The High Containment Isolator System (HC-IS) is a GMP Class 2 modular containment enclosure designed for the most challenging containment levels during manipulation of potentially hazardous compounds for research & development, production and quality control.
High Containment Isolator System (HC-IS)
Maximum Safety: Maximizing operator protection is the primary characteristic of a containment isolator. Our HC-IS assures very stringent containment levels (≤50ng /m3) due to 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).
Modular Based Configuration: 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.
Integrated Wash-In-Place: 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.
Automatic Leak Test: The 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).
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 50μm diameter.
Ease of Maintenance: 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.
- Modular based configuration of the system
- Fully PLC controlled isolator system
- Integrated Wash-In-Place (WIP)
- Handles with integrated safety switch
- LED lighting system
- Integrated compact control module
- Virtual Private Network
- Complete documentation package according to Tema Sinergie standards
- Complete validation package, Factory Acceptance Test (FAT) and Site Acceptance Test (SAT)
- Installation Qualification/Operational Qualification (IQ/OQ) protocols and execution upon request
- Performance Qualification (PQ) protocols and execution upon request