title: Oxygen permeation and microbial ingress through a film-coated and uncoated elastomeric closure in A glass vial: a comparative study.
abstract: This is a comparative study of oxygen permeation and microbial ingress into a drug vial stopper that is an elastomeric pharmaceutical compound versus the same compound coated with a thin Teflon-type film coating. The objective of this study is to determine if the film coating causes any changes in the rate of oxygen permeation or microbial ingress into the vial from the environment. From the data obtained it is concluded that the film did not change either the oxygen or microbial ingress into the vial; therefore the stoppers are essentially equivalent with respect to these parameters.
authors.affiliation: Abbott Laboratories, Ashland, Ohio 44805, USA. mark.andress@abbott.com
authors.forename: Mark
authors.initials: M
authors.lastname: Andress
authors.forename: Henry
authors.initials: H
authors.lastname: Dull
authors.forename: Thomas
authors.initials: T
authors.lastname: Gurley
authors.forename: Ed
authors.initials: E
authors.lastname: Remo
authors.forename: John
authors.initials: J
authors.lastname: Grillo
authors.forename: Fredy
authors.initials: F
authors.lastname: Navasca
authors.forename: Thomas
authors.initials: T
authors.lastname: Berger
mesh_terms: D001412:Bacillus subtilis / Q000254:growth & development; D004349:Drug Packaging; D020724:Elastomers / Q000737:chemistry*; D004866:Equipment Contamination / Q000517:prevention & control*; D004867:Equipment Design; D010100:Oxygen / Q000737:chemistry*; D013242:Sterilization / Q000379:methods*; D013678:Technology, Pharmaceutical
chemical_list: D020724:Elastomers; D010100:Oxygen