The Challenge

Pfizer sought a third-party re-certification of their BSL-3 and ABSL-3 laboratories at the Pearl River Site. In addition, they required validation testing on their Medium Steam Sterilizers located in the newly renovated BSL-3 facility.

The Solution

World BioHazTec performed the annual certification of Pfizer’s BSL-3 and ABSL-3 laboratories. We conducted a field survey of the laboratory to identify deficiencies. The bases of the survey are the requirements of the Centers for Disease Control (CDC) and the National Institutes of Health (NIH) Guidelines as outlined in the document entitled, “Biosafety in Microbiological and Biomedical Laboratories” (BMBL), 6th Edition, and the NIH BSL-3 Certification Checklist. The BMBL, 6th Edition guidelines and the requirements of the checklist need to be met to receive a laboratory certification from World BioHazTec.

We performed validation testing on Pfizer’s Medium Steam Sterilizers located in the newly renovated BSL-3 facility. We were charged with developing validation protocols and performing hands-on testing of the equipment based on “worst case scenario” use conditions. The validation protocols were determined by Pfizer principals and our subject matter experts.

The Result

Following the issuance of the Certification Assessment Reports, we provided Pfizer with certificates of compliance, affirming that all necessary standards and regulations were met. As part of our process, we conducted decontamination validation and reviewed biological indicator results. We then compiled a comprehensive validation report detailing the entire process and documenting the results. This final report served as a formal record, providing Pfizer with clear documentation of the validation process and ensuring transparency and accountability in all aspects of the project.