Disinfection Validation
In a procedure that’s critical for controlled clean room environments, all disinfectants must be validated to be considered effective for intended use. This procedure creates documented evidence that a disinfection product will consistently destroy or inactivate appropriate challenge microorganisms in or on treated manufacturing areas or equipment.
Microtest’s environmental sciences group possesses many years of experience performing validation for a wide variety of clean rooms.
Our trained microbiologists use standard strains of bacteria plus fungi and environmental isolates to determine the effectiveness of a given concentration of disinfectant. The disinfectant is challenged with a known concentration of these organism (s). Specific criteria must be met, depending on the test being performed.
Each environment presents its own difficulties; clean room managers should call Microtest to discuss their unique spaces and processes.
Microtest validation testing uses the following standard microorganisms:
- Use dilution testing: Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella choleraesuis
- Phenol coefficient testing: Salmonella typhi, Pseudomonas aeruginosa, Staphylococcus aureus
- Sporicidal testing: Bacillus atrophaeus and Clostridium sporogenes
- Germicidal testing: Trichophyton mentagrophytes, Salmonella choleraesuis, Staphylococcus aureus, and Pseudomonas aeruginosa
All standard cultures are derived from ATCC strains. Reporting data is in summary format acceptable to U.S. FDA.
References
USP draft General Chapter <1072>, Disinfectants and Antiseptics (cGMP)
Requirements of 21 CFR 211.56 (Sanitation) & 21 CFR 211.67 (Equipment cleaning and maintenance)
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