I’m a little uneasy going too deep into this topic, as I definitely am not a subject matter expert with sustainable packaging. I can tell you, however, from observations at the street level, many of our medical device packaging engineers are feeling a great deal of pressure to manage waste as we push towards a global plan for sustainable packaging.
I’ll try to cover this area in future blogs as more information reveals itself in 2019. I can only tell you that I have observed an area that may be a good starting point if your company wishes to get a jump on managing packaging waste.
As I have mentioned before in other blogs medical device packaging engineers will do just about anything to avoid a revalidation process. Unfortunately, this has caused multiple layers of issues for the medical device companies as reevaluating and reinvigorating systems is essential to maintain viability.
On the regulatory side, the general consensus is a revalidation of our medical device packaging plan will turn our company completely upside down, possibly expose other failures, and will roll the quality staff into a Fibonacci sequence of duties, tasks, and delays.
The truth is, however, medical device manufacturers do not necessarily need to completely revalidate a process if there is only a minor change in their process that isn’t globally impactful, in fact, this is what the standard specifies under 5.7.3:
“The need for revalidation shall be evaluated and documented. If the situation does not require that all aspects of the original validation be repeated, this revalidation does not have to be as extensive as the initial validation.”
This, I believe, is why many companies avoid changing packaging material as they do not wish to get involved with a revalidation of their medical device packaging program. I’ve seen devices come into our empirical lab that are packaged in a multi-pouched configuration in a pouch that is exceedingly too large for the device. Not only is this a huge waste in material, but it also possibly presents with a medical device delivery risk at the point of care.
My recommendation is to always reevaluate the amount of packaging that is used to make sure that you are not utilizing a “one-size-fits-all” mindset, as this will create huge amounts of packaging waste for your firm.
Obviously, the goal is to deliver your medical device safe and sterile to the point of care without risking the efficacy or the sterile barrier. As medical device manufacturers, we have to be careful that we do not succumb to the general packaging pressure that tells us to reduce waste at all cost. Clearly, we face steep regulatory issues, as well as functional issues. We cannot expect to be able to turn on a dime when it comes to packaging sustainability for medical devices. We first have the mandate to be certain that our medical devices will not be affected as we work to minimize our packages. I would love to hear what issues you are faced with regarding sustainability at your company.