PCL is a leader in medical packaging engineering & testing due in large part to our experience working with a wide range of products and materials. We enjoy the opportunity of seeing what passes and what doesn’t, and using that information to help future clients with root cause analysis and design improvement. Recently we encountered a curious case of open seals with a failure mode not before seen at the lab. Though it was a challenging endeavor, we learned and grew from the investigation and were ultimately successful in identifying and recreating the root cause.
PCL has had the opportunity numerous times to work with clients at validating their sealer and pouch/trays so that they are capable of running on a production line. The process of validating a sealer and package involves many steps. The first step is to properly install the sealer (IQ). But before starting the operational qualification (OQ) and process qualification (PQ), there is one important step that needs to occur. This step is process characterization. The purpose of process characterization is to prove that critical product parameters and associated process parameters are capable of meeting certain requirements. Typical requirements involve the seal strength, seal width, and visual characteristics.
The Grand Rapids Business Journal published an article in the June 26th edition detailing some of the recent success that PCL has had as we continue to grow! Check it out at the article here:
The rise in the pharmaceutical and medical device packaging industry has been increasing over the past few years. In 2015, revenue from pharmaceuticals and medical devices reached $1.1 trillion and $350 billion, respectively. This increase in global demand is due to a jump in the use of pharmaceutical and medical devices, the rising middle class, and an aging population. By 2020, the population of those 65+ will surpass the number of children under five years old.
Our customers have spoken, and PCL listened.
At PCL, we routinely specify, purchase, install and validate medical pouch sealers of all technologies and brands. These activities are either performed at the client’s manufacturing facility where we roll up our sleeves, get our hands greasy, install the sealer, and then train the local engineering team how to use it. Or we temporarily install sealers in our lab for initial de-bugging and optimization before sending them to our client for permanent installation. We have learned a lot through these experiences and want to share some best practices that may be helpful on your next project.
In late 2016, we took a break from solving all the world’s problems and focused on one of our own – we were running out of space. After 18 months in our current location, we had added enough equipment and team members to fill our test and office spaces. While many would describe this growth as a good problem to have, it was still something that needed to be addressed. As luck would have it, the neighboring suite in our building became available in December and didn’t hesitate for a second to stake our claim on it. Shortly after the New Year, we knocked down some walls and began the expansion process. The footprint of our space doubled in size including the laboratory and office area.
Since diving into the medical device realm, a little over a year ago, I have found one clear fact—The medical device market is information driven, making it relatively immune to Facebook, Twitter, or other modern day tactics. Having personally come from a consumer product marketing background filled with hashtags, Twitter parties, and Facebook live feeds, this change was drastic and confusing to me at first. Since the head first plunge, it has been interesting to evaluate where the “buzz” comes from in this industry. Here are some personal observations and tips I’ve learned along the way…
Those of us who have spent a career in healthcare packaging know all too well the sentiment of “it’s just packaging” or “just put it in a pouch and box” without a deeper appreciation for FDA’s expectations on packaging development and validation. It’s not until the dreaded response from FDA comes back, filled with challenging comments about packaging, is it truly realized how technically complex a packaging project can be. Many of our clients engage with us at this critical juncture. We work with our clients to develop a sound path forward and help to accelerate the process of getting their products to market.
This is a common question we are asked by clients that doesn't always have a right or wrong answer. The benefits of aging your product at a higher temperature is that it simulates the aging interval faster, but it has risks to different products. Everyone wants to age their products at the highest possible temperature that they can, to pull the lead times in as much as possible, but there are risks and trade offs to that. We have had clients age their products at two separate temperatures for the same aging interval, that way they are able to pull their timeline in if the higher temperature products are able to pass the integrity testing.