USP <797>

The U.S. Pharmacopeia’s (USP) General Chapter <797>, Pharmaceutical Compounding Sterile-Preparations sets out practice standards to help ensure that compounded sterile preparations (CSPs) are of high quality.  Theses standards can help prevent harm to patients suffered as a result of contaminated preparations.

Who and What does this apply to?

“The standards in this chapter are intended to apply to all persons who prepare CSPs and all places where CSPs are prepared (e.g., hospitals and other healthcare institutions, patient treatment clinics, pharmacies, physicians’ practice facilities, and other locations and facilities in which CSPs are prepared, stored and transported).  Persons who perform sterile compounding include pharmacists, nurses, pharmacy technicians, and physicians. These terms recognize that most sterile compounding is performed by or under the supervision of pharmacists in pharmacies.  This chapter applies to all healthcare personnel who prepare, store, and transport CSPs.

  • Note: CSP stands for Compounded Sterile Preparations.  (Above from page 2 of the Official Document) 

   
As the nation’s leading provider of calibration, validation, certification, and decontamination, ENV Services, Inc. can provide your facility with a complete package of testing services designed to meet the testing requirements of the above standard.  A brief outline of some of these services are:

  • Cleanroom Certification in compliance with ISO-14644 and CETA CAG-02-2006
  • Equipment Certification
  • Viable Particulate Sampling
  • Non-Viable Particulate Sampling
  • Room Pressure Differentials
  • Air Changes per Hour compliance
  • HEPA Filter Leak Tests
  • Ventilation Assessments
  • Pressure Gauge Supply, Installation, and Calibration
  • Temperature Mapping of Refrigerators and Drug Storage

For a custom package unique to your facility, please fill out the below and we will be happy to contact you in a prompt manner!

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