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Equipment (Section 110.40 of 21CFR)

In General (a) - All plant equipment and utensils shall be designed and constructed of material and with workmanship that makes the equipment cleanable, and maintainable. The design, construction, and use of equipment and utensils shall prevent and eliminate the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants. All equipment should be installed and maintained to facilitate cleaning of the equipment and surrounding areas. Food-contact surfaces shall be corrosion-resistant and shall be made of nontoxic materials and designed to withstand the operating environment which includes intended use, food, and cleaning /sanitizing agents. Food-contact surfaces shall be maintained to protect food from being contaminated by any source, including unlawful indirect food additives or cross-contamination of allergens and other harmful additives.

Reliability begins with following and understanding best practices. Good Manufacturing Practices (GMPs) are the foundation to building operational and maintenance best practices to manage food safety risks. For the food industry, GMPs come from the FDA in 21CFR- Part 110.

Section 110.40 of 21CFR concerns the design of the equipment and the area around the equipment and how easy it is to maintain a sanitary condition necessary in the food industry. This requires input from the maintenance technicians and operators, they are in the best position to see where contaminates are collecting and entering the manufacturing process. Without this input, a company is likely to fail this section of the standard. Each subsequent generation of equipment should be more accessible, maintainable, operable, and reliable with fewer surfaces and points of contamination. Equipment design is an important part of the foundation for producing safe and reliable food products. When these designs do not include shop floor input the result is higher life cycle costs, more risk to contamination and lower morale.

(b) Seams on food-contact surfaces shall be smoothly bonded or maintained so as to minimize accumulation of food particles, dirt, and organic matter and thus minimize the opportunity for growth of microorganisms. Maintenance must manage to assure that the proper skills and job plans are available when welding on pipes, chutes or surface which food comes in contact. Improper welding can result in a buildup of product and microbiological risks in many food plants. Metal is not the only thing welded. Belts also are spliced and welded.

(c) Equipment that is in the manufacturing or food-handling area and is not directly involved with the food processing shall be constructed of material which can be maintained in a clean condition. In areas where sanitation chemicals must be used or lots of water, the support equipment (non-food contact equipment) must be constructed and designed to withstand the normal operating condition. Improperly designed support equipment and structure will only lead to points of contamination and higher maintenance and operating costs.

(d) Holding, conveying, and manufacturing systems, including gravimetric, pneumatic, closed, and automated systems, shall be of a design and construction that enables them to be maintained in a sanitary condition. This requires easy disassembly and assembly for cleaning, accurate alignment in the sections of multiple pieces to avoid gaps on the inside. These gaps can create growth points for microbes. Installation on sensitive equipment like scales and other instrumentation must be robust to handling the cleaning, inspection and wash down. Otherwise, maintenance cost will be high due to calibration, yield and recipe issues

(e) Each freezer and cold storage compartment used to store and hold food capable of supporting growth of microorganisms shall be fitted with an indicating temperature measuring device, or temperature-recording device to show the temperature accurately within the compartment. The Temperature of the compartment should be closely monitored and it is recommended to have an alarm system to indicate a significant temperature change. Cold storage can lead to raw material spoilage and possible adulteration of the produced product and risk to our consumers. Therefore, there needs to be an integrated maintenance plan for the Cold storage equipment which includes operator inspections, maintenance inspections, maintenance replacements, predictive maintenance and condition monitoring through the distributed control system.

(f) Instruments and controls used for measuring, regulating, or recording temperatures, pH, acidity, water activity, or other conditions that control or prevent the growth of undesirable microorganisms in food shall be accurate and adequately maintained, and adequate in number for their designated uses. Some of these devices are CRITICAL CONTROL POINTS and are the last or only defense from sending tainted or adulterated product to the consumer. Other instruments protecting the consumers are metal checks, x-ray and scales. Maintenance has a significant responsibility to meet this portion of any of the six food standards and it is summarized in one phrase, CALIBRATION AND DOCUMENTATION, defines what we are going to do and shows that we did it.

(g) Compressed air or other gases mechanically introduced into food or used to clean food-contact surfaces or equipment shall be treated in such a way that food is not contaminated with unlawful indirect food additives. This requires compressed air to have food contact lubrications, desiccant cannot be part of the air stream, no water can be in the air or other compressed gases, metal particles or other contaminants. Maintenance departments must think about the functionality of the equipment and how the functionality is used. Compressed air is one utility which can be overlooked when doing Hazard Analysis in a Food Plant. Do you have compressed air actuating valves of reject systems in the manufacturing area? If yes, when the air is discharged from the valve or reject device where does it go?

The prerequisite programs for a HACCP process which is required by every food manufacture are a series of processes which are fundamentally GOOD MAINTENANCE PRACTICES.

Met Demand has resources to assist your organization in implementing an integrated solution which will meet Food Safety Standards and create profit by improving Maintenance and Reliability Best Practices.

Contact us: www.metdemand.com
888.427.4330

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