The Standard Group of Companies design and manufacture Flexible Barrier Isolators for the Pharmaceutical, Healthcare and Chemical Industries.
Standard Group are specialists at manufacturing bespoke, client specific Barrier Isolator systems to cGMP and cGAMP standards. We manufacture both Rigid and Flexible barrier isolator systems and a variety of workstation process equipment.
Supplied with zip door entry with multiple glove ports our flexible barrier isolator solutions are ideal for small scale weighing and dispensing operations, handling highly potent API’s.
Our flexible isolator systems are an ideal, cost effective system which creates a risk-free environment for operator safety. These systems are also employed in the Healthcare sector to treat patiences with contagious infections and diseases.
Design & Customisation
Design Features
- Cost effective construction - Stainless Steel Frame and Flexible Anti-Static FDA film
- Laminar Airflow
- Zip door entry
- Push-push type safe changeable HEPA filters on inlet and outlet vents
- Integrated Options: Weighing Scale, Nutsche Filter, Vacuum Tray Dryer, Continuous liner port & Drum loader Oxygen monitoring / Nitrogen inertization
- Complete Documentation – FDS, DQ, FAT, IQ, OQ, OMM, Leak test, Lux, Noise, Air change, Filter integrity, Glove test and OEL
- Integration with RTP for safe and rapid transfer
- Split Butterfly valve for safe transfer of material
- Multiple or Single Chambers
- Isolator raise/lower systems for operator comfort
Operational Benefits
Operational Benefits
- Clear visibility during operation and cleaning
- Operator safety - controlled working environment with multiple glove stations
- High-integrity substance processing - uncontaminated process media
Technical Specification
Technical Specification
- Containment breach alarm
- Filter choked alarm HEPA Filters on inlet and outlet orifices
- OEL Categories OEL 1-4 (see Table)
- Light Vacuum (20-60 Pa) system (optional)
- Transfer System designs to suit application (optional)
- Manual drum tippers (Automated optional)
Applications
Chemical Applications
- Pilot plant and laboratory equipment
- Toxic Argochemical applications (Negative Pressure Isolators)
- Filter Dryers and Fluid Bed Dryers (FBD's)
Pharmaceutical Applications
- Micronizers, Multi-milling, Pulverising, Jet Milling, Sieving and Weighing
- Handling Cytotoxic drugs
- Oncology drugs and Pack-off
- Tablet presses and coaters
- Dispensing and Sampling
- Tray Drying (VTD's)
- Roll Compactors
API & Bulk Drug Isolators Duties
- Dispensing & Sampling Isolator
- Reactor Charging Isolator
- ANFD Discharge Isolator
- Centrifuge Isolator
- Reaction & Distillation Isolator
- Filtration & Drying Isolator
Formulation Isolator Duties
- Granulation Isolator
- QC Isolator
- Milling & Blending Isolator
- Pack off Isolator
- Reactor Charging Isolator
- Sieving & Weighing Isolator
Other Applications
- Health Care Contagious Disease treatment - Swine Flu / Ebola (Negative Pressure Isolators)
- Electronics Manufacturing
- Beverage / Juice processing
- Food Research & Development labs
OEL Standards
OEL Standards
Industry standard OEL hazard categories and descriptions are shown below;
- OEL 1 - Harmful and / or low pharmacological activity
- OEL 2 - Harmful and / or moderate pharmacological activity
- OEL 3 - Moderately toxic and / or high pharmacological activity
- OEL 4 - Toxic and / or very high pharmacological activity
- OEL 5 - Extremely toxic and / or extremely high pharmacological activity
