- OEB (OCCUPATIONAL Exposure Band)
- OEl (OCCUPATIONAL Exposure Limit)
Uses of protected areas in Pharma Industry
- Protection of product vs biological and particulate contaminations in ASEPTIC PROCESSING
- Protection of people vs chemical contamination in CONTAINMENT PROCESSING
- Protection of Product & protection of people in ASEPTIC PROCESSING OF TOXIC PRODUCT
- Air leaktightness of an enclosure is very important, i.e.
- To avoid any interference between inside and outside of the enclosure,
- To be able to measure the level of contamination,
- To allow a cross protection people/product
- ISO 10648-2
- Classification of enclosures according to their leaktightness
- Intended for « sensitive products requiring a special atmosphere and/or a sterile medium » i.e.applicable for the isolators (0,1 to 0,5% of the volume/h of leak -Class 2 & 3-) and for the DPTE® RTP system class 1.
ULTIMATE LEVEL OF CONTAINMENT
