Equipment cleaning validation is a documented process or audit trail conducted by specialised engineers, it explains the procedures required and actions taken to effectively remove microbial or chemical residues from manufacturing equipment. In the pharmaceutical industry, this validation process is essential, helping avoid the risk of product contamination, maintaining consumer safety, and sustaining compliance with regulatory standards, such as the ASME guidelines for bioprocessing equipment (BPE). Cleaning specialists will focus on specific aspects of this process, such as degreasing and passivation.
In this article, we’ll look at the main reasons underpinning the importance of cleaning validation in pharmaceutical industry:
A consistent and reliable cleaning process reduces the risk of contamination and helps maintain the quality of your pharmaceutical products. Financially, this can increase profits by reducing recalls, wastage, and reputational damage, and also ensures that your products meet the standards expected by your regulators. The ultimate goal of any pharmaceutical cleaning validation process, however, is to protect the health and safety of the people who consume your products. By keeping equipment free from potentially harmful residues, corrosion, and waste products, manufacturers can avoid adverse reactions and ensure that their products are safe for human consumption.
Cleaning validation verifies that all residues from previous products and processes (including cleaning products) are completely removed from the equipment before a new manufacturing process begins – preventing cross-contamination. This is essential to avoid unintended interactions between different pharmaceutical products and other chemicals.
Thorough cleaning goes hand-in-hand with passivation to prevent contamination and maintain hygiene in pharmaceutical equipment. Together, these two processes protect your product purity and consumer safety. Cleaning validation is sometimes used as a preliminary process before passivation, as it highlights any cracks, defects, or areas of corrosion on a stainless steel surface that could harbour bacteria or dirt. The same process is then often carried out post-passivation to check that the treatment has been successful and the new passive layer is robust and even across the material surface.
The validation process also verifies the safety and efficacy of the cleaning process itself and highlights areas in need of improvement – the goal being to establish a process capable of cleaning equipment reliably and consistently to the same high standards. For example, if an item fails cleaning validation, it could be due to a coverage issue with your clean-in-place (CIP) equipment, which can be resolved through recalibration or maintenance.
Hygiene and safety are governed by various UK and international statutes and regulatory guidelines. One of the most important of these is the American Society of Mechanical Engineers Bioprocessing Equipment Guidelines or ASME BPE. The ASME BPE guidelines for pharmaceutical equipment provide a stringent, internationally recognised framework for designing and constructing pharmaceutical plants to facilitate effective cleaning and validation.
Get in touch with Inox Passivation today to find out more about our ASME BPE-compliant cleaning validation and passivation of stainless steel services for pharmaceutical equipment, and how this can be beneficial for your pharmaceutical equipment.