The Standard Group of Companies, incorporating Schematic Engineering Industries, are specialists at manufacturing bespoke, client specific Barrier Isolator systems to cGMP and cGAMP standards.
Positive pressure isolator systems are a key part of the Schematic Engineering Industries capabilities.
Sterility testing of sterile pharmaceutical products is required by Pharmacopoeias regulations, as to ensure the batch meets all strict guidelines and standards.
This is a critical part of validation and it must be performed, plus this also will negate the risk both false positive and false negative results.
Positive pressure barrier Isolator designs are used throughout the industry and include sterile injectable drug filling to cytotoxic sterile drug compounding.
Positive pressure barrier isolators are also essential where external contamination from either the clean-room environment or personnel in the vicinity have the capability of sterility infringement.
In simplistic terms the air pressure in the isolator is greater than that outside of it, therefore the equipment rejects possible contamination and the sterile process media is protected.
These positive barrier isolation systems provide superior sterility compared to that of open front clean air devices such as laminar flow clean benches and cabinets.
Key parts of the technical specification:-
- ISO 14644-1: class ISO 5 (Class 100, Grade A)
- Filter choked alarm
- Interlocked door system
- HEPA Filters
- +ve pressure to 50-100 Pa system
- 300 Lux light
Typical applications in the pharmaceutical industry:-
- Compounding Aseptic Isolator
- Sterile loading and unloading of vials into lyophilize (freeze dryers)
- Sterile Compactor, Granulators and filling lines
- Aseptic and Asepsis processes
- Capping & Sealing Lyophilized (Freeze Drying) Isolator
- Pilot plant and laboratory equipment
- Electronics Manufacturing
- Beverage / Juice processing
Additional benefits of using a Positive Pressure Barrier Isolator
- Ability to maintain sterility of equipment over a period of time
- Less expensive to operate versus clean room
- Virtually no sterility false positives
- No gowning required
- Process media contamination elimination
- Stable and accurate results
- Clear visibility during operation and cleaning
- Operator safety - fully interlocked air-locks, doors and visors
- cGAMP - Alarms and safety measures in case of breach
- Automated Operation - reduced operator error likelihood
For more information click here or contact our UK or Indian offices.