Proof of Design: Easing the Transport of Temperature-Sensitive Products
A solutions provider offers years' worth of design and qualification experience to ease the pain of qualification.
EnviroCooler (Huntington Beach, CA) launched a new tool called the EnviroCooler Proof of Design (ePOD) at the PDA Conference in Bethesda earlier this year. The aim of the tool is to make it easier for any-sized organization to select a proven temperature-sensitive-product (TSP) packaging solution that can lower selection costs, increase the speed of qualification and use, and provide increased documentation for regulatory compliance.
A biopharmaceutical organization looking to select, qualify, and implement a reliable and proven TSP packaging solution for its products can request an ePOD and review testing data history for that solution, at no cost. Each Proof of Design package contains performance and qualification data for a specific cooler solution under numerous thermal profiles, both industry standard and global client confidence interval profiles. EnviroCooler has developed an ePOD for its portfolio of core product and platform offerings.
Below, Rod Derifield, president of EnviroCooler, responds to questions about the new tool.
Your ePOD campaign makes a number of promises in regard to increasing the speed of qualification and use of your coolers and increasing the documentation required for regulatory compliance. Isn’t that a very tall order?
It’s funny you should say that; we actually have an ePOD Menu for that ‘Tall Order’! Seriously though, essentially what we have done with our Proof of Design packages is taken all the data we have collected over our 15 years of design and qualification projects and collated it together in easy-to-understand packages. The ePOD packages are intended to be comprehensive in the information and supporting data they house; each package provides all information needed on the product and the performance of the product with varying loads, acceptance criteria, and under various thermal profiles to which we have tested. Organizations looking for a new solution can now see what qualification work has already been done with that potential solution. They can then decide whether they could potentially skip a portion of laboratory testing (i.e., design qualification [DQ] and operational qualification [OQ]) and go straight to the performance qualification (PQ) portion of their validation, saving both time and money.
How would someone know which ePOD package to request from you?
As I mentioned, we have an ePOD Menu that takes you through a three-step exercise guiding you to your potential cooler solution. Step 1 involves identifying your primary load type (parcel, bottle and bags, pallet, Celsius-Pak, or Cryotank); Step 2 covers your acceptance criteria and load volumes; and Step 3 takes you to your potential cooler solution. Then all you do is call or e-mail to request the ePOD for that solution.
EnviroCooler is known as a designer of custom TSP packaging solutions. Are you now changing your position?
Heat and cold profiles based on numerous industry studies would be provided in ePOD packages.
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When EnviroCooler started 15 years ago, there was no alternative other than to be a custom-solutions designer. At that time, transporting temperature-sensitive biologics presented new and unique problems that did not have solutions, so there was no other alternative than to design, build, and qualify according to each challenge as it arose. We developed unique solutions for unique problems. But after 15 years, we feel we have designed and developed a solution platform for pretty much every challenge that a biopharma organization may face today. So the answer to your question is, No, we are not changing our position. We will continue to design and innovate where necessary. The difference is that we don’t believe that it is right to duplicate work already done or solutions already proven. We continue to grow as a business because we innovate—our ePODs represent business innovation.
What makes EnviroCooler’s Proof of Design any different from the pre-qualified offerings on the market?
Does anyone really know what ‘pre-qualified’ means? I don’t. The question I always ask is, “How can something be ‘pre’–qualified?” Either it is qualified or it is not qualified, that’s it. You can get “pre-qualified” for a mortgage, but that doesn’t guarantee you that you will get the mortgage. The difference between ‘pre-qualified’ and ‘Proof of Design’ is that with Proof of Design, you see what you get, and you get what you see. The information and supporting data is unadulterated and unbiased.
How has the concept been received by the market?
The feedback from those who have requested an ePOD to help in the assessment of a potential solution has been tremendously positive and appreciative. They “love the documentation.”
Rather than take EnviroCooler’s word for it, consider the feedback of the following professionals who have requested the ePOD packages:
Kathryn Huschke, packaging engineer for Bio-Rad Laboratories, comments on the ePOD: “There were a lot of variables to consider when organizing our shipping validations (e.g., different shipping destinations, temperature requirements, and multiple packages/products). I found the ePOD very user-friendly and full of the right information, which helped our company select the best container for our specific shipping needs.”
Haidee Gonzaga, global clinical development for Bayer Healthcare, says: “In clinical development, clinical supply is a significant task to ensure medication is delivered to patients in a timely manner. The packaging, labeling, and distribution of medication to ensure efficient delivery of temperature-sensitive materials to clinical investigative sites and patients is a daunting task. EnviroCooler’s ePODs were a very informative first step in the distribution process. The ePODs gave us useful insights on the specifications and proof of performance of the cooler solutions’ temperature profiles, which we use as a realistic standard to benchmark against other shipping solutions.”