Sterility test isolator FCTS

Sterilisation
Chemistry
Pharmaceutical/Biotech
The FCTS Sterility Test Isolator has been designed for for the aseptic filling and sterility testing and meets all the requirements of the FDA, EMA, WHO ...
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Isolateur pour tests de stérilités équipé d'un vaporisateur H2O2 - FCTS
The FCTS Sterility Test Isolator has been designed for for the aseptic filling and sterility testing and meets all the requirements of the FDA, EMA, WHO and associated pharmacopoeia as well as all applicable EN standards and directives and international norms.

Suitable for:
  • Injectable liquids

  • Ophthalmic ointments

  • Sterile antibiotic powders

  • Incoming raw materials

  • Freeze-dried drugs

The FCTS Sterility Test Isolator offer a superior reliability and an easier repeatability for the validation of the infertility control and the aseptic filling of the manufactured drug batches.

USES

The Sterility test isolator FCTS is mainly used for the aseptic filling and sterility testing in sectors of highly varied market:

  • Pharmaceutical industry

  • Cosmetic industry

  • Biotech industry

  • Chemical industry

  • Agri-food sector

PROCESS

Sterilisation

SERVICES

Qualification / Validation

PRODUCTS

Cartridges
Flasks
Liquid ampoules
PE and PP single dose ampoules
Syringes

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TECHNICAL DATA

  • Working chamber has non-directional BA surface finishing (Ra ≤ 0.4 μm)

  • Air-tightness is 100% guaranteed by ultra-safe doors

  • Equipped with an internal stainless steel trolley for material transfer from pass-box to working chamber assuring continuous loading of the isolator with materials

  • Customizable internal storage and racks: can be designed according to customers' needs

  • Integrated pressure decay leak test both for chambers and gauntlets

  • FCTS is modular: customers can choose the positioning of the pass-box, the number of working chambers and gloves