FCIS – Pharmaceutical isolator

Equipped with FHPV – Fedegari Hydrogen Peroxide Vaporizer

Applications:
Bio-pharmaceutical
Loads:
Processes:
Contamination control Isolation

The FCIS pharmaceutical isolator have been designed primarily for :

  • pharmaceutical dispensing/handling of API and High Potent Ingredients
  • to assure sterile continuity after unloading sterile process machines
  • to guarantee aseptic filling during manufacturing phase.

To achieve these goals, FCIS unit uses a barrier in order to separate the operator – working in C or D EU cGMP grade area (ISO7, ISO8 US cGMP) – from the working area – in A grade area EU cGMP (ISO5 US cGMP) – where all operations occur. The isolator meets all the requirements of the FDA, EMA, WHO and associated pharmacopoeia as well as all applicable EN standards and directives and international norms.

Fedegari’s pharmaceutical isolator can be integrated with a side transfer hatch designed to introduce/remove all the containers and material necessary for the process. 

Fedegari has developed for the pharmaceutical isolators the same solution standardized for its bio-decontamination pass-boxes, since the performances and reliability of third party H2O2 vaporizers were not satisfactory.  Moreover, the Fedegari Hydrogen Peroxide Vaporizer (FHPV) excludes the need of propietary consumables, reducing significantly operational costs.

Through H2O2 sensors and other devices, vapor concentration is directly monitored (over traditional estimated calculations) by process controller Thema4 and remains extremely constant (within ± 15 ppm) thus allowing process repeatability .

Design & Technical Features

  • Manufactured to the highest GMP quality standards, AISI stainless steel chambers with bright annealed surface finishing (Ra ≤ 0.4 μm).
  • Doors are protected with a double gaskets system to ensure the highest level of safety for the operators.
  • Integrated pressure decay leak test both for chambers  and gauntlets
  • Exhaust air from the isolator is filtered by a H14 HEPA filter before being expeled to outside environment.
  • Customizable and modular unit manufactured according to customers’ needs.

Key benefits

  • Operations guaranteed in a grade A environment
  • Avoid risk of material/operator cross contamination
  • Utilities savings compared to clean rooms
  • Integrated Hydrogen Peroxide Vaporizer (FHPV)
  • Bespoke racking and storage to suit customer’s application
Get a quotation

First Name

Last Name

Telephone

Email

Company name

Country

City

Industrial sector

Message

 Subscribe to our newsletter


Your data will be processed for communications and marketing purposes, including commercial communications, events organization, advertising, market research and statistical analysis for marketing purposes.
Your details will not be communicated or disclosed to third parties , and you may require at any time, the access, the rectification, the erasure, the restriction, the portability and to object their use (according to Articles 15, 16, 17, 18, 20, 21) by sending an e-mail privacy@fedegari.com.


I authorize the use of my personal data in compliance with UE Regulation n.67/2016 on the protection of natural persons with regard to the processing of personal data (GDPR).

My details will not be communicated or disclosed to third parties , and I may require at any time, the access, the rectification, the erasure, the restriction, the portability and to object their use (according to Articles 15, 16, 17, 18, 20, 21) by sending an e-mail privacy@fedegari.com.

Powered by Thema4 Find a distributor