Cleaning validation for single use and reusable devices

Cleaning validation demonstrates that cleaning processes are capable of removing or reducing residues, contaminants and microbial burden to acceptable levels, based on the intended use of the device and the applicable risk profile.

SteriLandBio supports companies in defining and documenting cleaning validation strategies for both single-use devices and reusable devices, considering product design, materials, manufacturing processes, clinical use and reprocessing requirements.

Our support may include cleaning process assessment, identification of critical residues and worst-case configurations, preparation or review of protocols and reports, acceptance criteria rationale, sampling strategy, deviation assessment and interpretation of test results.

We help companies demonstrate that cleaning processes are controlled, effective and supported by clear technical documentation suitable for regulatory review and quality system requirements.