AP-IS Series | Aseptic Processing Isolator Systems
The Aseptic Sampling Isolator is a custom-designed cGMP Class A/ISO 5 isolator system specifically designed for handling large containers/bags and sampling sterile powders (API).
This specific AP-IS Series isolator has been designed to meet mandatory user requirements.
An AP-IS Series Isolator assures the highest air quality of the isolated environment thanks to:
– An engineered filtration system composed of High-Efficiency Particulate Air (HEPA).
– HYPER, Tema Sinergie’s integrated Vapour Phase Hydrogen Peroxide (VPHP) bio-decontamination system for very fast bio-decon cycle (Rapid Gas Chamber complete cycle in 30 minutes, full aeration included).
– Inflatable seals made of FDA-approved White Silicon Bio-Guardian®, with anti bacteria inhibitors.
Interlock system with integrated light barriers which interrupts the automatic process for operator safety.
An AP-IS Series isolator is a custom-designed aseptic processing isolator system, which can be composed of several modules.
The specific isolator configuration is composed of a 4-gloves working chamber, an inlet transfer chamber and outlet transfer chamber. This makes an AP-IS Series isolator perfectly suitable to every need and process. A select number of available options may be added at a future date.
The AP-IS Series 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(E).
An integrated control module made of AISI 304 stainless steel allows direct access for all maintenance operations. A Virtual Private Network (VPN) connection allows a secure and private communication via Internet network and provides remote access and assistance, updates and maintenance any time, everywhere.
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 an AP-IS Series isolator.
The AP-IS Series has been upgraded with DataWall, a software application developed by Tema Sinergie for data management.
The AP-IS Series isolator has been equipped with the 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 100μm diameter.
Thanks to the new sustainable low voltage ventilation fans, the isolator has a very low energy consumption throughout its life.