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Cleaning Validation for Pharmaceuticals

Cleaning validation for pharmaceutical APIs, finished products, excipients and pharmaceutical packaging.

Intertek Pharmaceutical Services supports the pharmaceutical industry with Cleaning Validation analytical expertise and support services. The laboratory validates cleaning procedures, helping ensure residues, contamination and cross-contamination risks are removed. In addition, Cleaning Validation can be required for critical changes in cleaning processes, formulations, equipment, procedures and other factors.

Cleaning Validation sampling techniques:

  • Swabbing
  • Rinsing
  • Other appropriate or specific techniques

Cleaning Validation, setting Acceptable Residue Limits (ARL):

  • ARL is critical in cleaning validations and should be logically determined
  • ARL must be practical, achievable and verifiable
  • Decomposition products should be checked
  • Initial criteria is visual check
  • 10 ppm limit – USP limit test (assuming residues to be as harmful as heavy metals), useful for materials with no toxicology data available, not applicable for potent compounds
  • No more than (NMT) 0.1% of therapeutic dose limit – minimum daily dose of current product carried over into maximum daily dose of subsequent product, identify worst case scenario

Cleaning Validation Analytical Methods:

  • Develop and validate analytical methods for cleaning validations
  • Critical aspects are LOD, LOQ, precision, linearity, selectivity, recovery-spiking, consistency of recovery
  • Use validated methods for routine analysis of cleaning validation samples

Non-Specific Methods:

  • Total Organic Carbon (TOC)
    • Useful for detecting all carbon containing compounds that are adequately soluble in water (which includes active species, cleaning agents and excipients)
    • TOC methods are sensitive to ppb range and less time consuming
    • Cannot specifically identify residue materials
  • Determination of Residual Micro 90
    • For determination of the amount of residual Micro 90 left after the completion of cleaning procedure
    • UV/Vis detection

API-Specific Methods:

  • Develop and validate methods to specifically identify and quantitate Active Pharmaceutical Ingredients (APIs) (including biopharmaceuticals) after cleaning procedure
  • If an active drug is highly toxic, a specific method is always recommended

Related Cleaning Validation Services:

  • Pharmaceutical Analysis
  • Intertek Pharmaceutical Services (Whitehouse, NJ)

to see how Intertek can help your organization with Cleaning Validation for Pharmaceuticals.