Cleanroom Certification & Validation Services

Gerbig Cleanrooms is one of the leading cleanroom validation companies in the country with over 30 years of cleanroom testing experience. Gerbig is a National Environmental Balancing Bureau (NEBB) accredited testing firm using highly trained technicians who can perform the necessary cleanroom validation procedure services for successful certification outcomes. Gerbig provides HEPA filter repair and replacement which is critical in keeping manufacturing cleanrooms from ISO 3 to ISO 9, industrial to scientific makes Gerbig a preferred source for cleanroom certification services.

Gerbig cleanroom testing is in accordance with:

  • • International Organization for Standardization (ISO)
    • Institute of Environmental Science and Technology (IEST)
    • National Science Foundation (NSF)
    • Controlled Environmental Testing Association (CETA)
    • Current Good Manufacturing Practices (cGMP)

 

Gerbig Offers:

  • Cleanroom Testing & Certification
    BSC Certification & Services
    Environmental Testing
    Cleanbench Testing
    Decontamination Services
    Fume Hood
    USP 797/800
    Cleanroom Evaluations & Audits
    cGMP Testing

Certification Sample Report

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Why Validate Your Cleanroom?

The cleanroom validation procedure is documented evidence that proves a system will produce a product that meets all specifications and standards. Each cleanroom needs to meet a certain amount of class standards, set by The National Environmental Balancing Bureau (NEBB), to be considered compliant and qualified for use. The facility using the system is solely responsible for validation. While it is common for a facility to contract an outside firm to perform this complex service, it is still the facility’s obligation to approve protocols and execute testing.

 

Validation is FDA-mandated for the pharmaceutical, biopharmaceutical, medical device, and food manufacturing industries. Although cleanroom certification is required, there are many reasons to have your cleanroom certified.

The cleanroom validation procedure ensures that the facility, equipment and environment:

  • Are fit for the cleanroom’s intended purpose
  • Meet User Requirement Specifications (URS)
  • Meet defined regulatory requirements
  • Function together as a system to meet standards

Primary Cleanroom Tests

Tests are recommended for all cleanrooms:

  • ISO 14644-1 particle counts
  • Velocities & air volume
  • Temperature & humidity uniformity
  • Room air change rates
  • Pressure differentials
  • HEPA filter integrity testing
  • Temperature & RH
  • Static electricity evaluation/dissipation testing

Optional cleanroom services include:

  • Particle recovery
  • Airflow visualization smoke test
  • BSC testing & decontamination
  • Fume hoods
  • Light and/or sound level testing
  • Laminarity
  • Clean benches

Cleanroom environmental monitoring:

Ongoing periodic monitoring for microbial and other key controlled environment attributes:

  • Airborne viable organisms
  • Surface viable organisms
  • Airborne particle counts

Cleanroom Testing Frequency

Your certification schedule will depend on your cleanroom class. You may need monthly, annual, or biennial checks. No matter the case, it’s important to stay up to date to avoid costly problems later.

Cleanroom Class Chart

ISO 14644-1 & FS 209E Class Limits

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