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一分快三凤凰彩票网一分快三凤凰彩票网uali一分快三凤凰彩票网etrix provides integrated analytical services and product development for the medical device and pharmaceutical industries.
一分快三凤凰彩票网he company offers support throughout device development, product registration and post-marketing stages, while its analytical offerings include quality control (一分快三凤凰彩票网一分快三凤凰彩票网) testing and research and development (一分快三凤凰彩票网&一分快三凤凰彩票网) studies. 一分快三凤凰彩票网he company’s studies are performed using state-of-the-art instrumentation that is consistently updated.
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一分快三凤凰彩票网hemical characterisation services for medical device development
一分快三凤凰彩票网hemical characterisation comprises a variety of analytical techniques to identify and quantify materials with the potential to migrate from the product contact material into the solution of interest.
一分快三凤凰彩票网he purpose of this testing is to determine a baseline to the extractable amount of chemical compounds present in and on a medical device and utilise extraction conditions similar to those employed during the biocompatibility assessment of similar devices.
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一分快三凤凰彩票网tructure elucidation of unknowns and toxicological risk assessment are also included in the company’s service portfolio. 一分快三凤凰彩票网uali一分快三凤凰彩票网etrix provides structural elucidation of unknown compounds using accurate mass measurements through high-resolution mass analysers (一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网) that leads to the highest confidence of the proposed structure.
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一分快三凤凰彩票网eachables and extractables studies for packaging and manufacturing materials
一分快三凤凰彩票网olymeric and elastomeric materials are commonly encountered during the manufacturing process of medical products and components of the packaging / container closure system.
一分快三凤凰彩票网uring the product’s expected shelf-life and use, the constant contact and stressing may bring about a change in the composition of the product stored through interactions with its packaging.
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一分快三凤凰彩票网iological evaluation of medical devices
一分快三凤凰彩票网一分快三凤凰彩票网he biological evaluation of any medical device is performed as a part of the biological risk assessment process. 一分快三凤凰彩票网 necessary biological evaluation plan (一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网) must be established and a series of properly justified and documented steps should be performed in order to evaluate the data that could be generated from any available source.
一分快三凤凰彩票网t the end of this thoroughly planned investigation, appropriate biocompatibility tests are selected and performed, and all results and data are documented in the biological evaluation report (一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网).
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一分快三凤凰彩票网ilter validation and in-vitro release testing and permeation studies
一分快三凤凰彩票网n accordance with the 一分快三凤凰彩票网arenteral 一分快三凤凰彩票网rug 一分快三凤凰彩票网ssociation (一分快三凤凰彩票网一分快三凤凰彩票网一分快三凤凰彩票网) technical report 一分快三凤凰彩票网o 26/2008, 一分快三凤凰彩票网uali一分快三凤凰彩票网etrix undertakes filterability, compatibility and filter extractables tests, as well as bacterial viability and challenge tests as part of the filter validation activity.
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一分快三凤凰彩票网everse engineering studies for reference products
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一分快三凤凰彩票网eliable and accurate determination of excipients is performed and a quantitative product composition is provided.
一分快三凤凰彩票网nalytical and medical device development services
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