Pharmaceutical USP Controlled Environmental Testing

In January of 2004, USP Chapter <797> “Pharmaceutical Compounding-Sterile Preparations”  became the first official, enforceable requirement for the compounding of sterile preparations. The goal of USP <797> is to protect clients from harm resulting from microbial contamination or medication errors in compounded sterile preparations.  An official revision of USP Chapter <797>, which took place in June 2008, now dictates that compounding be performed under ISO 5 (Class 100) conditions.  Compliance with this chapter is something that will be strictly enforced and can be a challenging requirement to meet for some facilities.

Additionally, the Joint Commission on Accreditation of Healthcare Organizations (The Joint Commission) is enforcing USP Chapter <797> within their standards.  For high-risk compounding, the Joint Commission may require stricter compliance to this chapter than the state Board of Pharmacy in some areas.

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.  Higgins provides clients with a comprehensive report on the results, including data on individual ISO classes and recommendations for improvement.  Higgins also offers 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
  • Provide on-site surface ATP sampling of microorganisms to audit cleaning/disinfecting practices
  • Provide garbing and gloving competency evaluation and recommendations for corrective actions
  • Provide differential pressure / air flow monitoring of buffer area to ante-area to general area