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CLEANING VALIDATION


Kymanox understands that cleaning validation, as with all CGMP activities, should be a controlled, quality-driven process that manages risk and ultimately ensures a safe and effective product for the patient. Our science-driven and planning-focused approach delivers Right First Time (RFT) results.


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Process Qualification and Cleaning Validation


The purpose of cleaning validation is to document that a process consistently results in equipment and devices that are clean to an acceptable level.

    “Equipment and utensils shall be cleaned, maintained, and, as appropriate for the nature of the drug, sanitized and/or sterilized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.”
    (21 CFR Part 211.67)

    To help you and your organization develop robust cleaning programs, our cleaning experts provide services in the following areas:

    • Development of Cleaning Validation Master Plans

    • Determination of Soils and Acceptable Residue Limits

    • Assessments of Gaps and Risks in Current Processes

    • Identification of Required Analytical Methods and Sampling

    • Validation Using Reasonable Worst-Case Conditions

    • Execution of Cleaning Process Qualifications

    • Delivery of Comprehensive Training

    • Implementation of Life Cycle Management and Process Surveillance

    Synergy with All Kymanox Services


    Kymanox holds a 360° view of all validation and augments our cleaning validation services with additional capabilities:

    • Analytical Sciences and Process Engineering

    • Project Management and Training

    • Quality Assurance, Quality Control, and Regulatory Compliance

    Integrating our science, engineering, quality, and compliance capabilities, Kymanox helps analyze your current and future cleaning processes helping you avoid costly and often irreversible missteps. Together with you, Kymanox helps select optimal procedures, methods, and equipment to develop effective and controlled cleaning programs from early product development through commercial manufacturing.

    Your Life Science Solutions Partner For Cleaning Validation

    Biotechnology | Pharmaceuticals | Medical Devices | Combination Products