GMP Compliant cleanroom
GMP Compliant Cleanroom
GMP or Good Manufacturing Practice guidelines provide guidance for manufacturing, testing and quality assurance as the respective manufacturer must meet the minimum requirements in the guidelines to assure that the products are of high quality and do not pose any risk or harm to the consumer or public.
Pharmaceutical, healthcare, chemical and food industry are some of the examples of industries that need to follow GMP guidelines. The cleanroom should be compliant with GMP EU Classification.
- Ceiling: Frame Flush Ceiling System / “Z” Lock Flush Ceiling System
- Wall Partition: Frame Flush Wall Partition System / “Z” Lock Flush Wall Partition System
* comes with Coving and Pharma-type Corner Post - Door: Pharma-type Swing Door / Sliding Door
- Lighting: Recessed Lighting
- Pass Box: Stainless Steel / EG Steel c/w Powder Coat
- Air Shower Unit: Stainless Steel / EG Steel c/w Powder Coat
- Filtration: HEPA Filter / ULPA Filter / Fan Filter Unit
- Vilament exchange times: 100000 levels ≥15 times; level 10000 ≥20 times; 1000 ≥ 30 times
- Voltage difference: The main workshop is ≥5Pa for adjacent rooms
- Average wind speed: level 10, level 100 0.3-0.5m/s
- Temperature: winter> 16 ℃; summer <26 ℃; fluctuation ± 2 ℃
- Humidity 45-65%
- The humidity of the GMP powder workshop is about 50%; the humidity of the electronic workshop is slightly higher to avoid static electricity
- Noise ≤65db (a)
- New wind supplement is 10%-30%of the total air volume
- Photo: 300lx
