Cleanroom Testing and Certification
Cleanrooms play critical roles in maintaining contamination free production environments for critical processes. A well-executed cleanroom testing and certification program is essential to proper cleanroom maintenance and operation and regulatory compliance. B&V is NEBB certified in cleanroom performance testing and offers comprehensive clean room testing, clean room certification and related services including environmental monitoring, HEPA filter integrity testing, repair, and replacement and clean room decontamination services.
B&V’s vast experience in cleanroom systems helps ensure these critical area are performing in accordance with international standards and customer quality specifications. B&V cleanroom testing and certification services are executed in accordance with B&V standard operating procedures (SOPs) which are updated to remain compliant with current Good Manufacturing Practices (cGMPs), International Organization for Standardization (ISO) and the Institute of Environmental Science Technologies (IEST). All cleanroom service results are thoroughly documented and quality-reviewed in accordance with the rigors of cGMP.
Cleanroom test protocols and report documentation can be customized to customer specifications.
Primary cleanroom tests include:
- Airflow volume/velocity profiling
- Room air exchange rates
- HEPA filter integrity testing
- Non-viable particulate monitoring
- Room pressurization monitoring
- Temperature and humidity monitoring
Optional tests include:
- Airflow visualization testing
- Viable environmental monitoring (EM) including airborne and surface microbial
- Enumeration and identification
- Lights testing
- Sound testing
- Vibration testing
- Other cleanroom tests as per IEST and/or ISO
Our vast technical knowledge and experience in cleanroom testing coupled with our steadfast commitment to quality and the highest standards of customer service, provide our clients with reliable, accurate and thoroughly documented clean room testing results, ensuring optimal cleanroom performance, documented regulatory and quality compliance, and minimized facility down time.
With each service call, B&V offers:
- Trained and accredited technical service of the highest quality
- Customized and quality-reviewed report documentation tailored to your needs
- Management of your equipment inventory and service records
Contact B&V today for superior cleanroom testing and certification services.
I would just like to say that the BSC recertification process this year was ridiculously smooth. Thanks to YOU and all the techs for a GREAT job! Your service has been fantastic!
- University Biosafety Program Coordinator
I just wanted to express my thanks to you and your team for all the help you have given us this week. Everyone has bent over backwards explaining things a million times and in accommodating our last minute requests and documentation needs. We would not have met our goal without all your help. Please pass along my thanks to anyone I might have missed.
- Biotech Lab Support Manager
Thanks for making everything come together last week. Your technician was awesome. He worked well with the folks that were here. He was very knowledgeable and professional. He is an asset to your company. Great job!!
- Director of Pharmacy, Maine Hospital
I can't thank you enough for your timely response. It is much appreciated by Lab Support and our researchers. Your service has been excellent.
- Biotech Lab Support Manager
The FDA is here on a PMA inspection and one of the areas that I had to present to them was the recertification binder for our ISO Class 7 Manufacturing Cleanroom. The auditor provided the following comment during his review: “This is one of the best put-together cleanroom reports I’ve seen”. Please keep up the great work you do for all of our facilities! It’s great to have partners that provide us quality work and are easy to work with too!
- Medical Device QA Engineer