Disinfectant Qualification Studies
Importance of Disinfectant Qualification
Contamination in controlled environments poses significant risks. Microorganisms and viruses can infiltrate cleanrooms via personnel, equipment, or airborne particles, potentially jeopardising facility operations and compromising experimental results. Therefore, validating your cleaning and disinfection procedures is crucial to maintaining safety and efficacy.
Cleaning and Disinfection Qualification Services
Our team provides a range of services to ensure your disinfectants and cleaning procedures are validated against a variety of standard microorganisms, as well as those isolated from environmental monitoring, including:
- Bacteria
- Fungi
- Mycobacteria
- Bacterial endospores
- Viruses, including viral vector surrogates and specific viral vectors
Key Services
Our rigorous testing procedures evaluate the effectiveness of your disinfectants against a wide range of standard, industry specific, and environmental isolate strains, ensuring they achieve the required reductions in your unique environment.
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Cleaning Procedure Validation
Assessment of cleaning procedures to verify they maintain a sterile and hygienic environment, mitigating contamination risks.
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Bespoke Substrate Testing
We test the efficacy of your disinfectants and cleaning procedures on different surfaces that are representative of the materials found in your facility. This guarantees confidence when considering biocide-material interactions and compatibility.
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Contact-Plate Neutralisation Validation
Ensuring environmental monitoring data accurately reflects surface contamination levels by validating the neutralisation of disinfectants on contact plates.
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Customised Validation Protocols
Our team develops bespoke validation protocols tailored to your facility, guaranteeing that the validation process is thorough, efficient, and in line with your specific needs.
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Ongoing Support and Maintenance
We provide continued support for revalidating processes as they evolve, ensuring compliance with changing regulations and efficacy against new strains identified through internal monitoring.
BluTest Laboratories - A Tentamus Company is committed to excellence and regulatory compliance, offering a partnership to maintain and enhance the safety and integrity of your facility's operations.
Below is a non-exhaustive list of the services we offer to aid with qualification of disinfectants in GMP/GLP facilities and other cleanroom or control environments. If there is a service you are interested in which is not listed here, please contact us to discuss.
Cleanroom Validations |
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Standard |
Test |
ASTM E2614 | Evaluation of cleanroom disinfectants |
USP 1072 | Disinfectants and antiseptics in controlled environments |
EN 13697 | Bactericidal/fungicidal surface test (modified for cleanrooms) |
EN 16777 | Virucidal surface test (modified for cleanrooms) |