Sanitation Related Preventive Controls: Systemic Methods to Ensure Food Safety in Your Operation

It is curious why FDA in their writing and publication of the “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Final Rule”, address equipment sanitation in Subpart A, Definitions, Subpart B on GMPs (117.35, 117.40, 117.80) and Subpart C on Preventive Controls (117.135). Was this oversight, unintended duplication or was this a message to the food manufacturing industry to put more effort into the cleaning and sanitizing of processing equipment?

Based on this FDA emphasis,  “visually clean” by itself is not adequate, even if one is using a boroscope with natural and UV light and significant magnification capability. Equipment cleaning and sanitizing have always been important in delivering safe food. What has changed is FDA and the industry’s need for better tools to determine the effectiveness of equipment cleaning and sanitation. However, using these tools without proper application and integration, still takes us back to relying on “visually clean”.  How can we change this?

Some new and some not so new equipment cleaning and sanitizing tools are listed below, but they must be used together and integrated to result in a systematic and effective cleaning and sanitation system for food processing equipment.

1. Life Cycle Analysis (LCA) benefits wider and exclusive use of hygienically designed processing equipment. Equipment meeting 3-A Sanitary Standards and/or standard hygienic design principles consistently drive profitability in the dairy processing industry by maximizing equipment operational times and reducing downtime related to equipment cleaning and sanitizing. It is a “no brainer” for most dairy processing and sanitation specialists in dairy plants that hygienically designed equipment can reduce cleaning and sanitation downtimes, resulting in a better “life cycle cost” (see formula below) versus non-hygienically designed counterparts. However, very few departments responsible for purchasing dairy processing equipment attempt to make this simple calculation, resulting in poor equipment purchasing decisions, lost profitability, extended cleaning and sanitizing times and unreliable equipment cleaning and sanitizing.

·      ^{Summarized Version: LCC = I + REPL - RV + TP(O.+M.+ELV.+UPC. Annualized over life of equipment)}

^{·        Expanded Version: Life-Cycle Cost = Initial Cost + Replacement Cost - Remaining Value + Time Period(Operating Cost, Maintenance Cost which increase over time, Estimated Lost Value due to Downtime from Cleaning, Sanitizing and Unplanned Repair Costs all annualized over the estimated life span of the equipment)}

^{Note: Multiply “TP” by “O.+M.+ELV.+UPC.” first, then, add and subtract the factors in the order the equation is written.}

2. Properly designed and installed CIP systems including efficient spray ball configuration and placement. The most effective CIP systems utilize a     minimum of three tanks, a freshwater tank, an alkaline wash tank and a rinse recovery tank. At the end of the wash cycle the reclaimed wash solution should be returned to the wash tank and then the post rinse returned to the rinse recovery tank. Sanitizers should not be recovered and reused.  Key components of a properly designed and installed CIP system should be based on computer modeling or an engineering analysis of the equipment and pipelines to be cleaned and sanitized with the goal of minimizing water, energy, and chemical usage without extending CIP cycle times. COP and manual cleaning should be converted over to CIP whenever possible. Since the adhesion of dairy fats, proteins and bacterial biofilms is known, computer modeling or engineering analysis is effective in theoretically challenging the CIP system to determine whether cleaning and sanitizing gaps are likely, their predicted location and how to eliminate these gaps. If allergens are a concern, the CIP design and engineering can be adjusted to allow for accommodation of these cleaning functions.
3. Proper choice of cleaning and sanitizing chemicals. The first step is to analyze the “soils” that are likely to attach themselves to product contact surfaces. This can be done by having a chemical analysis of the first rinse water to establish a chemical profile of these “soils”. Based on this chemical profile, the correct chemical cleaner and sanitizer mix can be selected, based on the following:

·      Since 95-98% percent of the cleaning solution is water, it is critical that the water itself be analyzed to determine what impact it will have on the cleaning process. The source water should be analyzed to provide a provide a chemical profile which will identify the best match of cleaning and sanitizing chemicals to remove expected “soils”. Also, the final rinse water should also receive the same chemical analysis to identify whether cleaning and sanitizing chemical residue indicate excessive use levels as well as provide an indication of potential chemical residues remaining on product contact surfaces that will end up in the product stream.

·      Fat-based Soils-usually present as an emulsion and can generally be rinsed away with hot water above the melting point. More difficult fat and oil residues can be removed with alkaline detergents which have good emulsifying or saponifying ingredients.

·      Protein-based Soils-range from simple proteins (relatively easy to remove) to more complex proteins (difficult to remove) with heat-denatured proteins proving very difficult to remove. A highly alkaline detergent with hypochlorite and peptizing or dissolving properties is required to remove protein soils. Wetting agents are used in the products to reduce surface tension and allow for more efficient soil removal.

·      Carbohydrate-based Soils- simple or complex sugars are readily soluble in warm water and are quite easily removed. Starch residues, individually, are also easily removed with mild detergents. Starches associated with proteins or fats can usually be easily removed by highly alkaline detergents.

·      Mineral Salt-based Soils-Calcium and magnesium are the most difficult mineral films, but iron and manganese can also create problems. These “soils” usually respond to acid cleaners.

·      Microbiological Biofilms-difficult to remove and usually require cleaners as well as sanitizers with strong oxidizing properties.

4. Utilizing significant numbers of data collecting sensors. Most CIP systems lack enough meaningful operational data to identify problems easily and quickly. Using adequate numbers of sensors throughout the CIP system, collecting the data from these sensors via computer software programs and analyzing the data with various statistical and artificial intelligence software can not only identify the cause of current CIP problems but predict when and where likely CIP problems will develop in the future based on past trends. Key factors include sensor type, location, calibration, data capture frequency and ability to capture CIP operational data in real time. For existing CIP systems, installing and monitoring additional sensors this should be the first step in evaluating CIP effectiveness to determine the need for modifications or capital improvements The programming of the CIP system and the interaction of the controls with the sensors can be the difference between a cost effective CIP system and a water, electricity chemical and financial resource sink. The term quality (programming in) = (cost effective operation out) is real.
5. Utilize UV light and LED “blue light” to reduce bacterial loading in the return rinse, cleaning and final rinse water which will in-turn, reduce the amount of chemical required for the CIP system to be effective.
6. Increase the use of “Pigs”.  By using the mechanical action of “pigs” instead of chemical and water flowrate, the use of these devices, if designed     for the challenges of cleaning dairy pipelines with many valves and other obstructions, can reduce water, chemical and energy use while achieving     pipeline cleaning equal to traditional CIP systems.

7.        Use of rapid detection technology such as ATP, allergen and pathogen detection systems need to be a routine part of any integrated cleaning and sanitizing preventive control program to demonstrate in real time that all the items previously identified are working in an integrated manner to effectively achieve sanitary equipment surfaces.

To summarize, many in the dairy industry believe their equipment cleaning and sanitizing systems are running in an optimal mode, when in-fact improvements could be made in almost all cases to increase efficiency, reliability, and effectiveness. There are many reputable chemical supply companies that have retained some of the best CIP technical professionals in the industry and are available to provide advice on all of the items listed, ranging from water analysis to chemical needs to proper use of sensors to fine-tune equipment cleaning and sanitizing systems.