Disinfectant Qualification Testing
Disinfectant Qualification or disinfectant efficacy or disinfectant challenge testing is a study at lab scale to demonstrate that the disinfectants applied on the nonporous surfaces which represent the actual environment are effective to decontaminate or inactivate potential contaminants. Dalton Pharma Services offers Disinfectant qualification testing by carrier test method to verify the efficacy of the disinfectant used within clean rooms and other classified areas in healthcare and pharmaceutical facilities.
Disinfectant Qualification Testing Parameters to be Considered:
- Typical surface materials (eg: stainless steel, glass, PVC, etc.)
- Chemical disinfectant (bactericide, sporicide, sanitizer, etc)
- Correct contact time to be established
- Application method (spraying, wiping, mopping)
- Test Organisms (eg: reference cultures, environmental isolates)
The pharma, biotech and medical device companies require working in controlled environments that use aseptically processed products. Cleanroom validation including disinfectant/sanitizer qualification for use in GMP facilities have become an imperative part of cGMP practices. This ensures the safe production of pharmaceuticals and medical devices in controlled environments. Regulators including US FDA, EMEA and Health Canada guidelines for current Good Manufacturing Practices mandates that aseptic areas are consistently maintained and validated cleaning and disinfection process is in place at all times.
Dalton Pharma Services has decades of skill, expertise and experience in cleaning and disinfection chemistries and has now extended services for developing a robust protocol for testing disinfectant efficacy. If you need to outsource your disinfection qualification, give us a call or contact us now.
We will work hand-in-hand to mimic your facility sanitization and disinfection by using the surface type, disinfectants and microbial isolates as per your custom needs or regulatory requirements.