Sterile Produktion
Isolators provide a physical and aerodynamic (air overpressure) barrier between the external room environment and a working process inside the Isolators. The Isolators are equipped with a number of glove ports. Operators can safely handle sterile material while protecting it from contamination using the installed gloves.
Design standards:
ISO 14644-7:2004: Cleanrooms and associated controlled environments Part 7: Separative devices
ISO 13408-6:2005: Aseptic processing of health care products Part 6: Isolator systems
Guidance on the Manufacture of Sterile Pharmaceutical Products by Aseptic Processing
PIC/S PI 014-3 Recommendation Isolators used for aseptic processing