Cleaning Validation Guidelines: The Basics You Need to Know

Considered a major component of maintaining Current Good Manufacturing Practices (CGMP), cleaning validation is the practice of proving through well-documented and verifiable means that the cleaning procedures in a manufacturing facility are effective and protect equipment and other tools from contamination.

The cleaning validation guidelines set by the FDA are important for the same reason cleaning and sanitizing in the pharmaceutical industry are necessary. When drugs or medical devices become contaminated during manufacturing (especially if the Active Pharmaceutical Ingredients are impacted), then the resulting finished product can pose a threat to public health and patient safety.

Here are a few key takeaways from the FDA’s guide on cleaning validation:

• Pharmaceutical manufacturers and other medical organizations must have written general procedures (SOPs) that details how cleaning processes are carried out and validated. They should include how cleaning is carried out for each batch of drugs, what the process for cleaning looks like and other essential details.
• A stakeholder must be nominated to oversee performing and approving the validation study, acceptance criteria, and when revalidation is needed.
• Written validation protocols must be prepared in advance for studies being carried out for a specific manufacturing system or piece of equipment. These protocols must state sampling procedures, what analytical methods will be used, and define the sensitivity to those methods.
• A final validation report must be approved by management, in which they verify which cleaning processes are valid and provide a conclusion that states they have been carried out to an “acceptable level.”

GMP cleaning must be done regularly to avoid any potential risks caused by these contaminated products, which can range from downtime and wasted materials to costly fines and sanctions from the FDA.

How Is Sanitation Typically Performed in a Medical Context?

There is no industry standard on exactly how cleaning should be performed in medical device or pharmaceutical production facilities, but a few of the common methods are below:

• Standard washing using spray devices, wash tanks, a rinse cycle, and a drying cycle
• Immersion that involves soaking the equipment within the cleaning agent
• Ultrasonic cleaning, which is more suitable for delicate components like filling needles
• Pressure cleaning that involves high-pressure sprays to dislodge large pieces of residue

And, of course, there will always be a place for tried-and-true manual washing, which involves staff members brushing and wiping down equipment by hand.

While official process validation guidelines don’t specify a frequency to conduct cleaning validation, the FDA does mention in its cGMP reports that the interval must be short enough so that drug adulteration does not occur.

From the management side, you should aim to conduct cleaning procedures regularly, especially during major changes in facility operations such as:

• Drug formulas
• Major Equipment
• Cleaning processes
• Cleaning agents

Just as important is the ability to verify that your cleaning procedures are effective at preventing contamination, which is what cleaning validation is meant to accomplish.

Are All Pharma Equipment and Medical Device Cleaning Processes Clearly Understood?

What Procedures Are in Place To Meet Regulatory Compliance?

Make Sure Your Laboratory Personnel Are Following FDA Cleaning Validation Protocols