Turnkey Design Validation?  Yes We Can!

Medical Sealer Validation
Sarah Rosenblum June 15 No Comments

Our customers have spoken, and PCL listened. 

It is our mission to help our clients accelerate the process of launching products to market by breaking down the barriers related to packaging.  Several of those “barriers” are well-recognized:  risk management, FDA expectations, understanding the fundamentals of ISO11607, solving test failures, and reducing lead times, to name a few.  But more and more we are hearing that the logistical issues of executing validation builds at the plant are becoming an increasing challenge. 

Startups, for example, often don’t have the capability to manufacture products internally and so they rely on contract packagers to provide that service.  Don’t get us started on the difficulty that many of our startup clients deal with – simply getting quotes and then onboarded into contract services can take months. 

Other clients with established production capabilities may still find it difficult to shut down a production line to build validation samples, or to expand and grow the clean room to accommodate new equipment.  Often engineering bandwidth is constrained, so even finding someone to manage and supervise a validation build is challenging. 

All the while, packaging timelines are being delayed and extended.  What is the monthly potential revenue for your new product line or VIP?  What is the opportunity cost for these delays? 

Last year, PCL announced the launch of our turnkey sealer validation program to solve these problems.  – more on that here.  Essentially, we temporarily install and validate sealers (whether bar seal, band seal, or even something larger like Form-Fill-Seal) under our roof, with our team of medical packaging professionals turned loose on the equipment to debug it and validate it properly. Then the sealer is shipped to the plant for a simple re-install and equivalency verification – saving the client weeks.

This program has been so successful at adding value, our clients have asked us to do more.  That’s where our Turnkey Design Validation program comes in. 

Our team extends the scope of work by retaining the sealer, developing robust packaging instructions, and training our expert team to actually build DV samples here at the lab. Both transit and aging, as well as other builds that may be needed (feasibility testing, marketing / sales samples, even sterilization validation).  We quarterback the sterilization of samples at your preferred sterilizer (or we can recommend one we work closely with), and then bring samples back to the lab for transit / aging testing. blog-1.jpg

Furthermore, in the unfortunate event of a transit or aging failure – by having the sealer, packaging materials, and sample devices at the lab, it is much easier for our team to troubleshoot, course correct, and rebuild, thus getting your schedule back on track immediately.  By the way, we ALWAYS recommend performing a preliminary transit study well in advance of DV to get a handle on how the system is performing and gain confidence in the design.  We offer a streamlined service – we call it our “Design Diagnostics” program – to meet this early stage feasibility evaluation. 

PCL is committed to offering a specialized suite of services in a way that no other lab can provide, all with the goal of making your project a success.  Our Turnkey Sealer Validation program and new Turnkey Design Validation program are designed to do just that. Please contact us today to learn how we can accelerate your timelines and help you speed to market with confidence.

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