Ensuring HPAPI containment pilot plant category OEB4.
Dispensing Rigid Isolator 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
- 1 scale Mettler Toledo
- split active valve DN100 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)
Dispensing 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
- washing in place system to drain the main chamber
Changes/hour:
- pre chamber Pass Box: 5 Vol/hour
- dispensing chamber:20 Vol/hour
Visual and acoustic alarms:
- internal pressure (high)
- differential pressure on filters (high)
- internal Temperature (indication, alarm high)
- fan failure
CSV Containment provides FAT, SAT, Validation and SMEPAC test and training to end user.
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
