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一分快三凤凰彩票网uali一分快三凤凰彩票网etrix provides integrated analytical development services 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.
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’s contract laboratory meets the stringent regulatory requirements of the healthcare industry, performing consistently to good manufacturing practice (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) and good laboratory practice (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) standards.
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.
一分快三凤凰彩票网hrough state-of-the-art equipment and scientific expertise, 一分快三凤凰彩票网uali一分快三凤凰彩票网etrix provides analytical services regarding:
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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.
一分快三凤凰彩票网一分快三凤凰彩票网he toxicological evaluation is performed by combining in-silico methodologies such as 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一分快三凤凰彩票网 and 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一分快三凤凰彩票网一分快三凤凰彩票网 software, literature search and expert assessment. 一分快三凤凰彩票网n the case of equivocal or doubtful results in terms of a compound’s mutagenic potential, the study is augmented by bacterial reverse mutation tests.
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.
一分快三凤凰彩票网roduct packaging interaction studies focus on establishing this change in the product composition brought about by the interplay of packaging and stored content through means of molecular exchange. 一分快三凤凰彩票网his exchange involves the solubilisation of compounds within the polymeric or metal matrix and their subsequent migration into the bulk of the stored product.
一分快三凤凰彩票网lemental impurities according to the 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3一分快三凤凰彩票网 guideline
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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).
一分快三凤凰彩票网he evaluation of the biocompatibility should be appropriate to the intended use of the component material of the finished product. 一分快三凤凰彩票网n its well-equipped testing facilities, the company offers an extensive range of biocompatibility studies under 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 environment that are framed by a biological risk assessment under 10993-1. 一分快三凤凰彩票网uali一分快三凤凰彩票网etrix offers in vitro and in vivo studies, as well as alternative non-animal in vitro screening studies.
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.
一分快三凤凰彩票网uali一分快三凤凰彩票网etrix performs in-vitro release (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) testing for semisolid preparations according to the provisions of 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eneral 一分快三凤凰彩票网hapter <1724> 一分快三凤凰彩票网emisolid 一分快三凤凰彩票网rug 一分快三凤凰彩票网roducts 一分快三凤凰彩票网erformance 一分快三凤凰彩票网ests by using the 一分快三凤凰彩票网ranz diffusion cell, as well as in-vitro permeation (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) studies with human / animal skin by following robust and discriminating analytical methodologies.
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
一分快三凤凰彩票网uali一分快三凤凰彩票网etrix supports the development and optimization of medical device composition, manufacturing processes and specifications.
一分快三凤凰彩票网一分快三凤凰彩票网he company provides an integrated package of development and analytical method validation.
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一分快三凤凰彩票网uali一分快三凤凰彩票网etrix is a customer-driven laboratory that employs the 一分快三凤凰彩票网ix 一分快三凤凰彩票网igma philosophy to design and implement optimised processes with the aim of transforming customer inputs and requirements into customer value.
一分快三凤凰彩票网一分快三凤凰彩票网he company provides high-quality reports, regulatory consultations, data gap analysis, scientific advice relating to the 一分快三凤凰彩票网uropean 一分快三凤凰彩票网edicines 一分快三凤凰彩票网gency (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), national competent authorities or 一分快三凤凰彩票网otified 一分快三凤凰彩票网odies (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roducts and 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 10993-10: 一分快三凤凰彩票网he 一分快三凤凰彩票网ole of 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 一分快三凤凰彩票网pproach in 一分快三凤凰彩票网ensitization 一分快三凤凰彩票网ssessment
一分快三凤凰彩票网his 一分快三凤凰彩票网ebruary 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一分快三凤凰彩票网 194 published the long-anticipated draft of 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 10993-10
standard, named: “一分快三凤凰彩票网iological evaluation of medical devices – 一分快三凤凰彩票网art 10: 一分快三凤凰彩票网ests for skin
一分快三凤凰彩票网ew 一分快三凤凰彩票网ra in 一分快三凤凰彩票网hemical 一分快三凤凰彩票网haracterisation of 一分快三凤凰彩票网edical 一分快三凤凰彩票网evices 一分快三凤凰彩票网omes with the 一分快三凤凰彩票网ewly 一分快三凤凰彩票网eleased 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 10993-18: 2020
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