Questions About Facilities Qualifications?
A cleanroom is an environment typically used for manufacturing or production of items that require a low level of environmental pollutants. These controlled environment areas (CEA) are rooms in which the concentration of airborne particles is controlled. The cleanrooms are also constructed and used in a manner to minimize the introduction, generation and retention of particles inside the room, and in which other relevant parameters are controlled.
The importance of doing routine testing to certify that the cleanroom is meeting the specified requirements is vital in maintaining confidence in quality assurance programs. These environments are certified by use of specialized instruments and trained technicians to comply with quality and regulatory testing.
Pace Analytical is ISO 9001 and NEBB quality certified. The highly trained staff can assist with the cleanroom certification at any step of the process and performs testing according to Current Good Manufacturing Practices (cGMP), ISO and IEST standards.
Cleanroom Certification services include:
- Particle Counts
- HEPA Filter Integrity
- HEPA Filter velocity/volume
- Room Air Changes
- Viable Air Sampling
- Viable surface Sampling
- Temperature and Humidity uniformity
- Room Pressure
- Room Recovery
ISO 14644-1 Cleanroom Standard
EU Guidelines to Good Manufacturing Practice
Pace holds a Cleanroom Performance Testing certification from the National Environmental Balancing Bureau (NEBB).
We Can Answer Your Facilities Qualification Questions.