Our certification professionals have been at the forefront of controlled environment certification since the 70s.
Our staff includes some of the first NSF accredited technicians for the certification of Class II Biological Safety Cabinets and participants in NSF, CETA and IEST standards development related to certification of controlled environments.
CEC was an active member of the original development team for the CETA National Board of Testing certifier accreditation program for Registered Certification Professionals-Sterile Compounding Facilities and the NSF International Accreditation Program for certification Class II Biological Safety Cabinets (BSC).
We continue to support both programs through active participation, and our technicians have been accredited through both the NSF and CNBT programs.
CEC has developed certification services for all engineering controls used for production of sterile products and containment of hazardous materials.
We are especially proud of our programs for certification of GMP pharmaceutical facilities regulated by the FDA and compounding facilities inspected against USP Chapters <795>, <797>, <800>, and <825>. By combining our facility design experience with our understanding of the certification process, we will walk the customer’s Designated Person through the process of determining appropriate acceptance criteria for each of the tests where standard criteria does not exist.
Our certification reports have been carefully designed to document the certification process in a manner that allows the end-user the ability to understand the report and more importantly, defend the contents of that report in a regulatory inspection.
Where applicable, CEC’s certifications reports will flow with the regulatory requirements of the regulations to which you will be inspected. For example, a sterile compounding facility that compounds hazardous and non-hazardous sterile preparations will be inspected against USP Chapters <797> and <800>. Chapter <797> references CETA CAG-003 for the certification procedures. CETA has developed a support guide for establishing good documentation practices; CAG-008. CEC’s reports have been developed to document all the tests outlined in CAG-003 using the documentation processes established in CAG-008.
We take pride in providing a full-service team designed to handle troubleshooting and repair of problems both minor and major.
We have access to replacement parts and experience servicing primary engineering controls. Our engineering and project management teams allow us to extend our support beyond traditional “hood” maintenance that most certification companies provide. We can also assist in development of solutions for exhaust, HVAC, and other facility related issues that affect the certification process.