Glossary

Microbial Limits

Microbiological acceptance criteria a product must meet, such as total aerobic count, total yeast and mould count, and absence of specified objectionable organisms.

Details

These criteria apply to products for which sterility is not required, and alongside total counts and yeast and mould they specify the absence of particular objectionable organisms such as Staphylococcus aureus, Escherichia coli, Salmonella, and Pseudomonas aeruginosa. Because the limits depend on the nature of the product, the way it is made, and its intended use, numbers cannot simply be carried over from another product. The corpus cites compendial monograph specifications and microbial limits not carried into the specification document, water that failed to meet its limits, and batch records missing the microbial limit test data.

Related sections

Related terms

Real inspection findings

See 6 findings that mention this term

Source

ICH Q6A (1999), §3.3.1(g) Microbial limits