A SCIENTIFIC SAFETY ALLIANCE COMPANY

763 233 7907
Get A Quote

A SCIENTIFIC SAFETY ALLIANCE COMPANY

763 233 7907
Get A Quote

Pharmaceutical Cleanroom Services

Schedule your certification now
Call us

Pharmaceutical Cleanroom Testing & Certification

Pharmaceutical cleanrooms are critical environments for manufacturing and packaging medicines, sterile drugs, vaccines, and more. Having these environments tested and certified ensures the safety and efficacy of all products in the facility. 

At CSI Testing, we provide testing, certification, and advisory services for pharmaceutical cleanrooms to ensure they meet regulatory standards and are functioning optimally. We test cleanrooms to ISO Class 5–8, perform viable and non-viable particle testing, and ensure compliance with key standards like USP 797 protocols.

We offer fast delivery of electronic reports and turn around for certifications. 

Primary Services

Ensures unidirectional and non-unidirectional flow areas are properly balanced and zones are maintaining adequate air patterns.
Documents leakage or defects and ensures HEPA filters for cleanroom provide the required filtration.
Conducted per ISO14644, reports the amount of airborne particulate of a specified size in the clean environment.
Verifies that the room differential pressures meet regulatory requirements.

Additional Services

Verifies airflow direction using a source of visible fog.
Confirms whether HVAC controls are functioning properly and uniformly.
Performed to design specifications for worker comfort.
Performed to design specifications for worker comfort.
Ensures gauges are calibrated to regulatory standards.
Replace any faulty / non-fixable HEPA filters.
Performed to determine whether an area is capable of returning to a specified cleanliness level after non-routine exposure events.
Ensures compressed air and gas systems meet the requirements of the cleanroom.
Determines if any bacterial and fungal contamination is present.
Ensures mag gauges are functioning according to equipment and regulatory standards.

Pharmaceutical Cleanroom Design & Advisory Services

At CSI Testing, we offer pharmaceutical cleanroom design and advisory services to help clients create compliant, efficient, and cost-effective cleanroom solutions. We bring over 45 years of experience in testing, certifying, designing, and providing advisory services for cleanrooms across various industries. 

We work with pharmaceutical manufacturers during all stages of cleanroom development. Our goal is to ensure your cleanroom environment is optimized for long-term compliance and efficiency.

Pharmaceutical Cleanroom Design Review

We work alongside cleanroom contractors to make sure that your new cleanroom is constructed and laid out properly for pharmaceutical manufacturing. Our third-party reviews provide clients with the confidence that their cleanroom is designed to industry standard.

Pharmaceutical Cleanroom operational performance audits

Our performance audits can provide valuable insights into actions you can make to improve the overall performance of your pharmaceutical cleanroom. We will also provide you with advice regarding safety and regulatory compliance.

Coaching on internal SOPs for Pharmaceutical Cleanrooms

With out coaching on internal SOPs for pharmaceutical cleanrooms, you can make sure your facility is adhering to all regulatory, industry, and safety standards. We make sure your staff are trained on all of the important procedures to keep you cleanroom 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. 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

Iowa
Des Moines
Cedar Rapids
Davenport

Nebraska
Omaha
Lincoln
Bellevue

Kansas
Wichita
Overland Park
Kansas City

Missouri
Kansas City
St Louis
Springfield

Massachusetts
Boston

New Hampshire

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

North Dakota

South Dakota

Wyoming

Montana

Wisconsin

Illinois

Indiana

Michigan

Ohio

Pennsylvania

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.

Contact Us