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Compliant TOC/TN Analysis in Pharma

Contents of the e-book

TOC cleaning validation plays an important role in pharmaceutical quality control. The sum parameter allows for a non-targeted, quantitative determination of the total organic residues originating from active ingredients (API), additives, break-down products and detergents in the trace range. This is why it is used as a worst-case screening parameter for cleaning validation of production equipment according to established pharmacopoeia TOC monographs. 

In the present e-book, we highlight some of the most common pharmaceutical TOC and TN applications that have been carried out with our new multi N/C x300 analyzers: Ultrapure water testing, TOC cleaning validation, analysis of extractable organic components from packaging materials and quality control of vaccines. We also provide details on how the FDA 21 CFR Part 11 Compliance module of the multiWin pro software supports you to ensure audit-safe and compliant data handling with a server-based central data management. You can also discover how a tailored service package facilitates qualification and on-site software validation helps you to get started faster.

Application and chapters notes include: 

  • Pharma Compliance in TOC/TN Analysis with multiWin pro 4
  • GMP compliant TOC cleaning validation in the pharmaceutical industry
  • TOC system suitability test according to USP 11 TOC performance test as per Japanese and Korean pharmacopoeia
  • Extractables testing from plastic packaging materials according to USP
  • Total protein assay in bio-pharmaceutical products (e.g. vaccines) by TN analysis via catalytic combustion
  • Qualification and validation services for the Pharmaceutical Industry 

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