RABS systems

A RABS device is a self-standing device with a vertical laminar air flow. It provides protection of pharmaceutical process carried out within the protected area of the device. The critical part of the line where the substance and the packaging are exposed to contamination from the surroundings is washed with a HEPA filtered laminar air flow, generated by the RABS device over the line. The protection offered by the device belongs to class 5 of ISO 14644 classification or in class A according to GMP guidelines.

Filling Line Upgrades

Iskra PIO offers complete package of services to upgrade existing filling line with RABS unit to comply with GMP Annex 1.

  • Analysis:
    • Process analysis
    • Production line analysis
    • Risk Analysis
  • Design of the system to comply with GMP Annex 1 
    • MOCK UP study 
    • Design Qualification 
  • System execution
  • On site implementation
    • Installation
    • Qualification
  • Automation compliant with CFR part 11
  • Documentation package
     

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