Written by Rachel Kohn
A controlled environment is critical to maintaining the potency and safety of pharmaceutical products across a supply chain stretching between R&D laboratories, manufacturing facilities, transportation and storage at healthcare facilities. Examples of controlled environments include laboratory refrigerators, laboratory freezers, blood bank refrigerators, chromatography refrigerators, laboratory incubators, stability chambers and temperature test chambers.
Equipment such as this as manufactured by Norlake Scientific and offered by Tovatech is designed and constructed to comply with standards developed and promulgated by the FDA, the AABB, the Red Cross and other agencies. Once the equipment is purchased, however, the facility operator assumes the responsibility of assuring it is installed and maintained according to FDA and related guidelines.
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Written by Rachel Kohn
As described by the FDA, stability testing provides evidence of the effect of time and environmental factors on the quality of pharmaceuticals and medicinal products. Such factors include light, humidity and temperature. Stability tests also establish a re-test period for the drug substance or a shelf life for the medicinal product along with recommended storage conditions.
Stability tests are conducted in validated stability chambers such as manufactured by Norlake for pharmaceutical (ICH), biological (BOD), scientific and laboratory applications. These tests, which subject the product samples to variations in temperature and humidity, are conducted during drug product development as well as once a candidate drug reaches use and are governed by current good manufacturing practices (cGMPs). They are regulated in the U.S. by 21 CFR Part 211 Section 166. (www.gmp1st.com/drreg.htm#211.166)
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