Isolator

Comecer, part of ATS Automation, is a primary European supplier of pharma equipment in Isolator barrier technology.
We design our isolators to guarantee aseptic conditions inside the machine processing area and to pro-tect operators from product toxicity.
These isolators, which guarantee sterility and containment, are deployed as filling equipment for the production of injectable drugs needed for oncologic treatments.
Our strong partnership with MAR, based on quality and experience, allows us to supply to our customers state of the art equipment, fully integrated and compliant to the latest regulation, such as cGMP, FDA, CE and UL.

All our isolators are designed and manufactured with the following features:
  • Ergonomics design that guarantees the appropriate operator access  
  • Filtration grade with H14 filters IN / OUT 
  • LED lighting, positioned outside of the aseptic process area 
  • Doors made of 12 mm thick tempered glass with inflatable gaskets 
  • Glove ports with independent safety barriers 
  • No return ducts, for optimal uniformity of the airflow 
  • Isolator walls made of 3 mm thick AISI 316L stainless steel with internal Mirror Brite finish
  • < 0.3μm and round corners of 20 mm radius 
  • Integrated Comecer VPHP (Vapor Phase Hydrogen Peroxide) for fast and automatic decontamination process  
  • Cleaning validation procedure for aseptic highly potent and toxic products.
  • The combination of Isolator & filling machine
    satisfies the containment level Class 3, ISO 10648-02
Equipment to be divided into two well-defined categories according to dosing system
  • Dosing unit with vacuum/pressure system
  • Dosing unit with auger system
The differentiation is mainly based on the type of powder to be dosed and its characteristics (particle size, specific weight, relative density, etc.)