EXPERT – MICROBIOLOGY & GLP
Question:
Which are the protocols for the correct use of the different types of biological indicators according to GLP?
Answer:
• Population Assay – Metal discs, Metal strips, Wires
• Population Assay – Prospore Ampoule
• Population Assay – Spore strips, Discs, Thread, Metal
• Population Assay – Spore suspension
• Steam D-value Determination
Notes
1. USP recommends using 3 specimen of the relevant biological indicator for determining a total viable spore count.
2. Perform population count on 3 separate biological indicators and average counts.