Welcome to another edition of DDL’s PackReview video series. In the first video of this two-part segment, DDL’s Packaging Engineer Peter Johnson provides a brief overview of combination products.
Combination products are becoming more prevalent in the life sciences industry. Understanding the classification of your combination product or what constitutes your sample as a combination product is key. Whether the combination product entails medical devices, pharmaceuticals, biologics, or all of these parts, understanding all facets will help drive the testing approach you need to utilize, in order to gain regulatory approval.
Medical devices have certain regulations you will need to abide by, pharmaceutical have regulations you need to comply with, and the same goes with biologics. Not to mention how these interact with each other. You will need to evaluate each part of your combination product within its regulatory environment. As technology advances, many of these combination products require a unique and in depth approach to your testing and evaluations.
You want to make sure you are utilizing the best path forward in satisfying the requirements for each part of the combination product for your regulatory approval process.
In the second video of this segment, DDL Packaging Engineers Scott Levy and Peter Johnson discuss how they counsel their customers on some of the challenges and considerations when validating packaging for combination products.
How have you been counseling your customers on combination products?
First, we work with our customers to better understand what type of product we are dealing with, is it a medical device, pharmaceutical or biologic? Many of the combination products we are currently working on are multi-layer sterile barrier systems. For example, a multi-layer sterile barrier system could be a foil pouch with a prefilled syringe inside. In this scenario, you then need to determine which one is the primary sterile barrier, or are both the sterile barrier? This example is considered a duel sterile barrier, which means the pouch is sterile as well as the inside of the prefilled syringe. The foil pouch will need to be validated in compliance with ISO 11607. You will also need to look at what is going on with the inside of the syringe. The easiest way to execute the validation on the pouch would be to get the expiration dating, the strength, integrity, and performance testing, and then look at the product itself. When dealing with a prefilled syringe for shelf life, the product inside would fall under the ICH guidelines. In addition, you will need to figure out if the sterility maintenance on the pre-filled syringe has been compromised or not by doing container closure integrity testing and various other tests.
What are some challenges customers are facing with combination products?
Whether its medical device, biologics, or pharmaceuticals each of those parts will need to be evaluated separately in order to meet regulatory compliance. “Odds are that the FDA is going to have two separate reviewers, one that will look at the medical device side of things and the other for pharmaceutical. I council my customers to make sure that everything is together for both areas in medical device and pharmaceutical regulatory compliance,” says Scott. “Make sure you do your due diligence on understanding where you are going to put your submission in and make sure that if you are claiming it as a medical device as well as a pharmaceutical product that all the various aspects of those products have been fulfilled,” he added.
What should be considered when validating a combination product
Understanding what the facets are for determining combination product classification is key. As well as understanding the interaction of these parts with each other. Since combination products often overlap with industry requirements for both medical device and pharmaceuticals; they do require a unique and in depth approach to make sure you are on the right path to meet the regulatory compliance process.