Ralph Nigro

Principal Scientist, R&D

November 04, 2014

Spotlight on the Common Failure Points of Sterile Barrier Packaging Validations

In a product’s development lifecycle, the importance of packaging can sometimes be overlooked until a packaging specialist becomes involved and can elucidate whether the packaging design is suitable and meets the tests for form, fit and function. Some companies that may not understand or emphasize the critical elements of a good package in the design phase may find out too late that the package is unsuitable after sustaining one or more failures during validation testing.

Once company experts have established the right packaging around the product configuration, then it must adhere to the design requirements. This is where preliminary testing through design of experiments (DOEs) or packaging engineering studies comes in.

Several items need to be considered before package testing can begin such as sample size, test method(s), acceptance criteria, dunnage[1] material or product, use of controls, thermal conditioning (hot and/or cold), transportation simulation testing and cost to name a few. What combination of variables you choose in a packaging test validation procedure can be based on a properly done risk assessment. So to arrive at that perfect combination is just the beginning.

So what if your packaging fails to perform as expected? Just because you had a test failure does not automatically mean that the packaging is inadequate. It does, however, demand evaluation and adjustments. A great place to start investigating a packaging failure is with the four most common failure points encountered in sterile barrier packaging validations.

  1. Oversealing
  2. Tears/pinholes
  3. Packaging Configuration
  4. Compatibility with Sterilization

[1] Dunnage was originally defined as loose materials used to support and protect cargo in a ship’s hold. That was when shipping vessels were the only form of international shipping. In the packaging industry it is material that provides padding in a shipping container that may or may not be representative of .