Merieux NutriSciences | Extractables and Leachables studies

Merieux NutriSciences | Extractables and Leachables studies
Product Description

Download our brochure: https://bit.ly/4dzryoA

Pharmaceutical packaging can release chemicals into the drug product that can not only impair its effectiveness, but also be harmful to the patient. Similarly, medical devices can undergo leaching processes during their use that could negatively affect their clinical outcome, and compromise their biocompatibility.


Mérieux NutriSciences performs Extractables and Leachables studies providing a full integrated testing strategy together with toxicological assessment and risk analysis, taking advantage from more than 20 years’ experience developed in food contact materials, medical devices and containers for pharmaceutical products.

Chelab

  • IT
  • 2020
    On CPHI since
  • 4
    Certificates
  • 1000 - 4999
    Employees
Company types
Other
Primary activities
Analytical Services
Contract Manufacturer
Laboratory Services
Specifications
  • Details
    Extractables and Leachables studies provide a full-integrated testing strategy together with toxicological assessment and risk analysis, in six main steps:
    • Profiling of extractables: generation of the extract
    • Characterization of extractables
    • Primary and secondary leachables profile
    • Unknown extractables/leachables tentative identification by HRMS techniques (if needed)
    • Toxicological evaluation and risk assessment
    • Development and validation of targeted methods suitable for the quantification of critical leachables

Chelab

  • IT
  • 2020
    On CPHI since
  • 4
    Certificates
  • 1000 - 4999
    Employees
Company types
Other
Primary activities
Analytical Services
Contract Manufacturer
Laboratory Services

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    The presence of foreign particles in sterile pharmaceutical products and/or medical device can affect their safety and efficacy.Foreign particles may originate from both organic and inorganic sources, as corroded or damaged equipment parts, cross contamination during the process, microplastics or from biological sources. The implementation of quality controls for particles can be a good strategy in order to minimize the contamination probability.


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