Pacific Plastics & Engineering offers Class 10,000 cleanroom assembly in order to provide start-to-finish operations for our clients. In offering extended services, there are certain qualifications that PPE's cleanrooms and ventilation facilities had to undergo, and inspections that we maintain.
Design Qualification (DQ)
The initial process to qualify for a cleanroom status begins with the actual design of the facility (DQ). This step requires that certain proof of records regarding construction are submitted. The equipment is required to meet critical specifications as it is in process, especially GMP requirements. This aspect also entails a general compliance with environmental and work safety. Qualification is based on the concept that the systems were part of planning and development of the facility and not something that is simply put in place and is be tested on a regular basis.
Installation Qualification (IQ)
Installed equipment is qualified in the installation qualification (IQ) process. This step is to ensure facilities and the equipment enclosed therein are built and installed according to specific rules and regulations. Ventilation systems, filters, sensors, and other components should be detailed with serial numbers in paperwork with checklists starting from day one of installation.
Operational Qualification (OQ)
This step is regarding how the facility will actually operate. Operational qualification (OQ) entails that recorded proof is gathered proving the facilities and equipment are capable of operating as planned. Also, a first run through of the facility is conducted at this point. All systems that are involved with the cleanroom have been be tested at this time.
Performance Qualification (PQ)
The final stage of the qualification process for a cleanroom facility is the performance qualification (PQ). This test requires proof that the critical systems and equipment listed in the risk assessment are able to function as planned and continuously within their parameters. Once all of the systems have been checked, another systematic test is conducted during normal running conditions with a fully staffed facility.
Part Performance Qualification (PPQ)
Where possible, product performance qualification testing should include performance testing under conditions that simulate actual use, and should be conducted using product manufactured from the same type of production, equipment, methods, and procedures that will be used for routine production.
Monitoring
PPE continuously monitors and measures our air quality, filter systems, and other critical parameters to ensure our cleanrooms maintain the highest levels of standards. Your medical devices are assembled by highly trained professionals in an environment that meets FDA and ISO standards.
