title: Microbial barrier assessment of Tyvek stopper packaging for rubber closures.
abstract: Two types of Tyvek and high density polyethylene or polypropylene packaging used for sterilization of rubber closures were evaluated for Microbial Barrier properties. The packaging evaluated was "Ready to Sterilize" (1) stoppers and a second test package (Test 2) which was designated as appropriate for a clean room, filled with washed and siliconized stoppers and then heat sealed. Each type of packaging was subjected to three different sterilization temperatures (125 degrees C, 128 degrees C and 131 degrees C) in a production sterilizer (15-18 psi). Following sterilization, a microbial barrier assessment was performed, using Bacillus subtilis niger (ATCC 9372), to determine whether the packaging could maintain a sterile barrier following sterilization. Results of the testing indicated that a microbial barrier was maintained for products in "Ready to Sterilize" packages at 125 degrees C and 128 degrees C. For products sterilized in the Test 2 container a microbial barrier could not be maintained at 128 degrees C, and no further testing was performed. Following sterilization at 131 degrees C physical defects were noted for the "Ready to Sterilize" bag and a microbial barrier could not be maintained.
authors.forename: J E
authors.initials: JE
authors.lastname: Moldenhauer
authors.forename: S A
authors.initials: SA
authors.lastname: Bass
authors.forename: M J
authors.initials: MJ
authors.lastname: Kupinski
authors.forename: M L
authors.initials: ML
authors.lastname: Walters
authors.forename: S L
authors.initials: SL
authors.lastname: Rubio
mesh_terms: D001412:Bacillus subtilis / Q000302:isolation & purification; D004340:Drug Contamination / Q000517:prevention & control*; D004349:Drug Packaging / Q000592:standards*; D005069:Evaluation Studies as Topic; D007087:Illinois; D008422:Materials Testing; D011108:Polymers; D012408:Rubber; D013170:Spores; D013242:Sterilization / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D011108:Polymers; C104709:tyvek; D012408:Rubber