Cleaning Validation Requirements for the Life Science Industry

Cleaning validation is a global regulatory requirement for the life science industry. The purpose of cleaning validation is to establish documented evidence with a high degree of assurance that the cleaning process will consistently yield results that meet predetermined specifications and quality attributes.

The goal of the cleaning process is to remove the following:

• All components from the previous product
• Bioburden
• Endotoxin
• Detergents

There are different cleaning methods that are used to clean manufacturing equipment in the life science industry. The following cleaning methods are commonly used in the life science industry and they all require cleaning validation:

• Clean-in-place (CIP) is a method of cleaning the interior surfaces of pipes, vessels, process equipment, filters and associated fittings, without disassembly
• Cleaning-Out-of-Place (COP) is defined as a method of cleaning equipment items by removing them from their operational area and taking them to a designated cleaning station for cleaning. It requires dismantling an apparatus, washing it in a central washing area using an automated system, and checking it at reassembly
• Immersion Cleaning
• Manual Cleaning

Cleaning validation requires documented evidence that the process work as intended. For cleaning validation, the following documents are created to provide documented evidence.

• Cleaning Validation Plan
• Cleaning Validation Protocols
• Cleaning Validation Summary Report

Cleaning Validation is a manual paper-based process that is very inefficient and time consuming. ValGenesis is a validation lifecycle management system that enables paperless cleaning validation and integration of all related data.

ValGenesis enables efficiency and data integrity by reducing cycle times and providing a secure integrated database with audit trails for all activities in the system. ValGenesis eliminates the data integrity challenges found in paper based cleaning validation processes which include data manipulation, falsification, alteration and loss of paper based records. ValGenesis paperless cleaning validation lifecycle management system is the best solution to eliminate the data integrity challenges found in paper based validation processes.