Today, the trend with vaccine packaging is ready-to-administer single-dose packaging. Whether in the form of prefilled syringes or single-dose twist-off containers, this type of packaging offers safety, convenience, and cost benefits over traditional multidose vials.
Falsified medicines are fake medicines that pass themselves off as real, authorized medicines. They may contain ineffective or incorrect doses of active ingredients and pose a major threat to public health and safety. As falsifications become more sophisticated, the risk of falsified medicines reaching patients in the EU increases every year. Not only do falsified medicines present an incalculable health risk for patients, they also damage the corporate image of pharmaceutical manufacturers and can lead to large financial losses.
The next milestone for manufacturers, November 27, 2017, is the date by which pharmaceutical manufacturers are required to print a unique product identification code on all Rx units of sale and homogenous cases distributed domestically.
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.