Standard Group of Companies are specialists at manufacturing bespoke, client specific Barrier Isolator systems to cGMP and cGAMP standards.
The group manufacture both Rigid and Flexible Isolator systems with negative and positive pressure (-ve and -ve)
An Aseptic containment isolator (Barrier Isolator) is also known as laminar flow glovebox isolator.
These containment isolators provide pharmacy technicians with a method of handling material during the compounding and material transfer process by providing a complete barrier from the material and technician.
HEPA filters support contaminated air from being recirculated back into the lab.
These isolators can be provided with or without the actual process equipment which makes the isolator bespoke and versatile to the customer application.
The standard Group use the latest technology when manufacturing these critical pieces if equipment.
Key factors included in the technical specification; -
- ISO 14644-1: class ISO 5 (Class 100, Grade A)
- Containment breach alarm
- Low pressure and high-pressure alarm
- Filter choked alarm
- Interlocked door system
- HEPA Filters
- +ve pressure to 50-100 Pa system
- Transfer System designs to suit application (optional)
- Valves and Control mechanism for recirculation of air
- 300 Lux light
These barrier isolators fit extremely well into many pharmaceutical applications.
Each isolator will be ergonomically designed to suit the individual requirements.
These are offered with multiple chambers and either a Gloved or Half Suit main chamber.
Re-circulation laminar flow airflow system or turbulent airflow systems are available to ISO 5 / Grade A classification (unidirectional only) with these continuous particle monitoring systems.
Additionally, there are many applications where these isolators are used.
These include: -
- Compounding Aseptic Isolator
- Sterility testing, Sterility transfer and Sterile filtration
- Sterile loading and unloading of vials into lyophilizers (freeze dryers)
- Sterile Compactor, Granulators and filling lines
- All Aseptic and Asepsis processes
- Capping & Sealing Lypholizer (Freeze Drying) Isolator
Key advantages of the Standard Group Barrier Isolators include:-
- 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
- Automated Operation - reduced operator error likelihood
- Virtually No Sterility False Positives
- Ability to maintain sterility of equipment over a period of time
- No gowning required
- Less expensive to operate versus clean room
- Integrates with 3rd party filling lines
- Adheres to regulatory standards
- Reduced risk of human intervention
- Improves filling line operation/performance
If you need any more information please contact the team.