Contamination poses one of the most serious risks in pharmaceutical manufacturing. Even trace residues of active ingredients, excipients, or cleaning agents can compromise product quality, patient safety, and regulatory compliance.

The Eurofins BioPharma Product Testing (BPT) network of laboratories provides a comprehensive suite of GMP-compliant cleaning validation services that spans risk identification, method development, sampling, analytical validation, and ongoing monitoring.

With more than 20 years of analytical chemistry experience, our experts work with drug manufacturers to develop and validate methods capable of detecting low level residuals to verify the cleaning processes. We can perform cleaning validations on virtually every type of product and surface, enabling us to streamline studies and save manufacturers both time and money. 

Whether your goal is a new site qualification, response to a regulatory audit, or routine process revalidation, we support you with an approach that includes:

• Risk Identification: Defining the health-based exposure limits, as suggested by the relevant agency guidelines, for shared facilities.
• Analytical Method Development: Non-specific methods such as Total Organic Carbon (TOC) may be used in low-risk contexts. For higher-risk applications, our experts recommend quantitative trace methods using chromatography (LC, GC, LCMS, GCMS, Headspace GCMS) with tailored detectors (UV, MS, FID).
• Sampling Strategy: We validate your chosen sampling technique (swabs, wipes, rinse water) and ensure representatives’ correct sampling of challenging equipment geometries and materials.
• Cleaning Process Design: Our team provides best practice guidance for cleaning parameters (e.g. temperature, duration, mechanical action) and agent concentrations through well-planned designs.
• Method and Process Validation: All cleaning validation studies are executed under GMP and ICH Q2 guidance, covering recovery rates, extraction efficiency, specificity, repeatability, and robustness.
• Ongoing Monitoring: Once validated, cleaning procedures require periodic verification. Partner with us for routine testing and documentation to maintain compliance through process changes or routine production cycles.

Whether you're launching a new manufacturing site or updating cleaning SOPs, Eurofins BPT provides the technical rigour, regulatory insight, and analytical capability you need to attain the highest standards of cleaning validation.