Pharmaceutical Cleaning Validation

Pharmaceutical Cleaning Validation

Ensuring that manufacturing equipment is free from contaminants is critical for the safety and efficacy of pharmaceutical products. At Apta Labs Pvt Ltd, we provide comprehensive laboratory analytical support for pharmaceutical cleaning validation, helping you meet stringent regulatory requirements and maintain the highest standards of quality.

Our Cleaning Validation Services Include:

  • Analytical Method Development and Validation:

    Creating and validating precise analytical methods tailored to detect residual contaminants on manufacturing equipment.

  • Swab and Rinse Sampling:

    Conducting thorough sampling using swabs and rinse methods to collect residues from equipment surfaces.

  • Quantitative Analysis:

    Measuring residual active pharmaceutical ingredients (APIs), cleaning agents, and other contaminants using advanced analytical techniques.

  • Detection and Identification:

    Utilizing cutting-edge instrumentation such as HPLC, GC, GCMS, LCMS and ICP MS etc to detect and identify trace amounts of contaminants.

  • Regulatory Compliance:

    Ensuring all cleaning validation processes adhere to regulatory guidelines from agencies such as the USFDA, EMA, and WHO etc.

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