Field Certification Offerings

Field Certification Offerings

Certifiers: We are offering Environmental Monitoring virtual trainings throughout 2023.  Click here for more details and training dates.

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 (2022) 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 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.