CSV Containment goes right into rigid isolator manufacturers with an innovative product, customer-specific solution
Rigid isolator OEB5 composed by:
Pre chamber Pass Box
- 2 glove ports
- compressed air
- chamber extraction
- purified water for spray gun
- drain with ball valve stainless steel body (DN40) on the bottom of the pre chamber
- internal door to connect air lock with dispensing chamber
Dispensing chamber
- 4 glove ports
- continuous liner DN 300 on the side of the chamber
- 2 scales – IP67-69 (Mettler Toledo)
- split active valve DN50 on the bottom (ChargePoint)
- spray gun with hose
- pressure reduction valve and modulating valve for air inlet
- inlet air cartridge filter, 0,2 micron retention grade or HEPA
- pressure transmitter internal chamber
- 2 push-push type HEPA filter on extraction with stainless steel container, DPI for filter clogging and connection for filter integrity test (DOP or equivalent)
- extract fan, centrifugal, variable speed
- pressure cascade
- isolator in negative pressure respect to surrounding area, dispensing chamber in negative pressure (about -70 Pa) respect pre chamber (about -35 Pa)
Rigid isolator general features and benefits:
- led lighting system, external mounting
- dedicated electrical and control system in accordance to the GAMP 5 (incl. annex11) and 21 CFR Part 11.
- operator interface panel
- electronic batch record
Changes/hour:
- pre chamber Pass Box: 5 Vol/hour
- dispensing chamber:15 Vol/hour
Visual and acoustic alarms:
- internal pressure (high)
- differential pressure on filters (high)
- internal Temperature (indication, alarm high)
- fan failure
CSV Containment is present in the pharmaceutical market and is focused on providing engineering, construction and validation solutions for the LifeScience world. For more information:containment@csv-ls.com
