Posts Tagged ‘Stability Chambers and Incubators’
How to Select a Stability Test Chamber
Knowing how to specify a stability test chamber calls for a clear understanding of what stability test chambers do, how they relate to the various components or ingredients that go into the product you manufacture and where these products are used.
In this post we’ll provide some examples of things to consider when specifying a stability test chamber then share suggestions on what to look for in this critical equipment.
As a refresher or for readers new to the subject here is an answer to what constitutes a stability test chamber.
What is a Stability Test Chamber?
Most stability test chambers resemble a large scientific refrigerator. Only instead of keeping contents cool, their function is to replicate variations in temperature, humidity and light over long periods of time. This is critical when pharmaceutical companies, for example, wish to bring new products to market.
It has everything to do with … Read the rest
How to Choose an Enzyme Storage Lab Freezer
Enzymes are the catalysts of the biochemical reactions that comprise metabolism; they do their job without changing themselves in the process. Enzymes are responsible for bringing about almost all of the chemical reactions in living organisms. Without enzymes, these reactions take place at a rate far too slow for the pace of metabolism.*
Enzymes being studied by researchers must be stored in a enzyme freezer at temperatures in the region of -10 to -25˚C (+14 to -13˚F). When stored at higher temperatures enzymes gradually denature and lose catalytic activity. Proper storage conditions are essential to ensure that the enzymatic activity on the label is indeed the activity inside the bottle. I have many not so fond memories of failed experiments in graduate school because the rather costly purified enzyme suspensions failed to perform as expected, all due to inadequate storage.… Read the rest
How to Choose a Laboratory Incubator
Laboratory incubators used in microbiology laboratories and other research and development applications provide an environment for growing cultures under controlled conditions such as humidity, temperature, and CO2. Several regulations apply to operating a laboratory incubator so it is important to be certain that the laboratory equipment you buy is designed to meet your particular requirements.
Experts suggest that even before purchasing a laboratory incubator you should first consider what it will be used for and where it will be located. So instead of buying an incubator and then trying to make it fit your process or needs, turn the procedure around. This makes sense not only for assuring proper performance; it helps you pick a model that is most cost-effective for your needs.… Read the rest
A Primer on Drug Stability Testing in Stability Chambers
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)
While these tests are conducted in stability test chambers, it is not simply a matter of buying a chamber and plugging … Read the rest
