Aseptic Filling Isolator

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.

Tema Sinergie, the ONE-STOP SHOP for your aseptic process!

Available downloads:
  • Barrier Isolation Technology Brochure

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GUARANTEED ASEPSIS

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 (Rapid Gas Chamber complete cycle in 20 minutes, full aeration included)
– inflatable seals made of FDA-approved White Silicon Bio-Guardian®, with anti bacteria inhibitors.

SAFETY

Interlock system with integrated light barriers which interrupts the automatic process for operator safety.

custom-designed

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.

AUTOMATIC LEAK TEST

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).

EASE OF MAINTENANCE

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.

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 an AP-IS Series isolator.

DATA MANAGEMENT

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.

GLOVE INTEGRITY TESTING

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.

ENERGY SAVING

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

KEY FEATURES

  • Integrated automatic filling and capping machine
  • Fully PLC controlled isolator system
  • Modular configuration concept of the system
  • Integrated VPHP generator (HYPER) and distribution circuit
  • Integrated viable (microbial) and non-viable (particle) monitoring system
  • VPHP resistant anemometer
  • VPHP resistant relative humidity and temperature (rH%+T) sensor
  • View/Access panel latches with integrated safety switches
  • LED lighting system
© 2022 TEMA SINERGIE S.p.A
Fiscal Code n. 00970310397
Business Register of Ravenna n. 00970310397  |  R.E.A. 111877
Capital Stock € 2.000.000,00 paid-up