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Monthly Archives: May 2011

Sterilty Testing

Posted on May 31, 2011 by Daniel

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 …

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USP Monographs

Posted on May 31, 2011 by Daniel

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. …

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Bacterial Identification

Posted on May 31, 2011 by Administrator

Gibraltar Laboratories helps its sponsors control microbial contamination in the manufacturing environment. Raw material and finished products are usually subject to a compendia and/or sponsor specification with respect to what organisms, if any, can be present. Microbial identification is the …

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Microbial Limits Testing

Posted on May 30, 2011 by Administrator

At Gibraltar Laboratories one of the most frequent questions we are asked about is what is the proper way to examine non-sterile products?  It is easy to test a sterile product because it is understood that the absence of pathogenic …

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Cytotoxicity Tests

Posted on May 28, 2011 by Daniel

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 …

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ICH Stability Testing – Gibraltar Laboratories

Posted on May 26, 2011 by Administrator

Gibraltar Laboratories is a respected testing laboratory providing stability testing. Our stability tests are ICH compliant, adhering to the guidelines and best practices recommended by the International Conference on Harmonization (ICH).

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Chemistry Testing

Posted on May 26, 2011 by Administrator

Gibraltar Laboratories provides chemistry testing and wet chemistry services for businesses, research institutions and government agencies both domestically and abroad.

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Antibiotic Testing

Posted on May 24, 2011 by Administrator

Gibraltar Laboratories performs certification of label claim testing regarding the potency of antibiotics (antibiotic testing). Certification is necessary to conform to US FDA current good manufacturing practice regulations.

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Endotoxin Testing

Posted on May 24, 2011 by Administrator

Gibraltar Labs Inc. is an ISO 17025 certified testing laboratory to perform Limulus Amebocyte Lysate (LAL) Test. LAL, also known as Bacterial Endotoxin test, is a highly sensitive test used to detect or quantify bacterial endotoxins.

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Steam Sterilization

Posted on May 17, 2011 by Administrator

Steam sterilization is a process of thermal sterilization employing highly pressurized saturated steam in a chamber [autoclave].

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