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Author Archives: Daniel

About Daniel

Dr. Daniel Prince is president of Gibraltar Laboratories Inc. He has led the Company’s expansion and growth since 1987.

The New Solution to Reprocessing: Decontamination, Inspection, Cleaning and Sterilization

Reprocessing is a relatively new critical discipline that requires a multidisciplinary approach. After a surgical procedure the instrument needs to be processed such that it is suitable for safe reuse in a patient. The basic requirement is that the instrument …

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2011 Holiday Party-New Services

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 …

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USP Viral Clearance and Test Methodologies

Virology test methods are increasingly important for the assessment of safety and effectiveness of medical treatments. For example, the development of biological (biologics and biotechnology-derived) products and therapies for human or animal use has created the need for sensitive viral …

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Regulations get stricter and stricter for Dietary Supplement Industry

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 …

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Bacterial Identification

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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Mycoplasma Testing

  Mycoplasma, like Mycoplasma pneumoniae, are microbial parasites that infect mammalian cells causing sickness in humans and many other animal species Biological and biotechnology companies must be very vigorous and alert to control Mycoplasma. If not. millions of dollars and …

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Virus testing Capabilites

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 …

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Sterilty Testing

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

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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Cytotoxicity Tests

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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