Certifying the performance of equipment used in biotechnology facilities is crucial for biotechnology companies to maintain compliance with strict regulatory standards. AM Technical Solutions (AM) has a deep bench of experts who can provide biotech companies with third-party certifications and compliance support.
We recently completed the certification of Grade B Cleanrooms and BioSafety Cabinets (BSCs) for a global biotech company at their U.S. manufacturing facility. Our subject matter experts (SMEs) worked closely with the client to review the facility’s capabilities and deliver a NEBB Stamped Certification Report.
With a focus on safety, quality, and efficiency, learn how our NEBB-certified SMEs successfully completed the assigned scope of work in accordance with the client’s timeline and Standard Operating Procedures (SOPs).
Our Cleanroom and BioSafety Cabinet Certification Services
Our team possessed the necessary expertise and certification skillsets that aligned well with the execution of this facility project. The SMEs executed a series of critical review activities in the cleanrooms to ensure our client could satisfy regulatory and operational requirements. Our review included the following:
- HEPA Filter Leak Tests on a specified number of filters.
- Differential Room Pressure Surveys on a set number of rooms.
- 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.
Each stage of the review was carefully planned with our client to ensure precision and adherence to stringent regulatory standards. This effort mattered because we believe the most effective way to achieve Right First Time results is through Early Quality Integration (EQI), which embeds project deliverable requirements into every stage of the project activities. Our SMEs followed through by using advanced tools and methodologies to streamline the process.
Upon completion of our review, the detailed NEBB Stamped Certification Report provided the client with the necessary documentation to demonstrate compliance with both FDA and international health agency regulations.
Throughout the project, we maintained open communication with the client, ensuring alignment and transparency to satisfy the pre-established timeline. By adhering to this schedule, we minimized operational downtime. We also prioritized safety during the review, adhering to our Platinum-status safety protocols and the client’s site-specific SOPs.
Overall, this project reinforced our ability to provide exceptional high-tech construction services within the Life Sciences sector. Our integrated approach – coupled with technical expertise – allowed for agile responses to dynamic needs throughout the certification process. The successful collaboration between our team and the client ensured the continuous functionality of the cleanrooms and BioSafety Cabinets in the facility.
“With 30+ years of global experience in Life Sciences projects, our unique EQI approach systematically integrates quality at every stage, ensuring industry-leading performance that exceeds client expectations,” says Brian Williams, AM SVP, Life Sciences. “We look forward to continuing to support our client with similar biotech facility requirements in the future.”
– 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 clients.
– Does your company need support with a biotech or another type of Life Science project? Contact us today to discuss our high-tech construction services.