You may not be aware, but Packaging Compliance Labs is the official test lab of The North Pole. Every year since our company was founded, Santa has been sending packages our way for testing before Christmas. Santa’s trip is wrought with peril, and he wants to make sure he doesn’t break little Billy or Susan’s hearts by leaving a broken toy under the tree. Seriously, who wants to deal with that sort of drama on Christmas? Not you, not Santa, and certainly not PCL.
Last week PCL hosted the West Michigan Institute of Packaging Professional’s (IoPP) quarter event. This event included package testing demonstrations and an exclusive presentation from Eric Hiser, the Technical Vice President of ISTA (International Safe Transit Association). It was truly a unique experience seeing Eric speak about standards while standing right next to a complete transit simulation set up!
Here at Packaging Compliance Labs we are consistently looking for opportunities for streamlining work and reducing waste while still focusing on quality to better serve and add value to our customers. To accomplish this, PCL uses Lean methodology to identify opportunities in the process of workflow, plan how the current process can be improved, execute and implement changes, and set metrics to review how the changes are working for our team and our customers.
Conditioning samples for testing is much like preparing a Thanksgiving dinner. Considerations need to be taken regarding storage and preparation to ensure that proper temperatures are used for the correct amount of time. Your Thanksgiving turkey is likely transported and stored in a frozen state, both to ensure it stays fresh until sold, and also to prohibit the growth of microorganisms such as E coli and Salmonella. If you cook that turkey for too long or at too high of a temperature it will likely be dry or burned, an unfortunate scenario since most people don’t like dry, crispy turkey (right, Clark?). Likewise, if you cook your bird at too low of temperature, you run the risk of undercooking it, which can lead to growth of microorganisms that cause foodborne illnesses (just like improper freezing). The goal is to find the perfect temperature and time – hot enough to cook the bird all the way through, but not long enough to burn it.
ASTM held it’s semi annual meeting in New Orleans on October 8 – 13th. PCL attended the first half of that conference focused on committee D10, which includes standards such as conditioning and transportation simulation. What an experience! It was a great opportunity for PCL to make valuable contributions to discussions about several key packaging standards and also understand potential changes coming down the pipeline. Here are a few takeaways affecting medical packaging that we thought were interesting:
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.