The Analytical Process Isolator (API series) offered by Flow Sciences is a continuous process isolator designed for virus screening and handling highly potent active pharmaceutical ingredients (HPAPIs). The enclosure ensures safety and features a unique design to meet specific application requirements.
The API series combines the functionalities of the Glovebox Workstation and the VBE (Vented Balance Enclosure). It provides a dual containment system with a uni-directional flow for highly toxic processes. Material enters through a pass-thru door and moves into the glovebox section where the operation takes place. The VBE section allows for a secondary wipe-down of material containers or equipment before they are removed from the enclosure.
The enclosure is designed to comply with standards such as USP 795 and USP 800, which govern pharmaceutical compounding and handling of hazardous drugs. Containment enclosures play an active role in maintaining clean processing work areas and controlling air changes in the room. Flow Sciences can assist in configuring the proper setup for compliance.
The interior of the enclosure meets or exceeds ISO 5 standards for clean processing work, thanks to a side-mounted HEPA filter inlet that creates a clean environment.
HEPA filtration is an integral part of the enclosure, with a 4″ inlet HEPA filter and two sets of primary and secondary 4″ HEPA filters. The filtered air can be recirculated into the lab or vented out through building exhaust.
The structural materials of the enclosure include a polypropylene superstructure and a phenolic resin-coated base. Viewing ports are available in either acrylic (ECP Series) or glass (ECG Series), depending on preference.
A cleaning station, known as the VBE, is included in the enclosure. This secondary open-faced environment allows for decontamination and cleaning of material containers and equipment before their complete removal from the enclosure system.
The enclosure can be equipped with an optional internal white LED light that provides direct illumination onto the application. An amber-colored light option is also available.
Standard sizes for the API series include 5′, 6′, and 7′ foot widths, with a depth of 36″ and an internal height of 24″. Custom sizes are also available to accommodate specific requirements.
All standard product lines from Flow Sciences undergo Factory Acceptance Testing (FAT) to ensure conformance to relevant standards such as ASHRAE 110-2016 and Tracer Gas Testing. Bespoke or custom designs are individually tested to ensure performance and construction quality.