The Aseptic Processing Isolator System – V Model (AP-IS V) is a cGMP Class A/ISO 5 isolator system specifically designed to guarantee the safest working conditions during the manipulation of viruses and vaccines.

It’s flexibility guarantees the best working conditions in different applications such as sterility testing, aseptic filling, aseptic dispensing & sampling and aseptic product transfer.

We also offer the AP-IS 2 which is a compact version of the aseptic processing isolator system.

Aseptic Processing Isolator

Aseptic Processing Isolator System (AP-IS)

Guaranteed Asepsis: The AP-IS-V assures the highest air quality of the isolated environment thanks to:
1. an engineered filtration system composed by High-Efficiency Particulate Air (HEPA) pre-filters and Ultra Low Penetration Air (ULPA U15) unidirectional down flow and return filters;
2. an integrated Vapour Phase Hydrogen Peroxide (VPHP) bio-decontamination system;
3. inflatable seals made of FDA-approved White Silicon Bio-Guardian®, with anti-bacteria inhibitors.

Automatic Leak Test: The AP-IS-V is equipped with a routine automatic leak testing system that 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 AP-IS-V is upgraded with the DataWall Data Management Software developed By Tema Sinergie.

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 Processing Isolator System.

Environmental Monitoring: The AP-IS-V is upgraded with an Integrated Viable (Microbial) and Non-viable (Particle) Monitoring System.

Energy Saving: Thanks to the new sustainable low voltage ventilation fans, the isolator has a very low energy consumption throughout its life.

  • Fully PLC controlled isolator system
  • Integrated VPHP generator and distribution circuit
  • VPHP resistant anemometer
  • VPHP resistant relative humidity and temperature (rH%+T) sensor
  • VPHP sensor for TLV environmental monitoring – safety sensor
  • VPHP sensor for concentration chambers’ monitoring
  • External monolithic Control Cabinet made of AISI 304 stainless steel
  • View/Access panel latches with integrated safety switches
  • LED lighting system
  • Rapid Transfer Port (RTP)