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The USP Controlled Room Temperature is a series of United States Pharmacopeia guidelines for the storage of pharmaceuticals; [1] the relevant omnibus standard is USP 797. [2] [3] Although 100% compliance remains challenging for any given facility, [4] the larger protocol may be regarded as constituting a form of clean room [5] which is included in a suite of best practices.
For instance, for the shipping and storage of pharmaceuticals, the United States Pharmacopeia-National Formulary (USP-NF) defines controlled room temperature as between 20 and 25 °C (68 and 77 °F), with excursions between 15 and 30 °C (59 and 86 °F) allowed, provided the mean kinetic temperature does not exceed 25 °C (77 °F). [17]
USP establishes documentary (written) and reference (physical) standards for medicines, food ingredients, dietary supplement products, and ingredients. These standards are used by regulatory agencies and manufacturers to help to ensure that these products are of the appropriate identity, as well as strength, quality, purity, and consistency.
Air temperature and humidity levels inside a cleanroom are tightly controlled, because they affect the efficiency and means of air filtration. If a particular room requires low enough humidity to make static electricity a concern, it too will be controlled by, e.g., introducing controlled amounts of charged ions into the air using a corona ...
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Mean kinetic temperature (MKT) is a simplified way of expressing the overall effect of temperature fluctuations during storage or transit of perishable goods. The MKT is used to predict the overall effect of temperature fluctuations on perishable goods. It has more recently been applied to the pharmaceutical industry.
Many polycarbonate grades are used in medical applications and comply with both ISO 10993-1 and USP Class VI standards (occasionally referred to as PC-ISO). Class VI is the most stringent of the six USP ratings. These grades can be sterilized using steam at 120 °C, gamma radiation, or by the ethylene oxide (EtO) method. [20]
In the pharmaceutical industry, drug dissolution testing is routinely used to provide critical in vitro drug release information for both quality control purposes, i.e., to assess batch-to-batch consistency of solid oral dosage forms such as tablets, and drug development, i.e., to predict in vivo drug release profiles. [1]