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?
Medical device manufacturers must take care up front with contractors and vendors to determine roles and responsibilities in the entire package development and validation process.
Most of the changes to the standard will have little effect on how you design your packaging and sterile barrier systems for your devices. However, there are some nuances that will require additional testing and some subtleties for performing a final package system validation as described in Clause 6. There are also other areas of relief from testing such as using previously documented studies for stability testing and documented evidence of previous evaluations for material compatibility.
For more information on how ISO 11607 revisions may affect you, listen to the DDL on-demand webinar. [HCP]
Patrick J. Nolan is COO of DDL Inc., a package, product, and material testing lab. He is part of the Task Group within the AAMI Sterilization Packaging Working Group that developed the revised Technical Information Report for the ISO 11607 revisions.
