Reducing Risk through Packaging, Part 1: Understanding the Nuances of ISO 11607


Reducing Risk through Packaging, Part 1: Understanding the Nuances of ISO 11607


The Sterilization Packaging Manufacturers Council (SPMC) is addressing a number of questions presented to them during their February 2008 Webcast, “Understanding the Nuances of ISO 11607.” You may also find a complete list of questions and answers at the SPMC Web site at www.sterilizationpackaging.org and at www.pmpnews.com.

And if you think of another question, please feel free to submit it to PMP News through Editor Daphne Allen at daphne.allen@cancom.com.

Can I have someone else validate my test methods?

You can hire someone to assist you in validating your test methods. However, the validation must be done on the actual equipment with appropriately trained personnel in the facility that the testing will occur.

How do you validate a test method when there’s only one person in the lab?

There are a couple of options to consider. First, you can have another non-lab person take part in a gauge (repeatability and reproducibility) R&R study. The person does not have to be a trained technician; however, he/she should have a basic understanding of the test to be performed. It is important to remember that a validation of this type is a test for the application of the method, and using a person unfamiliar with the test method will assess the robustness of the method. If there are issues with variation owing to this person’s inexperience, it can be overcome with training.

Second, you can compare your data with those from a round-robin study, such as that typically found in an ASTM test method, and you can see how close or relatively close you are to that data. If you do this, Annex B in AAMI TIR 22:2007 states that the repeatability data from your lab should be compared with the reproducibility results from the interlaboratory study in the existing standard.

How do we know which standards to validate?

Test methods are standards that have a result and are used to determine product performance or conformance. Test methods must be validated in order to meet the requirements of ISO 11607. It is important to remember that accelerated aging and distribution are conditioning methods and are not test methods. For example, accelerated aging is a way to condition your samples for use with a test method such as dye penetration.

Do you have any recommendations for successfully creating channels in a tray-and-lidstock sterile barrier system for the dye-penetration integrity test method validation?

In validating ASTM F1929, a 0.002-in. tungsten wire was used to create the channels. The wire was sealed within a seal and then pulled out after cooling. To facilitate removal, one end of the wire may be left spooled or wrapped around a cylinder.

Are you aware of any medical device manufacturer that has validated visual inspection for part 2 compliance without identifying it as a special process?

A “special process” is one for which the product cannot be fully verified (for example, the ability of a heat-sealing process to meet a seal-strength specification cannot be fully tested without destroying the seal). This is why that process must be validated. Visual inspection is a test method (not a process) and should be validated as such.

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