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Definitions
The GMP requires that you keep your facility and all equipment, utensils and food contact surfaces clean and sanitary, but it does not tell you how to do it. So we will begin this Module with detailed information on how to properly clean and sanitize and then follow with a discussion of the specific GMP requirements. Before we discuss how to clean and sanitize, it is important to understand the definitions of cleaning, sanitizing, and food contact surfaces. Cleaning means the removal of dirt, food residue, and any other materials from a surface, utensil, or equipment using detergents or other cleaning aids and either mechanical or detergent scrubbing actions, followed by rinsing. Sanitizing means the application of a chemical or heat to a clean surface that will kill microorganisms. The definitions section of the GMP regulation states that: Sanitize means to adequately treat food-contact surfaces by a process that is effective in destroying vegetative cells of microorganisms of public health significance, and in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer. Food contact surfaces are defined in the GMP as those surfaces that contact human food and those surfaces from which drainage onto the food or onto surfaces that contact the food ordinarily occurs during the normal course of operations. Food-contact surfaces include utensils and food-contact surfaces of equipment. Because food contact surfaces represent the highest risk of direct food contamination, they may need to be cleaned and sanitized more often and more vigorously than other areas of your processing facility. Food contact surfaces may include employee garments, gloves, and hands in addition to equipment and utensils.
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How To Clean
Remove Soil: Lets start with cleaning, which is the process of removing the soil from the plant and processing equipment. The soil that we want to remove can include food debris made up of fats, carbohydrates, proteins and minerals, dirt, and other undesirable material which build up on food contact surfaces and provide nutrients that bacteria can use to grow and multiply. After cleaning, a sanitizer is applied to destroy microorganisms that may be left on the surface. It is important to remember that a sanitizer will lose its effectiveness against bacteria unless food debris has been completely removed from equipment and food contact surfaces. There are two basic types of cleaning methods: manual and Clean-In-Place (CIP). Manual Cleaning is not just a brush and bucket! It involves selecting the right cleaners, using the right method to apply cleaning agents, and then using whatever mechanical action is needed to remove the soil from the food contact surface. Clean-In-Place (CIP) is a method of cleaning enclosed pipes and equipment that uses re-circulation of cleaning and sanitizing solutions. This method is used for equipment that cannot be easily broken down for cleaning.
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Cleaning Basics
For both manual and CIP cleaning, there are several factors that need to be considered including: contact time, temperature, concentration, and scrubbing. Lets review them. Contact time: Detergents or cleaners do not work instantly. It takes time for them to penetrate the soil or food debris on the food contact surface that you want to clean. That is why a dirty pan is easier to clean after it has been soaked in warm soapy water. You need to consider how cleaning agents will be applied, and how long they need to stay in contact with the item to be cleaned. The directions for use on the label of your cleaning agent should outline recommended dilutions and contact time. You should always refer to these directions when using any cleaner.
Soaking: If you need to extend contact time, the most common way is to use a soak tank or sink for portable items such as utensils, pans, cutting boards and other small pieces of equipment. Each item can be soaked in a solution of the detergent and warm water for as long as necessary. This is one reason why most state and local regulatory agencies require a two or three compartment sink equipped with hot water so that one of the compartments is dedicated to washing the equipment or utensils. However, not all equipment can be submerged in a detergent solution. Larger pieces of equipment, walls, and other vertical surfaces which require an extended contact time might need to be cleaned using a foam application - which will be discussed later.
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Cleaning Basics
Temperature: As discussed earlier, each detergent has an optimum temperature at which it performs the best. If the water temperature is too cold, the detergent may not work properly. If the temperature is too high, soil could be baked onto equipment. Some detergents tend to degrade at higher water temperatures. Concentration: There is an optimal concentration of detergent for each cleaning task. Again, check the directions for use on the container when deciding how much to use. Scrubbing: Manual cleaning requires water, a detergent, and a physical scrubbing action in order to release the food debris that your detergent has loosened. It is not enough just to pour water with detergent on the surface of the equipment to be cleaned. You must also use some sort of brush, pad or other tool and physical labor!
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Cleaning Tools
Design Considerations: Since scrubbing is such an important part of the cleaning process, you should also consider how easy your cleaning tools are to use. For some cleaning tasks, brushes with long handles can make scrubbing easier and for others more difficult. Cleaning tools that are awkward or cause user fatigue may decrease your employees motivation to clean as thoroughly as possible. Tools to Avoid: Some cleaning tools such as sponges, wiping cloths and mops should never be used for routine cleaning in food plants. These items are very difficult to clean and sanitize. They also retain moisture and water which will promote the growth of bacteria that could contaminate the surface or item that you think you are cleaning. Disposable, single-use paper towels should be used if surfaces need to be wiped. Keep Your Cleaning Tools Clean: Damaged or dirty brushes, pads or brooms can actually be a source of contamination if they are not routinely cleaned and sanitized. Cleaning tools should also be dedicated to a specific job. For example, brushes, brooms or squeegees used to clean the dirtiest areas of your plant such as floors or drains should never be used on equipment or food contact surfaces. Using different colored cleaning tools for different jobs can be an effective way to make sure that the right tool is used for the right job. This concept will be discussed in more detail in Module 8.
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Cleaning Tools
GMP TV: Click on the images in the GMP TV below for additional information on cleaning tools.
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Clean-In-Place Systems
For some types of cleaning jobs, neither manual or foaming application of a detergent would be effective. This is usually the case for closed processing systems such as heat exchangers, valves, pipes or fluid lines used to convey milk or other liquid food products. These types of food processing systems are typically cleaned without disassembling each section using the second method of cleaning that was briefly mentioned before - a Clean-In-Place or CIP system. For CIP systems, specially formulated low foaming detergents are usually required for cleaning. These detergent solutions are pumped through equipment lines at pre-determined intervals for routine cleaning. It may be necessary to periodically disassemble the entire system for more thorough cleaning. It is important to follow manufacturers directions for these systems and select the proper cleaning and sanitizing chemicals to prevent product contamination.
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Sanitizing or Disinfection
After cleaning, you need to apply a sanitizer to kill any bacteria or other microorganisms that may still be present. Remember, sanitizers are less effective when food debris is present. Food contact surfaces must be completely free of food residue before sanitizers are applied. Traditionally the words disinfect and disinfectants were used to respectively describe the procedures and agents used to kill microorganisms and reduce their numbers to a safe level. In the GMP regulation, and in this course, the word sanitize has the same meaning as disinfect, and the disinfectants or agents used to kill harmful microorganisms are called sanitizers. Microorganisms can be destroyed by heat, chemicals, ultraviolet (UV) light, or radiation. Two of these options, heat and chemicals, are commonly used in food processing or storage facilities. Heat may be an option for sanitizing certain pieces of equipment or utensils, but is not appropriate for large pieces of equipment, or the floors, walls, ceilings and other parts of the plant.
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Choosing A Sanitizer
Using Sanitizers: Just like detergents, there are also many different types of sanitizers that can be used in food processing facilities. By law, you can only use chemical sanitizers that have been approved for use in food facilities, and specific requirements or regulations may vary from state to state. As always, it is essential that you follow directions provided on the manufacturers label, and that the chemicals are stored properly. If not used properly, sanitizers could make the food you produce unsafe and harm your employees. Choosing A Sanitizer: The following table describes the advantages and disadvantages of common sanitizers that are approved for use in food processing facilities. Click here to print out this chart for future reference. (24k pdf)
Type of Sanitizer
Chlorine
Advantages
Kills most microorganisms Effective at low temperature Test strips determine concentration Relatively inexpensive Does not form films Kills most microorganisms Less affected by organic material Solution color indicates activity Dissipates slowly & leaves residue Non corrosive Residual activity if not rinsed Less affected by organic material Test strips determine concentration Can be applied as foam Kills most microorganisms Stronger oxidizer than chlorine Less affected by organic material Less corrosive than chlorine Kills most microorganisms Stronger oxidizer than chlorine & chlorine dioxide
Disadvantages
May corrode metal & weaken rubber Irritating to skin, eyes & throat Unstable, dissipates quickly Loses strength with organic material May be unstable at high temperature May stain plastic & porous materials Inactivated above 120F (49C) May be unsuitable for CIP Inactivated by most detergents Ineffective for certain microorganisms Effectiveness varies with formulation May be inactivated by hard water May be unsuitable for CIP Unstable and cannot be stored Potentially explosive and toxic Relative high initial equipment cost More expensive than many sanitizers Unstable and cannot be stored May corrode metal & weaken rubber Potentially toxic Inactivated by organic material More expensive than some sanitizers Inactivated by some metals May corrode some metals Not as effective against yeast & molds
Iodine
Ozone
Peroxy Compounds
Works well on bacteria in biofilms Kills most microorganisms Relatively stable in use Effective at low temperature Suitable for CIP
Continued
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Kills most microorganisms Penetrates irregular surfaces Suitable for CIP Relatively inexpensive Kills most microorganisms Sanitize and acid rinse in one step Low foaming, suitable for CIP Stable if organic material is present Less affected by hard water Sanitize and acid rinse in one step Very stable Less affected by organic material Can be applied at high temperature Not affected by hard water
May form films or scale on equipment Potential burn hazard for employees Contact time sensitive Inappropriate for general sanitation Inactivated by some detergents Less effective than chlorine at low temp. May damage some materials Less affective against yeast & molds pH sensitive Effectiveness varies by microorganism More expensive than some sanitizers May corrode some metals Unsuitable for CIP due to foaming
Acid-Anionic Sanitizers
Adapted from Sanitation Control Procedures Manual, National Seafood HACCP Alliance, Florida Sea Grant Report No. 119, Gainesville, FL, 2000.
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Iodine
Quats
50 ppm 8 or less 100 ppm 10 or less Maximum 200 ppm for FCS 12.5 to 25 ppm 5 or less 75F or 24C Maximum 25 ppm for FCS Minimum concentra- Follow manufacturer 75F or 24C tion per manufacdirections. turer directions Water hardness must Maximum 200 ppm be 500 ppm or less for FCS 100 to 200 ppm Maximum 200 ppm for FCS Minimum and Maximum amounts of hydrogen peroxide, acetic acid, peroxyacetic acid, peroxyoctanoic acid and other ingredients as specified for approved formulas in 21 CFR 178.1010
Maximum and minimum concentration values for Food Contact Surfaces (FCS) are specified in approved sanitizer formulas in 21 CFR 178.1010, Sanitizing Solutions. pH and minimum temperatures are from the 2001 FDA Food Code. Contact time is at least 1 minute. Table adapted from FDA Food Code and Sanitation Control Procedures Manual, National Seafood HACCP Alliance, Florida Sea Grant Report No. 119, Gainesville, FL, 2000.
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Additional Resources
If you would like to learn more technical details about cleaning and sanitizing chemicals, how they work, and how to use them, click on the links below to university fact sheets. More information is also available from trade associations, university or extension food safety specialists, and government agencies. Click on the buttons below to review these resources. Use your browsers BACK button at the top of the screen to return to this module.
There are many different chemical suppliers. Most of them have a national network of distributors. One way to locate a chemical supplier would be to check your yellow page listings under food processing or restaurant equipment and supplies. For additional information, Click on the following links which contain directories of many different chemical and cleaning suppliers across the U.S.
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Equipment Storage
GMP TV: Click on the GMP TV below to learn more about proper storage of cleaned equipment, utensils or other items that come in direct contact with food.
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on how to prepare cleaning and sanitizing solutions properly and test or verify their concentration. on how to apply these solutions. for each of the steps in the procedure and their proper order or sefor proper storage of cleaned equipment. cleaning tools to be used for each task.
quence.
Instructions
When each cleaning and sanitizing task will be done. Who will conduct each task. Different types of procedures may be needed. For example, some operations may need one procedure for cleaning and sanitizing the tables, walls and floors for their entire plant at the end of the day. Other firms may need one procedure for the area of the plant that handles raw products, and a different procedure for the area of the plant where finished products are packaged. You may also need different procedures for different pieces of equipment that are cleaned and sanitized in place, and for portable items and utensils that are cleaned and sanitized in a three-compartment sink. Implement each of the cleaning and sanitation procedures that are needed. Implementation includes purchasing the necessary chemicals and equipment to complete all tasks, placing these items in the proper location, and storing them properly. Train employees who have cleaning and sanitizing responsibilities to make sure that they understand what tasks must be completed and how to conduct them properly. Monitor cleaning and sanitizing activities to make sure that they are conducted properly and consistently. Monitoring could include testing to verify that the procedures developed are effective.
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How To Monitor
Periodic checks of the condition of the facility, equipment and utensils should be conducted as described in Modules 3, 4, 5 and 6 to make sure that they are in acceptable condition. Cleaning and sanitizing activities should be routinely checked to be sure that they are conducted properly and at the proper time as described in your sanitation procedure. This may include monitoring the proper use of detergents and cleaning aids, sanitizers, and cleaning and sanitizing procedures. Additional periodic checks using monitoring tools for cleanliness and/or tests for specific types of bacteria should be conducted as needed or required by regulations for certain types of food products. Although the current GMP does not require monitoring records, you may want to keep a record of the results of your observations for your own use. If any corrections are necessary to correct problems, those actions should also be noted on a written record.
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GMP Requirement: Substances used in cleaning and sanitizing. Cleaning compounds and sanitizing agents used in cleaning and sanitizing procedures shall be free from undesirable microorganisms and shall be safe and adequate under the conditions of use. Compliance with this requirement may be verified by any effective means including purchase of these substances under a suppliers guarantee or certification, or examination of these substances for contamination. These two sections of the GMP require that the sanitizing agents used in food establishments be effective and safe to use and that you have some type of documentation that the products that you are using are acceptable and free of contamination from undesirable microorganisms.
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FDA-Approved Sanitizers in 21 CFR Part 178 EPA-Tolerance Exemptions 40 CFR Part 180
Use Effective Procedures: These GMP requirements also say that the procedures, equipment or service that is used for cleaning and sanitizing must be acceptable, and that you need assurance that they will routinely provide adequate cleaning and sanitizing. Standard cleaning and sanitizing procedures identified in reference information from government, university, or trade associations should be acceptable if implemented properly. One such standard procedure was provided earlier in this Module. When using special sanitizing equipment, you may need technical information or a statement from the manufacturer indicating that it provides adequate cleaning and sanitizing consistent with current regulations if used according to instructions.
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How To Monitor
Keep appropriate records from your supplier to show that the cleaning and sanitizing chemicals that you use are approved and adequate when used properly. Monitor cleaning and sanitation procedures daily to be sure that they are conducted properly. Use test strips to confirm that you have the appropriate sanitizer concentration each time that sanitizing solutions are prepared. Although the current GMP does not require monitoring records, you may want to keep a record of the results of your observations for your own use. If any corrections are necessary to correct problems, those actions should also be noted on a written record.
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Do you need to develop any new procedures or use new chemicals, delivery methods, or cleaning tools or modify any existing ones? If so, how will you make the necessary changes and where will you get the necessary chemicals, equipment or tools? What resources are available to help such as sanitation suppliers, university specialists, or trade associations? Do you train employees who conduct cleaning and sanitizing activities to make sure that they understand how to conduct procedures properly? Do you need to add new training programs, modify existing ones, or conduct them more frequently? Do you routinely monitor the effectiveness of cleaning and sanitizing procedures using visual inspections and testing if necessary? Do you need to develop new monitoring procedures or modify existing ones?
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