The Standard Group of Companies are specialists at manufacturing bespoke, client specific Barrier Isolator systems to cGMP and cGAMP standards.
Negative Pressure Isolator Systems are a key part of the Schematic Engineering Industries capabilities.
Negative pressure barrier isolators are essential where the process media is hazardous, dangerous or has an unacceptably high toxic level.
This negative pressure inside the isolator is lower than its surroundings, air is allowed to flow into the isolator but toxic air is not allowed to escape.
Additionally -VE pressure reduces the chances of airborne toxins from escaping the isolator and entering the cleanroom environment which will be harmful to any operators.
Basically air will always flow from area's with higher pressure to area's with lower pressure and this principle stops contaminated air from escaping the closed environment.
In a negative air pressure containment system, the -ve pressure is achieved by inputting an inlet of air at 10-30 per cent lower than the supply air.
These isolator types are used in both API and formulation sectors of the pharmaceutical industry.
API isolators include: -
- Dispensing & Sampling Isolators
- Reactor Charging Isolator
- ANFD Discharge Isolator
- Centrifuge & Distillation Isolators
- Filtration & Drying Isolators
Formulation isolators include: -
- Granulation Isolator
- QC Isolator
- Milling & Blending Isolator
- Pack off Isolator
- Sieving & Weighing Isolators
Key parts of the technical specification include: -
- SO 14644-1: class ISO 5 (Class 100, Grade A)
- Low pressure and high-pressure alarm
- Filter choked alarm
- Interlocked door system
- HEPA Filters
- OEL Categories OEL 1-5
- Light Vacuum (100 Pa) system
- Pilot plant and laboratory equipment
- Toxic Agrochemical applications
- Filter Dryers and Fluid Bed Dryers (FBD's)
- Micronizes, Multi-milling, Pulverising, Jet milling, Sieving and Weighing
- Handling Cytotoxic drugs
- Oncology drugs and Pack-off
- Aseptic and Asepsis processes
- Electronics Manufacturing
- Beverage / Juice processing
- Food Research & Development labs
- Dispensing and Sampling
Benefits of negative -VE Barrier Isolators:-
- Stable and accurate results
- Clear visibility during operation and cleaning
- Operator safety - fully interlocked air-locks, doors and visors
- Uncontaminated process media
- cGAMP - Alarms and safety measures in case of breach
Negative pressure isolators have become less common over time but are still more effective than more traditional methods which are vulnerable to contamination and can expose the worker to harmful hazards if not operated properly.
For more information click here or contact our Indian and UK offices.