Cleaning Validation

Cleaning Validation

Clean Beyond Visible. Compliant Beyond Doubt.

Agon’s Cleaning Validation services help you establish scientifically sound, regulator-approved cleaning processes that guarantee product safety, eliminate cross-contamination, and support multi-product facility approvals. From protocol development to analytical testing, we cover the full lifecycle of cleaning validation, ensuring every surface meets the highest global standards

What We Deliver

Risk-Based Cleaning Strategy

Product grouping, equipment matrix development, and worst-case selection
Maximum allowable carryover (MACO) calculations based on toxicity, batch size, and dosage
Lifecycle approach aligned with ICH, WHO, and PIC/S expectations

Protocols & Execution

Cleaning validation protocols customized for CIP, manual, or semi-automatic processes
Swab and rinse sampling techniques tailored for different surfaces and equipment
Execution support for initial, periodic, and campaign-based validations

Analytical Method Support

Recovery studies and LOQ/LOD determination
Analytical method selection for target residue detectionn plans to address identified issues
Data interpretation, deviation handling, and trending reports

Why It Matters

Essential for multi-product facilities
Required for regulatory approvals and audit defense
Reduces product recall risks
Demonstrates robust contamination control strategy
Reinforces patient safety and GMP compliance

Categories

We understand the importance of approaching each work integrally and believe in the power of simple.

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