USP 797 Cleanroom Services
USP 797 Required Testing and Maintenance
USP 797 refers to chapter 797 of the United States Pharmacopeia, which outlines the requirements and standards for pharmaceutical cleanrooms. These cleanrooms are most often used for manufacturing pharmaceuticals and medical devices.
Our USP 797 testing and maintenance services ensure that your pharmaceutical cleanroom is meeting the required standards, functioning as it should, and performing optimally. We are here to support your facility by ensuring compliance and safety.
Our team has years of experience certifying, testing, and maintaining various cleanrooms across multiple industries. You can trust us to keep your facility running smoothly with our wide range of expertise.
Primary Services
Filter Airflow Volume/Velocity and Uniformity
Filter leak tests
Non-viable particle counting cleanliness test
Room pressurization
Additional Services
Airflow visualization
Temp/RH% Testing
Light level testing
Sounds Level testing
Magnehelic gauge calibration and installation
HEPA filter replacement
Room recovery testing
Compressed Air/Gas Testing
Viable air and surface sampling
Mag Gauge Testing / Installation / Calibration
Additional USP 797 Services
If your facility is required to follow USP 797 requirements, we are here to support you. We offer multiple services to make sure you and your staff are aware of the standard practices, maintenance protocols, and requirements.
We also offer review and auditing services to ensure that your cleanroom’s design is functional and operating optimally. We have over 45 years of experience working with and advising pharmaceutical cleanroom owners. Our goal is to make sure your laboratory is the best it can be in every aspect.
Cleanroom Design Review
If you are building a new cleanroom, our team can go over the designs before they’re implemented to ensure that they not only meet compliance but that the layout will allow for the optimal execution of daily operations. With years of experience designing and maintaining cleanrooms, our team has the knowledge to make sure your cleanroom is designed perfectly for your needs.
USP 797 operational performance audits
Our USP 797 Operational Performance Audits are designed to make sure protocols are being followed and that the day-to-day operations are being performed effectively. We will provide advice on actionable improvements and advice regarding safety and compliance.
Coaching on USP 797 Standards & Requirements
If you have a new cleanroom or an existing cleanroom with staff who need to learn or be updated on USP 797 requirements, we’re here to help. Our coaching services delve into all of the important standards and protocols that need to be followed by your staff in order to remain compliant.
ABout
Why Choose CSI Testing
CSI has tested and certified controlled environments for over 45 years. When we started CSI testing we serviced Minneapolis and the surrounding areas. Today we service the entire Midwest and the New England area. Our team has over 100 collective years of experience in the industry, serving over 600 medical device, pharmaceutical, academic, and other clients.
We test, certify, and service all controlled environments, including cleanrooms, biosafety cabinets, fume hoods, and isolators. We provide biosafety cabinets, cleanbenches and fume hood reports the same-day, and turnaround electronic cleanroom reports in two weeks. For any emergency, we can get a technician to your site quickly.
We are proudly 100% founder and employee owned. CSI is a certified minority business enterprise.
Experience
45 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 primarily service the below states:
Minnesota
Minneapolis
Saint Paul
Rochester
We also service these additional states through our sister companies at the Scientific Safety Alliance:
Virginia
West Virginia
North Carolina
Washington DC
Maryland
South Carolina
Kentucky
Tennessee
Wyoming
Montana
As a regional service provider, CSI Testing provides scientific safety services across the United States. We offer regional coverage through our network of partner companies to better serve your facilities.