We provide expert services to test disinfectants and cleaning effectiveness in critical areas to ensure successful control of your environment in accordance with USP<1072>. In addition to validating the cleaning process, we also qualify the disinfectants and preservatives implemented.
Fig.1 Pharmaceutical environmental disinfection efficacy
For your disinfectant or sanitizer efficacy studies, we can also perform simulation studies, hard surface testing, and testing under nominal conditions/procedures. CD Formulation has characterization of the disinfectant itself, and testing requirements vary by category, while disinfection products are related to consumer health and safety. Tests include active ingredient content determination, stability testing, pH determination, heavy gold measurement and microbial kill testing. Microbial kill tests may also include in vitro testing: time termination studies or suspension tests, specimen or carrier testing, environmental monitoring and in situ testing.
When designing your disinfectant efficacy verification or validation solution, our experts will consider the following factors.
1. Surfaces present in critical areas, including different conditions or types of the same material.
2. Each disinfectant and dilution will be challenged by a representative set of organisms.
3. Standard USP microbial testing: Staphylococcus aureus, E. coli, Pseudomonas aeruginosa, Bacillus subtilis (spores), Candida albicans, and Aspergillus braziliensis.
4. Panels include environmental isolates collected from environmental monitoring of facilities or critical areas.
5. Expiration date verification through the use of aged disinfectant formulations.
6. Neutralization of disinfectants, such as suitability testing.
7. Recovery method evaluation or control.
8. Overview and validation of cleaning processes: facility materials and environment, disinfectant preparation, cleaning procedures and contact times, facility surfaces, facility-specific bacteria and fungi.
If you have a requirement about our services, please contact us by phone or email, our colleagues will reply to you within three working days.