A SCIENTIFIC SAFETY ALLIANCE COMPANY

763 233 7907
Get A Quote

A SCIENTIFIC SAFETY ALLIANCE COMPANY

763 233 7907
Get A Quote

Medical Device Cleanroom Services

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Medical Device Cleanroom Testing & Certification

At CSI Testing, we offer various services to aid medical device cleanrooms in operational efficiency and compliance with industry standards. Our team tests and certifies cleanrooms of all sizes to ISO Class 5-8 standards. ISO Class 5-8 cleanrooms are used for manufacturing the most critical medical devices, such as surgical tools and implantable devices.

These medical devices must be manufactured and packaged in a certified cleanroom that meets higher standards to ensure that medical devices are not contaminated. 

We deliver fast, accurate reports and electronic cleanroom certifications in just two weeks.

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.

Medical Device Cleanroom Design & Advisory Services

At CSI Testing, we also offer medical device cleanroom design and advisory services. With over 45 years of experience in the industry, we work with medical device manufacturers to make sure their cleanrooms are appropriately designed before construction starts.

If you have a medical device cleanroom, we offer performance audits and coaching services to ensure your cleanroom is operating at maximum efficiency and that your workplace practices meet regulatory standards.

Medical Device Cleanroom Design Review

We can work alongside your cleanroom contractor to make sure that your new cleanroom is designed properly. We provide independent, third-party reviews of preliminary cleanroom designs. We can also do the first testing/certification once the cleanroom is constructed.

Medical Device Cleanroom operational performance audits

We perform operational performance audits to help identify areas for improvement, ensure ongoing compliance, and maintain integrity of the cleanroom environment.

Coaching on internal SOPs

CSI can work alongside your internal team to make sure your internal SOP adhere to regulatory, industry, and safety standards. We perform, independent, third-party reviews enabling our customers to ensure they’re operating at the highest standard.

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

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.

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