Process Containment Isolators
Process Containment Isolator
Hosokawa designs and builds a full range of Pharmaceutical Isolators including systems which are designed to achieve Occupational Exposure Limits (OELs) down to 10 ng/m3( 8hr TWA).
The development of increasingly potent and potentially toxic pharmaceutical products and chemicals has led to demands for increased operator protection from exposure to harmful dusts. In response Hosokawa has pioneered the development of a range of high containment enclosures or Isolators and Gloveboxes which create a physical barrier between the operator and the product. This enables âshirt sleeve operationâ without the need for Personal Protective Equipment. Isolators are available for both manual and automated handling and processing procedures and are available in single units or multi-cell variants where defined barriers separate individual processes and offer complete operator safety and product integrity.
They are ideal for such critical processes as milling, micronizing, drying, dispensing and product pack off. Integrated Containment Technology Hosokawa’s Stott Isolators can be designed to contain either Hosokawa or third party processing equipment such as micronizers, tray dryers, granulators etc.
Hosokawa’s own range of equipment can be specially designed for installation inside an Isolator to offer a highly engineered, bespoke, contained processing solution. Mobile Isolators for companies looking for a lower cost alternative to the stainless steel isolator and shorter lead time for testing, trials or production processes the Mobile, plug and play, Isolators offer containment levels <1”g/mÂł.
How it Works
Operators access the internal workspace using glove ports, allowing safe manipulation of materials without direct contact. Materials can be introduced or removed via airlocks or transfer systems, minimizing exposure to the external environment.
High-efficiency particulate air (HEPA) filtration systems ensure that air entering or exiting the isolator is filtered to remove particulates, with safe-change filters used for contamination control during maintenance. For processes requiring high hygiene or sterility, optional integrated cleaning systems (CIP/WIP) and VHP sterilization can be included.
Airflow within the isolator is carefully managedâeither through recirculating filtered air or using unidirectional (laminar) flow in sterile applications. Continuous monitoring of particles, pressure, and system performance ensures the isolator operates within specified safety and cleanliness parameters at all times.
Every isolator is designed to integrate with upstream and downstream equipment, whether from Hosokawa or third parties, supporting seamless, enclosed material handling throughout the process.
Typical Uses
- Protecting operators/environment from toxic and harmful dusts, vapors, and liquids
- Typical industries:
- Food
- Cosmetics
- Chemicals
- Defense
- Nuclear
- Pharmaceutical
- In the nuclear industry in particular, the gloveboxes are used for:
- Fuel preparation
- Waste processing
- Radioactive materials processing
- In the pharmaceutical industry:
- Primary and secondary manufacturing of APIs and intermediates
- For everything, including chemical powders, respiratory drugs, antibiotics, and painkillers
Key Features
- Handles and processes hazardous, toxic and potent materials
- Excellent build quality and performance levels
- Energy-efficient, using the latest technology
- Available in a range of sizes and configurations
- Equipment OELs down to 10ng/m3 (8-hour TWA)
- ISO Class I nuclear gloveboxes with leak tightness to less than 0.05% volume per hour
- cGMP, GAMP and FDA-compliant isolators and sterile isolators for aseptic product handling
- ATEX compliant integrated nitrogen purge systems
- CE/UKCA and UL-certified equipment Integrated CIP and WIP systems
- Safe change HEPA filtration systems
- Unidirectional air flow systems
- Viable and non-viable particle monitoring
- Integrated VHP sterilisation available
- Negative or positive internal pressure control options
- Push button or HMI operator control interfaces available
- Integration with customer DCS
- Tailor-made equipment and integrated process systems
- Manual or automated handling and processing solutions available
- Full testing and validation service, including IQ/OQ execution, OEL testing and filter DOP testing
- Document packs for certification and materials traceability
- Full operating manuals supplied
- Site installation and commissioning service
Specifications
- Our isolators and gloveboxes are custom-made for every customer's individual needs and can be operated on its own or within a system
- Multi-faceted systems that can be used in various process industries and handle harmful materials/contain toxic substances
- The Flexible Compact Isolator  offers a containment level of <1”g/m³ (8-hour TWA)
- Smaller or larger versions can be manufactured to accommodate a lab/process equipment, but the standard version has a footprint of 100 cm x 50 cm
- Can be offered as a freestanding 'plug and play' model set on castors for location flexibility
- It can also be supplied on legs without castors or as a benchtop version if a permanent location is required
- The isolator's based is manufactured from long-lasting, high-grade stainless steel
- Designed to be durable and easy to use, with a clear pressure gauge display and simple controls at the front and inlets/outlets located to the side or rear
- The freestanding version includes sturdy braked swivel castors for transportation
- Various material options are offered for the hinged canopy
- Standard 250 mm (10 inch) oval glove ports which can be tailored to your preferences
- Optional features:
- Integrated CIP/WIP system
- Nitrogen inertion capability
- Air handling system
- Plug socket for powering lab equipment
- Drain connection
- Amoxicillin
- Cellulose
- Homeopathic products
- Proteins
- Hormones
- Active Pharmaceutical Ingredients
- Excipients
- Dry Powder Inhalation (DPI)
