The Ultimate Guide to Cleaning Validation

Cleanliness and hygiene are critical considerations in any environment, whether commercial or residential. Germs, bacteria, and dirt can all negatively impact a building’s appearance  and the safety it provides to visitors. In some industries, however, the value of cleanliness goes beyond simply protecting well-being.

In the pharmaceutical, healthcare, and food production sectors, companies must adhere to strict guidelines for cleaning to protect the integrity of products, defend against cross-contamination, and minimize risks. 

Cleaning validation, as a component of a comprehensive quality control strategy, ensures companies implement the most effective cleaning procedure for their environment, and adhere to regulatory requirements within their industry.

In this guide, we’ll discuss the importance of cleaning process validation, and explore how organizations can craft and implement the ideal cleaning validation protocol to protect their reputation, staff, and consumers from unnecessary risks. 

What is Cleaning Validation? An Introduction

Cleaning validation is a systematic and documented process designed to authenticate the effectiveness of cleaning procedures in removing dirt, germs, bacteria, and microbes from surfaces and environments. It’s a common part of the quality assurance methods used in pharmaceutical manufacturing, the food and beverages industry, and within medical offices

Cleaning validation helps to ensure companies can consistently produce and maintain a safe environment for the manufacturing of various products. Notably, however, it’s not exactly the same as cleaning verification. 

Cleaning validation requires a thorough and planned set of activities conducted to establish evidence that each cleaning procedure used in an organization is consistently effective. It involves the use of dedicated equipment for rigorous testing and documentation. 

Cleaning verification, on the other hand, is a more routine process in quality control that confirms a cleaning procedure has been effective in a specific instance. Companies offering cleaning and disinfecting services often perform a verification process after each cleaning event to ensure that manufacturing equipment meets the correct standards before it is used again.

Why is There a Need for Cleaning Validation?

As mentioned above, cleanliness is crucial in all environments, but it’s particularly essential within facilities that manufacture products for human consumption. A cleaning validation protocol ensures the safety and quality of products in industries where hygiene is paramount. 

It’s a concept outlined by various regulatory guidelines, including Good Manufacturing Practice (GMP). Companies, and cleaning service providers use cleaning validation techniques to ensure they meet regulatory guidelines for hygiene and safety. 

Without cleaning validation services, businesses are at greater risk of various problems. Proper cleaning practices can eliminate the risk of contamination (the presence of unwanted substances in products) and cross-contamination in professional settings. 

They help prevent dangerous residue and substances from transferring to products that could be consumed by the public, reducing the risk of product quality issues, and regulatory violations. Failure to follow effective cleaning validation strategies can lead to everything from product recalls to legal penalties and loss of customer trust.

When to Perform Cleaning Validation?

Cleaning validation processes form an integral part of the process used to maintain product quality and safety in various industries. As such, it’s a task that needs to be carried out by experienced professionals on a regular basis. The cleaning validation process can be carried out:

  • Before a new manufacturing process begins: Validating a cleaning procedure before a manufacturing process begins helps to ensure the environment is adequately prepared for a safe and hygienic production process, by identifying any dangerous residues or contaminants.
  • When changing cleaning procedures: Any changes in cleaning procedures, the cleaning agent used, and other strategies require cleaning validation. Modifications to the cleaning process, such as the decision to use green cleaning products, can alter its efficacy, making it essential to reevaluate procedures.
  • When updating equipment: A new medical device or piece of equipment in a professional environment can present new cleaning challenges. Cleaning validation at this stage helps companies determine the right cleaning processes to maintain high levels of hygiene and safety. 

The frequency with which cleaning validation procedures are implemented can vary depending on various factors. The complexity of the production equipment, the nature of the product being manufactured, and other elements can identify the need for a more or less frequent validation process. 

FDA Guidelines for Cleaning Validation

Regulatory bodies like the US Food and Drug Administration (FDA) publish guidelines designed to assist organizations with the implementation of cleaning validation and analytical methods. Guidelines like CFR Title 21 set forth the requirements for the manufacturing, processing, packaging, and storage of pharmaceutical products to ensure they meet safety and quality standards. 

They also highlight the importance of using effective cleaning and disinfection methods and validating cleaning procedures to prevent contamination and cross-contamination. 

Appropriate cleaning methods and analytical processes verify the efficacy of cleaning strategies, such as establishing sampling locations and swab sampling techniques to search for evidence of residue before a manufacturing process begins. They can also identify when automated and manual cleaning methods are appropriate, and when expertise may be necessary. 

Documentation and accurate record-keeping also play a pivotal role in the FDA’s cleaning validation guidelines. Companies are required to maintain records that highlight their commitment to preserving the efficacy of their cleaning methods and outline any changes to the cleaning process. 

Organizations need to maintain records that share the results of validation efforts, and standard operating procedures, which must be made readily accessible for FDA inspection.

The Steps of the Cleaning Validation Process

The precise steps involved in your cleaning validation process will vary depending on your industry, the regulatory guidelines you need to follow, and your location. Typically, however, the core stages of an effective approach will include:

  • Planning: Companies will need to identify the scope and objectives of the cleaning validation, ensuring all essential equipment and areas are properly validated. The planning process can include selecting products and residues to target, based on the risk they may pose to product quality and safety. 
  • Protocol development: Next, businesses need to develop a validation protocol that outlines the cleaning and disinfection strategies to be used. The protocol should include criteria for acceptable cleanliness levels, methods of analysis to be used (such as swab analysis), and documentation requirements. 
  • Execution: The next stage is implementing the cleaning procedures and validation strategies as outlined in the validation protocol. This step involves applying the chosen cleaning method, using specific cleaning agents, and validating the cleanliness of equipment or surfaces according to preset guidelines. 
  • Reporting and documentation: At this stage, companies record the results of their cleaning validation process in a comprehensive report. This report outlines the effectiveness of the process, confirms compliance with the accepted criteria, and highlights any deviations or corrective actions that may have been taken.

Specialized Cleaning Agents 

To adhere to regulatory guidelines for health and safety, companies need to ensure they’re selecting the right cleaning agents based on the risks in their environment. Each commercial space has its own requirements to consider when it comes to cleaning. For instance, in some environments where leftover cleaning product residue could lead to issues with product quality or contamination, companies may adopt ultrasonic cleaning methods. 

Some of the most common cleaning agents used in various industries include:

  • Detergents: Used in general cleaning practices to remove organic and inorganic residue.
  • Solvents: Used to dissolve specific types of residues that may not be removed easily by detergents and water. 
  • Disinfectants: Products used to minimize microbial contamination on surfaces. 

An effective cleaning service provider should be able to help you identify the right cleaning agents and solutions for your equipment, based on a comprehensive risk assessment. 

Specialized Cleaning Methods

Alongside selecting the right cleaning agents, organizations must adhere to the correct cleaning processes based on the equipment they use and the substances that surfaces and environments are exposed to. Common strategies include:

  • Clean-in-place: CIP cleaning methods involve cleaning the equipment surface without dismantling or moving anything. This strategy is commonly used for equipment that’s difficult to dismantle. 
  • Clean-out-of-place: With COP strategies, equipment and components are dismantled and cleaned in a dedicated area, away from the primary workspace.
  • Immersion cleaning: This strategy involves immersing components of a piece of equipment into a cleaning solution, tailored to the potential residues that need to be removed.
  • Ultrasonic washing: With ultrasonic washing, companies use ultrasound and cleaning solutions to clean intricate parts and components.
  • High-pressure spraying: Commonly used in external settings, high-pressure spraying removes residue with high-pressure water or cleaning solutions. 
  • Manual cleaning: Manual cleaning involves cleaning equipment and surfaces by hand with cloths, brushes, and carefully chosen cleaning agents.

Most organizations will be required to use a variety of different cleaning methods for different types of surfaces and equipment in their facility. 

The Importance of Sampling in Cleaning Validation

Sampling is one of the most important elements of the cleaning validation process. It allows companies and cleaning professionals to guarantee that a surface or piece of equipment adheres to cleanliness and hygiene standards. 

Companies can explore various sampling methods, such as direct surface sampling, which involves using swabs or contact plates to collect and examine residues from equipment surfaces. Companies can also use rinse sample methods to rinse a surface with a solvent and then analyze the rinse solution for residue. 

Effective sampling helps ensure that companies can validate their equipment cleaning process or the cleaning strategies used by their commercial cleaning team. It also provides organizations with the data and details they need for thorough documentation.

The Importance of Thorough Cleaning Validation

Cleaning validation is a crucial part of the quality management process for countless companies manufacturing products for human consumption. The right cleaning validation procedure ensures you can guarantee the safety and quality of your products, and adhere to regulatory guidelines. 

As experts in delivering tailor-made cleaning services, antimicrobial coating solutions, and disinfection services, Pritchard Industries understands the value of effective cleaning validation strategies. We follow stringent cleaning validation processes when delivering our services to ensure companies can adhere to the latest industry regulations. 

Contact Pritchard Industries today to learn how we can help you optimize and enhance your cleaning processes and preserve quality and safety standards. 

Contact Pritchard Industries here.


What is the FDA validation of the cleaning process?

The FDA’s guidelines for cleaning validation require companies to effectively demonstrate that a cleaning process can consistently clean equipment to a predetermined standard. Sampling and analytical test methods need to be scientifically sound, and must provide insights to support the validation, available via documentation. 

What is the lifecycle of cleaning validation?

The cleaning validation lifecycle starts with assessment or planning, followed by the development of validating and cleaning operation procedures. Next, companies must implement their cleaning strategies and validation methods, and document the results. 

Is cleaning validation required for dedicated equipment?

Yes, cleaning validation isn’t just intended to reduce the risk of cross-contamination. It’s a comprehensive strategic process designed to ensure that all cleaning methods used in a facility are consistently effective. You’ll still need to validate your cleaning methods when using dedicated equipment for specific processes. 

What is the maximum safe surface residue?

The Maximum Safe Surface Residue, or MSSR, refers to the maximum amount of residue that can remain on equipment surfaces without posing a risk to consumers or patients. It’s mathematically calculated by dividing the maximum safe carryover area by the total area of shared contact. 

What ISO is used for cleaning validation?

ISO 19227 outlines the objectives and requirements of an effective cleaning validation process for medical offices, pharmaceutical companies, and other businesses. It provides a framework for verifying the effectiveness of cleaning processes and their impact on consumer and employee safety in a range of sectors.