Pharmaceutical isolator

asepticcontainmenttransfer

The Aseptic Containment Isolator System for Oncology Products is a cGMP Class A/ISO 5 isolator system specifically designed for the Sterile processing of High Potent Active Pharmaceutical Ingredients (HPAPIs). GUARANTEED ASEPSIS The Aseptic Containment Isolator System assures the highest air quality of the isolated environment thanks to: (1) an engineered filtration system composed by High-Efficiency Particulate Air (HEPA H14) inlet and exhaust filters and Ultra Low Penetration Air (ULPA U15) unidirectional down flow and return filters; (2) an integrated Vapour Phase Hydrogen Peroxide (VPHP) bio-decontamination system for very fast bio-decon cycle; (3) inflatable seals made of FDA-approved White Silicon Bio-Guardian®, with anti bacteria inhibitors. EASE OF MAINTENANCE An external monolithic sliding control module made of AISI 304 stainless steel, containing electrical and pneumatic components, allows direct access for all maintenance operations. A Virtual Private Network connection allows a secure and private communication via Internet network and provides remote access and assistance, updates and maintenance any time, everywhere. GLOVE INTEGRITY TESTING The isolator can be equipped with an integrated Automatic Glove Leak Testing System (AGLTS) which performs an independent leak test cycle for each glove mounted on the isolator system according to the Positive Pressure Decay Method described in the international standard ISO 14644-7 Annex E.5. Wireless Wi-Fi data transmission based on a TCP/IP protocol. Recognition of the glove to be tested by means of Radio Frequency IDentification (RFID) Technology. Detection of holes down to 100μm diameter.