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Cleaning Validation

The aim of the cleaning validation is to verify the effectiveness of the cleaning procedure for removal of product residues, degradation products, preservatives, excipients, and/or cleaning agents as well as the control of potential microbial contaminants. In addition one needs to ensure there is no risk associated with cross-contamination of active ingredients.

Steps:

  • Select and evaluate effective cleaning methods and processes
  • Establish residue limits and calculate sample acceptance criteria
  • Select sampling and analytical methods
  • Simplify the cleaning validation program
  • Evaluation of critical risks and calculation of allowed residue levels on manufacturing equipment
  • Applying wide range of available techniques: Microbiology tests, Endotoxin Test, HPLC techniques
  • Analysis of validation samples (direct surface samples and rinse samples)

Out puts:

  • Providing Cleaning Validation Protocol
  • Providing Cleaning Validation Reports

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