Corporate Partner Spotlight: ATS Labs
No two compounding pharmacies face the same disinfection challenges.
USP <797> compliance requires a formal, verified cleaning and disinfection plan to minimize microbial contamination introduced into the clean room environment by pharmacy staff and the inanimate instruments they use. Scheduled disinfection of the anteroom and compounding area should be based on the classification of the room and area surfaces.
Compounding pharmacies with validated disinfection programs:
- Understand the effectiveness of their site-specific disinfectant products and disinfection processes.
- Can correct and control clean room environment contamination.
- Have the confidence—and necessary documentation—to stand up to FDA facility audits.
ATS Labs tailors disinfection validations around each compounding pharmacy’s unique processes, surfaces and disinfectant products. We qualify site-specific disinfection practices for compounding pharmacies, as we do for traditional pharmaceutical manufacturers, thereby mitigating potential contamination issues. Furthermore, per FDA guidance, we offer genotypic microbial and fungal identification services to support environmental monitoring activities, ultimately validating your disinfection practices.
- Disinfection Qualification Testing
- Expert Disinfectant Product Knowledge
- Rigorous Regulatory Compliance
- Site-Specific Environmental Isolates
- Protocols Tailored For Your Unique Facility/Process
To discuss whether a disinfection qualification is appropriate for your compounding pharmacy, please contact:
Director, Business Development