Abstract
Current sterility tests for human viral vaccines were evaluated. A total of 43 lots of bulk suspension of live viral vaccines (measles, mumps, rubella and oral poliomyelitis) produced by six manufacturers in Japan were evaluated for bacteriostatic and mycoplasmastatic activities. Some of them showed fairly high bacteriostatic and mycoplasmastatic activities, due to antibiotics added during vaccine production. It was concluded that the current sterility test for mycoplasmas is not reliable to detect viable mycoplasmas in live viral vaccines.
Publication types
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Research Support, Non-U.S. Gov't
MeSH terms
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Acholeplasma laidlawii / drug effects
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Acholeplasma laidlawii / growth & development
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Acholeplasma laidlawii / isolation & purification
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Anti-Bacterial Agents / pharmacology
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Bacillus subtilis / drug effects
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Bacillus subtilis / growth & development
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Bacillus subtilis / isolation & purification
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Drug Contamination*
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Evaluation Studies as Topic
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Humans
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Microbial Sensitivity Tests
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Micrococcus luteus / drug effects
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Micrococcus luteus / growth & development
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Micrococcus luteus / isolation & purification
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Mycoplasma / drug effects
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Mycoplasma / growth & development
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Mycoplasma / isolation & purification
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Staphylococcus aureus / drug effects
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Staphylococcus aureus / growth & development
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Staphylococcus aureus / isolation & purification
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Viral Vaccines / pharmacology
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Viral Vaccines / standards*
Substances
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Anti-Bacterial Agents
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Viral Vaccines