module 7 • page 1 of 44 Sanitary Operations: Cleaning and Sanitizing In Module 5 we outlined the need to design, construct and use food processing equipment and utensils that are easy to clean. In this module we will discuss the part of the GMP that requires you to properly clean that equip- ment along with the rest of the processing facility. This module will help you understand the GMP require- ments for: • General maintenance and sanitary condition of buildings, fixtures and facilities. • Proper selection and use of cleaning and sanitiz- ing chemicals. • General cleaning and sanitizing procedures. • Proper cleaning and sanitation of food contact surfaces. • Storage and handling of cleaned equipment and utensils. These requirements are found in Subpart B, Section §110.35 of the GMP regulation. There are 44 pages, 5 GMP TVs, 10 links to Internet resources, and 6 questions in this Module. We’ll continue to use the GMP TV to provide some examples of good and bad practices. module 7 • page 2 of 44 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 sur- face, 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 veg- etative 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. module 7 • page 3 of 44 How To Clean Remove Soil: Let’s 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 undesir- able 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 microorgan- isms 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 ac- tion 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. module 7 • page 4 of 44 Use The Right Tools Whether you use a manual or clean-in place system, developing an effective cleaning and sanitizing program requires that you have the right tools for the job. These tools should include: • Plenty of potable water (both hot and cold water may be needed). • Detergents appropriate for use in food plants. • Acceptable cleaning tools such as brushes, pads, brooms, foam applicators, and sprayers. • Approved sanitizing solutions that will kill microorganisms but not contaminate food. • Effective cleaning and sanitizing procedures for your facility and all of its equipment and utensils. • Trained employees to conduct cleaning & sanitizing procedures properly. • Monitoring activities to verify that procedures are effective. Let’s look at each of these items in more detail. module 7 • page 5 of 44 Water Is Essential For Cleaning Water Quality: You must have an adequate water supply to clean soiled equipment. A desirable water sup- ply must be free of microorganisms (clean and potable), have a neutral pH (near pH 7), and a low mineral content. Some firms may have to treat their water to achieve these qualities. A good water supply in- cludes both an adequate amount of hot and cold water and adequate water pressure. Water Temperature: The tempera- ture of the water is also important. Some cleaners may not be effective if the water is too hot or too cold. Check the label on the cleaner that you use to see if the manufacturer recommends an appropriate water temperature. The GMP requirements for delivering hot and cold water to conduct cleaning and sanitizing activities were covered in Module 4. Pre-Cleaning: Before you use water for cleaning equipment, you need to remove large particles and any heavy soil that has built up during food handling or processing. You can do this by physically removing large scraps of food and by scraping any areas that have food debris that is difficult to remove. If you don’t remove the heavy soil, you will end up trying to wash utensils and equipment in a soupy mixture of water, food debris, and deter- gent - a very ineffective way of cleaning. module 7 • page 6 of 44 Detergents and Their Use Now that you have determined that you must have an adequate supply of potable water at a suitable temperature and with enough pressure, you need to decide on what type of detergent you will use. This will depend on: • The type of soil or food debris to be cleaned, • The type of surfaces that you are cleaning, • The type of cleaning equipment that you will be using, and • The amount of water available and its chemistry (hard or soft water). Detergents have different ingredients that aid in cleaning. Some reduce the hardness or alkalinity of the water, others tie up metals in the water, which increases wetting ability, and some make fats easier to dissolve in water. It is important to check the label instructions and match the detergent to the type of soil to be removed. There are many different products available and you should consult with your supplier to find the right product for your situation. module 7 • page 7 of 44 How Detergents or Cleaners Work In order to select the right detergent for the right job, it is necessary for you to understand just how detergents work. Most detergents are composed of a mixture of in- gredients that are formulated for specific types of dirt or food residue. Basic Ingredients: Certain ingredients in the detergent make the residue that you are trying to remove dissolve better in water. Most detergents are designed to work best in hot or warm water. One ingredient in many deter- gents is called a surfactant, which binds equally well to water and fats or oils. These ingredients promote physical cleaning by helping to wet, foam, and dissolve the food debris to be removed so that it can be washed away with water. Chemical Agents: Other ingredients are either alkaline or acidic, and are designed to chemically remove certain types of soil or food debris. For example, alkaline ingredi- ents like strong caustic soda or potash, or milder agents like phosphates are used to remove fatty material. They bind to fat to form soap, which can then be washed away with water. Other detergents that contain weak or strong acids dissolve mineral deposits, which can then be washed away with water. Special Additives: Additional ingredients may be added to some products to make them more effective for specific types of cleaning. Foods like milk that are high in protein can be very difficult to remove—especially if they have been heated. Specially formulated deter- gents that are alkaline, contain wetting agents, or ingredients like enzymes may be need- ed to dissolve or break down proteins. module 7 • page 8 of 44 Biofilms and Detergents Biofilms: Sometimes, no matter what you do to clean, some types of bacteria can produce a substance that protects them from their environment and helps them to stick to food contact surfaces. These bacterial communities are known as biofilms. If a biofilm develops on a food contact surface, it cannot be eas- ily seen or detected and it is very difficult to remove. Harmful bacteria can be dislodged from the biofilm during processing and contaminate food products. Removing Biofilms: Specially formulated detergents that con- tain an oxidizing agent such as chlorine or peroxide, in addition to other ingredients, may be needed to remove these biofilms. There are many different cleaning products available for use in food processing plants. You should talk to your supplier to de- termine what products will be most effective for your particular needs. Once you determine what products to use, it is important to remember to follow all manufacturers directions when using them and make sure that they are stored properly. module 7 • page 9 of 44 Choose An Effective Cleaner That Won’t Damage Equipment While it is important to use a detergent that will remove all dirt and food debris, you also need to consider the type of surface you are trying to clean. Caustic alkaline or acidic cleaners may be effective in removing food debris, but they can also be cor- rosive to softer metals such as aluminum, copper, or lower grades of steel. Stress cracking and clouding can also occur when hard plastics are exposed to corrosive cleaning agents for prolonged periods of time. Higher grades of stainless steel are likely to be more resistant to corrosion over time, which is why it is a preferred material for handling foods that are acidic, salty, or high in fat or water. If cleaning agents cause the surfaces that are being cleaned to deteriorate, it will be much more difficult to keep them clean. For this reason it is important to use cleaning agents that are effective and get the job done, but are not so aggressive that they pit, crack, rust, corrode or otherwise damage your food contact surfaces. Contaminated food is eaten by customers Foodborne illness occurs and customers get sick module 7 • page 10 of 44 Cleaning Basics For both manual and CIP cleaning, there are several factors that need to be considered including: contact time, temperature, concentration, and scrubbing. Let’s 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 compart- ments 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. module 7 • page 11 of 44 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 concen- tration 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! module 7 • page 12 of 44 Cleaning Tools and Scrubbing Scrubbing is Essential: There are no detergents that are ideal for every situation. Ap- plying the right detergent for the recommended time can loosen or begin to dissolve dirt and food debris, but scrubbing is usually necessary to finish the job. This is especially true if the soil has dried or been cooked onto the surface. For most situations you will need to scrub the item or surface to be cleaned with a brush, pad or other cleaning tool to loosen all of the dirt and food debris so that it can be washed away. Types of Cleaning Tools: There are many different types of cleaning tools. Let’s look at two of the most common types, and some of the things to consider when deciding which tools to use. Brushes should be designed for use in food operations and constructed of a material that is easy to clean and will not be damaged by the detergents that you are using. When se- lecting brushes you should consider how they will be used. Brushes with stiff bristles may be appropriate for flat or difficult to clean surfaces. Softer bristles may be needed to clean curved surfaces or things that may be susceptible to scratching. Pads are popular cleaning aids. They can be used for many different tasks because they readily conform to the surface being cleaned and may only require light pressure to loosen food debris. They are also useful for cleaning utensils and hard to reach areas such as un- der the lip of a processing table. Pads should be designed for use in food establishments and made of a synthetic material that will not be damaged by cleaning chemicals. It is important to use pads that are designed for the type of material to be cleaned. Avoid Damage: Pads, brushes, or other cleaning tools that are too abrasive can cause damage such as scratching and rusting. This damage could increase the chance that bacteria will attach to the surface and form a biofilm, which could then contaminate food products over time with harmful bacteria or other microorganisms. module 7 • page 13 of 44 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 employee’s 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 actu- ally 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 squee- gees 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. module 7 • page 14 of 44 Cleaning Tools GMP TV: Click on the images in the GMP TV below for additional information on cleaning tools. module 7 • page 15 of 44 Foam Application Systems Not all equipment can be washed or soaked in a sink. If you are cleaning large pieces of equipment like processing machinery, tables, coolers, conveyors, floors and walls, that re- quire a longer contact time for detergent to work, a foam application system can be used. How Foamers Work: A foam application system combines air with a foaming detergent that has the consistency of shaving cream when it is applied. The foam tends to cling to vertical surfaces to allow enough contact time for the detergent to do its work. This type of application can also produce a consistent detergent concentration, and is highly visible to ensure that you have uniform coverage of the surface to be cleaned. Use Foam Detergents Properly: It is important to follow manufacturer directions. Us- ing too much of the cleaning product or leaving it on surfaces too long can make clean- ing more difficult and damage your equipment. Some important things to consider when using foam detergents is that you need an applicator, the foam needs a certain amount of contact time, and you may still need to manually scrub the equipment for the detergent to be effective. Again, all of this information is typically found in the “directions for use” on each detergent container label. Let’s take a look at some foam application systems in the GMP TV on the next page. module 7 • page 16 of 44 Foam Application Systems GMP TV: Click on the Photos in the GMP TV below to learn more about different types of foam applications. module 7 • page 17 of 44 Clean-In-Place Systems For some types of cleaning jobs, neither manual or foaming application of a detergent would be effec- tive. 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 manu- facturers directions for these systems and select the proper cleaning and sanitizing chemi- cals to prevent product contamination. module 7 • page 18 of 44 Other Types of Cleaning Equipment and Pressure Washing Cleaning Machines: Some food processing facilities may use special types of cleaning equipment such as automated dishwashers, tote washers, rack washers, or other types of cleaning cabinets. This equipment should be operated according to the manufacturers direc- tions and properly maintained so that it cleans your equipment adequately without damaging it. The FDA Food Code and most local and state regulations have specific requirements for the installation and operation of equipment such as dishwashers. Pressure Washers: Pressure washers are widely available and it is tempting to consider us- ing them for cleaning food processing areas to remove dirt and food debris. However, pres- sure washers should not be used because of the potential for re-contaminating cleaned areas. Cleaning in food processing areas generally starts from the top down (walls to equip- ment to floor). When a high pressure spray hits the floor, a mist will be created that contains the water, dirt, food debris and harmful bacteria like Listeria that are likely to be on the floor. These contaminants will then settle on and re-contaminate the surfaces that have already been cleaned. This problem will be even worse if high pressure is directed at or near floor drains, which are likely to contain harmful bacteria. Summary: Whether you are using a manual or CIP system, you need to choose the right detergent and application system for the types of soils and equipment at your facility. You should always check the directions on the label of your detergents to make sure that you are using the proper amount, the right water temperature, and an effective application method. You also need to make sure that your detergents are properly labeled and stored so that they will not contaminate the food you are receiving, storing or processing. module 7 • page 19 of 44 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 stor- age 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. module 7 • page 20 of 44 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 com- mon 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 Advantages Disadvantages Chlorine Kills most microorganisms May corrode metal & weaken rubber Effective at low temperature Irritating to skin, eyes & throat Test strips determine concentration Unstable, dissipates quickly Relatively inexpensive Loses strength with organic material Does not form films May be unstable at high temperature Iodine Kills most microorganisms May stain plastic & porous materials Less affected by organic material Inactivated above 120ºF (49ºC) Solution color indicates activity May be unsuitable for CIP Dissipates slowly & leaves residue Quaternary Ammonium Non corrosive Inactivated by most detergents Compounds Residual activity if not rinsed Ineffective for certain microorganisms (Quats or QAC) Less affected by organic material Effectiveness varies with formulation Test strips determine concentration May be inactivated by hard water Can be applied as foam May be unsuitable for CIP Chlorine Dioxide Kills most microorganisms Unstable and cannot be stored Stronger oxidizer than chlorine Potentially explosive and toxic Less affected by organic material Relative high initial equipment cost Less corrosive than chlorine Ozone Kills most microorganisms More expensive than many sanitizers Stronger oxidizer than chlorine & Unstable and cannot be stored chlorine dioxide May corrode metal & weaken rubber Potentially toxic Inactivated by organic material Peroxy Compounds Works well on bacteria in biofilms More expensive than some sanitizers Kills most microorganisms Inactivated by some metals Relatively stable in use May corrode some metals Effective at low temperature Not as effective against yeast & molds Suitable for CIP Continued module 7 • page 20 of 44 Hot Water Kills most microorganisms May form films or scale on equipment 171 to 190ºF (77 to 88ºC) Penetrates irregular surfaces Potential burn hazard for employees Suitable for CIP Contact time sensitive Relatively inexpensive Inappropriate for general sanitation Carboxylic Acid Kills most microorganisms Inactivated by some detergents Sanitize and acid rinse in one step Less effective than chlorine at low Low foaming, suitable for CIP temp. Stable if organic material is present May damage some materials Less affected by hard water Less affective against yeast & molds pH sensitive Acid-Anionic Sanitizers Sanitize and acid rinse in one step Effectiveness varies by microorganism Very stable More expensive than some sanitizers Less affected by organic material May corrode some metals Can be applied at high temperature Unsuitable for CIP due to foaming Not affected by hard water Adapted from Sanitation Control Procedures Manual, National Seafood HACCP Alliance, Florida Sea Grant Re- port No. 119, Gainesville, FL, 2000. module 7 • page 21 of 44 Using Sanitizers Correctly Just like detergents, sanitizers must be used and applied properly or they will either be ineffective in killing microorganisms or cause damage to the plant, processing equipment, or employees. Concentration: First, you must use the right sanitizer at the right strength or concentra- tion. If the sanitizer concentration is too low, you will not kill microorganisms. If the con- centration is too high, you could make the food you produce unsafe, damage equipment, or even harm employees. The federal regulations for sanitizing solutions in 21CFR Part 178.1010 give the maximum amount of active sanitizer that should be used in food pro- cessing establishments. The following table gives the maximum concentration allowed and the most commonly used concentration range for common sanitizers. Sanitizer Concentrations Commonly Used in Food Processing Facilities Sanitizer Concentration pH Minimum Temp. Chlorine 50 ppm 8 or less 75°F (24°C) 100 ppm 10 or less 55°F (13°C) Maximum 200 ppm for FCS Iodine 12.5 to 25 ppm 5 or less 75°F or 24°C Maximum 25 ppm for FCS Quats Minimum concentra- Follow manufacturer 75°F or 24°C tion per manufac- directions. turer directions Water hardness must Maximum 200 ppm be 500 ppm or less for FCS Chlorine dioxide 100 to 200 ppm Maximum 200 ppm for FCS Peroxy Compounds 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. module 7 • page 22 of 44 Use The Right Amount of Sanitizer Concentration: Sanitizer concentration is measured in ppm or parts per million. This is an extremely small amount of ac- tive sanitizer. To help you appreciate just how small this is, 100 parts per million would be equivalent to: • 8 1/3 feet in 16 miles; or • 1 hour and 40 minutes in 2 years; or • 6 ¼ pounds in 64,000 pounds; or • One $100 dollar bill in a stack of 10,000 $100 dollar bills; or • 100 cars in a bumper-to-bumper traffic jam from Cleveland to San Francisco. Making Sanitizer Solutions: To make solutions that have the proper amount of sanitizer, you need to carefully follow the directions for use provided on the sanitizers’ label. Because the amount you need is so small, if even a little mistake is made when these solutions are prepared, the concentration could be too high or too low. That is why you need to check the concen- tration of your sanitizing solution with a test strip each time it is prepared and periodically during use to make sure that you have the right concentration so that the sanitizer will work properly. module 7 • page 23 of 44 Measuring Sanitizer Concentration Test Strips or Kits: Your chemical supplier should be able to provide an appropriate test strip or kit for the sanitizer that you are using. Test strips are available for chlorine, iodine, Quats, peroxide and other sanitizers. When these test strips are dipped in the solution that you have prepared for a certain amount of time, they will change color based on the amount of the active sanitizer in the solution. The final color of the strip is compared to a color chart on the container to tell you the amount of sanitizer in the solution. Each sani- tizer will need a different test strip. For example, test strips for chlorine will not measure iodine or Quats. You should also make sure that the strips you use are capable of mea- suring in the concentration range that you are working with. For example, if you need to measure chlorine in the 100 to 200 ppm range, the strip you use should not measure in the 0 to 10ppm range. GMP TV: Click on the GMP TV below to learn more about test strips that can be used to measure sanitizer concentrations. module 7 • page 24 of 44 Using Sanitizers Properly Sanitizers, just like detergents, aren’t effective if they are not used properly. You need to consider contact time, water, organic material or the amount of soil present in the solution, and their application. Let’s look at each of these factors. Contact Time: Just like detergents, sanitizers must be in contact with the cleaned surface long enough to kill bacteria and other microorganisms. In general, sanitizers like chlorine, iodine, and Quats need at least 1 minute of contact time with the cleaned food contact surfaces in order to be effective. Some sanitizer formulas may have different suggested contact times, and you should follow the directions on the sanitizers’ label. Sanitizers like Quats may provide residual sanitizing activity over a longer period of time if the surface is not rinsed after the sanitizer has been applied. Water Chemistry and Temperature: The effectiveness of some sanitizers may be af- fected by the pH (acidity or alkalinity) or the hardness of the water that is used to make up the sanitizer solution. For example, chlorine is especially affected by pH and it will lose its effectiveness if used in very basic (alkaline) solutions. Again, it is important to check the directions for use on the label and prepare your sanitizer accordingly. For most appli- cations, room temperature water at approximately 75°F (24°C) should be used to make up sanitizer solutions. module 7 • page 25 of 44 Using Sanitizers Properly Organic material: Sanitizers like chlorine will react with the organic material in food debris that contains protein, fat or carbo- hydrate and make the sanitizer unavailable to kill bacteria and other microorganisms. That is why it is necessary to clean food contact surfaces to remove this soil before they are sanitized. If sanitizers are used in solutions where employees are dipping their hands, the amount of available sani- tizer also decreases as organic material builds up. For this reason you need to pe- riodically check the concentration of these solutions during the work day and change them as often as necessary. Application: Just like detergents, you may also need to consider how you will apply a sanitizer solution to food contact surfaces, equipment, floors and walls after cleaning. For utensils and portable items, it is easy to immerse them in a sanitizing solution after cleaning. For large pieces of equipment, walls and floors it may be necessary to spray the sanitizer solution onto the surface in a way that will ensure that it is in contact with the surface for at least 1 minute or for the time suggested by the manufacturer. Options can include portable sprayers or even in-line metered systems that mix the proper amount of sanitizer and water. Application methods and tools can often be provided by your chemical supplier. module 7 • page 26 of 44 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 re- sources. 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 dis- tributors. One way to locate a chemical supplier would be to check your yellow page list- ings under food processing or restaurant equipment and supplies. For additional informa- tion, Click on the following links which contain directories of many different chemical and cleaning suppliers across the U.S. module 7 • page 27 of 44 Basic Cleaning and Sanitizing Procedure So far this module has discussed the things you should consider when selecting cleaning and sanitizing products. Now you need to develop and implement a procedure for clean- ing and sanitizing everything in your processing facility. To do this you should start with a basic procedure for proper cleaning and sanitizing, and then identify any variations that may be needed for various areas of the plant, specific processing or storage equipment like refrigeration units, and portable equipment and utensils. Let’s look at the basic steps that should be included in a complete cleaning and sanitizing procedure. module 7 • page 28 of 44 Developing Your Cleaning and Sanitizing Procedures General Components: You can use the information provided in this Module to develop effective cleaning and sanitizing procedures for your operation to meet GMP requirements. The GMP requires you to have effective procedures but it does not currently require that they be written down. Each procedure should include how and what you will clean and sanitize, where and when this will be done, and who will do it. Basic Procedures: The basic 10 Step procedure described on the previous page can be used to help you develop a procedure that describes how you will clean and sanitize. Some operations may only need one or two procedures. For example, one procedure for cleaning all equipment and fixed items like tables, conveyors, and processing machines, and another procedure for portable items and utensils using a three-compartment sink. More complex operations may need to develop separate procedures for different areas of the plant, for different pieces of equipment, or for different processing systems. You will also need procedures for cleaning and sanitizing cleaning tools like brushes, pads, scrap- ers, brooms, and squeegees. Customized Procedures: For each procedure you must decide which cleaning agents and sanitizer will be used, the concentration that is needed, and how they will be applied. You may need different cleaners, sanitizers, and application methods for different parts of the facility or pieces of equipment. These different procedures should be included in your sanitation procedure to be sure that employees who do routine or periodic cleaning and sanitizing tasks know exactly how to clean and sanitize each utensil, piece of equipment, or processing area. module 7 • page 29 of 44 Developing Your Cleaning and Sanitizing Procedures Set Up A Schedule: You must also decide when and how often you need to clean and sanitize your facility and its equipment and utensils. At a minimum, it is likely that all food contact surfaces will need to be cleaned and sanitized at least once per day, and those areas that become dirty during processing may need to be cleaned and sanitized more than once per day. Some areas or equip- ment such as refrigerated coolers, freez- ers, or dry storage areas may only need to be cleaned and sanitized periodically. Your procedure should describe when each routine and periodic task should be completed. The goal of the GMP require- ment is to make sure that you protect food from being contaminated with filth and harmful bacteria on unclean food contact surfaces. Assign Tasks: Finally, your cleaning and sanitizing procedure should indicate who is responsible for cleaning and sanitizing tasks. Some firms may have a dedicated clean- ing crew who conducts these tasks after food handling or processing stops at the end of the shift or workday. Others may assign specific cleaning and sanitizing tasks to produc- tion employees that must be completed at the end of their shift. Each employee who has a cleaning and sanitizing responsibility must be trained to understand why their task is important and how to do it properly. module 7 • page 30 of 44 Monitoring The Effectiveness of Your Procedures Monitoring: Because cleaning and sanitizing is so important to protect the food you are processing from contamination, you should monitor these ac- tivities. At a minimum, a supervisor or other des- ignated person should visually inspect equipment, utensils and other food contact surfaces to make sure that they are clean before food is handled and processed each day. Cleaning and sanitizing tasks should also be monitored routinely to make sure that the procedures you have developed are being conducted properly. Monitoring Tools: Because visual inspections are subjective, you may also want to periodically measure how effective your procedures are. Several types of tools are available to help you measure the effectiveness of your cleaning and sanitizing procedures. However, the GMP only requires that your sanitation procedures be effective, it does not require testing. Since these monitoring tools can be expensive, each firm must decide whether or not they are needed and how to use them. Sanitation test kits are available to measure the amount of organic material (food de- bris and bacteria) on a surface. This type of test involves swabbing a food contact surface that has been cleaned and sanitized. The swab is then exposed to an enzyme solution that reacts with a particular chemical in food debris and soil to produce light. The amount of light produced is measured by an instrument that indicates how much organic material was picked up on the swab. Other quick test kits can detect protein or sugars on food con- tact surfaces. A food contact surface is swabbed and the swab is immersed in a solution that reacts with the protein or sugar on the swab to produce a color that shows how well the surface was cleaned. These measurements do not distinguish between living bacteria and food debris, but provide a general estimate of cleanliness. Several different companies manufacture instru- ments or test kits to measure cleanliness. Check with your sanitation supplier or search the Internet using the terms ATP Testing or Luminometers. module 7 • page 31 of 44 Monitoring The Effectiveness of Your Proce- dures Bacterial Testing: In some situations, you may want to know if bacteria have survived the cleaning and sanitizing process on surfaces. Test kits, such as contact plates, are available for some types of bacteria. These plates are touched to the surface to be tested and stored at the proper temperature for one or more days. The plates are visually checked to estimate the number of bacteria that were on the surface. For some food products, there may be specific requirements for testing for certain types of bacteria like Listeria, E. coli, or Salmonella. Food testing laboratories can provide the necessary sup- plies to take appropriate samples and determine if these bacteria are present. Resource Information: One useful resource for information on commercial test kits for different types of bacteria can be found on the Internet in the Compendium of Fish and Fishery Product Processes, Hazards, and Controls at the University of California at Davis. For information on testing for different types of bacteria click here. When you get to this site, click on the organism or test of interest in the Biological Hazards section, and then click on commercial test kits. module 7 • page 32 of 44 GMP Requirements for Cleaning and Sanitizing Now that you have a basic understanding of how to clean and sanitize your facility and measure the effectiveness of your program, complying with the GMP requirements should be easy. Let’s take a look at those requirements and what you can do to meet them. GMP Requirement: General maintenance. Buildings, fixtures and other physical fa- cilities of the plant shall be maintained in a sanitary condition and shall be kept in repair sufficient to prevent food from becoming adulterated. Cleaning and sanitizing of utensils and equipment shall be conducted in a manner that protects against the contamination of food, food-contact surfaces, or food packaging materials. Maintenance: The first part of this GMP requirement says that not only your building, but also everything in the facility must be kept in a sanitary condition to prevent the food that you receive, process or store from getting contaminated. The control strategies that we reviewed earlier for the maintenance of your facility, its equipment, and your employee’s practices in Modules 3, 4, 5 and 6 are included in the GMP to make sure that you can maintain your facility in a sanitary condition. To comply with this part of the GMP you also need to have procedures to clean and sanitize those parts of your facility that may not come in direct contact with food, but may eventually lead to food or food contact surface contamination if they are not kept in a sanitary condi- tion. Cleaning and Sanitizing Equipment and Utensils: The second part of this GMP re- quirement says that you must clean and sanitize your equipment and utensils in a way that will protect your food and anything that comes into contact with food from contami- nation. This will require that the procedures that are routinely used to clean and sanitize equipment and utensils will not contaminate any food in your facility. For example, this is why it is necessary to remove all food products from the area before you begin your cleaning procedures. module 7 • page 33 of 44 Sanitation of Food Contact Surfaces GMP Requirement: Sanitation of food contact surfaces. All food contact surfaces, in- cluding utensils and food contact surfaces of equipment, shall be cleaned as frequently as necessary to protect against contamination of food. Food Contact Surfaces: This part of the GMP focuses on all of the things in your opera- tion that will come into contact with food. These food contact surfaces include things like: cutting boards, food preparation tables, conveyor belts, processing machinery, knives, spoons, other utensils, pans, tubs, totes, ice and any other item that will come in direct contact with food during handling, processing, or storage. Frequency of Cleaning: This GMP requirement says that all food contact surfaces must be cleaned as frequently as necessary to prevent contamination. There is no rule for deciding how often it is necessary to clean all of the different pieces of equipment or uten- sils in your plant that may come in contact with food. Most food contact surfaces should be cleaned at a minimum of once a day depending on the food being processed. In some cases equipment and utensils may need to be cleaned after every use. Also, if a piece of equipment is accidently contaminated by the plant environment itself, it would need to be cleaned. For example, if someone uses a high pressure hose to clean the floor, and the water from the dirty floor splashes onto cleaned food contact surfaces, those food contact surfaces would need to be re-cleaned and re-sanitized before they are used. Factors that Effect Frequency Can Include: • The type of food. • Whether the processing environment is wet or dry. • The ambient temperature in the processing area. Every operation must determine how often cleaning and sanitizing is necessary based on their processing activities, the types of equipment used, and most importantly on the food that is being processed. For example, if you are processing a ready-to-eat product (a food that will not be cooked before it is eaten) then cleaning and sanitizing may need to be done more frequently to prevent these foods from being contaminated by harmful bacteria like Listeria. module 7 • page 34 of 44 Special Requirements for Low Moisture Foods and Wet Processing GMP Requirement: Food contact surfaces used for manufacturing or holding low moisture food shall be in a dry, sanitary condition at the time of use. When the surfaces are wet-cleaned, they shall, when necessary, be sanitized and thoroughly dried before subsequent use. GMP Requirement: In wet processing, when cleaning is necessary to protect against the introduction of microorganisms into food, all food contact surfaces shall be cleaned and sanitized before use and after any interruption during which the food contact surfaces may have become contaminated. Where equipment and uten- sils are used in a continuous production operation, the utensils and food contact surfaces of the equipment shall be cleaned and sanitized as necessary. The GMP has special requirements for two different types of food that can help you decide both how and how often food contact surfaces should be cleaned and sanitized. Low moisture foods are foods like grain or cereal products, baked goods, and dried foods that have a low amount of moisture. Because there is not enough water available in these foods, harmful microorganisms cannot grow. We will discuss the appropriate mois- ture content for these foods further in our review of process controls in Module 10. This part of the GMP requires that equipment, utensils or other items that come in contact with these foods must be dry to prevent these foods from absorbing moisture. It also states that if this equipment is wet cleaned, it must be thoroughly dried before it is used. Wet processing activities are generally used for foods like seafood, meat, poultry, fruits, and vegetables. Because it is much easier for contaminants like bacteria and other micro- organisms to contaminate food contact surfaces in a wet environment, this GMP require- ment says that firms that receive, store or process these foods must clean and sanitize equipment, utensils and any other food contact surface before it is used and after any interruption in processing activities that could have caused them to get contaminated. For continuous operations, the GMP requires processors to use good judgment to decide how often it is necessary to clean and sanitize equipment to prevent contamination. module 7 • page 35 of 44 Non-Food Contact Surfaces of Equipment GMP Requirement: Non-food contact surfaces of equipment used in operation of food plants should be cleaned as frequently as necessary to protect against the contami- nation of food. The GMP also requires that the parts of equipment that do not routinely come in con- tact with food must also be cleaned as often as necessary to prevent contamination. This requirement is included because of the potential for dirty water and harmful bacteria or other microorganisms to be easily transferred to the parts of the equipment that do come in contact with food when it is being used. Each operation must evaluate the equipment that they use and determine how and when non-food contact parts of equipment need to be cleaned. For some items such as knives, both food and non-food contact parts are likely to be cleaned and sanitized at the same time. For large pieces of processing machinery it may be necessary to clean or sanitize food contact surfaces once or more per day, but other parts that do not come in direct contact with food may only need to be cleaned and sanitized every few days or once per week, depending on how they are used and the likelihood of contamination. module 7 • page 36 of 44 Storage of Cleaned Equipment & Single Service Articles GMP Requirement: Storage and handling of cleaned portable equipment and utensils. Cleaned and sanitized portable equipment and utensils should be stored in a lo- cation and manner that protects food contact surfaces from contamination. GMP Requirement: Single service articles (such as utensils intended for one time use, paper cups and paper towels) should be stored in appropriate containers and shall be handled, dispensed, used, and disposed of in a manner that protects against contamination of food or food contact surfaces. These two parts of the GMP are included to make sure that equipment, utensils, and other food contact surfaces are stored properly after they are cleaned and sanitized so that they do not become contaminated before they are used. Disposable or single-use items must also be stored properly to prevent contamination that could be transferred to food. Proper Storage Conditions: Cleaned equipment and utensils should be stored in a lo- cation that will allow them to dry and prevent them from getting contaminated by work activities or the plant environment. At a minimum, cleaned items should never be stored on the floor, which is likely to be the dirtiest part of the plant. Cleaned items should be stored in a way that will prevent water from splashing or dripping on them. For reference, the FDA Food Code requires cleaned equipment, utensils, single use items, and laundered linens to be stored at a minimum of 6 inches above the floor. Items that have been wet cleaned should be stored in a dry environment, turned upside down or otherwise allowed to drain and protected from dust. module 7 • page 37 of 44 Equipment Storage GMP TV: Click on the GMP TV below to learn more about proper storage of cleaned equip- ment, utensils or other items that come in direct contact with food. module 7 • page 38 of 44 What You Can Do To meet the general GMP requirements for cleaning and sanitizing food contact surfaces, equipment, utensils, and non-food contact surfaces in the plant environment as necessary you need to: Develop sanitation procedures for equipment, utensils, containers, processing areas, and all other plant facilities as necessary. These procedures must be effective but the GMP does not currently require that they be written down. A complete sanitation procedure should describe: • What areas of your facility and what equipment and utensils need to be cleaned and sanitized. • How each item or area will be cleaned and sanitized including: • The chemical cleaning and sanitizing products to be used. • Instructions on how to prepare cleaning and sanitizing solutions properly and test or verify their concentration. • Instructions on how to apply these solutions. • The cleaning tools to be used for each task. • Instructions for each of the steps in the procedure and their proper order or se- quence. • Instructions for proper storage of cleaned equipment. • 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 por- table items and utensils that are cleaned and sanitized in a three-compartment sink. Implement each of the cleaning and sanitation procedures that are needed. Imple- mentation 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 prop- erly and consistently. Monitoring could include testing to verify that the procedures developed are effective. module 7 • page 39 of 44 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 rou- tinely checked to be sure that they are conducted properly and at the proper time as described in your sanitation procedure. This may include monitor- ing 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. module 7 • page 40 of 44 Use Safe and Effective Cleaners and Sanitizers GMP Requirement: Sanitizing agents shall be adequate and safe under conditions of use. Any facility, procedure, or machine is acceptable for cleaning and sanitizing equipment and utensils if it is established that the facility, procedure, or machine will routinely render equipment and utensils clean and provide adequate cleaning and sanitizing treatment. 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 con- ditions of use. Compliance with this requirement may be verified by any effective means including purchase of these substances under a supplier’s guarantee or certification, or examination of these substances for contamination. These two sections of the GMP require that the sanitizing agents used in food establish- ments 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. module 7 • page 41 of 44 Use Safe and Effective Cleaners and Sanitizers Use Approved Sanitizers: There are specific regulations that identify what sanitizing so- lutions are acceptable. This regulation is found in Part 178 of Title 21 of the Code of Fed- eral Regulations. Part 178.1010 states that: Sanitizing solutions may be safely used on food processing equipment and utensils, and on other food contact articles within the following conditions: a: Sanitizing solutions are used, followed by adequate draining, before contact with food. b: The solutions consist of one of the following, to which may be added components that are generally regarded as safe or components which are permitted by prior sanction or approval. The remaining section of this regulation describes 46 different acceptable sanitizing solutions and the minimum concentrations of active sanitizer that are needed for each type. The U.S. Environmental Protection Agency (EPA) also has regulations related to sanitizers in Part 180 of Title 40 of the Code of Federal Regulations. This regulation describes EPA tolernace exemptions for active and inert ingredients for use in anti-microbial formula- tions. Food contact surface sanitizing solutions can be found in section 180.940. Click on the buttons below to see these regulations. Use your browsers BACK button at the top of the screen to return to this module. 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 sanitiz- ing. Standard cleaning and sanitizing procedures identified in reference information from government, university, or trade associations should be acceptable if implemented prop- erly. 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 manu- facturer indicating that it provides adequate cleaning and sanitizing consistent with cur- rent regulations if used according to instructions. module 7 • page 42 of 44 What You Can Do To meet the GMP requirements to use safe and effective cleaning and sanitizing agents that are free from harmful microorganisms you need to: Evaluate all cleaning and sanitizing agents used in your facility to determine if they are approved for use in food establishments. Obtain written documentation from the manufacturer or supplier of your cleaning and sanitizing chemicals to verify that these products meet current regulations and are approved for use in food establishments. Check your procedures to verify that they are consistent with manufacturer rec- ommendations and label directions for the proper use of all cleaning and sanitizing products including test kits to verify sanitizer concentration. Monitor chemical deliveries to verify that the proper products are received, that the proper documentation is on file, and that the instructions for use have not changed. 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 clean- ing 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. module 7 • page 43 of 44 Checklist Questions for GMP Requirements in Module 7 In Module 7 we reviewed the GMP requirements for: the sanitary condition of the building and facilities; selecting and using cleaning and sanitizing chemicals; proper cleaning and sanitizing procedures for food contact surfaces, equipment, utensils and facilities; and the proper storage and handling of cleaned and sanitized equipment and utensils. We have compiled the items from the What You Can Do sections of this Module into a simplified se- ries of questions to help you create a list of things that you may need to do to meet these GMP requirements. Use this list to remind yourself to: • Evaluate the status or condition of your existing facilities or systems, and to develop a plan to make any changes that are needed. • Create new procedures or change existing procedures if necessary. • Develop new monitoring procedures or change your existing procedures. To download the Checklist below as a PDF file that you can print, click on the button. Download Module 7 Checklist and Internet Resources Cleaning and Sanitizing Procedures Do you have cleaning and sanitizing procedures for all food contact surfaces, equip- ment, utensils, processing lines, conveyors, storage units, and non food contact sur- faces and facilities that describe: • What cleaning and sanitizing chemicals will be used? • How the proper solutions will be prepared and the concentration will be checked? • How cleaning and sanitizing solutions will be applied and what cleaning tools should be used? • The proper sequence of steps for each cleaning and sanitizing procedure? • When these procedures will be conducted? • Who will conduct these procedures? module 7 • page 43 of 44 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 us- ing visual inspections and testing if necessary? Do you need to develop new monitor- ing procedures or modify existing ones? Cleaning and Sanitizing Agent Do you have documents from suppliers of cleaning and sanitizing chemicals that demonstrate that they comply with all current regulations for use in food establish- ments and are safe to use? If not, what documents are needed and how can you obtain them? Do you have written or label instructions that describe how to use and store all clean- ing and sanitizing chemicals properly? If not what information is needed and how can you obtain it? Do you have procedures to check all deliveries of cleaning and sanitation chemicals to make sure that they are what were ordered and that all of the necessary instructions and documentation are on file? If not, what procedures are needed and how will they be developed? module 7 • page 44 of 44 Check Your Knowledge This concludes the study material for Module 7. You now need to review the 6 ques- tions for this Module, find the correct answer to each question, and submit your answers while you are logged into the course with your Username and Password. Each of the following pages has a single question that will appear on your screen. Click on the answer you think is correct. You will see a text box that will tell you if this answer is correct or wrong and why. When you find the correct answer, be sure to write down the question number and the correct answer. Then move on to the next question. Click on the Forward button at the top of this page to go to the first question.
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