Cleanroom Testing and Certification Services

Regulatory Guidance / Test Methods:

We test and certify cleanrooms to ensure that facilities are compliant with the required standards and customer specifications. Our services are designed to meet regulatory, industry, and certification requirements according to various standards including: ISO, cGMP, CNBT, NSF, FDA, IEST, among others.

Cleanrooms should be certified annually at a minimum to ensure compliance with industry, regulatory, and client standards. Some clients certify every 3 or 6 months. In addition, tests should be performed after any significant changes in the cleanroom (i.e construction, equipment upgrades)

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.
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Why choose Keystone

Keystone has tested and certified controlled environments for over 25 years. When we started Keystone we serviced Virginia and the surrounding areas. Today we service the east coast. Our team has over 100 collective years of experience in the industry, serving over 200 pharmaceutical, university, research, and advanced manufacturing 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. Keystone is a certified minority business enterprise.

Experience

25 years of company history

Quality

Highly trained technicians (average 10-year tenure)

Report Turnaround

We prioritize prompt delivery of reports.

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

As a regional service provider, Keystone provides testing and certification services across the it should be the midatlantic region and east coast.