Monday, March 8, 2021

The Importance of Clean Breaks in Production

Scheduled production downtime is often perceived as a loss of profit. In actuality, fewer machine breakdowns mean a more efficient operation, and scheduled downtime for sanitation provides a “clean break.” By definition, a clean break is a production break that involves a documented, verified, and validated cleaning and sanitation process to ensure sterility upon completion. In practice, a clean break is a damage limiting event that defines the maximum quantity that could be recalled in case of a contamination. It assures microbial contamination cannot overlap from one production run to another. Financially, a clean break is like an insurance policy, money spent on something you hope gives you no return on investment. Emotionally, a clean break is peace-of-mind.

Clean breaks are an important component of an effective traceability program. If a recall were to occur, it will include all product that was packed from the last full cleaning and sanitizing event forward. The product that is processed between clean breaks is called a lot. The more frequently clean breaks are established, the smaller the lot. If a facility’s clean break cannot be defended during a recall, then as far as an investigator is concerned, that company did not have one. When that happens, the recall will only grow. In October 2018, McCain Foods recalled 63 different products back to a shipped date of January 1, 2016 because they did not have a more recent clean break.

If contamination is detected, the question of how far back to recall can be painstaking, especially if the decontamination process utilized is not 100% effective. Typical cleaning and sanitization methods can have difficulty guaranteeing that all organisms have been contacted or contacted with the proper effective dosage. Therefore, these techniques may not eliminate all of the organisms, leaving some to reproduce. Modern fumigation methods, such as use of gaseous chlorine dioxide, can completely eliminate all of the organisms and thereby “reset” a facility. Chlorine dioxide gas is able to achieve a complete 6-log sporicidal decontamination of all surfaces within a space, including hard-to-reach areas such as cracks and crevices, because it is a true gas above -40 degrees and its molecule size is smaller than the smallest virus. Once the gas has been removed, the area is safe and does not require additional cleanup. 

Similar to a firebreak in a forest, a clean break provides companies with that line of safety. The strategic use of preventive scheduled downtime leads to a safer, more reliable, more efficient operation. By using chlorine dioxide gas routinely for decontaminating a facility before an issue arises, the chance of a contamination and/or a recall declines drastically, potentially saving money, disruptions to business, and perhaps lives. ClorDiSys’ decontamination method and approach to process control has enabled us to be trusted to keep critical environments safe, including most major pharmaceutical companies and 31 of the Top 100 food manufacturers. If you would like to learn more about clean breaks, how to establish the scope of a project, or our decontamination services in general, please contact us at or complete this form.