Pharmaceutical manufacturing facilities and other testing facilities need to maintain a cleanroom, free of dust and microorganisms to a level acceptable to both local and International Regulations & Standards.
BVS has unparalleled experience and expertise in the testing and validation of cleanrooms. This in-depth and detailed process includes establishing defined control limits, developing monitoring programs and documenting all results for review, reference and record. As a partner to global retailers, manufacturers, and distributors, we enable our customers to set, meet and evolve their quality, safety and performance standards.
An OQ procedure is performed for the Cleanroom in order to verify that the HVAC System, associated equipment, controls and monitoring systems have been tested under operating conditions by certified technicians using calibrated instruments. The OQ procedure also demonstrates that the system achieves specific environmental parameters under representative operating conditions.
OQ – Operating Quality
This OQ also verified that the HVAC control system operates appropriately to maintain the proper environmental conditions, provide proper response to specified alarm conditions and ensures that peripheral instrumentation accurately measures and records critical parameters.
The following list provides an example of the OQ tests performed:
- HVAC Start-up Operation test
- Cleanroom HEPA Filter Leak testing
- BioSafety Cabinet Operation test
- Cleanroom Temperature test
- Cleanroom Humidity test
- Cleanroom Ventilation Rate test
- Cleanroom Pressurization test (also Differential Pressures)
- Cleanroom Non-Viable Particle Count test
- Cleanroom Viable Particle Count test
- Depyrogenation Oven Certification test
- Cleanroom Uneventful Operational test
- Cleanroom Eventful Operational test
PQ - Performance Qualification
A PQ procedure is performed for the Cleanroom in order to verify that the HVAC System, associated equipment, controls and monitoring systems have been tested under operating conditions that are representative of standard batching procedurs.
The following list provides an example of the PQ tests performed:
- BioSafety Cabinet Operation test
- Cleanroom Temperature test
- Cleanroom Humidity test
- Cleanroom Ventilation Rate test
- Cleanroom Pressurization test (also Differential Pressures)
- Cleanroom Non-Viable Particle Count test
- Certification Means Quality
We support the following standards and practices for the certification of cleanrooms, laminar flow hoods and mini-environments:
Federal Standard 209E
ISO 14644-1
IES-RP-cc006.2
Regular testing of your cleanroom facility should be performed on a quarterly, semi-annual or annual basis. The focus of the testing program is to monitor the performance of your facility in order to identify significant changes in efficiency. This will ensure changes can be addressed before they become a major source of contamination affecting productivity. By reviewing our customer’s current contamination controls, developing enhanced cleanroom procedures and training cleanroom personnel, we keep our customers ahead of problems and away from crisis.
- Airborne Particle Counts
- Surface Particle Counts
- Filter Velocity and Uniformity
- Differential Pressures
- HEPA/ULPA Leak Scanning
- Parallelism
- Airflow Visualization (Fog)
- Temperature and Humidity
- Noise and Lighting Level Testing
- ESD Testing
- Analytical Testing
- Protocol Evaluation