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With stability testing, pharmaceutical industry inspects the quality of drug substances and drug products as per the guidelines outlined by US Food and Drug Administration and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use to make sure that they retained the quality over the period of time.
There are many industries where moisture control is critical. Moisture sensitive foods and pharmaceuticals are put in packaging with controlled MVTR to achieve the required quality, safety, and shelf life. In clothing, MVTR as a measure of breathability has contributed to greater comfort for wearers of clothing for outdoor activity.
Several common factors can include: assurance of patient safety, assurance of the efficacy of the drug through the intended shelf life, [1] uniformity of the drug through different production lots, thorough documentation of all materials and processes, control of possible migration of packaging components into the drug, control of degradation ...
A control dial is usually provided that permits the user rough adjustment of the humidity level. More sophisticated designs link the cooler to a settable digital hygrometer, allowing very precise humidity level control. Another form of electronic dry box technology utilizes multi-porous molecular sieve desiccants to absorb moisture.
Vacuum drying is the mass transfer operation in which the moisture present in a substance, usually a wet solid, is removed by means of creating a vacuum.. In chemical processing industries like food processing, pharmacology, agriculture, and textiles, drying is an essential unit operation to remove moisture. [1]
Silica gel is able to adsorb up to 37% of its own weight in moisture in high-humidity environments. [7] This moisture can be released upon heating at about 120 °C (248 °F) [8] [7] for 1–2 hours. [7] This makes it reusable multiple times with very little, if any, loss of efficiency. [7]
A common use for desiccators is to protect chemicals which are hygroscopic or which react with water from humidity. The contents of desiccators are exposed to atmospheric moisture whenever the desiccators are opened. It also requires some time to achieve a low humidity.
With this framework – according to Hinz [2] – the FDA tries to motivate the pharmaceutical industry to improve the production process. Because of the tight regulatory requirements and the long development time for a new drug, the production technology is "frozen" at the time of conducting phase-2 clinical trials.
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