AP-IS Series | Aseptic Processing Isolator Systems
The Aseptic Filling Isolator is a custom-designed cGMP Class A/ISO 5 isolator system specifically designed for batch scale pharmaceutical production of injectable products for pre-clinical and clinical trial studies.
This specific AP-IS Series isolator has been designed to meet mandatory user requirements and fully integrates AseptiFill, our automatic vials filling and capping machine.
Compatible with AGLTS 2, the new glove integrity testing machine designed to support operators and pharmaceutical companies in the management of all glove testing-related operations.
Tema Sinergie, the ONE-STOP SHOP for your aseptic process!
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 H14) inlet, unidirectional down flow, return, and exhaust filters
– HYPER, Tema Sinergie’s integrated Vapour Phase Hydrogen Peroxide (VPHP) bio-decontamination system for very fast bio-decon cycle (the Rapid Gas Chamber completes cycle in 20 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.
A base isolator configuration is composed of a 4-gloves working chamber, an inlet transfer chamber and outlet transfer chamber to allow a unidirectional workflow. 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.
An 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).
A remote 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 risk 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.
An AP-IS Series isolator can also be upgraded with an Integrated Supervisory Control And Data Acquisition (SCADA) – iFIX with Historian Data Management Software (DMS) from GE Digital. DataWall, a software application developed by Tema Sinergie for data management, is also available upon request.
An AP-IS Series 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 100μm diameter.
Thanks to the new sustainable low voltage ventilation fans, the isolator has a very low energy consumption throughout its life.