Indicators for sterility testing | Pharmaceutical Microbiology | SNS INSTITUTIONS

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Indicators for Sterility Testing in Pharmaceutical Microbiology
Indicators confirm that the sterility test is valid and can detect microorganisms if present. They ensure the test conditions are correct.
1. Negative Control

Sterile media with no product sample or inoculum added.
Purpose: Shows that the media and test environment are free from contamination.
Expected result: No growth (media remains clear after 14 days).
If growth appears: Test is invalid due to contamination.

2. Positive Control

Fresh media inoculated with a small number of standard microorganisms.
Standard organisms: Bacillus subtilis, Staphylococcus aureus, Pseudomonas aeruginosa (aerobic bacteria); Clostridium sporogenes Candida albicans, Aspergillus brasiliensis (fungi).
Purpose: Proves that the media supports microbial growth and is not inhibitory.
Expected result: Visible growth within 3–5 days
Performed: Before using a new batch of media.

3. Product Inocuity Control

Product sample added to media along with a small number of the same standard microorganisms.
Purpose: Confirms that the product does not inhibit microbial growth, which could cause false negatives.
Expected result: Growth of added organisms within 3–5 days, similar to positive control.
If no growth: Product is inhibitory → direct inoculation method is invalid; use membrane filtration with rinsing or neutralizers.

These indicators are required by pharmacopeias . The sterility test result is valid only when all three controls give satisfactory results.