What Do ISO 11607 Revisions Mean To You?

By Patrick Nolan, COO

ISO 11607 is the foremost guidance document for validating packaging for terminally sterilized medical devices.  Packaging must comply with ISO 11607 to ensure that the enclosed medical device is kept sterile throughout all the elements and hazards generated by the manufacturing, shipping and storage environments.

The ISO 11607 standard is now being revised to incorporate the provisions of the EN 868-1 standard.  As a result, the new ISO 11607-01 will be compromised of two parts:

• Part 1 - Materials & Designs
• Part 2 - Processes

Medical device manufacturers and packaging professionals should take note of the upcoming revisions to the ISO 11607 standard, as the revisions could mean the difference between pass or fail when it comes to package validation.

Terminology

Many terms have been added or eliminated from the current standard, including:

The definition of “medical device”
ISO 11607-01 includes some medical devices that were not previously covered by the old standard.

“Primary package” replaced by “sterile barrier system”
This is defined as the “minimum package that prevents ingress of microorganisms and allows aseptic presentation of the product at the point of end use”.   

“Final package” replaced by “package system”
This is defined as “(the) combination of the sterile barrier system and protective package.”  This combined package could include the second sterile barrier, or outer package, in a dual pouch or tray; a paperboard carton or shelf box; and the shipping container.  These all may combine to form the “package system.”

The elimination of “package Integrity”
This was defined as “unimpaired physical condition of a final package”. Now it is implied that package integrity is lost if the sterile barrier system is breached or does not “prevent the ingress of microorganisms to the product.” 

Test Methods

Test data will only be accepted from ISO 11607 validated test methods, which include a Precision and Bias statement which is based on Round Robin testing of the test method itself.  This is not to say that a test method developed by an individual company could not be used to test a specific attribute of the material or package.  However, the method must be validated by determining its precision and bias against a “standard”.  The validation must be documented and retained as evidence that the repeatability and reproducibility were determined.  In addition, the sensitivity of the method must be determined. This would apply in the case of a package leak test to demonstrate package integrity.    

Compliance Requirements

Compliance responsibilities that were clearly outlined in section 4.4 of the current standard have been omitted from the new 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?

The medical device manufacturer must take care up-front with contractors and vendors to determine roles and responsibility 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 at http://www.testedandproven.com/11607-on-demand-webinar.html