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Life Sciences: Controlled Temperature Chambers, aka "Freezers, Refrigerators, and Incubators” NATE ROMAN, GENESIS AEC How important is temperature control?
• calibrated as required by a calibration program
Temperature is one of the most important parameters to control. Food and drug products must be stored and transported according to predetermined conditions (for example, 2°C - 8°C). The distribution of products must be transported, handled, and stored in a manner that mitigates the risk of exposure to temperature excursions. Current Good Manufacturing Practices (cGMP), according to the FDA, are requirements to maintain the products' safety, quality, and efficacy. Storage temperature is very important in maintaining these critical attributes because drug products or samples stored are temperaturedependent and must be well sustained and controlled.
• equipped with backup power or have alternate storage available in the event of a power failure • equipment should be commercial grade and not be of any household type
Controlled Temperature Chambers (CTC) used to store drug products should be qualified. We are all familiar with equipment such as freezers, refrigerators, incubators, and walk-in cold rooms, but perhaps we don’t all know what goes into keeping them maintained and in a state of compliance. A manufacturing facility or a research laboratory operating in the Health and Life Science Industry must comply with regulatory requirements, and that is no simple task. Doing so ensures that products are manufactured and delivered safely under meticulous regulations and standards. These regulations and standards are well-known to those in the industry, but the questions sometimes come from finding the best way to comply.
knows what needs to be done, but " Everybody they’re not always sure how to get there. We
definitely know how to get there because that’s what we do, over and over again. We do things in ways that have been proven to be effective. Each firm is responsible for selecting suitable equipment used in research and development, manufacturing, or storage to produce, distribute and store quality products in accordance with CGMP. Their equipment should consist of the following, but limited to; • be well-maintained • equipped with alarms • free from excess frost buildup • allow for adequate air distribution and organized storage within the chamber • equipped with sensors for continuous monitoring • alarms located at the points representing the temperature's worst-case scenarios
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Regulations also require that manufacturers in healthcare industries, pharmaceutical companies, and research laboratories use equipment, systems, and processes that are up-to-date and fit for purpose.
those of you that aim to comply with " For regulatory requirements, there's a continued
emphasis by regulators on the need to perform temperature mapping on controlled temperature storage units. Validation: Proving the process ensures the endproduct Qualification of storage environments must be performed to ensure conditions match the stability requirements of the products. This is also a requirement as per international standards to ensure that the products are always stored and distributed within the specified temperature limits. To ensure and demonstrate that proper environmental conditions and temperature and /or humidity controls are obtained, qualification and/or validation is expected to be carried out. Temperature Mapping studies must be carried out regularly as part of the equipment installation and operational qualification (IOQ) to ensure that the controlled temperature chamber is capable of accurate and repeatable performance.
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