What ISO 11607 revisions mean to you
Compliance responsibilities that were clearly outlined in section 4.4 of the current standard have been omitted from the new International Standards Organization (ISO) 11607-01. Therefore, confusion may arise over certain areas of responsibility such as: • Who should test the packaging suppliers' seals? • Who is responsible for validating package sealing equipment? • Who is responsible for evaluating the biocompatibility or other material characteristics such as microbial barrier properties?
May 10, 2006
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