Assessment of risk of microbial contamination by use of multidose containers of injectable products.
At a vaccination centre 200 emptied multidose vials were tested for sterility. All vials had contained 10 doses of a vaccine without added preservative. None of the 200 vials was culture-positive. The vaccine did not comply with the pharmacological test for effectiveness of antimicrobial preservatives.
Christensen
E A
EA
Control Department, Statens Seruminstitut, Copenhagen, Denmark.
Mordhorst
C H
CH
Jepsen
O B
OB
D004340:Drug Contamination; D004349:Drug Packaging / Q000592:standards*; D006801:Humans; D011310:Preservatives, Pharmaceutical; D012307:Risk Factors; D014765:Viral Vaccines / Q000592:standards*
D011310:Preservatives, Pharmaceutical; D014765:Viral Vaccines