The author discusses why two of the industry's common practices for preventing microorganism contamination in USP hot-ware and purified-water systems may have no scientific basis.
José E. Martinez
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José E. MartÃnez is a consultant at JEM Consulting Services, Box 4956 PMB 652, Caguas, PR 00726, tel. 787.349.3857.
Articles by José E. Martinez
Low levels of some microorganisms that are present in oral solid dosage forms are unlikely to present a risk to patients. The amount of water activity in these products can help determine when microbiological testing should be conducted.
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