This week is simulation week and our project is on Bottle Label Development for a Hydrophilic Coating Product. This got me thinking about package development for products and the types of test they must pass. Any testing done on the packages should measure the effects and interactions of the levels of packaging, the package contents, external forces, and end-use. The testings usually involve controlled laboratory experiments in which documentation is very important. If you have any experience or know about the process that goes behind package development for medical devices, my question for you is: what are some examples of testings done and how was the procedure documented?
Packaging development is a very important part of a medical device project, and in my company, we have engineers who are dedicated to package development. For packaging, and especially sterile packaging, the tests that are performed are usually very standardized, and the packaging engineer does not have to define new tests each time we are developing a new product. We often rely on our packaging suppliers to develop the testing protocols, which includes the test procedure, and these protocols are then reviewed and signed by representatives from my company. Some common packaging tests include real time and accelerated aging, ship testing, and sterile barrier testing. The procedures are defined based on an ASTM standard or some other standard, and I have listed several ASTM standards below if you would like more info.
ASTM F1980: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM D4332: Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
ASTM F2096: Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
ASTM F88/88m-09: Standard Test for Seal Strength of Flexible Barrier Materials (Peel Test)
Not for medical devices, but I’ve been involved with testing shipping containers that would be used to ship out my company’s products. Tests were done with accordance to ASTM D4196-16 specs. These tests involved rotational flat drops of around 3 inches using a quick release mechanism, and vibration for a set amount of hours. The vibration profile was usually truck level with varying degrees of severity, ranging from truck level 1 to 3 which range from 0.40 to 0.75Grms. I’ve also used air level profile but rarely. These tests were selected based on the environment our products would experience during their transit to the customer. If the shipping container passed shock & vibration the doc team would create a report of all observations seen during or post testing and have the container approved up the higher ups.
When developing packaging for medical devices there are two primary concerns. The first is maintaing product integrity throughout the shipping and storage process. This means we want to make sure the device does not get damanged between the time it is packaged and the time in goes into the hands of the physician or patient. To determine that we would subject the device to simulated extreme shipping and storage conditions prior to design verification and validation testing.
The second main concern in packaging development is to ensure that the product can be sterilized and that the sterile barrier is maintained until the product is opened by the user. As part of design verification/validation we would test the sterilized product to ensure the sterilization process was effective and test the sterile barrier using the ASTM test method mentioned above to make sure that sterility was maintained after simulated extreme shipping and storage.
I do not have experience with packaging but have heard from John Crombie the details associated with the packing. Early evaluation of product-packaging compatibility helps to detect design of manufacturing problems. In the worst case scenario that the packing does not meet certain specifications, the early evaluation will help. Basically, packaging design should be started early. Size of the packaging is the next factor to look over. From reading different resources common factors associated with size are friction, pressure, and transportation. All of these sub-factors are considered when developing packaging. Another factor is having a detailed packaging protocol. Concerns with packaging have to be addressed as soon as the project starts.This should be a prerequisite before the device goes into manufacturing because contingencies plans can be made.
From research I did, there are 6 steps to package development for medical devices. The first step is consulting the regulations. This step is to determine if the medical device falls under the FDA requirements regulations for packaging. The second step is gathering packaging design requirements.The third step is establishing packaging system conformity requirements. This step is to determine the durability of the package. The fourth step is investigating labeling requirements. The next step is conducting distribution and handling tests. And finally perform stability testing, accelerated and real-time aging of the sterile barrier system. This uses the ISO 11607.
Adding to the discussion, from my academic experience, for the documentation for any test done for a medical device,in general the risk management file which is done by QA department. For example, a medical electrical device evaluated according to standard IEC60601-1.
- Instructions for use, labeling and marking , including information essential for using the correct
test parameters, such as frequency of the power supply, electrical operating voltages, degree of protection against moisture, etc.
- Definition drawings, technical data
- List of critical electrical components (always requested when evaluating a medical electrical device)
And regarding the packaging for a medical device, the FDA has several regulations mentioned on "medical device packaging design - Sec. 820.130 Device packaging under Subpart K--Labeling and Packaging Control.
https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm095308.pdf
One of the tests I have seen done to check the integrity of the package is known as the burst test. Basically, it works just like it sounds. The package is connected to a machine that increases the internal pressure until the package seal is broken. This allows packaging and engineering to figure out where the weaker points of the package are and plan their designs accordingly. The tests are usually documented in data collection forms from within a protocol which is then reported via report.
Packaging, Testing, & Documentation plays essential role for any project for a company. For Testing the steps are: Repeatability, Reproductivity, and Sensitivity then for Qualification they firstly look at testing to aid critical processes(instrumentation qualification), secondly it tests upper & lower parameter limits to ensure properties meet the requirement(operational qualification), and lastly comes protocol qualification. In Documentation comes tests protocols and reports, validation protocols and reports also supporting documents like calibration records.
As @hc255 mentions the burst test. I actually YouTube'd different burst tests and it is has proven extremely informative and entertaining. It is really interesting to watch the video examples to see how the different testing is done. Some even just do it for the product themselves one entertaining one was for UPS "Burst Test is used to measure the amount of pressure it would take to puncture a corrugated box. This test should be used as a quality assurance measure to ensure the box strength rating is performing to specification."
As @ala26 mentions, I've seen some sterility and integrity tests as well as the burst tests referred to by@hc255. However, in my experience, I have seen additional tests that do not only comment on the integrity of the box but also on the artwork or the design of the box. Some of these tests include comparing colors to a standard and visually inspecting for any defects. Typically, during testing, there is a certain number that is scrapped out of the incoming batch of new material and used for testing purposes and then the results are noted on controlled documents. These documents allow a paper trail to identify what the material is and where it has been. On most of the documents exists a Certificate of Conformance that indicates what the material is made out of and when it was manufactured. This can give insight into the expiration date and the integrity of the packaging material. Documentation of everything continuously provides a paper trail in case an FDA auditor visits or in case something needs to be addressed in production.
