Long-term stability of BCG vaccine sealed in ampoules under nitrogen with reference to its short-term heat resistance.
11 batches of BCG vaccine were each distributed into two kinds of ampoules, lyophilized, and sealed under vacuum or nitrogen, respectively. Their viability during storage at +4 degrees C was followed for up to 10 years. The number of culturable particles decreased after that period to approximately 70% of the initial values, irrespective of the mode of preparation. Generally, the figures after 10 years storage at +4 degrees C were close to those after 4 weeks storage at +37 degrees C for the individual lots. Recommendations for sealing of BCG vaccine preferentially under vacuum instead of under nitrogen are no longer valid, therefore, if appropriate techniques for the sealing and gassing operations are used.
Freudenstein
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D001500:BCG Vaccine / Q000592:standards*; D004355:Drug Stability; D006358:Hot Temperature; D009163:Mycobacterium bovis / Q000254:growth & development; D009584:Nitrogen; D013997:Time Factors
D001500:BCG Vaccine; D009584:Nitrogen