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Christmas in July: Pharmaceutical Temperature Controlled Labeling

As we near the end of this season, we’re reflecting on summer’s temperature controlled labeling jobs—why this type of labeling is important and how it keeps on giving year-round.

 

It’s boiling hot outside, so maybe I should view this cold chain labeling job as a break from the heat. Yeah right; that feeling of euphoria only lasts for about 15 minutes in the 2 to 8°C finishing area.

Temperature Controlled Labeling Services

Look at my team—we look like we’re getting ready to go caroling. This might be plausible, but then again, you’ve never heard me sing.

Yeah it’s cold, but I know we have a job to do; I know how important this is to clients and ultimately, the patients. I know that by minimizing any unnecessary exposure to higher temperatures, clients speed products to market and reduce the cost of clinical trial development.

Cold Chain Labeling Services

I know about this concept of a stability checkbook and that each product has a current balance. By labeling products under refrigerated conditions instead of normal room temperature conditions, my team does not make any unnecessary withdraws from the stability checkbook, maximizing the balance available to support my clients’ clinical trial programs.

I know that in some cases, after my client collects more stability data, this proves to be an unnecessary precaution.  However, I also understand that during early stages of development, this is a necessary precaution that may pay dividends.  These dividends may be in the form of extended expiry dating of scarce clinical trial product.

I also know that by carefully tracking time in and out of various temperature conditions I can add to my client’s understanding of their product’s stability in a production setting. I know what’s ultimately important: ensuring that patients are receiving the best quality products at the point of use.

When we provide temperature controlled labeling services in July, or in any month, it reminds me of giving, and we consider it a small inconvenience to work in our 2 to 8°C finishing area so that we can give our clients’ products more time. Maybe even increase clinical trial product availability.  Maybe speed a new therapy to the market.

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Curtis Strother

Curtis Strother

Project Manager & Senior Technical Services Scientist at BioConvergence LLC
Curtis has extensive experience in BioPharma API and drug product contract manufacturing, including sourcing, technology transfers, process validations, and supply chain management. His project experience spans from early stage development through late life cycle and has included complex global projects involving US, European, and other global regulatory authorities. Prior to joining BioConvergence in 2010, he worked for Targanta Therapeutics (now The Medicines Company) and Eli Lilly in a number of management roles.