Double chamber weighing and dispensing isolator: a universal solution for weighing and dispensing raw material from unknown containers of any size with unidirectional flow.
Performing risky operations, such as handling, weighing and dispensing high potent raw materials, in pharmaceutical manufactory has become safer and safer thanks to the double chamber weighing and dispensing isolator.
The double chamber weighing and dispensing isolator allows raw material containers of various sizes up to medium volumes to be transferred safely into the weighing chamber.
In addition, the same containers do not need to be decontaminated but can be safely transferred outside the weighing chamber by means of a bag out liner
Features
Pre chamber Pass Box:
- 2 glove ports
- Negative pressure control
- Exhaust circuit HEPA filtration with push-push safe changed device
- Compressed air/nitrogen filtered inlet exhaust circuit HEPA filtration with push-push safe changed device
- Purified water for spray gun
- Opening front door
- Drain with ball valve stainless steel body (DN40) on the bottom of the pre chamber
- Internal door to connect air lock with dispensing chamber
- Exhaust fan, centrifugal, variable speed
Dispensing chamber:
- 6 glove ports
- Continuous liner DN 400 on bottom of the chamber equipped with a container lifter
- ChargePoint Split active valve DN100 on the bottom equipped with a slide to couple its passive and active side
- 1 scale Mettler Toledo
- Spray gun with hose
- Pressure reduction valve and modulating valve for air inlet
- Compressed air/nitrogen filtered inlet exhaust circuit HEPA filtration with push-push safe changed device
- 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)
- Exhaust 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:
- ATEX rated zone 2,22
- 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
- Internal finishes lower than 0,5 Ra
- Scotch-bright external finishes
- Gaskets and seals FDA compliant and conductive
- EDPM conductive gloves
- Conductive flanges
- OEB5 containment performance
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 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
