Unfortunately, there are no specifications as to how your process needs to be validated. As you stated, it is required that you do it and but it is up to medical device manufacturers to show how they prove it.

I would suggest that you do seal-strength testing at the beginning and the end of your production runs. This would include each lot of product as you inquired about. I would also suggest that you continue to do integrity testing at a minimum at the end of the run.

Should you have additional questions regarding process validations, please contact Scott Levy at scott.levy@testedandproven.com

Unfortunately, there is no guidance on a minimum specification required for the strength of a package. The underlining criterion is whether the sterility has been breached or not. Your most economical package design will probably be the lowest achievable peel strength value that does contribute to the breaching of the package’s sterility.

It is left up to the medical device manufacturer to determine the acceptable minimum value. Some things to consider when determining this minimum value are the weight and shape of product itself and the material substrate of the package.

The most frequent thing we encounter during the performance of our tests that cause sterility breaches or failures is when the primary package is folded and placed into another secondary or tertiary package. This can cause undo stress at the points the package is folded over making it more susceptible to failures. The other cause results in not taking into account any obtrusive or sharp edges or points on the product itself and than not properly placing or packing it inside of the primary package.

There are several good machine manufacturers in the industry that will meet the requirements of the ASTM standards. I would also suggest that you take the time to determine your critical criteria for your testing because you want to make sure you are not paying for additional equipment capabilities that you may or may not need.

Some of the more reputable manufacturers in industry for seal strength equipment are Instron, Test Resources, and Chatillon. Some of the more reputable manufacturers for bubble leak test equipment are TM Electronics and Carleton Technologies. There are also possibilities of designing your own source for air in performing this test.

Some things to consider in determining the packaging material are that gamma sterilization can product elevated temperatures and you want to make sure that your materials can withstand these temperatures. They will also be nonporous in nature to maintain the moisture barrier you are requiring.  I would recommend the following article that was published in MD&DI in the February 2000 issue to assist in this decision entitled “Polymer Materials Selection for Radiation-Sterilized Products,” by Karl Hemmerich.

The ultimate solution to this problem is to monitor your distribution environment and come up with a test profile specific to your shipping environment.  Because this can be timely and expensive, many of our customers will default to the International Safe Transit Association (ISTA) 7D standard.

I would avoid direct contact with the dry ice. This could be done by creating a cavity that is surrounded by dry ice and placing your product in the cavity.

Another suggestion might be to design an interior package system (corrugated box) that is placed in the thermal container and then the dry ice could be packed around it.

To my knowledge, there are no standards that require a shelf life on individual packaging system components. This is only required on the entire package system, as you currently do. I believe there is no additional action required for you and your company in this regard.

If the vacuum leak test does not work because there is no air in the package for expansion (and internal pressurization), how about simply applying a compressive load to the package and allowing it to sit over time. The load would be small so as not to cause the seals to open over time (creep), but if there was a small leak, the fluid would be forced out and/or the package would begin to deflate. Many pouches could be set-up for testing using small plate weights. There is no ASTM method for this test, but you could validate it by making small holes in control packages and observing the results. This is how I would perform the test.

I would recommend utilizing a Haug vacuum leak tester. Visit www.haugquality.com.

Depending upon the packaging itself, I would propose ASTM D3078 “Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission” or ASTM D4991 “Standard Test Method for Leakage Testing of Empty Rigid Containers by Vacuum Method.”

The utilization of D3078 is for more flexible nonporous packages, while ASTM D4991 is used for rigid nonporous packaging.