High Containment Isolator System
The High Containment Isolator System (HC-IS) is a GMP Class 2 modular HPAPI containment enclosure designed for the most challenging containment levels during manipulations of potentially hazardous compounds for Research & Development, Production and QC.
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Maximizing operator protection is the primary characteristic of a containment isolator. Tema Sinergie HC-IS assures very stringent containment levels (≤50ng /m3) thanks to a perfect combination of design and manufacturing strategies. The system is equipped with inflatable and/or static seals made of FDA approved EPDM (Ethylene Propylene Diene Monomer) to guarantee air tightness Class II (ISO 10648:2). The HC-IS is therefore the perfect adaptable solution for different applications, such as Product Transfer, Manual Sampling, Weighing and Dispensing operations of High Potent Active Pharmaceutical Ingredients (HPAPI).
The system is based on a versatile modular concept: the base isolator configuration is composed of a single working chamber which can be easily expanded with additional chambers and/or airlocks. This makes HC-IS perfectly suitable to every need and process. A select number of available options may be added at a future date.
HC-IS 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 10648-2:1994(E).
HC-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 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.
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.
An integrated compact sliding control module made of AISI 304 stainless steel, containing electrical and pneumatic components, allows direct access for all maintenance operations. An external monolithic sliding cabinet made of stainless steel AISI 304 is also available alternatively. 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.
The HC-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.