METHODS FOR MANUFACTURING NON-GLASS PREFILLED SYRINGES

A method of sterilizing a prefilled syringe comprises assembling a syringe assembly and performing at least one ethylene oxide (EtO) sterilization procedure cycle. The assembling step includes inserting a tip cap at a first end of a plunger, filling a non-glass barrel with sterilization sensitive ma...

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Hauptverfasser: Carpenter, Curt, Leginski, Jessica, Kuehne, Kelly
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creator Carpenter, Curt
Leginski, Jessica
Kuehne, Kelly
description A method of sterilizing a prefilled syringe comprises assembling a syringe assembly and performing at least one ethylene oxide (EtO) sterilization procedure cycle. The assembling step includes inserting a tip cap at a first end of a plunger, filling a non-glass barrel with sterilization sensitive material at a second end of the barrel, and inserting the plunger into the barrel at a second end to seal the sterilization sensitive material within the barrel. The EtO sterilization procedure cycle comprises undergoing a preprocessing stage, 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 as defined by the United States Pharmacopeia. The disclosure also discusses inserting an assembled prefilled syringe into a procedure tray prior to performing the EtO sterilization procedure cycle.
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The assembling step includes inserting a tip cap at a first end of a plunger, filling a non-glass barrel with sterilization sensitive material at a second end of the barrel, and inserting the plunger into the barrel at a second end to seal the sterilization sensitive material within the barrel. The EtO sterilization procedure cycle comprises undergoing a preprocessing stage, 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 as defined by the United States Pharmacopeia. 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subjects CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, ORSURGICAL ARTICLES
CONVEYING
DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY
DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROMTHE BODY
DISINFECTION, STERILISATION, OR DEODORISATION OF AIR
HANDLING THIN OR FILAMENTARY MATERIAL
HUMAN NECESSITIES
HYGIENE
MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGINGARTICLES OR MATERIALS
MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICALARTICLES
MEDICAL OR VETERINARY SCIENCE
METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS INGENERAL
PACKING
PERFORMING OPERATIONS
STORING
TRANSPORTING
UNPACKING
title METHODS FOR MANUFACTURING NON-GLASS PREFILLED SYRINGES
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