RT Journal Article
SR Electronic
T1 Oxygen Permeation and Microbial Ingress through a Film-Coated and Uncoated Elastomeric Closure in A Glass Vial: A Comparative Study
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 32
OP 44
VO 58
IS 1
A1 Mark Andress
A1 Henry Dull
A1 Thomas Gurley
A1 Ed Remo
A1 John Grillo
A1 Fredy Navasca
A1 Thomas Berger
YR 2004
UL http://journal.pda.org/content/58/1/32.abstract
AB 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.