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<h1>Contract Sterilization - Isotron</h1>
<p>Isotron is Europe's leading provider of contract sterilization services. Through a network of 17 sites in 8 countries across Europe, Asia and South Africa, Isotron provides outsourced services to manufacturers; in particular sterilizing single use medical products, enhancing the performance of polymers and providing technical laboratory services.</p>
<h2>Sterilization</h2>
<p>Sterility is a critical issue. When dealing with sterilization and related issues it is important for manufacturers to work with an experienced, knowledgeable and skilled partner. For over 30 years, Isotron has been the partner of choice within the healthcare industry providing sterilization solutions. Isotron operates in eight countries and offers the three principal sterilization technologies of gamma, electron beam and ethylene oxide (EtO).</p>
<p>We also offer microbiological testing and sterilization validation studies to assist customers in meeting the requirements of various national and international standards for the manufacture of medical devices and pharmaceuticals. These include meeting the requirements of ISO 11137 and ISO 11135.</p>
<h2>Lab Services</h2>
<p>The staff at Isotron’s laboratories are committed to turning their technological expertise into added value for our customers. Customers can expect a proactive approach: suggesting alternatives to reduce lead times, facilitating cost reductions and improving turn around times for product release.</p>
<p>Utilising modern laboratory facilities and employing dedicated and professional scientific staff we work closely with our many multinational clients. We assist customers in ensuring their products comply with requirements and standards in medical device (ISO 11135, ISO 11137, EN 550/552/6) and pharmaceutical (USP, EP) manufacture. Please contact our laboratories in Thorne, South Marston, Tullamore, Kuala Ketil or Ede if you have any specific requirements. A short movie of our laboratories can be found under the technology section.</p>
<p>Our subsidiary company JMJ Laboratories is a market leader in the fields of clinical pathology and drugs of abuse testing. Click here to visit their website.</p>
<p>Another subsidiary of Isotron is the pharmaceutical laboratory of RegiLabs (www.regilabs.com). With its two sites in Utrecht and Ede they are market leader in pharmaceutical analysis of raw materials and final products. They are also experienced in the analysis of homeopathic products and cosmetics. They also provide laboratory services to public and hospital pharmacies. </p>
<h2>Material modification</h2>
<p>Radiation treatment using either cobalt-60 gamma or electron beam irradiation is a recognised and well established process for initiating changes at a molecular level in polymers and other materials. These changes can bring about a wide range of improvements including mechanical strength, electrical properties, heat resistance, chemical resistance, particle size, melt characteristic, colour changes, surface alterations and material compatibility. Examples of areas where these changes are applied include:</p>
<ul>
<li>semiconductor carrier lifetime control</li>
<li>cross linking & chain scission</li>
<li>gemstone enhancement</li>
<li>wear measurement</li>
<li>radiation testing</li>
</ul>
<h2>Contamination control</h2>
<p>Various materials are routinely treated at our sites to achieve microbial reduction ie, to reduce, or eliminate altogether, the number of microorganisms. Isotron's processing technologies are of particular benefit in ensuring that naturally derived materials, typically with high microbiological counts, are sanitised prior to being incorporated into the final product. Isotron's treatment processes are routinely used to treat cosmetics and toiletries, pharmaceutical raw materials, veterinary products, laboratory disposables, dyes and colourants, horticultural products, food packaging and food.</p>
<p>Each of these product types is very different in terms of material composition and the initial level of microbial activity (the bioburden) and hence the processing conditions necessary to meet a given microbial specification will differ. It is also essential that the materials used in the product are compatible with the process. We have the expertise and variety of treatments to ensure that the appropriate solution is available to satisfy these conditions.</p>
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