Rigid Positive Pressure Isolator’s
Rigid Positive Pressure Isolator’s
Positive Pressure Isolators are Stainless Steel Chambers, specifically designed keeping Product Safety as its Primary objective. These systems create a Positive pressure in the Chamber with respect to room pressure. This Isolator is specifically used where the drug must be processed in a sterile atmosphere.
In case of a breach, air from the Isolator escapes into the outer room, thereby minimising the chances of outer contaminants entering the sterile area. This minimises the risk of product contamination.
These Isolators work on “Once Through” air cycle & maintains a Positive pressure ranging from 60 Pascal’s to 80 Pascal’s inside the chamber with respect to the room. An ISO Class 5 atmosphere is achieved using Laminar HEPA filtered air over the work surface. The down coming clean air washes away partials that are generated on the working surface.
Inlet Air quality is achieved using a single stage HEPA filters over the work surface. Air exhaust also passes through HEPA filters there by ensuring that the partials remain within the system.
- MOC is SS 316L with Mirror Finish for Contact Parts. Non-contact parts are made up of SS 304 with Matt finish.
- Round corners for all internal bends.
- All welded surfaces are ground & polished.
- Flame Proof / Non Flame proof systems as per customer’s requirements.
- EU 14 HEPA filters for supply air. EU 13 HEPA filters at exhaust.
- PLC/HMI controlled system with 10” Touch Screen HMI’s, 21 CFR as per the requirement.
- System can be upgrade to Industrial PC with SCADS based operating system.
- Dual coloured LED lights (White / Yellow) for handling regular drugs or Light sensitive Drugs.
- Differential pressure transmitter for Chamber & Filters constant pressure monitoring & alarm.
- Blower over drive in case of a breach or emergency.
- Clean-In-Place / washable to reach every corner of chamber.
- Oxygen monitoring / Nitrogen purging, RH & Temperature monitoring, if required.
- De-contamination using Vaporised Hydrogen Peroxide (if required), with Cycle monitoring.
- Multiple options for material handling that varies from pass boxes, BIBO ports, RTP Ports, SBV’s etc.
- Isolator integration with new or existing Process equipment’s i.e. Filling lines, API Lines, QC / IPQC equipment’s etc
- Height raising / lowering system for enhanced ergonomics (if required).
- Sterility Testing.
- Sterile Filling Line.
- Sterile Packaging.
- Sterile Reaction.
- Lyophilization unloading & packing.
- R & D.
- QC / IPQC.
