Aseptic Containment Isolator System for Oncology Products

Aseptic Containment Isolator System

The Aseptic Containment Isolator System for Oncology Products is a cGMP Class A/ISO 5 isolator system specifically designed for the Sterile processing of High Potent Active Pharmaceutical Ingredients (HPAPIs).

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KEY FEATURES

  • Fully PLC controlled isolator system
  • Integrated manual & automatic Wash-In-Place (WIP)
  • Integrated VPHP generator and distribution circuit
  • VPHP sensor for TLV environment
  • VPHP sensors for chambers’ concentration monitoring (Hi/Low)
  • VPHP resistant anemometer
  • VPHP resistant relative humidity and temperature (rH%+T) sensor
  • Integrated Weighing Scales and Operator Terminals
  • Integrated High Containment Split Butterfly Valves (HCSBVs)
  • Rapid transfer port and transfer container
  • Aseptic rapid transfer system
  • Integrated Viable & non-viable monitoring system
  • External monolithic Control Cabinet made of AISI 304 stainless steel
  • View/Access panel latches with integrated safety switches
  • LED lighting system

GUARANTEED ASEPSIS

The Aseptic Containment Isolator System assures the highest air quality of the isolated environment thanks to:
(1) an engineered filtration system composed by High-Efficiency Particulate Air (HEPA H14) inlet and exhaust 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 for very fast bio-decon cycle;
(3) inflatable seals made of FDA-approved White Silicon Bio-Guardian®, with anti bacteria inhibitors.

EASE OF MAINTENANCE

An external monolithic sliding control module made of AISI 304 stainless steel, containing electrical and pneumatic components, allows direct access for all maintenance operations. A Virtual Private Network connection allows a secure and private communication via Internet network and provides remote access and assistance, updates and maintenance any time, everywhere.

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 Containment Isolator System.

AUTOMATIC LEAK TEST

The 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 10648-2:1994(E).

DATA MANAGEMENT

The isolator can also be upgraded with an Integrated Supervisory Control And Data Acquisition (SCADA) – iFIX with Historian Data Management Software (DMS) from GE Digital.

MAXIMUM SAFETY

Maximizing operator protection is the primary characteristic of a containment isolator. The Aseptic Containment Isolator System assures very stringent containment levels thanks to a perfect combination of design and manufacturing strategies. The system is equipped with inflatable and static seals to guarantee air tightness Class II (ISO 10648:2). The isolator is therefore the perfect solution for sterile processing of High Potent Active Pharmaceutical Ingredients (HPAPIs)

INTEGRATED WASH-IN-PLACE (WIP)

The system is provided with Integrated manual & automatic Wash-In-Place (WIP) for cleaning processes, thus improving safety for the operators involved in the production of potentially hazardous compounds and reducing the risk of possible cross contamination.

ENERGY SAVING

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

© 2020 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