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.
PCL was recently hired by a client to conduct a transit study per ASTM D4169 on a newly developed product line. After the “shake rattle and roll” was complete, samples were brought into our controlled environment room and subjected to tests including visual inspection (ASTM F1886), bubble leak testing (ASTM F2096) and seal strength testing (ASTM F88).
ISO 11607 can be difficult to read, to say the least! Aside from being lengthy, the details can be very dry leading people to skim through and miss key details. This is the reason we have put together the 3 Pillars to Packaging Validation : Your Guide to Understanding ISO 11607. The guide is aimed to be a cliff notes version summarizing the key points and highlighting the often missed points within ISO 11607: 2006. Check it out by clicking the button below.
It depends on what you are testing for integrity.
Matt Lapham, our President, and Sarah Rosenblum, our Marketing Manager, will be at the MD&M West conference in Anaheim, California from Tuesday to Thursday this week. They are looking forward to connecting with our clients and friends from all over the country that come to attend the show. If you are interested in meeting up with Matt or Sarah at the conference please email firstname.lastname@example.org or call/text 616-426-2893. They hope to see you out in sunny California!
Packaging Compliance Labs is committed to maintaining short lead times and quick turnaround for all projects, no matter how big or small.
PCL was contracted by a client for root cause analysis of post-transit integrity failures. To determine the cause of the failures, a transit feasibility study was run with visual inspection after each schedule of transit conditioning. Based on the results of the inspections, it was determined that drops (rather than compression or vibration) were causing seals to rupture.
The first step to ensuring success is reading the equipment manual to better understand the machine and any recommended settings from the manufacturer. By reading up on all the settings you’ll get familiar with the machine which makes it easier to ask the right questions. One of the first questions you’ll want to ask and answer is, “What are the critical seal parameters?”