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Chemical Surface Bio- Decontamination Applied to Material Transfer into Sterile Enclosures

Presentation outline

  • Material transfer to sterile suite issue and available technologies;
  • Surface bio-decontamination drivers;
  • QbD and risk assessment and mitigation overview;
  • Surface chemical bio-decontamination cycle;
  • Cycle validation approach;

The material transfer issue…

  • It is critical to adequately control material (e.g., in-processsupplies, equipment, utensils) as it transfers from lesser to higher classified clean areas to prevent the influx of contaminants… [FDA, September 2004 Pharmaceutical cGMPs ]

 

  • The transfer of materials into and out of the unit is one of the greatest potential sources of contamination… [EU Guidelines to GMP, November 2008, Annex 1, Manufacture of Sterile Medicinal Products]

 

  • Precautions to minimize contamination should be taken during all processing stages…[WHO, 2010, GMP for sterile pharmaceutical products]

Bio-decontamination drivers

  • Plastic Single Use devices more and more used for Aseptic Processing less cleaning and downtime;
  • Primary containers, stoppers, clean room garments etc. outsourcing;
  • Bio-decontamination drivers
  • Material transfer of heat sensitive items might magnify the risk of viable contamination delivery into the sterile suite;
  • HPV surface bio-decontamination can mitigate this step.
[…]
  • author: Mauri Sergio

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