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We celebrated together on December 16, 2011 enjoying a great meal and especially our talented performers. We have posted pictures and videos on our Facebook and YouTube pages. You are invited to look at them. As the year comes to …
Gibraltar Laboratories Dietary Supplement Program The Food and Drug Administration has recently defined its regulations for the Dietary Supplement Industry. These regulations place that industry under current Good Manufacturing Practices (CGMP) guidelines. This step, designed to assure a consistency of …
Validation of a biological manufacturing process requires that adventitious viral contaminants be destroyed or purified from the final product. Of concern are a variety of viruses which may originate from non-human animal ingredients such as serum. Of course human viruses …
The Sterility Test specified in USP General Chapter <71> is understood to mean that pathogenic bacteria, yeast and/or fungi are absent from the article labeled “sterile”. In the United States, Europe, Japan, Australia and Canada the word “sterile” has that …
The United States Pharmacopeia (USP) is a non–governmental, official public standards–setting authority for prescription and over–the–counter medicines and other healthcare products manufactured or sold in the United States. USP also sets widely recognized standards for food ingredients and dietary supplements. …
Cytotoxicity tests are performed at Gibraltar Laboratories for many different applications. The classic cytotoxicity tests found in the USP is “<87>, Biological Reactivity, in vitro”. It is designed to determine the biological reactivity of mammalian fibroblast cells [L-929 (ATCC cell …