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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Written by Rachel Kohn
Pharmaceutical laboratories, manufacturing facilities and healthcare providers must establish standard operating procedures to assure safe vaccine storage. Because many vaccines must be kept frozen to maintain potency it is important to select the correct laboratory freezer and institute practices to be followed by laboratory or healthcare facility personnel responsible for vaccine storage.
Lab freezers as offered by Norlake and available from Tovatech come in several sizes. While size is important, the critical purchasing decision is deciding between a manual defrost laboratory freezer and an auto-defrost laboratory freezer.
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Written by Rachel Kohn
Those following progress in precision manufacturing know well that products are becoming more precise. Taken to an extreme, robotically controlled machines are capable of producing components so small their features are observable only under magnification.
While cleanliness is an important criterion across the board in such instances, it is crucial when it comes to surgical instruments. An example is found in tubes produced by A.M.I. GmbH (Agency for Medical Innovations) in Feldkirch, Austria, and used in the manufacture of instruments designed to place implants in the human body. Welded and calibrated to perfection by means of drawing them through a die body, the tubes are 400 mm (15.74”) in length with an I.D. of 4mm (0.15”) and O.D of 4.5mm (0.177”). In this instance some 20,000 pieces are produced annually.
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Written by Bob Sandor
Precision digital scales and analytical balances must be recalibrated for accuracy to be in compliance with international standards and to maintain good laboratory practices. Analytical balances such as the Kern ABJ series can be recalibrated using internal motor-driven weights. The internal calibration sequence is initiated manually. Semi-micro analytical balances such as the Kern ABT series automatically recalibrate using internal weights under four scenarios: 1) Four hours after the previous calibration; 2) When there is a fluctuation in temperature of 0.5oC (0.9oF); 3) When the balance is switched from standby to weighing mode and condition (1) or (2) has been met or 4) If the balance was disconnected from its power source.
Other scales require external recalibration, which is performed by using test weights under procedures that should be spelled out in your company’s Quality Management manual.
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