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Cleaning Validation

Cleaning validations is to improve the quality and value of your process

Shoolin validation specialists have experience working within the compliance requirements of established regulated companies.

Our specialists are experts in industry validation standards and will produce validation documents which will meet or exceed your exacting standards. Our goal in all cleaning validations is to improve the quality and value of your process while ensuring your customers’ safety and your compliance with all applicable regulations.

Shoolin can validate all of your systems. We can provide any level of service required, from validating test methods to automating cleaning validation reports to reviewing your quality system to ensure that you have a compliant cleaning program.

Cleaning Validation Methodology

Our validation experts will incorporate your cleaning protocols, SOPs, and methods into a suite of custom templates that allow for quick execution and turn-around of the cleaning validation. Cleaning studies are initiated with the creation of a cleaning validation plan, complete with scheduling, role assignment, email notifications, and project tracking.

After a cleaning protocol is executed and cleaning samples analyzed, a cleaning validation report is generated to document that the cleaning process meets the defined requirements. Our cleaning validation documents are designed to demonstrate that your process meets all of your business requirements, plus regulatory requirements. Finally, Quality Control review of the cleaning validation and report is documented, step by step, ensuring compliance and reporting accuracy.

Throughout the process, a Traceability Matrix is updated to ensure that all validation requirements are addressed. If necessary, a formal risk assessment can be created to identify areas for improvement.

  • Cleaning Validation Methodology
  • Worst Case Product Selection Matrix
  • Analytical Development
  • Visual Examination – Sampling, Swab Sampling, Rinse Sampling
  • Analytical Testing and Reporting
  • Cleaning Validation Sampling and Testing
  • Qualification and Validation

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