{"id":61,"date":"2022-01-12T10:29:28","date_gmt":"2022-01-12T10:29:28","guid":{"rendered":"http:\/\/www.biochem-bcm.com\/?page_id=61"},"modified":"2022-12-09T15:49:46","modified_gmt":"2022-12-09T15:49:46","slug":"prove-di-laboratorio","status":"publish","type":"page","link":"https:\/\/www.biochem-bcm.com\/en\/prove-di-laboratorio\/","title":{"rendered":"LABORATORY TEST"},"content":{"rendered":"
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The selection of Biochem is distinguished by being customized and tailored to the needs of the customer; it is also diverse and extensive. Biochem has started its activity as a laboratory for microbiological testing of food products and the control of medical devices.<\/p>\n\n\t

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BIOCOMPATIBILITY<\/h3>\n\n\t
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The tests required by ISO 10993 and USP for the evaluation of the safety of the materials used in the biomedical field are meant to highlight the potential and predictable risks associated with the human use.\nThe tests are chosen according to the type of medical device, its invasiveness, and the duration and type of contact with human tissue.
\nBiochem has decades of experience, highly qualified staff, high level references, and is the right partner for achieving your goals.
\nBiochem, in addition to execution of the tests, provides a support service in the selection of tests to be performed, the method of operating specific for the device or the material to be examined, also through the drafting of Rational for choice of tests and operating protocols.<\/p>\n

See complete list<\/a>if you do not find the test or service of your interest please contact our If you have not found the test or service of your interest please contact our Sales Department.<\/a>.<\/p>\n\n\t

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TEST DI EFFICACIA<\/h3>\n\n\t
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Biochem employing a team of talented and competent staff may supply you with a complete service to verify the efficacy of medical devices. Biochem is able to perform screening and\/or prolonged tests in order to verify the efficacy of your items versus disease such as allergic asthma, colitis, rhinitis, sinusitis, dermatosis\/dermatitis, and other. The efficacy protocols are designed chasing the method of administration, the physical appearance form, the specific requirements and claims that the client appoint to the item.<\/p>\n

If you do not find the test or service of your interest please contact our If you have not found the test or service of your interest please contact our Sales Department.<\/a>.<\/p>\n\n\t

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REPROCESSING FDA<\/h3>\n\n\t
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Biochem is able to issue the test protocols more suitable for You based on the type of device, level of criticality and use, to validate the reprocessing both for microbiological and cleanability as for absence of disinfection residues.<\/p>\n

We have a solid experience of success of several recordings of reprocessing, prices and definitely competitive times with leading international laboratories.<\/p>\n

Please contact our If you have not found the test or service of your interest please contact our Sales Department.<\/a>.<\/p>\n\n\t

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EXTRACTABLES E LEACHABLES<\/h3>\n\n\t
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Biochem offers a comprehensive approach with regards to Extractables\/Leachables (E\/L) testing and evaluating. Our approach combines a technical and analytical expertise, polymer and rubber knowledge, understanding of regulatory requirements per type of application, all combined in a tailored approach to our customers.<\/p>\n

What are extractables and leachables?<\/strong><\/p>\n

Extractables are compounds that can be extracted from a component under extreme conditions, such as the presence of harsh solvents or elevated temperatures.<\/p>\n

Leachables are compounds that leach into the drug product formulation from the component as a result of direct contact with the formulation under normal conditions; they are typically a subset of extractables. These compounds, both organic and inorganic substances, come from plastic components, elastomers, coatings, accelerants, antioxidants, inks, vulcanizing agents, additives, residual solvents or derive from degradation processes. Phthalates are one specific example. As new delivery devices, disposables, and medical devices are developed, it is certain that FDA will continue to demand information about these components so that the agency can make informed decisions on risk and safety. For this reason the development of E\/L testing is of increasing importance.<\/p>\n\n\t

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TOXICOLOGY<\/h3>\n\n\t
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Toxicology studies enable to assess the interactions between substances and biological systems, in order to determine possible adverse effects on health. The toxicology aims to assess the nature and impact of these effects on living organisms, through the examination of biological alterations induced.
\nBiochem has decades of experience, highly qualified staff, high level references, and is the right partner for achieving your goals. Biochem realizes the biocompatibility and toxicology tests required by various Pharmacopoeias, by the UNI EN ISO 10993, chosen according to the type of devices, their invasiveness, and the duration and type of contact with human tissue. The chemical characterization of the component materials of Medical Devices is a preliminary and essential part of the Studies of Biocompatibility, which have increasing importance for compliance with the Animal Welfare.
\nSee complete list<\/a>if you do not find the test or service of your interest please contact our If you have not found the test or service of your interest please contact our Sales Department.<\/a>.<\/p>\n\n\t

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MICROBIOLOGICAL TESTS<\/h3>\n\n\t
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We perform microbiology tests on different matrices: food, water, cosmetics, medical devices, pharmaceutical preparations, air and work surfaces for all controlled environments (for example in the Hospital Sector; production Galenists, Medical Devices, Aseptic Production, Catering ...).
\nThe Microbiological tests are aimed at qualitative and quantitative research of microorganisms and sterility control.<\/p>\n

Biochem also performs:<\/p>\n