The Aseptic Containment Isolator System (AC-IS) is a modular cGMP Class A/ISO 5 isolator system specifically designed for the sterile processing of high potent active pharmaceutical ingredients (HPAPIs).
Guaranteed Asepsis: The Aseptic Containment Isolator System assures the highest air quality of the isolated environment due to an engineered filtration system composed of High-Efficiency Particulate Air (HEPA H14) inlet and exhaust filters and Ultra Low Penetration Air (ULPA U15) unidirectional down flow and return filters and an integrated Vapor Phase Hydrogen Peroxide (VPHP) bio-decontamination system.
Ease of Maintenance: An external monolithic sliding control module made of AISI 304 stainless steel allows direct access for all maintenance operations.
Automatic Leak Test: 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 10648-2:1994(E).
Data Management: The isolator can also be upgraded with an Integrated Supervisory Control And Data Acquisition (SCADA) – iFIX with Historian Data Management Software (DMS) from GE Digital.
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.
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.
Ergonomic Design: Maximizing operators’ effectiveness is essential to minimize the risks of accidents, eliminate unscheduled downtime and boost production quality. Operators are assured the most comfortable working conditions by the outstanding ergonomics of the Aseptic Containment Isolator System.
- Fully PLC controlled isolator system
- Integrated manual & automatic Wash-In-Place (WIP)
- Integrated VPHP generator and distribution circuit
- VPHP resistant anemometer
- VPHP resistant relative humidity and temperature (rH%+T) sensor
- External monolithic Control Cabinet made of AISI 304 stainless steel
- View/Access panel latches with integrated safety switches
- LED lighting system
- VPHP sensor for TLV environment
- VPHP sensors for chambers’ concentration monitoring (Hi/Low)
- Integrated Weighing Scales and Operator Terminals
- Integrated High Containment Split Butterfly Valves (HCSBVs)
- Rapid transfer port and transfer container
- Aseptic rapid transfer system
- Integrated Viable & non-viable monitoring system
- 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