The Sterility Testing Isolator System (ST-IS) is a cGMP Class A/ISO 5 modular isolator system specifically designed for sterility testing, which guarantees the safest working conditions during quality control operations.
Guaranteed Asepsis: The Sterility Testing 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.
Data Management: The ST-IS can be upgraded with an Integrated Supervisory Control And Data Acquisition (SCADA) – iFIX with Historian Data Management Software (DMS) from GE Digital.
Modular Based Configuration: The system is based on a versatile modular concept: the base isolator configuration is composed of a single 2 to 4-glove working chamber which can be easily expanded with additional modules. This makes ST-IS perfectly suitable to every need and process.
Automatic Leak Test: The ST-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.
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 this isolator.
- Fully PLC controlled isolator system
- Modular configuration concept of the system
- 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
- 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