However, when you are not the expert on a certain process in the medical device packaging supply chain, having your sterile packaging in-house can create problems.
Systems are available that MDMs can put in place to ensure that their sealing and packaging process remains good over time, and one of them is in-process testing. There are three parts to the running tests, and we’ll look at each below.
1. Choose the right test methods for in-process testing. Think about what happens in your facility during the packing process. Your operators are dressed in the clean room, insert your device into the packaging and seal it. Therefore, your in-process testing should assess the sealing process. It is imperative that the sealing process stays good over time and it is important that sealed packages are tested in-process for each batch to ensure that there are no weak seals in the market .
Choosing test methods for your in-process testing should be done with thought and planning. The recommendation for determining which testing methods you should use is to refer to your medical device packaging validations and base your ongoing testing on that.
Peel strength is a common test method used in packaging validation and is an excellent test method to prove that the sealing process is still good over time. While the bubble leak is an excellent package integrity test for the entire package, this test method would not be ideal for testing seal integrity.
2. Integrate your test methods. Now that you have determined which test methods will be part of your in-production testing, you need to ensure that these test methods are properly integrated into a test method validation (TMV).
Many MDMs perform various package integrity tests for their current tests, for example, bubble leak, dye leak, and peel strength. However, it is not very often that these companies perform any form of test method validation or understand what is expected when commissioning these test methods.
Validation of a test method is part of the documented process for adopting a test method internally. The VMT is intended to demonstrate that the method can be performed with repeatability and reproducibility and that the results obtained from the test are reliable. TMV may include installation qualification (IQ) and equipment calibration, method training of personnel, performing instrumentation R&R studies, and establishing control methods and quality check.
Often, MDMs perform in-process testing, but lack the proper documentation or training to ensure quality and reliability when performing this testing. This creates the potential risk that defective packaging will pass inspection, which could cause potential harm to the end user.
Having a well-documented TMV allows customers to be considered validated to perform in-process testing on their packaging.
3. Integrate a test method for ongoing tests. There are generally three phases to integrating a test method for ongoing testing: qualifying the installation, performing test method validation, and continuing education. Here are the considerations for each phase.
1.) Installation Skills:
a. The IQ is the first phase, which consists of verifying that the equipment needed to perform the test is correctly installed and calibrated, and that it works as intended.
b. During this step, you want to make sure that all of the equipment components are in place and that you read the manual to understand how to use the machines correctly.
2.) Conducting the test method validation:
a. Develop the TMV plan and write the TMV protocol.
b. Train personnel on the equipment, test method, protocol, and all applicable work instructions.
vs. Run the TMV study and analyze the results to determine efficacy and reliability.
3.) Continuing education:
a. Once the test method has been validated on your site, possibly additional operators will be required. They must be trained and validated in the test method. Later, they will need periodic refresher training.
b. You’ll want to make sure multiple people are trained to perform the test to account for staff turnover, shift changes, etc.
vs. Create a schedule to ensure there is ongoing training and to stay informed of updates to test method standards.
This three-part approach to in-process testing should help ensure that your sealing and packaging process remains robust over time.
The author, Sarah Rosenblum, is senior director of sales and marketing at Packaging Compliance Labs. She is the Communications Chair of the IoPP Medical Device Packaging Technical Committee. For more information about the IoPP, visit www.iopp.org.