The High Containment Isolator System (HC-IS) has been designed for pharmaceutical industries which require the highest containment levels during manipulations of potentially hazardous compounds for research & development, production and quality control. HC-IS is a GMP Class 2 modular containment enclosure. The base isolator is composed of a single chamber with 3 or 4 glove ports. However, additional chambers and/or airlocks can be supplied according to the process to be performed.
High Containment Isolator System (HC-IS)
HC-IS has been designed for pharmaceutical industries which require the highest containment levels during manipulations of potentially hazardous compounds for Research & Development (R&D), Production, and QC.
HC-IS is a GMP Class 2 modular containment enclosure. The base isolator is composed of a single 3 or 4 gloves working chamber, but additional chambers and/or airlocks can be supplied according to the process to be performed.
The high level of containment conditions achievable within the isolated environment makes HC-IS the perfect flexible equipment for different applications, such as Product Transfer, manual Sampling, Weighing, & Dispensing operations of High Active Pharmaceutical Ingredients (HAPIs).
This isolator system will be equipped with a turbulent air flow system, and constantly guarantees a pressure gradient between the chamber(s) and the lab environment.
The high air quality of the isolated environment is assured by High Efficiency Particulate Air (HEPA H14) inlet and outlet filters.
The system is equipped with inflatable seals to guarantee air tightness Class II (ISO 10648:2); the inflatable seals are made of FDA approved Ethylene Propylene Diene Monomer (EPDM).
Operator safety is crucial because of the dangerous nature of the materials (OEL5: < 0.1 µm / m3)
The isolator is also fitted with Virtual Private Network (VPN) that allows a secure and private communication via Internet network. VPN provides remote access & assistance, updates, and maintenance any time, everywhere.
The concepts the HC-IS is based upon are modular containment, cost-effectiveness, and ease of use.
- 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
- Main shell structure made of AISI 316L stainless steel
- Sheathings and support structure made of AISI 304 stainless steel
- Mirror Brite internal finishing (<0.3 µm) and Scotch Brite external finishing (<0.8 µm)
- Weldings ground, smoothed, and polished
- SIMATIC HMI TP700 Comfort Siemens, 7″ Touch Panel with TFT colour widescreen display
- PLC Science S7 series
- 21 CFR part 11 compliant
- GAMP 5 compliant software development
- VPN connection for remote access & assistance, updates, and maintenance
- Rapid Transfer Ports, and Transfer containers
- Integrated weighing scales & operator panels
- High containment valves
- Fully automatic Clean-In-Place (CIP)
- Integrated inert gas distribution and monitoring system
- rH%+T sensors
- Vacuum dryers
- Vacuum cleaner
- On-board Automatic Glove Leak Testing System (AGLTS)
- Integrated 21 CFR part 11 compliant paperless recorder or panel thermal printer
- External monolithic control module made of stainless steel AISI 304
- 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