The Modular Aseptic Containment Isolator System
The Aseptic Containment Isolator System is a modular cGMP Class A/ISO 5 isolator system specifically designed for the Sterile processing of High Potent Active Pharmaceutical Ingredients (HPAPIs).
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 AC-IS perfectly suitable to every need and process. A select number of available options may be added at a future date.
The Aseptic Containment Isolator System assures the highest air quality of the isolated environment thanks to:
– an engineered filtration system composed of Efficiency Particulate Air (EPA E11) inlet and exhaust filters and High Efficiency Particulate Air (HEPA H14) unidirectional down flow and safe charge return filters (bag in/bag out);
– HYPER, Tema Sinergie’s integrated Vapour Phase Hydrogen Peroxide (VPHP) bio-decontamination system for very fast bio-decon cycle;
– inflatable seals made of FDA-approved White Silicon Bio-Guardian®, with anti bacteria inhibitors.
Maximizing operators’ protection is the primary characteristic of a HPAPI containment isolator. The Aseptic Containment Isolator System assures very stringent HPAPI containment levels thanks to a perfect combination of design and manufacturing strategies. The system is equipped with inflatable and static seals to guarantee air tightness Class II (ISO 10648:2). The isolator is therefore the perfect solution for sterile processing of High Potent Active Pharmaceutical Ingredients (HPAPIs).
The system is provided with Integrated manual & automatic Wash-In-Place (WIP) for cleaning processes, thus improving safety for the operators involved in the production of potentially hazardous compounds and reducing the risk of possible cross contamination.
The isolator 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).
An integrated sliding control module made of AISI 316L stainless steel, containing electrical and pneumatic components, allows direct access for all maintenance operations.
A Virtual Private Network (VPN) connection allows a secure and private communication via Internet network and provides remote access and assistance, updates and maintenance any time, everywhere.
Maximizing operators’ effectiveness is essential to minimize the risk of accidents, eliminate unscheduled downtime and boost production quality.
Operators are assured the most comfortable working conditions by the outstanding ergonomics of the AC-IS.
The AC-IS 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 TC P/IP protocol. Recognition of the glove to be tested by means of Radio Frequency IDentification (RFID) Technology. Detection of holes down to 100μm
The AC-IS can also be upgraded with an Integrated Supervisory Control And Data Acquisition (SCADA) – iFIX with Historian Data Management Software (DMS) from GE Digital. DataWall, a software application developed by Tema Sinergie for data management, is also available upon request.
Thanks to the new sustainable low voltage ventilation fans, the isolator has a very low energy consumption throughout its life.