USP 797 Testing Services
B&V is pleased to offer expert turn-key USP <797> compliance solutions to pharmaceutical sterile compounding facilities under the direction of CETA-Certified Cleanroom Professionals for Sterile Compounding Facilities and our in-house Staff Microbiologist. With 35 years of field experience, B&V offers an unrivaled combination of USP <797> services including primary and secondary engineering control testing and certification to CAG 003 (cleanrooms, biosafety cabinets, LAFWs, isolators), air and surface environmental monitoring, micro-results consultation, compounding staff competency didactic training and testing, and contamination remediation. USP 797 testing services are executed in accordance with B&V standard operating procedures (SOPs) which are updated to remain compliant with current national and international industry standards. Testing results are quality-reviewed and documented in a comprehensive easy-to-follow final report.
B&V USP 797 testing services include:
- Testing and certification of ISO Class 5 Primary Engineering Controls (PECs) including biological safety cabinets, laminar flow clean benches and clean air devices and isolators.
- Testing and certification of ISO Class 7 (or better) cleanrooms (buffer areas) and anterooms including particle counting, airflow volume profiling, air exchange rates, HEPA filter integrity testing, room pressurization monitoring and temperature and humidity monitoring
- Videotaped in-situ air pattern analysis (smoke studies) of ISO Class 5 PECs under dynamic conditions for inspection compliance
- Isolator Performance Qualification (required for isolators outside of buffer areas)
- Hazardous drug preparation and storage area airflow and pressure testing
- Airborne and surface microbial environmental monitoring of PECs and SECs including sample plan development, plate collection, incubation, analysis, growth identification, reporting and data trending
- Compounding staff initial and ongoing competency training and testing services for Garbing/Gloving and Aseptic Technique/Media Fill
- Cleaning and contamination remediation services featuring hydrogen peroxide vapor bio-decontamination of cleanrooms and equipment
- Contamination investigations and consultation with staff microbiologist
- Full engineering control repair services for biosafety cabinets, clean benches, isolators and cleanrooms
B&V’s vast technical knowledge and experience coupled with our steadfast commitment to quality and the highest standards of customer service, provide our USP 797 pharmacy clients with reliable, accurate and thoroughly documented testing results, ensuring optimal performance of their engineering controls, documented regulatory and quality compliance results, and minimized equipment 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 USP 797 testing services.
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
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
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 wanted to let you know that they did an outstanding job with the VHP decontamination. I was impressed by their professionalism and determination; they were on site from noon till 1 am on Thursday, and back again at 9 am the next morning. In addition, they were efficient, knowledgeable, and a pleasure to work with.
- Research Institution Biosafety Officer
Working with B & V is more than a vendor/customer relationship; it is truly a partnership that makes my job so much easier and safer. Thanks to all the competent techs at B&V!
- Lab Animal Research Facility Director