Engineering, fabrication, assembly and test is done in an ISO 9001 accredited facility in ISO class 8 and 7 cleanrooms to a strict set of SOPs.  Prior to leaving the factory, each isolator undergoes a variety of quality control steps and is pressure tested to ensure containment performance.

Each isolator is labelled with the part number, serial number and date of manufacturing.  The anti-static CSP Pharmaflex™ flexible film has a shelf life of 5 years from the date of manufacture.