Fight Bacteria with QualityLabs! Testing and Certification of Antimicrobial Materials

In response to the continuously increasing frequency of pathogen resistance to antibiotics, the medical device industry is now confronted with a great market-driven challenge regarding the antibacterial properties of their products.
 
April 4, 2008 - PRLog -- QualityLabs BT GmbH is an accredited, independent laboratory for testing the antimicrobial activity of substances, materials and proprietary products.

Gone are the times during which a good disinfection of the treatment areas in hospitals and medical practices was thought to provide adequate protection against pathogenic microorganisms for the treated patients. Today, more than ever multiresistant pathogenic microorganisms represent a serious problem, especially in sensitive medical areas such as operating rooms and intensive care units. Against this background, it is logical that the demands on the quality of medical devices are also increasing. These should namely, if possible, not even allow the colonization (adhesion) and most certainly not the growth (proliferation) of pathogenic microorganisms on their surfaces.

To achieve this, a number of manufacturers of medical devices (e.g., of catheters, infusion tubes, etc.) are already following the current technological trend of mixing their materials with antibacterial active substances or coating the materials with an appropriate product. A very ingenious method for this is, for example, the use of silver technology.
QualityLabs BT GmbH is an independent test laboratory that is state accredited in accordance to ISO DIN EN 17025 for a very innovative test for determining the antimicrobial properties of products and for describing the adhesive or anti-adhesive properties of surfaces. The accreditation was awarded by the ZLG (Central Authority of the States for Health Protection Regarding Medicinal Products and Medical Devices), and is also monitored by this agency. The accreditation not only ensures that QualityLabs provides its clients with a high quality level as a test laboratory but also guarantees its clients a high degree of valuable product safety and independent testing.
Medical device manufacturers can submit QualityLabs BT test reports throughout Europe at notified bodies as recognized test certificates for marketing approval of antimicrobial medical devices. In this manner QualityLabs BT GmbH helps its clients shorten development times and accelerate market introduction through its efficient testing. In the USA, the measurement methods are already deposited as a Device Master File at the US Food and Drug Administration (FDA).
The performance of QualityLabs’ method makes it also extremely well-suited for the quality control of relevant products.
For silver-coated materials, the company also offers voltammetry, a quantitative method for measuring the release of antibacterial silver ions, for example, life cycle kinetics.

Contact:
QualityLabs BT GmbH
Dr. Reiner Hommel
Neumeyerstr. 46a
90411 Nuremberg
Germany
Tel.: ++49 (0) 911- 2526 212
E-mail: reiner.hommel@qualitylabs-bt.de
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