Rigid Isolator with double chamber for HPAPI containment

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CSV Containment goes right into rigid isolator manufacturers with an innovative product, customer-specific solution

Rigid isolator
Rigid Isolator with double chamber render

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

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