September typically marks new deadlines in the rollout of FDA’s Unique Device Identification (UDI) final rule. That’s not the case this year – FDA’s next deadline doesn’t go into effect until 2018 – but we want to use the opportunity to provide a refresher.
Welcome to the life of a PCL lab technician! Every day is a new exciting challenge with new types of testing, engineering design verification and client interactions--you name it we can help test it. All mornings begin with the production meeting, we recap what’s happened the previous day, formulate our game plan for the day, and are vigilantly trying to stay ahead of the curve with any potential incoming studies. Communication is one of our biggest allies, even when working in a tight knit environment. It is essential to be as current as possible with information relating to testing. This helps to ensure we are working hard to meet client commitments and expectations are throughout the life of the study.
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.
As maintaining a sterile barrier is the most essential task in sterile packaging, a recent push towards sustainable packaging has called for a new shift in the medical packaging. With costs of oil on the rise, it logically follows the resin costs will increase with it.