Containment

Preventive actions, containment management & maintenance

  • RAPA (New Approach): Risk Analysis & Preventive Actions

    GAPA (New Approach): GMP Gap Analysis & Preventive Actions

  • Closed process equipment & transfer systems
  • Specific protection equipment for personnel, & safe design to protect products & environmental areas, by means of : biological hoods (Clas II, 2A/B),  closed passive or active isolators
  • Dedicated manufacturing rooms
  • Limited & controlled access
  • Physical & mechanical segregation
  • Mechanical systems backup & redundancy, (HVAC, direct extracton fans, pressure cascade & containment, IBC Technologies, Hemi-Scaphandre, Pneumatic Transfer, RTP α/β Ports, Split Valves, ...)
  • Written & approvedcontainemnt procedures
  • Electrical power backup supply & UPS
  • Bag In & Bag Out Filters
  • Cleaning & chemical sanitisation
  • Specific protective gowning
  • Fire protection alarm & signalisation
  • Implementation of evacuation & emergency exit procedures
  • http://www.linkedin.com/pub/aziz-chraibi-phd-eng/b/a38/170

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