Wernher von Braun, the father of modern rocketry famously stated, “one test is worth a thousand expert opinions.” The FDA has put their own regulatory spin on this axiom: “if you didn’t document it; it didn’t happen.” This extends beyond the drug therapies themselves to the packaging and logistics practices that are used to distribute them; what the FDA refers to as the “holding” of a drug.
In recent years, container closure integrity (CCI) testing has steadily moved up the pharmaceutical manufacturing agenda. Latest research has shown that not only ampoules are prone to CCI defects. Other primary packaging types such as vials, cartridges and syringes equally require thorough testing, especially when filled with lyophilized products. Consequently, the United States Pharmacopeia (USP) has been revising its General Chapter 1207, calling for more quantitative, validated CCI test methods. A significant shift is expected towards non-destructive technologies.
Global regulatory authorities are placing increased scrutiny on documenting control over distribution environments. While there is obviously a link between your shipping conditions and your thermal protection (packages), the challenge is that there is no clear, reliable industry standard temperature profile for the design of insulated packaging systems used for the distribution of products. This is because temperature profiles for packaging design should be rationalized based on not only your product characteristics, but your distribution logistics. This paper examines the lack of consistency in the current methodology for designing temperature profiles, why commonly used standards should not be used on their own, and identifies the needed parameters for consideration.
With the ever evolving developments in the biopharmaceutical Industry there has never been a greater need for assured Reliability when it comes to the transportation of Pharmaceutical payloads and the guaranteed robustness of Temperature-controlled packaging is proving ever more vital.
Shelf life is the length of time that foods, beverages, pharmaceutical drugs, chemicals, and many other perishable items are given before they are considered unsuitable for sale, use, or consumption.
Shelf life studies are used to determine how long a product can reasonably be expected to maintain its quality, safety, and character. These studies take into account not only products’ functional qualities such as safety and effectiveness, but also cosmetic qualities such as color and texture that make them appealing to customers.
The packaging of time- and temperature-sensitive healthcare products has changed very little over the past quarter century. However, the advent of new, fragile cell therapies demands the need for greater temperature precision, and the ability to collect multiple data of environmental and handling conditions within the distribution environment through continuous real-time monitoring and on-line accessibility.