NZ748836B2 - Methods for manufacturing non-glass prefilled containers - Google Patents
Methods for manufacturing non-glass prefilled containers Download PDFInfo
- Publication number
- NZ748836B2 NZ748836B2 NZ748836A NZ74883617A NZ748836B2 NZ 748836 B2 NZ748836 B2 NZ 748836B2 NZ 748836 A NZ748836 A NZ 748836A NZ 74883617 A NZ74883617 A NZ 74883617A NZ 748836 B2 NZ748836 B2 NZ 748836B2
- Authority
- NZ
- New Zealand
- Prior art keywords
- sterilization
- eto
- barrel
- range
- temperature
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims abstract 22
- 239000011521 glass Substances 0.000 title 1
- 238000004519 manufacturing process Methods 0.000 title 1
- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 claims abstract 15
- 230000001954 sterilising effect Effects 0.000 claims abstract 14
- 238000004659 sterilization and disinfection Methods 0.000 claims abstract 12
- 238000012414 sterilization procedure Methods 0.000 claims abstract 9
- 229920000089 Cyclic olefin copolymer Polymers 0.000 claims abstract 8
- 239000000463 material Substances 0.000 claims abstract 7
- 239000004713 Cyclic olefin copolymer Substances 0.000 claims abstract 4
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims abstract 4
- 230000003750 conditioning effect Effects 0.000 claims abstract 4
- 239000011780 sodium chloride Substances 0.000 claims abstract 4
- NNJVILVZKWQKPM-UHFFFAOYSA-N Lidocaine Chemical compound CCN(CC)CC(=O)NC1=C(C)C=CC=C1C NNJVILVZKWQKPM-UHFFFAOYSA-N 0.000 claims abstract 2
- 229960004194 lidocaine Drugs 0.000 claims abstract 2
- 238000007781 pre-processing Methods 0.000 claims abstract 2
- 229940071643 prefilled syringe Drugs 0.000 claims 3
- 238000005273 aeration Methods 0.000 claims 1
- -1 bromobutyl Chemical group 0.000 claims 1
- 229920005557 bromobutyl Polymers 0.000 claims 1
- 229920005556 chlorobutyl Polymers 0.000 claims 1
- 230000000977 initiatory effect Effects 0.000 claims 1
- 238000007789 sealing Methods 0.000 claims 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/08—Radiation
- A61L2/10—Ultraviolet radiation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
- A61L2/20—Gaseous substances, e.g. vapours
- A61L2/206—Ethylene oxide
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/001—Apparatus specially adapted for cleaning or sterilising syringes or needles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/3129—Syringe barrels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31501—Means for blocking or restricting the movement of the rod or piston
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
- B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
- B65B55/02—Sterilising, e.g. of complete packages
- B65B55/027—Packaging in aseptic chambers
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
- B65B55/02—Sterilising, e.g. of complete packages
- B65B55/04—Sterilising wrappers or receptacles prior to, or during, packaging
- B65B55/10—Sterilising wrappers or receptacles prior to, or during, packaging by liquids or gases
Abstract
method of sterilizing prefilled containers, such as syringes made of cyclic olefin polymer (COP) or cyclic olefin copolymer (COC), using an ethylene oxide (EtO) sterilization procedure. The method involves assembling the container and filling with a material that is sensitive to EtO sterilization, such as saline, heparinized saline or lidocaine, before performing at least one EtO cycle. The EtO sterilization procedure cycle comprises undergoing a pre-processing stage to raise the temperature and humidity, a wash and conditioning stage, an EtO sterilization stage and a wash and post exposure stage. Upon completing the EtO sterilization procedure cycle, a resultant pH of the sterilization-sensitive material does not exceed an acceptable pH range of between 4.5 and 7. The disclosure also discusses inserting an assembled prefilled container into a procedure tray prior to performing the EtO sterilization procedure cycle.
Claims (13)
1. A method of EtO sterilizing a prefilled syringe, comprising: assembling a syringe assembly including: inserting the plunger into barrel at a second end to define a chamber therein, wherein the barrel is formed of at least one of a cyclic olefin polymer (COP) and a cyclic olefin copolymer (COC); filling the barrel with sterilization sensitive material at a first end of the barrel, the sterilization sensitive material one of saline, heparinized saline, and lidocaine; inserting a tip cap at a first end of the barrel to seal the sterilization sensitive material within the barrel; performing at least one ethylene oxide (EtO) sterilization procedure cycle of the assembled syringe assembly, wherein the sterilization procedure cycle comprises undergoing a preprocessing stage including raising the temperature and humidity of a preconditioning area into which the syringe assembly is located to a predetermined level and where the temperature is within the range of 32.2222 °C - 54.4444 °C (90-130 °F), and where the humidity is within the range of 45-95%, a wash and conditioning stage including sealing the syringe assembly within a sterilization chamber and raising the temperature to a conditioning temperature within a range of 29.4444 °C - 54.4444 °C (85-130 °F), an EtO sterilization stage and a wash and post exposure process, wherein upon completing the EtO sterilization procedure cycle, a resultant pH of the sterilization-sensitive material is between 4.5-7.0.
2. The method of claim 1, wherein the sterilization sensitive material is introduced into the barrel in an aseptic environment.
3. The method of claim 1, wherein the prefilled syringe assembly is autoclaved prior to undergoing the EtO sterilization procedure cycle.
4. The method of claim 1, wherein the prefilled syringe assembly is subjected to a UV light sterilization process prior to undergoing the EtO sterilization procedure cycle.
5. The method of claim 1, wherein a stopper is assembled to the plunger before introduction into the barrel, the stopper being manufactured of either bromobutyl or chlorobutyl rubber.
6. The method of claim 1, wherein the preconditioning area is also an aeration area.
7. The method of claim 1, further comprising initiating an evacuation process simultaneous with raising the temperature to the conditioning temperature.
8. The method of claim 7, wherein the evacuation process applies vacuum pressure within a range of 25.4-609.6 mmHg (1-24 inHgA).
9. The method of claim 7, wherein the evacuation process applies vacuum pressure to a set point of 254mmHg (10 inHgA), within a tolerance of ±12.7 mmHg (±0.5 inHgA.)
10. The method of claim 7, further comprising performing a leak test for a predetermined time period within the range of 5-60 minutes.
11. The method of claim 1, further comprising introducing moisture into the sterilization chamber to achieve a predetermined dwell pressure.
12. The method of claim 11, wherein the predetermined dwell pressure is within the range of 58.42-355.6 mmHg (2.3-14 inHgA).
13. The method of claim 12, wherein the dwell pressure is maintained for a dwell time within the range of 15-
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US15/169,962 US20170349313A1 (en) | 2016-06-01 | 2016-06-01 | Methods for manufacturing non-glass prefilled syringes |
| PCT/US2017/033719 WO2017209998A1 (en) | 2016-06-01 | 2017-05-22 | Methods for manufacturing non-glass prefilled containers |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| NZ748836A NZ748836A (en) | 2024-05-31 |
| NZ748836B2 true NZ748836B2 (en) | 2024-09-03 |
Family
ID=
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US11786664B2 (en) | Prefilled container systems | |
| CN101247838B (en) | Methods of sterilizing elastomeric sealing articles | |
| AU2022204394B2 (en) | Methods for manufacturing non-glass prefilled containers | |
| US4628969A (en) | Method of producing prefilled sterile plastic syringes | |
| US4718463A (en) | Method of producing prefilled sterile plastic syringes | |
| JP2015519125A5 (en) | ||
| US20020172615A1 (en) | Apparatus for and method of manufacturing a prefilled sterile container | |
| WO2014187779A1 (en) | Method for sterilizing the surface of a prefilled syringe | |
| WO2015091104A1 (en) | Plasma system with a separately transportable vessel | |
| US20150057733A1 (en) | Surface modified devices and sterile packaging therefor | |
| NZ748836B2 (en) | Methods for manufacturing non-glass prefilled containers | |
| AU2002254138A1 (en) | Apparatus for and method of manufacturing a prefilled sterile container |