ISO 9001, NEBB and CETA/CNBT quality certified

Facility qualification of new controlled environments and ongoing certification and environmental monitoring of existing cleanrooms is an important quality activity. Pace Analytical is ISO 9001, NEBB and CNBT quality certified to assure compliant vendor qualification, testing and reports for all your critical equipment and facilities.

Pace Analytical assures compliant vendor qualification, testing and reports for all your critical equipment and facilities. We offer cleanroom certification to ISO 14644 and formal facility qualification (IQOQPQ) services, an extensive list of equipment qualification IQOQs, and compressed gas contaminant testing.

  • National Service backed up by the stability and long-term success of Paces nationwide network
  • State-of-the-art instrumentation and technician training.
  • Best in class reports
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Pace holds a Cleanroom Performance Testing certification from the National Environmental Balancing Bureau (NEBB).

OUR FACILITY SERVICES

Offerings include User Requirements (URS), Design Qualifications (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)

Pace Analytical offers additional services to support your cleanroom testing and qualification business needs. The highly trained facility and equipment qualification staff is your ideal partner during every phase of a project.

ISO 9001 and NEBB quality certified. The highly trained staff can assist with the certification at any step of the process and performs testing according to Current Good Manufacturing Practices (cGMP), ISO and IEST standards.

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. We can assist with anything from purchasing the appropriate equipment to use of equipment to protocol developm

Equipment certification on Biological Safety Cabinets (BSC), Laminar Flow HEPA Workstations, Fume Hoods, compounding isolators and other equipment that has specific user requirements.

Chamber Mapping is performed on most chambers where the environmental conditions are defined in a production process and that can affect the strength, identity, safety, quality and purity of regulated products. The chamber mapping study helps to establish confidence that the equipment is capable ...
Compressed gas and air lines are commonly found in cleanrooms and used during the manufacturing process. These systems are required to meet the same standards as the controlled environments where they are located. Since systems have the potential of direct product contamination or indirect produc ...

Pharmacy Services

Our CETA National Board of Testing certified staff can provide all required cleanroom testing and certification, to help ensure compliance with USP 797 and 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.

Other Services:

  • Particle Counts
  • HEPA Filter Integrity
  • HEPA Filter velocity/volume
  • Room Air Changes
  • Room Pressure
  • Room Recovery
  • IQ/OQ/PQ
  • HEPA Filter Integrity
  • HEPA Filter velocity
  • Airflow Visualization
  • Viable Air Sampling
  • Viable surface Sampling
  • Temperature and Humidity uniformity
  • HEPA filter replacement
  • Installation of monitoring systems
  • CEA HVAC test and balance work
  • Contamination control consulting
  • Contamination control audit