The Romaco approach to contamination control: Belleak™ and FlatSeal™

When handling HPAPI or cytotoxic products, as disciplined in the latest Annex 1 release, the use of appropriate Barrier technologies should be taken into consideration.

In order to ensure necessary conditions and reduce microbiological contamination linked to direct human interventions in the production area, isolators are the kind of technology the pharmaceutical industry is relying onto.

There are nevertheless many zones of potential contamination in any isolator, which should be assessed in the Risk Analysis and in the Contamination Control Strategy.

Your Processing & Packaging challenges

  • Preventing product contamination

  • Ensuring operators’ safety

  • Implementing an effective contamination control strategy

  • Gloves integrity tests…but not only!

  • Validating the process

  • Thoroughly cleaning the system

  • Loading of components

  • Assembling and disassembling the machine units in sterile conditions

Our solution

  • 6-walls isolation design, up to OEB 5, including safe transfer of all components

  • Enhanced cleaning capability thanks to:

    • Automatic CIP/WIP

    • FlatSeal™inflatable gasket proprietary design

  • Belleak™ technology:

    • Active Breathing functionality, Internal Pressure SetPoint in order to maintain negative throughout the cycles

    • Pressure decay integrity test on bellows



Working products under isolation technology?

We are ready to bring your production to the next level of contamination control.