AM Technical Solutions (AM) recently certified Grade B Cleanrooms and BioSafety Cabinets (BSCs) for a global biotech company at their U.S. manufacturing facility. The project has now advanced to the second phase of providing additional BioSafety Cabinet certification support and facility services.
Our team is excited about the opportunity to continue working with our client to certify more cleanrooms and BSCs that will support their ongoing work. We will provide highly qualified personnel to ensure our client’s expanded facility continues to meet the requirements of the FDA and international health agencies.
Learn how our subject matter experts (SMEs) will work closely with our client to review the facility’s latest capabilities and deliver a NEBB Stamped Certification Report to verify those capabilities.
Our Cleanroom and BioSafety Cabinet Certification Services
We have a deep bench of SMEs capable of providing Architectural & Engineering Design, Engineering, Construction, startup, and Commissioning Qualification Validation (CQV) solutions. We will be tapping into our expertise to deliver the following project scope:
- HEPA Filter Leak Tests on a specified number of filters.
- Differential Room Pressure Surveys on a set number of cleanrooms.
- Airflow Volumetric Readings on the filters and ACH verification in the rooms.
- Airflow Cleanliness Classifications at multiple locations.
- Bio-Safety Cabinet Reviews on EU Grade A particle counts.
Based on our discussions with our client’s team, we outlined the project scope in accordance with their Standard Operating Procedure (SOP) to drive toward successful project completion.
Our team will employ several advanced methods and tools to successfully and safely complete the certification project on time, within the client’s budget, and of the highest level of quality. To achieve Right First Time results, we will embed Early Quality Integration (EQI) of project deliverable requirements into project activities.
After we complete the review, our SMEs will provide our client with a detailed NEBB Stamped Certification Report that can be used to demonstrate compliance with all relevant requirements for operating the expanded facility.
Throughout the project, we will work closely with our client’s teams on the ground to ensure alignment with the set timeline. Through our proactive approach to addressing unforeseen constraints, we will help minimize operational downtime across the rest of the facility.
“We are confident that our collaborative, communication-driven approach will enable us to satisfy our client’s latest facility needs,” says Brian Williams, AM SVP, Life Sciences. “We look forward to delivering the required certification after the successful completion of the second phase of this project.”
– Find out more about our capabilities to support large-scale biopharmaceutical facility projects.
– View our portfolio of award-winning high-tech construction projects for Life Science and biotech clients.
– Does your company need support with a biosafety cabinet certification review? Contact us today to discuss our high-tech construction services.