USP<797> requires an ongoing environmental sampling program that creates a documented state of control over environmental conditions in the pharmacy. This CANNOT be achieved by testing semi-annually.
Compliance requires monthly testing of the pharmacy environment to: maintain environmental control, identify deviations as close to real time as possible, and provide trended data that is used to monitor pharmacy performance. Quality Solutions can develop and execute your environmental sampling program in a cost-effective manner that frees up pharmacy resources.
Our streamlined reports and data analysis serve as tools for managing the monitoring program as required by USP<797>/USP<800>. We offer microbial identification of bacterial and fungal species.
We can schedule onsite testing or work with your pharmacy to establish an environmental sampling kits that provides instructions, consumables, equipment, testing locations and staff training for your staff to execute testing in a consistent and compliant way.
Quality Solutions can also support your in-house air and surface monitoring program by offering plate enumeration and microbial identification services.
- Primary Cleanroom Tests
- • Differential Pressure Testing
- • Non-Viable Airborne Particle Count Testing
- • Viable Surface Sampling
- • Viable Airborne Particle Sampling
- • Temperature/Relative Humidity Testing (optional)
- • Chemo wipe analysis (for HD/Chemo Cleanrooms only).