USP 797 Testing
Following the test procedures implemented by USP <797/800> in CETA CAG-003-2006, our CETA National Board of Testing (CNBT) accredited technicians provide the expertise needed to keep you compliant and up to date on the latest standards from USP <797/800>. Each aspect of the cleanroom must work together to reach optimal performance; understanding them is imperative to compliance.
The Primary Engineering Control (PEC) is instrumental in sterile compounding facilities and is your first line of defense to prevent contamination of your sterile preparations. The BioSafety Cabinets (BSCs), Laminar Air Flow Workstations (LAFW) and Isolators provide your product with a particle free environment when operated properly. Our accredited technicians have years of instruction for the proper testing of all types of PECs. We can even provide education to those unfamiliar with their operation, demonstrating good technique and visualizing where “first air” is present inside every PEC. This is crucial to protecting the critical site from contamination.
Primary Services
- Room conditions
- Face velocity tests
- Sash operation test
- Verification of proper air flow and patterns
- Evaluation of low air flow
Additional Services
- General Repairs
The Secondary Engineering Control (SEC) is the continually working cleanroom. Understanding the dynamic operation is important to keeping your cleanroom clean and compliant. HEPA filter integrity testing, airflow measuring and pressure gradient analyzation are the foundation of a cleanroom, but only the beginning of compliance. Where there might be failure or shortcoming, we can provide the consultation necessary to achieve total compliance. A compliant cleanroom should give you “state of control” providing reliable operation. Performing ISO 14644 non-viable particle counting and viable(microbial) surface/air sampling is an important part of USP<797/800>. We can evaluate your facility and recommend a comprehensive microbial testing plan; this helps prove how well your cleanroom is functioning and if adjustments need to be made to your process, work flow or equipment. All microbial sampling is sent to an ISO 17025 accredited lab for analyzation.
It’s important that you have an experienced certification firm that can perform all the tests required by CETA CAG-003-2006 and CETA CAG-002-2006 and can also provide solutions to resolve issues that surface during testing. We understand cleanroom technology and have the experience behind us to demonstrate compliance and keep your sterile compounding pharmacy operational.
ABOUT
Why Choose Class 1 Air
The Midwest’s largest single source for all of your air quality and certification needs. Our dedication to training and industry accreditations is demonstrated by having the LARGEST service team in the Midwest. Our technicians are NSF49* and (CETA) CNBT-RCCP- SCF** accredited.
We utilize cutting edge training facilities along with the most recognized names in the industry. Educational institutions include the Eagleson Institute, CETA, NEBB, Harvard School of Public Health, IEST, Research Triangle Park, CDC, NIH and various manufacturers of clean air devices.
Our service team has accredited technicians to maintain your cGMP, USP797/800 and NSF49 mandated certification cycles along with emergencies and project deadlines. Our dedicated staff truly cares and we are proud to serve you. We have offices in Milwaukee, Madison, and Chicago to serve your needs across the midwest
Experience
20 years of company history
Quality
Highly trained technicians (average 10-year tenure)
Report Turnaround
2 weeks for cleanrooms, same-day for hoods, BSCs, etc.
Urgency
We take emergency calls seriously. We can get technicians on-site quickly
People
Founder and employee-owned. Certified minority business enterprise
Our Locations
We are a regional service provider
We have offices in Milwaukee, Madison, and Chicago to serve your needs across the midwest. Class 1 Air is your single source company for air filtration products and critical environment compliance testing. We proudly serve the upper Midwest. Our company is committed to leadership throughout Wisconsin and the Midwest in biological safety.
We primarily service the below states: