By Travis Hudson, Singota Solutions
Evaluating vendor qualification of thermal solutions is not an indictment of the vendor; it is due diligence in an industry where risk guides nearly all decision-making, as well as many regulatory mandates. Usage of a system can be justified based on a vendor’s qualification in many cases, but no single model is all-inclusive.
Singota’s vendor qualification evaluation process examines the criteria the vendor used — thermal profile, maximum and minimum bracketing of payload sizes, thermal probe placement, etc. — and determines how that vendor’s established system fits each client’s business model, ensuring solutions are employed optimally.
First, the evaluation determines whether the vendor adequately qualified the package, which typically is not an issue. Most
vendors are experienced, properly document everything, and their equipment has been properly calibrated. Many of those factors are directed by industry guidance documents (e.g., PDA Technical Report No. 72 – Passive Thermal Protection Systems for Global Distribution: Qualification and Operational Guidance).
Second, and more critical, the vendor qualification is evaluated against a client organization’s specific needs. Is it sufficient, and does it align, with their processes and products? Singota identified a need for this targeted diligence based on the high volume of clients, shipping lanes, and products we serve. We have been able to learn from, and build upon, our experience, giving our on-the-ground team the resources they need to select appropriate solutions on a case-by-case basis.
Often, because of the high client and product volumes with which we work, lane-by-lane or product-by-product evaluation is unmanageable. Thus, a compromise must be found: a solution-management process determining when to evaluate individual lanes or products, when to take a broader approach, and when to identify a middle ground.
These decisions ultimately are risk-based. If we are shipping a high-value product across the hemisphere, to a location where transfer between customs entities and transportation providers is delayed, or infrastructure issues present themselves (e.g., appropriate storage is not available along the transit route), individual product or lane-focused evaluation based on real-world data that can be gathered may be warranted. Conversely, in the case of less complex shipments utilizing an express service whose process may shield package contents from temperature extremes, a risk-based evaluation may determine the vendor’s qualification and strategy are adequate for initial adoption.
This triage approach is one of multiple reasons to consistently monitor process performance. This exercise confirms the effectiveness of our evaluation and implementation of any given process. It also guards against issues that may occur unrelated to the package itself. For example, a carrier may be utilizing new transportation lanes or transition depots, or climate change may prompt ambient temperature extremes in an area that previously was not problematic.
To this end, any thermal excursions in packaging automatically alert us via email (metrics posted on the Singota website). This system proved invaluable several years ago when a “polar vortex” weather event swept North America and revealed some solutions to be potentially susceptible to extreme temperatures. We quickly responded to onboard new technology that was more robust. We also evaluate tracker data in real time to identify trends that necessitate tweaks in our processes (e.g., a certain container does not work well in a certain region during the middle of summer).
Singota’s Promise of Precision
In the modern life sciences industry, nearly every product requires special handling. Sometimes, temperature range demands fall within recognized industry standards: 2-8°C, 15-25°C, -20°C, or dry ice. Other products require adherence to more specific temperature ranges, which Singota can deliver.
While we obviously cater to the large biopharmaceutical companies, including several of the world’s top 10 firms, our services are ideal for small, mid-sized, and emerging biotechs, as well. Singota is just as adept operating in the development and clinical phase, where 200 grams of API may be all that exist, as we are in commercial volumes. For these organizations with fewer resources to dedicate to shipping, we offer cold chain process design: a client can come to us empty-handed in terms of shipping lanes or expertise, provide its requirements, and trust us to build out a plan using the systems we already have in place. Singota has done all the work up front to provide the best solutions possible, bolstered by vendor qualification evaluations (themselves reinforced by regular process monitoring), to expert carriers we have thoroughly vetted.
Singota constantly reevaluates what is happening in the world and in our clients’ operational spheres, revisiting the solutions we have in place to determine anything that should be tweaked to provide optimized service. Do we need more variety among our offerings? Do we need to devise a solution for specific scenarios? Because, ultimately, the best diligence a thermal solutions partner can exercise is to thoroughly evaluate risk and act in the best interest of itself and its clients.
To learn more, visit us at https://singota.com/ and follow us on LinkedIn.
About Singota Solutions
Singota Solutions is a contract development and manufacturing organization (CDMO) focused on helping clients in the pharmaceutical, animal health, and biotechnology industries move their products through the drug development pipeline faster by being agile, accountable, and transparent.