The newest round of Star Wars mania got me thinking about one of the themes in the movie series — mentoring.
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.
When your warehouse stores temperature sensitive pharmaceuticals and life science products, a top of the line HVAC system with carefully placed thermostats is not enough to ensure product quality and consumer safety. Why? It is the nature of warehouse facilities, no matter the size, to experience temperature gradients.
While the development of a combination product comes with significant patient benefits through technology and molecule innovation, that reward can be offset by the range of regulatory complexity and uncertainty encountered with bringing a product to market, in addition to any post-marketing activities.
A major advantage for using the TriStar II with the Krypton Option is the ability to measure low surface areas. Although the TriStar II standard nitrogen system can measure surface areas as low as 0.01 m2/g, the Krypton Option enables you to measure areas as low as 0.001 m2/g and provides increased accuracy for materials under 1.0 m2/g. Krypton is also useful for analyzing materials that are difficult to sample or have very low density; pharmaceutical lubricants, for example.
Krypton is an excellent choice for low surface area measurements. At 77 K, nitrogen has a saturation pressure of 760 torr, whereas krypton has a saturation pressure of only 2.5 torr.
Sterility testing in the pharmaceutical industry has long been based on growth media culture methods. The general approach is to incubate for 14 days and then determine potential contamination with a visual inspection of the media sample