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Field Certification Offerings

Field Certification Offerings

CriticalPoint’s Field Certification eLearning Curriculum

CriticalPoint has developed an introductory-level eLearning course covering the major testing and certifications related to sterile compounding primary and secondary engineering controls. This course, which contains 9 eLessons, is consistent with current (2008) and proposed (2019) USP standards.

  • Overview of Certification Testing
  • PEC and SEC High-Efficiency Particulate Air (HEPA)–Filter Integrity Testing
  • PEC Airflow Velocity Testing
  • Airflow Smoke-Pattern Test for Primary Engineering Controls (PECs) in Sterile Compounding Facilities
  • Total Particle Count Testing for ISO-Classified Environments
  • Airflow and Room-Segregation Testing for Sterile Nonhazardous Cleanroom Suites and C-SECs
  • Specific Testing for Restricted Access Barrier Systems (RABS)
  • Facility Site Installation Tests for Laminar Airflow Systems (LAFS) and Containment Testing for Biological Safety Cabinets (BSCs)
  • Certification Report Best Practices




Field Certifier Peer Network Subscription

Join our Peer Network with a subscription designed specifically for field certifiers. The Peer Network provides online access to the latest information, tools, and resources related to sterile compounding. In addition to access to the “Frequently Asked Questions” database, webinars, instructional videos, featured articles, white papers, and more, you will have access to content covering the major testing and certifications related to sterile compounding primary and secondary engineering controls. This subscription also gives certifiers the opportunity to “Ask the Experts” 3 questions per year.






Field Certification Standard Operating Procedures

Certification companies range in size from large companies to small, family-owned businesses. Regardless of company size, a quality-based organization must have standard operating procedures (SOPs). CriticalPoint has developed a set of SOP and accompanying form templates to meet the unique operational and quality needs of a certification company performing testing for sterile compounding organizations. These customizable templates ensure certification compliance with USP 797 and 800 as well as CETA’s Application Guides and other associated industry standards and guidance while allowing the certification company to add detail specific to its testing procedures. The SOPs take the guesswork out of how to manage an internal quality system, as they include instructive guidance and suggestions that may be incorporated if appropriate to the certifying company’s operation.




*Early adoptors will receive a 25% discount on the SOPs when purchased before December 31, 2021. Discount will be automatically be added to your cart.