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STAND-ALONE-SOLUTIONS

 

BROCHURE

 




Due to increasing market demand Steriline has developed a new range of Stand Alone Isolators for the following applications:

  • Quality Control
  • Sterility Testing
  • Dispensing
  • Weighing
  • Compounding
  • R&D

The Isolators are designed to work with sterile products either toxic or not-toxic, granting the highest safety level for product and operator.
AISI316L stainless steel walls with high level surface finishing grant ease of cleaning and sanitization.
ISO 5 environment is maintained inside the isolator with unidirectional or turbulent air flow according to process needs.
The isolator is equipped with fans and HEPA filters to supply sterile air. In the return duct the exhaust air is filtered again by “Bag-In-Bag-Out” HEPA filters, easy to access for maintenance.

 

 

 

The best components available on the market and the collaboration with the primary brands allow a complete integration for:

  • Process automation
  • Air pressure control
  • VHP Sanitization

RTP ports enable In-Out product and waste transfer without safety or sterility failure.
The cycle automation is achieved through the synoptic HMI for production phase, decontamination phase, aeration, integrity test and maintenance.
Mock-up studies and tests allow perfect accessibility of the operator to all isolator functions.

 

The integrated control system is composed of PLC and touch screen operation panel for operator interface (HMI).
All Steriline isolators are in compliance with cGMP, GAMP and 21CFR Part11 requirements.