Fast, Cheap and effective. Too often these are (in descending priority) the requirements employed by the well-intentioned when selecting distribution packaging for temperature sensitive pharmaceutical products. It may be the result of poor planning, a project afterthought, an accelerated launch schedule, or just plain ignorance that causes the panic. In any case, it seems that distribution operations - those required to get the product out the door - are the last to be notified - and while the hot potato of blame and responsibility gets tossed around the organization, the scramble for transport packaging begins.
I have not only been the victim of this scenario, I have seen it played out repeatedly across the breadth of the pharmaceutical industry. What I have learned, and what I have observed (other than it is the worst of all approaches) is that there is no such thing as fast, cheap and effective when it comes to insulated packaging. You can only ever meet two of these criteria, never all three.
~ Fast and Cheap will not be effective
~ Cheap and Effective will not be fast
~ Fast and Effective will not be cheap
Which combo you choose depends greatly on who within your organization has the most influence, and who is making the decision. Distribution/Operations wants it fast. Procurement/Purchasing wants it cheap. Engineering/Quality wants it effective. So, what's it going to be? All are less than desirable - and all have consequences. It's as if you had to decide whether or not to leap from the third story window of your mistresses burning, oceanfront apartment building just to avoid being swept away by the oncoming tsunami.
The Fast and Cheap combo will allow you to get product out the door under a tight time line but its ability to effectively protect the product from temperature extremes in transportation is minimal, at best. I call this the "Minnow Bucket" solution. The type of insulated container you can buy at your local grocery store or bait shop - thin wall, low density, inferior quality, manufactured by who-knows-who, who-knows-where. The same goes for the gel pack refrigerant - minimum mil thickness polyethylene bags filled with a solution that may or may not be homogeneous, microbe-free, or filled to a consistent volume.
The Cheap and Effective combo, or the "David Copperfield" solution is nothing more than an illusion. The illusion is derived from the assumption that the product must be protected from temperature extremes because of its novel components. The "perception-deception" may include "space age materials", foil liners, temperature indicator strips or gels that perform "better than ice". Test data to support their claims of performance, if it exsists, is usually weak, sketchy, poorly documented - and often biased. They give the appearance that the integrity of the product has not been compromised when, in fact, they do little to eliminate the heat bridge between the environment and your precious product.
The Fast and Effective combo is probably the best short term solution. Expensive? Yes. But is it the costliest? This is the "Penalty Packaging" solution - where development, testing, qualifying and implementing an optimal solution is something for which you have neither the time, resources, nor budget. There are several reputable companies who have off-the-shelf, pre-qualified thermal packaging solutions for the tightly controlled temperature requirements inherent to pharmaceuticals and biologics. These are sophisticated, highly engineered packages with more complex configurations, that have passed rigorous, and well documented transportation and thermal tests. They often include phase change materials (PCM's) in addition to; or in place of regular gel packs. All offer a high degree of assurance that your product will be protected from temperature extremes during transit and come in various sizes, designs and shipping durations. Pay the penalty. And continue to use these pre-qualified packages with confidence until such time you can develop a custom package that fits your specific need without the added pressure of getting / keeping your product on the market. The benefits will be: a qualified, long-term solution consisting of a properly engineered package from a reliable supplier that reduces material cost, labor, weight and freight expenses.
Ultimately, your company's reputation depends on the decisions you and your organization make, the packaging solutions you choose, and suppliers with whom you have partnered. Temperature sensitive drugs have a unique vulnerability. We all have an obligation to provide the safest, highest quality drug to the end user - one day, that will be you and me.
