sealing preformed packaging containers under aseptic conditions
US3968195A (en) 1974-06-17 1976-07-06 Marilyn Bishop Method for making sterile connections
US4121263A (en) 1977-07-27 1978-10-17 The Singer Company Method and apparatus for control signal separation to regain synchronization between a visual image projector and an audio program
US4157723A (en) * 1977-10-19 1979-06-12 Baxter Travenol Laboratories, Inc. Method of forming a connection between two sealed conduits using radiant energy
USRE32056E (en) 1977-10-19 1985-12-24 Baxter Travenol Laboratories, Inc. Method of forming a connection between two sealed conduits using radiant energy
US4187846A (en) * 1978-06-22 1980-02-12 Union Carbide Corporation Sterile connectors
US4242310A (en) 1978-11-13 1980-12-30 Baxter Travenol Laboratories, Inc. Sterile connection apparatus
US4209013A (en) 1979-04-05 1980-06-24 Baxter Travenol Laboratories, Inc. Sterile connection system using flexible container
US4265279A (en) 1979-08-06 1981-05-05 Weikert Roy J Package for maintaining asepsis of a sterile web of bags and method of using
FR2509689A1 (fr) 1981-07-17 1983-01-21 Ceca Sa Dispositif et procede pour assurer le transfert de facon aseptique d'un liquide contenu dans un recipient jusqu'a un autre recipient
SE453887B (sv) 1982-03-09 1988-03-14 Terumo Corp Anordning for overforing av medicinsk losning samt anslutningsorgan i sadan anordning
US4507119A (en) 1982-07-06 1985-03-26 E. I. Du Pont De Nemours And Company Sterile docking process, apparatus and system
US4521263A (en) 1982-08-16 1985-06-04 E. I. Du Pont De Nemours And Company Automatic splicing device and process
US4610670A (en) * 1983-06-13 1986-09-09 E. I. Du Pont De Nemours And Company Sterile connection process, apparatus and system
DE3482309D1 (de) 1983-08-19 1990-06-28 Baxter Int Vorrichtung zur ausueben einer antibakteriellen strahlung.
JPS6099254A (ja) 1983-11-02 1985-06-03 テルモ株式会社 医療チユ−ブの連結具の自動無菌着脱装置
FR2567406B1 (fr) 1984-07-12 1986-12-19 Monoplast Connecteur sterile notamment pour tubulures medicales
ES2016839B3 (es) 1986-03-03 1990-12-01 Courtaulds Packaging Australia Ltd Estacion de llenado aseptico.
JPH0657253B2 (ja) * 1986-11-17 1994-08-03 テルモ株式会社 コネクタ−の接続解離方法およびその補助装置
US4816221A (en) * 1986-12-08 1989-03-28 Baxter Travenol Laboratories, Inc. Method of simultaneously assembling and sterilizing a unitary container and a fluid transfer set
DE3808058C2 (de) * 1988-03-11 1995-05-24 Tetra Pak Ab Vorrichtung zum sterilen Verpacken von fließfähigen Füllgütern
DE68918160T2 (de) 1988-06-02 1995-04-06 Piero Marrucchi Verfahren und Vorrichtung zum Behandeln und Uebertragen von Stoffen zwischen abgeschlossenen Räumen.
US4910435A (en) 1988-07-20 1990-03-20 American International Technologies, Inc. Remote ion source plasma electron gun
GB8824925D0 (en) 1988-10-25 1988-11-30 Bowater Packaging Ltd Aseptic filling apparatus
US5009654A (en) * 1989-03-10 1991-04-23 Baxter International Inc. Sterile product and method for sterilizing and assembling such product
US5645796A (en) * 1990-08-31 1997-07-08 Abtox, Inc. Process for plasma sterilizing with pulsed antimicrobial agent treatment
US5215636A (en) 1991-09-27 1993-06-01 American International Technologies, Inc. Pulsed discharge surface treatment apparatus and process
SE9301428D0 (sv) * 1993-04-28 1993-04-28 Tetra Laval Holdings & Finance Sa Elektronaccelerator foer sterilisering av foerpackningsmaterial i en aseptisk foerpackningsmaskin
US5612588A (en) 1993-05-26 1997-03-18 American International Technologies, Inc. Electron beam device with single crystal window and expansion-matched anode
US5414267A (en) * 1993-05-26 1995-05-09 American International Technologies, Inc. Electron beam array for surface treatment
US5557109A (en) * 1993-11-01 1996-09-17 International Research And Development Radiation sterilization unit
RU2084243C1 (ru) * 1993-11-01 1997-07-20 Московский радиотехнический институт РАН Конвейерная установка для радиационной стерилизации
US5557163A (en) 1994-07-22 1996-09-17 American International Technologies, Inc. Multiple window electron gun providing redundant scan paths for an electron beam
JP3422452B2 (ja) 1995-12-08 2003-06-30 テルモ株式会社 チューブ接続装置
US5637953A (en) 1996-01-22 1997-06-10 American International Technologies, Inc. Cathode assembly for a line focus electron beam device
US5928213A (en) * 1996-05-13 1999-07-27 B. Braun Medical, Inc. Flexible multiple compartment medical container with preferentially rupturable seals
KR100248600B1 (ko) * 1996-12-11 2000-03-15 아마노 시게루 튜브 접속 장치
US6006946A (en) * 1997-12-05 1999-12-28 Automated Prescriptions System, Inc. Pill dispensing system
US6113583A (en) 1998-09-15 2000-09-05 Baxter International Inc. Vial connecting device for a sliding reconstitution device for a diluent container
US7264771B2 (en) * 1999-04-20 2007-09-04 Baxter International Inc. Method and apparatus for manipulating pre-sterilized components in an active sterile field
US6191424B1 (en) 1998-12-03 2001-02-20 I-Ax Technologies Irradiation apparatus for production line use
US6140657A (en) 1999-03-17 2000-10-31 American International Technologies, Inc. Sterilization by low energy electron beam

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103316388A (zh) * 2012-03-19 2013-09-25 董东生 由穿刺连通的一体式输液容器
CN103316388B (zh) * 2012-03-19 2016-03-30 北京万生人和科技有限公司 由穿刺连通的一体式输液容器
CN106456812A (zh) * 2014-06-11 2017-02-22 西德尔合作公司 通过脉冲电子轰击去污容器的盖件或颈部的方法和系统
CN108367113A (zh) * 2015-11-19 2018-08-03 豪夫迈·罗氏有限公司 一种用于多部件医疗装置的无菌组装的方法及其套件
CN108367113B (zh) * 2015-11-19 2021-05-28 豪夫迈·罗氏有限公司 一种用于多部件医疗装置的无菌组装的方法及其套件
US11027869B2 (en) 2015-11-19 2021-06-08 Roche Diabetes Care, Inc. Method for separate sterilization and aseptic assembly

Also Published As

Publication number Publication date
CA2365557C (en) 2010-03-30
WO2000062820A2 (en) 2000-10-26
US20020006353A1 (en) 2002-01-17
US20060110282A1 (en) 2006-05-25
US20050161614A1 (en) 2005-07-28
DE60043813D1 (de) 2010-03-25
KR20020008843A (ko) 2002-01-31
WO2000062820A3 (en) 2001-03-08
HK1045469A1 (zh) 2002-11-29
ATE457184T1 (de) 2010-02-15
US7655198B2 (en) 2010-02-02
NZ514683A (en) 2003-10-31
CN101391107A (zh) 2009-03-25
EP1171167B1 (en) 2010-02-10
US20030156973A1 (en) 2003-08-21
IL145784A (en) 2006-09-05
EP1171167A2 (en) 2002-01-16
CA2649673A1 (en) 2000-10-26
US20020018731A1 (en) 2002-02-14
CA2649673C (en) 2010-06-15
CA2365557A1 (en) 2000-10-26
AU760376B2 (en) 2003-05-15
KR100675710B1 (ko) 2007-02-01
US7264771B2 (en) 2007-09-04
BR0009908A (pt) 2002-01-08
IL145784A0 (en) 2002-07-25
JP2002541922A (ja) 2002-12-10
AU4455600A (en) 2000-11-02

Similar Documents

Publication Publication Date Title
CN1352570A (zh) 在有效的灭菌场内处理预先灭菌的部件的方法和设备
RU2504357C2 (ru) Устройство, содержащее камеру, для заполнения его веществом, и способ изготовления и заполнения веществом устройства, содержащего камеру
US10967994B2 (en) Apparatus for asepticaly filling pharmaceutical containers with a pharmaceutical fluid using rotary stage
US6929040B2 (en) Sterile filling machine having needle filling station within e-beam chamber
US9102097B2 (en) Resealable member and method of resealing same
TW410161B (en) Sterilization apparatus
KR20040011462A (ko) 열밀봉식 캡을 갖춘 약병, 및 이 약병을 충진하는 장치 및방법
JP2002165864A (ja) 複室容器の製造方法
JPH0910282A (ja) 易滅菌用接続部付医療用容器
JPH1015033A (ja) 輸液容器
MXPA01010719A (en) Method and apparatus for manipulating pre-sterilized components in an active sterile field
JP2000210370A (ja) 接続部付き容器の滅菌方法

Legal Events

Date Code Title Description
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
C06 Publication
PB01 Publication
C12 Rejection of a patent application after its publication
RJ01 Rejection of invention patent application after publication
REG Reference to a national code

Ref country code: HK

Ref legal event code: WD

Ref document number: 1045469

Country of ref document: HK