Sponsor or Organizer: ComplianceOnline

Description: This Sterilization validation training will review the general requirements for validation as described in ISO 11137:2006.

Gamma radiation processing is used as a product sterilization method for enormous volumes of finished medical devices and other surgical, clinical, and diagnostic products. The most common method employed to validate or qualify the process for devices has historically been Method 1, and in more recent years the alternate VDmax method has also become very popular. Both methods employ product bioburdens testing followed by analysis with sub lethal radiation exposures. This presentation will review the general requirements for validation as described in ISO 11137:2006.

Dates: 10/20/2010

Location: Palo Alto, CA, USA