SPIP SPIP

Quality laboratory

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The group invests relentlessly in equipments for its Quality Laboratory, where all control measures and tests are done. Some examples in two different application fields:

- Microbiological contamination control of our ISO7 and ISO8 cleanrooms:

- bacteriological controls,
- Biodurden testing,
- Control of air cleanliness (ISO 14644),
- Microbiological samples of air and surface areas (ISO 14698).
Test reports on cleanroom performances etc.

 

- “Dimensional Laboratory” for the product control:

- Control during the manufacture,
- Batch Release,
- Capability studies: Cp – Cpk,
- Control charts…

Glossary

 

 

  • Particles: dusts from of organic, mineral, vegetable, animal origin and others…
  • Micro-organisms: little sizes organisms (yeast, mould, bacteria, virus…)
  • CFU: colony-forming unit
  • FDA = Federal Drug Administration
  • CGMP = Current Good Manufacturing Practices
  • PCI = Particulate Count Index
  • USP = United States Pharmacopeia
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