Aseptic containment isolator

type AR&Dsampling

The Aseptic Isolator, AP-IS Series, is a cGMP Class A/ISO 5 isolator system specifically designed for R&D, batch scale pharmaceutical production and pharmacies. It’s a flexible equipment that guarantees the best working conditions in different applications such as Aseptic Filling, Aseptic Dispensing & Sampling and Aseptic Product Transfer. GUARANTEED ASEPSIS The Aseptic Isolator, AP-IS Series, assures the highest air quality of the isolated environment thanks to: – an engineered filtration system composed of High-Efficiency Particulate Air (HEPA H14) inlet, unidirectional down flow, return, and exhaust filters – HYPER, Tema Sinergie’s integrated Vapour Phase Hydrogen Peroxide (VPHP) bio-decontamination system for very fast bio-decon cycle (the Rapid Gas Chamber completes its cycle in 20 minutes, full aeration included) – inflatable seals made of FDA-approved White Silicon Bio-Guardian®, with anti bacteria inhibitors. MODULAR BASED CONFIGURATION The system is based on a versatile modular concept: the base isolator configuration is composed of a single 4-gloves working chamber which can be easily expanded with additional chambers/ airlocks. This makes the Aseptic Isolator, AP-IS Series, perfectly suitable to every need and process. A select number of available options may be added at a future date. AUTOMATIC LEAK TEST The Aseptic Isolator, AP-IS Series, is equipped with a routine automatic leak testing system which performs an independent leak test cycle for each chamber according to the pressure change method (5.2) ISO 10648-2(E).