The use of metered-dose inhalers (MDIs) for the treatment of diseases such as asthma has become popular since their introduction in the late 1950s. MDIs come in the form of nasal or oral inhalers and are much appreciated by patients who depend on them for their treatment. MDIs are designed to deliver precise/accurate and reproducible doses of the drug to the lungs or nose. This is crucial as patients rely on their inhaler to deliver the required medication at often crucial times when physical strength may be very low.
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
Certain sterile pharmaceutical products require deep cold storage, either at dry ice (-80°C) or even cryogenic (−196 °C) temperatures.
Sterile liquid filling lines are increasingly being implemented with nitrogen purge capability during filling.
When the Food and Drug Administration published “Guidance for Industry: Container and Closure System Integrity in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products”