The Standard Group of Companies design and manufacture Rigid Negative Pressure Barrier Isolators for the Pharmaceutical, Food, Beverage 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 with a negative pressurised internal environment and Rigid isolators with positive pressurised internal environments.
Our Standard Group negative pressure barrier isolators are essential where the process media is hazardous, dangerous or has an unacceptably high toxic level.
These barrier isolator systems operate under a light vacuum (100 Pa) to provide an uncompromising and continuous isolation of the interior from the external environment. This also provides a risk-free environment for the operator as potent vapours are taken to the systems filtered exhaust rather towards to operator.
Typical barrier isolator types/applications in both API and Formulation sectors are shown below, together with the design features and technicial attributes of Standard Group Rigid Barrier Isolator solutions.
API Isolators
API Isolators Types
Isolator designs vary depending on the application/duty. Typical Schematic solutions for API and Bulk Drug Isolator applications include;
- Dispensing & Sampling Isolators
- Reactor Charging Isolator
- ANFD Discharge Isolator
- Centrifuge & Distillation Isolators
- Filtration & Drying Isolators
Design Features
Design Features
- Rugged 316 Stainless Steel build with fully welded, large radius and polished corners
- Push-push type safe changeable HEPA filters on inlet and outlet vents
- cGAMP - PLC/HMI controlled - Digital pressure controller or Electrical controller to maintain a constant pressure
- Integrated Clean In Place / washable to reach every corner of chamber
- Integrated Weighing Scale, Nutsche Filter, Vacuum Tray Dryer, Continuous liner port and Drum loader
- Laminar airflow
- 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
- 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
Technical Specification
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
- OEL Categories OEL 1-5 (see Table)
- Light Vacuum (100 Pa) system
- Transfer System designs to suit application (optional)
- Manual drum tippers (Automatic optional)
Applications
Chemical Industry Applications
- Pilot plant and laboratory equipment
- Toxic Argochemical applications
- Filter Dryers and Fluid Bed Dryers (FBD's)
Pharmaceutical Industry Applications
- Micronizers, Multi-milling, Pulverising, Jet milling, Sieving and Weighing
- Handling Cytotoxic drugs
- Oncology drugs and Pack-off
- Aseptic and Asepsis processes
- Tablet presses and coaters
Other Industry Sectors
- Electronics Manufacturing
- Beverage / Juice processing
- Food Research & Development labs
- Dispensing and Sampling
- Roll Compactors
OEL Hazards
OEL Hazards
Industry standard OEL hazard categories and descriptions are shown below. Schematic can supply Barrier Isolators to all OEL categories shown.
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