Top Packaging Questions Answered

Q: Are packaging validations required?

A: Yes. ISO 11607, "Packaging for Terminally Sterilized Medical Devices," and EN 868, "Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized," are the best references for starting a validation. Also, the packaging-material manufacturer may have information for planning a validation.

Q: What is involved?

A: A validation includes, but is not limited to: packaging-material qualification, packaging design, processing requirements, sterilization compatibility, physical and chemical properties, barrier properties, device/packaging compatibility, labeling/packaging compatibility, distribution, handling, and shelf life.

Q: When should it be done?

A: It should be included in the design control process of developing a new product and should be completed by the time the product is ready for approval. Any change in the packaging of an existing product should trigger an evaluation as to the need of a full or partial revalidation.

Q: Is there a need to revalidate the packaging if the sterilization method is changed?

A: Most definitely. Packaging may be compatible with one sterilization method, but not another. A full validation may not be needed, but the need must be evaluated.

Q: As part of the validation, should the packaging be exposed to multiple sterilization cycles or extreme doses?

A: It is recommended that this should be done. It would eliminate the need to perform such testing at an inopportune moment or repackaging thousands of product because the compatibility of the package (and product) to multiple cycles/extreme doses is not known.

Q: How is shelf life verified?

A: To establish a shelf life/expiration date, one must do age testing. Real-time aging is required, and accelerated aging can be used as a substitute until the real-time aging results are available. It may be a good idea to test packages at various time points along the way to the desired shelf life/expiration date. The tests to be performed at all time points should be the same as those used to initially qualify the package.