Manufacture of sterile medicines – Advanced workshop for SFDA GMP inspectors
Nanjing, November 2009
Poorly designed or maintained equipment Blow fill seal machine
Chills mold plates used to form the container-closure into which the sterile drug is filled.
Demineralized potable water. Held in tank, chilled (when sampled, yields very high microbial counts)
Sterility failure and media fill failure
Pseudomonas, sp. and Acinetobacter, sp. found in media fill
Stenotrophomonas maltophilia identified as Sterility Failure isolate
Several lots rejected
Both the sterility failure and media fill failure attributed to cooling water contamination
Root cause of non-sterility was leak/s/ in aseptic filling machine’s mold plates. Cooling water directly contaminated product.
CAPA Issue: Exact date of problem occurrence unknown.