Pharmaceutical manufacturers perform cleaning validation (or cleaning verification) studies to demonstrate that specific residues are removed from equipment items to amounts at or below defined cleaning limits through execution of appropriate cleaning procedures following a specific manufacturing process. Parsolex has a rich history executing cleaning validation studies in our own production facilities. We offer the same analytical services to our clients to assist with their cleaning validation studies.
Cleaning validation studies incorporate the sampling and testing of manufacturing equipment using validated test methods. Samples are most often acquired by the swabbing or rinsing of equipment surfaces. The laboratory test methods may require specific (e.g., HPLC-UV, IC, or HPLC-MS) or non-specific (e.g., TOC analysis or conductivity) forms of analysis.
Critical parameters involving the cleaning validation study must be understood before……
Download our PDF to learn more on design and execution of compliant cleaning validation studies to support your drug development efforts.
Why Choose Parsolex?
Parsolex offers analytical services to our clients to support Cleaning Validation Studies. Parsolex is committed to fully understanding our clients’ requirements and to delivering each project on agreed upon timelines with high-quality deliverables. Parsolex possesses in-depth experience with the successful execution of Cleaning Validation Studies per current regulatory guidance.
Contact us today to discuss how we can support your Cleaning Validation Studies need.