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.