Oxygen permeation and microbial ingress through a film-coated and uncoated elastomeric closure in A glass vial: a comparative study.
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.
Andress
Mark
M
Abbott Laboratories, Ashland, Ohio 44805, USA. mark.andress@abbott.com
Dull
Henry
H
Gurley
Thomas
T
Remo
Ed
E
Grillo
John
J
Navasca
Fredy
F
Berger
Thomas
T
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
D020724:Elastomers; D010100:Oxygen