FACILITIES
CLEANROOM TESTING & CERTIFICATION
Routine testing and certification of cleanrooms is critical for safety and compliance standards, and a key aspect of maintaining confidence in quality assurance programs.
Services For Your Lab / Cleanroom Testing & Certification
CLEANROOM CERTIFICATION
Our professionals are highly trained to perform testing according to Current Good Manufacturing Practices (cGMP), ISO and IEST standards.
EQUIPMENT CERTIFICATION
Pace® is skilled in providing equipment certification on Biological Safety Cabinets (BSC), Laminar Flow HEPA Workstations, Fume Hoods, compounding isolators and other equipment that has specific user requirements.
FACILITY QUALIFICATION
Facility qualification is performed in most manufacturing, testing and production environments and applies to cleanrooms, controlled environments, laboratories and other areas where specific conditions are necessary to be in compliance. Qualification provides documented verification that a finished facility complies with the engineering design specifications and requirements.
EQUIPMENT QUALIFICATION
Equipment qualification provides documented verification that equipment complies with engineering design specifications and requirements. Equipment qualifications are performed on water systems, compressed air and gas systems, HVAC systems, autoclaves, stability chambers, incubators, refrigerators, freezers, ovens and other equipment that has specific user requirements.
Our CETA National Board of Testing certified staff can provide all required cleanroom testing and certification, to help ensure compliance with USP General Chapter <797> and USP General Chapter <800>. Services include certification of all primary engineering controls (BSC, LAFW, CI/CACI), viable and non-viable particulate, HEPA integrity, room airflow and air changes per hour, room pressurization, and videotaped static/dynamic airflow visualization testing.
As part of cleanroom systems, compressed gas and air lines must meet requirements for controlled environments and should be performed routinely. We perform compressed gas and air testing at any step of your process and provide custom reports that include test results and a map of testing locations.
Compressed gas and air testing services include:
Additional services available to support your cleanroom testing and qualification business needs:
What You Need to Know about Cleanrooms
YOUR INTEGRATED SERVICE PARTNER
TRAINED TECHNICIANS
Our highly trained technicians are equipped with specialized instruments to offer support at any point of the certification process.
EXPERIENCED MICROBIOLOGISTS
Our experienced microbiologists offer testing performed in compliance with current USP/NF, and client-supplied methodology.
EXPERT CONSULTANTS
Our consulting team can support compliance strategy, master planning, validation and contract services to ensure your facility satisfies industry standards.
Proven Performance
RESOURCES
TERMS
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
CLEANROOM GUIDES
ISO 14644-1 Cleanroom Standard
EU Guidelines to Good Manufacturing Practice
CERTIFICATIONS
A2LA, BSI, CETA, ISO9001, NEBB
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To help ensure compliance with USP General Chapter <797> and USP General Chapter <800>, our CETA National Board of Testing certified staff provide all required pharmacy cleanroom testing and certification.