STERILINE ISOLATORS

 

Process vials, cartridges, syringes and ampoules

steriline isolators
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steriline isolators

Steriline isolators are typically installed in Class C or D rooms. Further, our isolators easily integrate into an aseptic production line.
In addition, the Isolators produce sterile products, either potent or non-potent, maintaining uncompromised, continuous isolation of its interior from the external environment.
HEPA filtered, unidirectional air (that vertically flows over the process area) achieves an ISO5 environment. Moreover, the exhaust fan maintains the pressure difference between the interior and exterior. The exhaust air is HEPA filtered by BIBO filters.

In addition, our isolators feature AISI316L SS metal contact surfaces (with finishes of at least Ra=0,5µm),
AISI304L SS for panels and guards and AISI316L SS for cleaning solution piping (with tri-clamp fittings).

Likewise, thick security glass (sealed with inflatable gaskets) comprises the doors . Further, silicone, Viton or EPDM compose the gaskets.
VHP sanitization by condensation or by VHP in vapour status; Aseptic applications incorporate Gloves into the design. While the mock-up test determines the quantity and position of gloves. Rapid Transfer Ports (RTP) are available in 105mm, 190mm, 270mm, 350mm diameters; A spray gun (fed by WFI or WFI mixed with inactivation agent) cleans the CIP internal surfaces
Continuous monitoring of viable and non viable particles. The PLC and touch screen operation panel comprises the isolator integrated control system. Lastly, the electrical cabinet can be located in the technical area, while the HMI is located close to the process unit.steriline isolators
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