Dispensing Isolator (QC Lab)

HC-IS Series

GMP Class 2 containment enclosure designed for the most challenging containment levels during manipulations of High Potent Active Pharmaceutical Ingredients (HPAPI) for analysis/quality control activities.

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  • Barrier Isolation Technology Brochure

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MAXIMUM
SAFETY

Maximizing operator protection is the primary characteristic of a containment isolator. Tema Sinergie assures very stringent containment levels thanks to a perfect combination of design and manufacturing strategies. The system is equipped with inflatable and/or static seals made of FDA approved EPDM (Ethylene Propylene Diene Monomer) to guarantee air tightness Class II (ISO 10648:2). Turbulent air flow system, negative pressure gradient between the chambers and the lab environment. The high air quality of the isolated environment is assured by High Efficiency Particulate Air (HEPA H14) filters.

ISOLATOR CONFIGURATION

The isolator configuration is composed of a 4-glove working chamber and an inlet/outlet transfer chamber.

AUTOMATIC LEAK TEST

The Dispensing isolator (QC Lab) 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).

GLOVE INTEGRITY TESTING

The Dispensing isolator (QC Lab) 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.

INTEGRATED WASH-IN-PLACE (WIP)

The Dispensing isolator (QC Lab) is provided with integrated manual 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.

INTEGRATED INERT GAS DISTRIBUTION SYSTEM

The Dispensing isolator (QC Lab) is equipped with an integrated inert gas distribution system (i.e. Nitrogen, supplied by the customer), as an alternative to compressed air or laboratory air ventilation, which allows to both blanket the chambers and maintain the oxygen concentration within the enclosures below 2%, so to preserve particular products from oxidation phenomena.

EASE OF MAINTENANCE

An integrated compact control module made of AISI 316L stainless steel, containing electrical and pneumatic components, 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.

CONTAINED PROCESS

Two continuous liners are integrated into the isolator for a fully contained material and samples transfer.

ENERGY SAVING

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

KEY FEATURES

  • Fully PLC controlled isolator system
  • Integrated Wash-In-Place (WIP)
  • Integrated inert gas distribution system
  • Handles with integrated safety switch
  • Sustainable low voltage ventilation fans
  • LED lighting system
  • Integrated sliding control module
  • Virtual Private Network (VPN)
  • Integrated continuous liners
  • Integrated High Precision Weighing Scale and Operator Terminal
© 2021 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