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Filling Line Isolators

 

BROCHURE

 



STERILINE isolators can be installed in Class C or D rooms. They are specially designed for fully integrated aseptic production line, in compliance with cGMP regulations.
The Isolators are designed for production of sterile products, either potent or non-potent, maintaining uncompromised, continuous isolation of its interior from the external environment.
ISO5 environment is achieved by HEPA filtered, unidirectional air that vertically flows over the process area. Pressure difference between the interior and the exterior is maintained by the exhaust fan. The exhaust air is HEPA filtered by BIBO filters.

 

The STERILINE isolators main features are:

  • AISI316L stainless steel for metal contact surfaces with finishes of at least Ra=0,5µm;
  • AISI304L stainless steel for panels, guards, etc. not in contact with the product and sanitizing solution;
  • AISI316L stainless steel for cleaning solution piping with tri-clamp fittings;
  • Doors made of thick security glass and sealed with inflatable gaskets. Gaskets are made of either silicone, Viton or EPDM;
  • VHP sanitization by condensation or by VHP in vapour status;

 

 
  • Gloves are incorporated into the design for aseptic applications. The quantity and position of gloves is determined during the mock-up test;
  • Rapid Transfer Ports (RTP) are available in 105mm, 190mm, 270mm, 350mm diameters;
  • CIP of the internal surfaces is achieved by means of spray gun fed by WFI or WFI mixed with inactivation agent;
  • Continuous monitoring of viable and non viable particles.

The integrated control system of isolators is composed of PLC and touch screen operation panel for operator interface (HMI). The electrical cabinet can be located in the technical area, while the HMI is located close to the process unit. 21CFR Part11 compliance is achieved by means of a separate PC.