Pharmaceutical USP Controlled Environmental Testing
Higgins provides USP 797 environmental non-viable and viable airborne particle testing services. Pharmacy or laboratory primary/secondary control areas are tested via an active air sampler per ISO 14689. These samples are incubated and colony forming units are statistically calculated, documented and compared to acceptable standardized levels.
We provide clients with a comprehensive report on the results, including data on individual ISO classes and recommendations for improvement. We also offer particle count testing per ISO 14644 techniques for total air particulate contaminates within any controlled environment.
Our USP 797 environmental testing services can also include:
Working with the laboratory or pharmacy manager to develop appropriate sampling plans
On-site surface ATP sampling of microorganisms to audit cleaning/disinfecting practices
Garbing and gloving competency evaluation and recommendations for corrective actions
Differential pressure / air flow monitoring of buffer area to ante-area to general area