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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