module 7 •  page 1 of 44Sanitary Operations: Cleaning and SanitizingIn Module 5 we outlined the need to design, constructa...
module 7 •  page 2 of 44DefinitionsThe GMP requires that you keep your facility and all equipment, utensils and food conta...
module 7 •  page 3 of 44How To CleanRemove Soil: Let’s start with cleaning, which is the process of removing the soil from...
module 7 •  page 4 of 44Use The Right ToolsWhether you use a manual or clean-in place system, developing an effective clea...
module 7 •  page 5 of 44Water Is Essential For CleaningWater Quality: You must have anadequate water supply to clean soile...
module 7 •  page 6 of 44Detergents and Their UseNow that you have determined that you must have an adequatesupply of potab...
module 7 •  page 7 of 44How Detergents or Cleaners WorkIn order to select the right detergent for the right job, itis nece...
module 7 •  page 8 of 44Biofilms and DetergentsBiofilms: Sometimes, no matter what you do to clean, sometypes of bacteria ...
module 7 •  page 9 of 44Choose An Effective Cleaner That Won’tDamage EquipmentWhile it is important to use a detergent tha...
module 7 •  page 10 of 44Cleaning BasicsFor both manual and CIP cleaning, there are several factors that need to be consid...
module 7 •  page 11 of 44Cleaning BasicsTemperature: As discussed earlier, eachdetergent has an optimum temperatureat whic...
module 7 •  page 12 of 44Cleaning Tools and ScrubbingScrubbing is Essential: There are no detergents that are ideal for ev...
module 7 •  page 13 of 44Cleaning ToolsDesign Considerations: Since scrubbing is such animportant part of the cleaning pro...
module 7 •  page 14 of 44Cleaning ToolsGMP TV: Click on the images in the GMP TV below for additional information on clean...
module 7 •  page 15 of 44Foam Application SystemsNot all equipment can be washed or soaked in a sink. If you are cleaning ...
module 7 •  page 16 of 44Foam Application SystemsGMP TV: Click on the Photos in the GMP TV below to learn more about diffe...
module 7 •  page 17 of 44Clean-In-Place SystemsFor some types of cleaning jobs, neither manual orfoaming application of a ...
module 7 •  page 18 of 44Other Types of Cleaning Equipment andPressure WashingCleaning Machines: Some food processing faci...
module 7 •  page 19 of 44Sanitizing or DisinfectionAfter cleaning, you need to apply a sanitizer to killany bacteria or ot...
module 7 •  page 20 of 44Choosing A SanitizerUsing Sanitizers: Just like detergents, there are also many different types o...
module 7 •  page 20 of 44Hot Water                          Kills most microorganisms               May form films or scal...
module 7 •  page 21 of 44Using Sanitizers CorrectlyJust like detergents, sanitizers must be used and applied properly or t...
module 7 •  page 22 of 44Use The Right Amount ofSanitizerConcentration: Sanitizer concentration is measured in ppmor parts...
module 7 •  page 23 of 44Measuring Sanitizer ConcentrationTest Strips or Kits: Your chemical supplier should be able to pr...
module 7 •  page 24 of 44Using Sanitizers ProperlySanitizers, just like detergents, aren’t effective if they are not used ...
module 7 •  page 25 of 44Using Sanitizers ProperlyOrganic material: Sanitizers like chlorinewill react with the organic ma...
module 7 •  page 26 of 44Additional ResourcesIf you would like to learn more technical details about cleaning and sanitizi...
module 7 •  page 27 of 44Basic Cleaning and Sanitizing ProcedureSo far this module has discussed the things you should con...
module 7 •  page 28 of 44Developing Your Cleaning and SanitizingProceduresGeneral Components: You can use the information ...
module 7 •  page 29 of 44Developing Your Cleaning and SanitizingProceduresSet Up A Schedule: You must alsodecide when and ...
module 7 •  page 30 of 44Monitoring The Effectiveness of YourProceduresMonitoring: Because cleaning and sanitizing is soim...
module 7 •  page 31 of 44Monitoring The Effectiveness of Your Proce-duresBacterial Testing: In some situations, you maywan...
module 7 •  page 32 of 44GMP Requirements for Cleaning andSanitizingNow that you have a basic understanding of how to clea...
module 7 •  page 33 of 44Sanitation of Food Contact SurfacesGMP Requirement: Sanitation of food contact surfaces. All food...
module 7 •  page 34 of 44Special Requirements for Low MoistureFoods and Wet ProcessingGMP Requirement: Food contact surfac...
module 7 •  page 35 of 44Non-Food Contact Surfaces of EquipmentGMP Requirement: Non-food contact surfaces of equipment use...
module 7 •  page 36 of 44Storage of Cleaned Equipment & SingleService ArticlesGMP Requirement: Storage and handling of cle...
module 7 •  page 37 of 44Equipment StorageGMP TV: Click on the GMP TV below to learn more about proper storage of cleaned ...
module 7 •  page 38 of 44What You Can DoTo meet the general GMP requirements for cleaning and sanitizing food contact surf...
module 7 •  page 39 of 44How To MonitorPeriodic checks of the condition of thefacility, equipment and utensils shouldbe co...
module 7 •  page 40 of 44Use Safe and Effective Cleaners andSanitizersGMP Requirement: Sanitizing agents shall be adequate...
module 7 •  page 41 of 44Use Safe and Effective Cleaners and SanitizersUse Approved Sanitizers: There are specific regulat...
module 7 •  page 42 of 44What You Can DoTo meet the GMP requirements to use safe and effective cleaning and sanitizing age...
module 7 •  page 43 of 44Checklist Questions for GMP Requirementsin Module 7In Module 7 we reviewed the GMP requirements f...
module 7 •  page 43 of 44  	 Do you need to develop any new procedures or use new chemicals, delivery methods,    or clean...
module 7 •  page 44 of 44Check Your KnowledgeThis concludes the study material for Module 7. You now need to review the 6 ...
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Cleaning and Sanitizing

  1. 1. module 7 • page 1 of 44Sanitary Operations: Cleaning and SanitizingIn Module 5 we outlined the need to design, constructand use food processing equipment and utensils that areeasy to clean. In this module we will discuss the part ofthe 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 thisModule. We’ll continue to use the GMP TV to provide some examples of good and badpractices.
  2. 2. module 7 • page 2 of 44DefinitionsThe GMP requires that you keep your facility and all equipment, utensils and food contactsurfaces clean and sanitary, but it does not tell you how to do it. So we will begin thisModule with detailed information on how to properly clean and sanitize and then followwith a discussion of the specific GMP requirements.Before we discuss how to clean and sanitize, it is important to understand the definitionsof 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 mechanicalor detergent scrubbing actions, followed by rinsing.Sanitizing means the application of a chemical or heat to a clean surface that will killmicroorganisms. The definitions section of the GMP regulation states that: Sanitize meansto 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 reducingnumbers of other undesirable microorganisms, but without adversely affecting the productor its safety for the consumer.Food contact surfaces are defined in the GMP as those surfaces that contact humanfood and those surfaces from which drainage onto the food or onto surfaces that contactthe food ordinarily occurs during the normal course of operations. Food-contact surfacesinclude utensils and food-contact surfaces of equipment. Because food contact surfacesrepresent the highest risk of direct food contamination, they may need to be cleaned andsanitized more often and more vigorously than other areas of your processing facility.Food contact surfaces may include employee garments, gloves, and hands in addition toequipment and utensils.
  3. 3. module 7 • page 3 of 44How To CleanRemove Soil: Let’s start with cleaning, which is the process of removing the soil fromthe plant and processing equipment. The soil that we want to remove can include fooddebris 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 bacteriacan 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 loseits effectiveness against bacteria unless food debris has been completely removed fromequipment 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 usesre-circulation of cleaning and sanitizing solutions. This method is used for equipment thatcannot be easily broken down for cleaning.
  4. 4. module 7 • page 4 of 44Use The Right ToolsWhether you use a manual or clean-in place system, developing an effective cleaning andsanitizing 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.
  5. 5. module 7 • page 5 of 44Water Is Essential For CleaningWater Quality: You must have anadequate water supply to clean soiledequipment. A desirable water sup-ply must be free of microorganisms(clean and potable), have a neutralpH (near pH 7), and a low mineralcontent. Some firms may have totreat their water to achieve thesequalities. A good water supply in-cludes both an adequate amount ofhot and cold water and adequatewater pressure.Water Temperature: The tempera-ture of the water is also important.Some cleaners may not be effectiveif the water is too hot or too cold.Check the label on the cleaner thatyou use to see if the manufacturerrecommends an appropriate watertemperature. The GMP requirements for delivering hot and cold water to conduct cleaningand sanitizing activities were covered in Module 4.Pre-Cleaning: Before you use water for cleaning equipment, you need to remove largeparticles and any heavy soil that has built up during food handling or processing. You cando this by physically removing large scraps of food and by scraping any areas that havefood debris that is difficult to remove. If you don’t remove the heavy soil, you will end uptrying to wash utensils and equipment in a soupy mixture of water, food debris, and deter-gent - a very ineffective way of cleaning.
  6. 6. module 7 • page 6 of 44Detergents and Their UseNow that you have determined that you must have an adequatesupply of potable water at a suitable temperature and with enoughpressure, you need to decide on what type of detergent you willuse. 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. Somereduce the hardness or alkalinity of the water, others tie up metalsin the water, which increases wetting ability, and some make fatseasier to dissolve in water. It is important to check the label instructions and match thedetergent to the type of soil to be removed. There are many different products availableand you should consult with your supplier to find the right product for your situation.
  7. 7. module 7 • page 7 of 44How Detergents or Cleaners WorkIn order to select the right detergent for the right job, itis necessary for you to understand just how detergentswork. Most detergents are composed of a mixture of in-gredients that are formulated for specific types of dirt orfood residue.Basic Ingredients: Certain ingredients in the detergentmake the residue that you are trying to remove dissolvebetter in water. Most detergents are designed to workbest in hot or warm water. One ingredient in many deter-gents is called a surfactant, which binds equally well towater and fats or oils. These ingredients promote physicalcleaning by helping to wet, foam, and dissolve the fooddebris to be removed so that it can be washed away withwater.Chemical Agents: Other ingredients are either alkalineor acidic, and are designed to chemically remove certaintypes of soil or food debris. For example, alkaline ingredi-ents like strong caustic soda or potash, or milder agentslike phosphates are used to remove fatty material. Theybind to fat to form soap, which can then be washed awaywith water. Other detergents that contain weak or strongacids dissolve mineral deposits, which can then be washedaway with water.Special Additives: Additional ingredients may be added to some products to make themmore effective for specific types of cleaning. Foods like milk that are high in protein can bevery 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.
  8. 8. module 7 • page 8 of 44Biofilms and DetergentsBiofilms: Sometimes, no matter what you do to clean, sometypes of bacteria can produce a substance that protects themfrom their environment and helps them to stick to food contactsurfaces. These bacterial communities are known as biofilms. Ifa biofilm develops on a food contact surface, it cannot be eas-ily seen or detected and it is very difficult to remove. Harmfulbacteria can be dislodged from the biofilm during processing andcontaminate food products.Removing Biofilms: Specially formulated detergents that con-tain an oxidizing agent such as chlorine or peroxide, in additionto other ingredients, may be needed to remove these biofilms.There are many different cleaning products available for use infood processing plants. You should talk to your supplier to de-termine what products will be most effective for your particularneeds. Once you determine what products to use, it is important to remember to follow allmanufacturers directions when using them and make sure that they are stored properly.
  9. 9. module 7 • page 9 of 44Choose An Effective Cleaner That Won’tDamage EquipmentWhile it is important to use a detergent that willremove all dirt and food debris, you also need toconsider the type of surface you are trying to clean.Caustic alkaline or acidic cleaners may be effectivein removing food debris, but they can also be cor-rosive to softer metals such as aluminum, copper, orlower grades of steel. Stress cracking and cloudingcan also occur when hard plastics are exposed tocorrosive cleaning agents for prolonged periods oftime. Higher grades of stainless steel are likely to bemore resistant to corrosion over time, which is whyit is a preferred material for handling foods that areacidic, salty, or high in fat or water.If cleaning agents cause the surfaces that are beingcleaned to deteriorate, it will be much more difficult to keep them clean. For this reasonit is important to use cleaning agents that are effective and get the job done, but are notso aggressive that they pit, crack, rust, corrode or otherwise damage your food contactsurfaces. Contaminated food is eaten by customers Foodborne illness occurs and customers get sick
  10. 10. module 7 • page 10 of 44Cleaning BasicsFor both manual and CIP cleaning, there are several factors that need to be consideredincluding: contact time, temperature, concentration, and scrubbing. Let’s reviewthem.Contact time: Detergents or cleaners do not work instantly. It takes time for them topenetrate the soil or food debris on the food contact surface that you want to clean. Thatis why a dirty pan is easier to clean after it has been soaked in warm soapy water. Youneed to consider how cleaning agents will be applied, and how long they need to stay incontact with the item to be cleaned. The “directions for use” on the label of your cleaningagent should outline recommended dilutions and contact time. You should always refer tothese directions when using any cleaner.Soaking: If you need to extend contact time, the most common way is to use a soak tankor sink for portable items such as utensils, pans, cutting boards and other small pieces ofequipment. Each item can be soaked in a solution of the detergent and warm water for aslong as necessary. This is one reason why most state and local regulatory agencies requirea 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 ofequipment, walls, and other vertical surfaces which require an extended contact timemight need to be cleaned using a foam application - which will be discussed later.
  11. 11. module 7 • page 11 of 44Cleaning BasicsTemperature: As discussed earlier, eachdetergent has an optimum temperatureat which it performs the best. If the watertemperature is too cold, the detergent maynot work properly. If the temperature is toohigh, soil could be baked onto equipment.Some detergents tend to degrade at higherwater temperatures.Concentration: There is an optimal concen-tration of detergent for each cleaning task.Again, check the “directions for use” on thecontainer when deciding how much to use.Scrubbing: Manual cleaning requires water,a detergent, and a physical scrubbing actionin order to release the food debris that yourdetergent has loosened. It is not enough just to pour water with detergent on the surfaceof the equipment to be cleaned. You must also use some sort of brush, pad or other tooland physical labor!
  12. 12. module 7 • page 12 of 44Cleaning Tools and ScrubbingScrubbing 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 dirtand food debris, but scrubbing is usually necessary to finish the job. This is especially trueif the soil has dried or been cooked onto the surface. For most situations you will need toscrub the item or surface to be cleaned with a brush, pad or other cleaning tool to loosenall 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 attwo of the most common types, and some of the things to consider when deciding whichtools to use.Brushes should be designed for use in food operations and constructed of a material thatis 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 maybe appropriate for flat or difficult to clean surfaces. Softer bristles may be needed to cleancurved surfaces or things that may be susceptible to scratching.Pads are popular cleaning aids. They can be used for many different tasks because theyreadily conform to the surface being cleaned and may only require light pressure to loosenfood 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 establishmentsand made of a synthetic material that will not be damaged by cleaning chemicals. It isimportant 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 causedamage such as scratching and rusting. This damage could increase the chance thatbacteria will attach to the surface and form a biofilm, which could then contaminate foodproducts over time with harmful bacteria or other microorganisms.
  13. 13. module 7 • page 13 of 44Cleaning ToolsDesign Considerations: Since scrubbing is such animportant part of the cleaning process, you shouldalso consider how easy your cleaning tools are touse. For some cleaning tasks, brushes with longhandles can make scrubbing easier and for othersmore difficult. Cleaning tools that are awkward orcause user fatigue may decrease your employee’smotivation to clean as thoroughly as possible.Tools to Avoid: Some cleaning tools such assponges, wiping cloths and mops should neverbe used for routine cleaning in food plants. Theseitems are very difficult to clean and sanitize. Theyalso retain moisture and water which will promotethe growth of bacteria that could contaminate thesurface or item that you think you are cleaning. Disposable, single-use paper towelsshould 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. Cleaningtools 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 neverbe used on equipment or food contact surfaces. Using different colored cleaning tools fordifferent jobs can be an effective way to make sure that the right tool is used for the rightjob. This concept will be discussed in more detail in Module 8.
  14. 14. module 7 • page 14 of 44Cleaning ToolsGMP TV: Click on the images in the GMP TV below for additional information on cleaningtools.
  15. 15. module 7 • page 15 of 44Foam Application SystemsNot all equipment can be washed or soaked in a sink. If you are cleaning large pieces ofequipment 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 detergentthat has the consistency of shaving cream when it is applied. The foam tends to cling tovertical surfaces to allow enough contact time for the detergent to do its work. This typeof application can also produce a consistent detergent concentration, and is highly visibleto 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 whenusing foam detergents is that you need an applicator, the foam needs a certain amount ofcontact time, and you may still need to manually scrub the equipment for the detergentto 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 inthe GMP TV on the next page.
  16. 16. module 7 • page 16 of 44Foam Application SystemsGMP TV: Click on the Photos in the GMP TV below to learn more about different types offoam applications.
  17. 17. module 7 • page 17 of 44Clean-In-Place SystemsFor some types of cleaning jobs, neither manual orfoaming application of a detergent would be effec-tive. This is usually the case for closed processingsystems such as heat exchangers, valves, pipes orfluid lines used to convey milk or other liquid foodproducts. These types of food processing systemsare typically cleaned without disassembling eachsection using the second method of cleaning thatwas briefly mentioned before - a Clean-In-Place orCIP system.For CIP systems, specially formulated low foamingdetergents are usually required for cleaning. Thesedetergent solutions are pumped through equipmentlines at pre-determined intervals for routine cleaning. It may be necessary to periodicallydisassemble 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.
  18. 18. module 7 • page 18 of 44Other Types of Cleaning Equipment andPressure WashingCleaning Machines: Some food processing facilities may use special types of cleaningequipment such as automated dishwashers, tote washers, rack washers, or other types ofcleaning cabinets. This equipment should be operated according to the manufacturers direc-tions and properly maintained so that it cleans your equipment adequately without damagingit. The FDA Food Code and most local and state regulations have specific requirements forthe 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 cleanedareas. 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 containsthe 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 alreadybeen cleaned. This problem will be even worse if high pressure is directed at or near floordrains, which are likely to contain harmful bacteria.Summary: Whether you are using a manual or CIP system, you need to choose the rightdetergent and application system for the types of soils and equipment at your facility. Youshould always check the directions on the label of your detergents to make sure that you areusing 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 theywill not contaminate the food you are receiving, storing or processing.
  19. 19. module 7 • page 19 of 44Sanitizing or DisinfectionAfter cleaning, you need to apply a sanitizer to killany bacteria or other microorganisms that may still bepresent. Remember, sanitizers are less effective whenfood debris is present. Food contact surfaces must becompletely free of food residue before sanitizers areapplied.Traditionally the words disinfect and disinfectantswere used to respectively describe the procedures andagents used to kill microorganisms and reduce theirnumbers to a safe level. In the GMP regulation, and inthis course, the word sanitize has the same meaningas disinfect, and the disinfectants or agents used to killharmful 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 otherparts of the plant.
  20. 20. module 7 • page 20 of 44Choosing A SanitizerUsing Sanitizers: Just like detergents, there are also many different types of sanitizers that canbe used in food processing facilities. By law, you can only use chemical sanitizers that have beenapproved for use in food facilities, and specific requirements or regulations may vary from state tostate. As always, it is essential that you follow directions provided on the manufacturers label, andthat the chemicals are stored properly. If not used properly, sanitizers could make the food youproduce 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 thischart for future reference. (24k pdf)Type of Sanitizer Advantages DisadvantagesChlorine 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 temperatureIodine 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 residueQuaternary Ammonium Non corrosive Inactivated by most detergentsCompounds 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 CIPChlorine 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 chlorineOzone 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 materialPeroxy 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
  21. 21. module 7 • page 20 of 44Hot Water Kills most microorganisms May form films or scale on equipment171 to 190ºF (77 to 88ºC) Penetrates irregular surfaces Potential burn hazard for employees Suitable for CIP Contact time sensitive Relatively inexpensive Inappropriate for general sanitationCarboxylic 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 sensitiveAcid-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 waterAdapted from Sanitation Control Procedures Manual, National Seafood HACCP Alliance, Florida Sea Grant Re-port No. 119, Gainesville, FL, 2000.
  22. 22. module 7 • page 21 of 44Using Sanitizers CorrectlyJust like detergents, sanitizers must be used and applied properly or they will either beineffective 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 Part178.1010 give the maximum amount of active sanitizer that should be used in food pro-cessing establishments. The following table gives the maximum concentration allowed andthe most commonly used concentration range for common sanitizers.Sanitizer Concentrations Commonly Used in Food Processing FacilitiesSanitizer 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 FCSIodine 12.5 to 25 ppm 5 or less 75°F or 24°C Maximum 25 ppm for FCSQuats 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 FCSChlorine dioxide 100 to 200 ppm Maximum 200 ppm for FCSPeroxy 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 178.1010Maximum and minimum concentration values for Food Contact Surfaces (FCS) are specified in approved sanitizer formulasin 21 CFR 178.1010, Sanitizing Solutions. pH and minimum temperatures are from the 2001 FDA Food Code. Contact timeis at least 1 minute. Table adapted from FDA Food Code and Sanitation Control Procedures Manual, National Seafood HACCPAlliance, Florida Sea Grant Report No. 119, Gainesville, FL, 2000.
  23. 23. module 7 • page 22 of 44Use The Right Amount ofSanitizerConcentration: Sanitizer concentration is measured in ppmor parts per million. This is an extremely small amount of ac-tive sanitizer. To help you appreciate just how small this is, 100parts 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 havethe proper amount of sanitizer, you need to carefully follow thedirections for use provided on the sanitizers’ label. Because theamount you need is so small, if even a little mistake is madewhen these solutions are prepared, the concentration could betoo 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 isprepared and periodically during use to make sure that you have the right concentrationso that the sanitizer will work properly.
  24. 24. module 7 • page 23 of 44Measuring Sanitizer ConcentrationTest Strips or Kits: Your chemical supplier should be able to provide an appropriate teststrip 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 solutionthat you have prepared for a certain amount of time, they will change color based on theamount of the active sanitizer in the solution. The final color of the strip is compared to acolor 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 measureiodine 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 tomeasure chlorine in the 100 to 200 ppm range, the strip you use should not measure inthe 0 to 10ppm range.GMP TV: Click on the GMP TV below to learn more about test strips that can be used tomeasure sanitizer concentrations.
  25. 25. module 7 • page 24 of 44Using Sanitizers ProperlySanitizers, just like detergents, aren’t effective if they are not used properly. You need toconsider contact time, water, organic material or the amount of soil present in thesolution, and their application. Let’s look at each of these factors.Contact Time: Just like detergents, sanitizers must be in contact with the cleaned surfacelong 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 contactsurfaces in order to be effective. Some sanitizer formulas may have different suggestedcontact times, and you should follow the directions on the sanitizers’ label. Sanitizers likeQuats may provide residual sanitizing activity over a longer period of time if the surface isnot 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 makeup the sanitizer solution. For example, chlorine is especially affected by pH and it will loseits effectiveness if used in very basic (alkaline) solutions. Again, it is important to checkthe 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 makeup sanitizer solutions.
  26. 26. module 7 • page 25 of 44Using Sanitizers ProperlyOrganic material: Sanitizers like chlorinewill react with the organic material in fooddebris that contains protein, fat or carbo-hydrate and make the sanitizer unavailableto kill bacteria and other microorganisms.That is why it is necessary to clean foodcontact surfaces to remove this soil beforethey are sanitized. If sanitizers are usedin solutions where employees are dippingtheir hands, the amount of available sani-tizer also decreases as organic materialbuilds up. For this reason you need to pe-riodically check the concentration of thesesolutions during the work day and changethem as often as necessary.Application: Just like detergents, you mayalso 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 easyto 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 ina way that will ensure that it is in contact with the surface for at least 1 minute or forthe time suggested by the manufacturer. Options can include portable sprayers or evenin-line metered systems that mix the proper amount of sanitizer and water. Applicationmethods and tools can often be provided by your chemical supplier.
  27. 27. module 7 • page 26 of 44Additional ResourcesIf 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 foodsafety 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 andcleaning suppliers across the U.S.
  28. 28. module 7 • page 27 of 44Basic Cleaning and Sanitizing ProcedureSo far this module has discussed the things you should consider when selecting cleaningand 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 abasic procedure for proper cleaning and sanitizing, and then identify any variations thatmay be needed for various areas of the plant, specific processing or storage equipmentlike refrigeration units, and portable equipment and utensils. Let’s look at the basic stepsthat should be included in a complete cleaning and sanitizing procedure.
  29. 29. module 7 • page 28 of 44Developing Your Cleaning and SanitizingProceduresGeneral Components: You can use the information provided in this Module to developeffective 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 thatthey be written down. Each procedure should include how and what you will clean andsanitize, where and when this will be done, and who will do it.Basic Procedures: The basic 10 Step procedure described on the previous page canbe 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 forcleaning 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 ofthe plant, for different pieces of equipment, or for different processing systems. You willalso 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 agentsand 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 ofthe facility or pieces of equipment. These different procedures should be included in yoursanitation procedure to be sure that employees who do routine or periodic cleaning andsanitizing tasks know exactly how to clean and sanitize each utensil, piece of equipment,or processing area.
  30. 30. module 7 • page 29 of 44Developing Your Cleaning and SanitizingProceduresSet Up A Schedule: You must alsodecide when and how often you needto clean and sanitize your facility and itsequipment and utensils. At a minimum,it is likely that all food contact surfaceswill need to be cleaned and sanitized atleast once per day, and those areas thatbecome dirty during processing mayneed to be cleaned and sanitized morethan once per day. Some areas or equip-ment such as refrigerated coolers, freez-ers, or dry storage areas may only needto be cleaned and sanitized periodically.Your procedure should describe wheneach routine and periodic task should becompleted. The goal of the GMP require-ment is to make sure that you protectfood from being contaminated with filth and harmful bacteria on unclean food contactsurfaces.Assign Tasks: Finally, your cleaning and sanitizing procedure should indicate who isresponsible 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 ofthe 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 hasa cleaning and sanitizing responsibility must be trained to understand why their task isimportant and how to do it properly.
  31. 31. module 7 • page 30 of 44Monitoring The Effectiveness of YourProceduresMonitoring: Because cleaning and sanitizing is soimportant to protect the food you are processingfrom 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 makesure that they are clean before food is handledand processed each day. Cleaning and sanitizingtasks should also be monitored routinely to makesure that the procedures you have developed arebeing conducted properly.Monitoring Tools: Because visual inspections aresubjective, 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 cleaningand sanitizing procedures. However, the GMP only requires that your sanitation proceduresbe 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 surfacethat has been cleaned and sanitized. The swab is then exposed to an enzyme solution thatreacts with a particular chemical in food debris and soil to produce light. The amount oflight produced is measured by an instrument that indicates how much organic materialwas 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 solutionthat reacts with the protein or sugar on the swab to produce a color that shows how wellthe surface was cleaned.These measurements do not distinguish between living bacteria and food debris, butprovide a general estimate of cleanliness. Several different companies manufacture instru-ments or test kits to measure cleanliness. Check with your sanitation supplier or searchthe Internet using the terms ATP Testing or Luminometers.
  32. 32. module 7 • page 31 of 44Monitoring The Effectiveness of Your Proce-duresBacterial Testing: In some situations, you maywant to know if bacteria have survived the cleaningand sanitizing process on surfaces. Test kits, suchas contact plates, are available for some types ofbacteria. These plates are touched to the surface tobe tested and stored at the proper temperature forone or more days. The plates are visually checkedto estimate the number of bacteria that were onthe surface. For some food products, there may bespecific requirements for testing for certain typesof bacteria like Listeria, E. coli, or Salmonella. Foodtesting laboratories can provide the necessary sup-plies to take appropriate samples and determine ifthese bacteria are present.Resource Information: One useful resource for information on commercial test kits fordifferent types of bacteria can be found on the Internet in the Compendium of Fish andFishery 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 thissite, click on the organism or test of interest in the Biological Hazards section, and thenclick on commercial test kits.
  33. 33. module 7 • page 32 of 44GMP Requirements for Cleaning andSanitizingNow that you have a basic understanding of how to clean and sanitize your facility andmeasure the effectiveness of your program, complying with the GMP requirements shouldbe 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 keptin repair sufficient to prevent food from becoming adulterated. Cleaning and sanitizingof utensils and equipment shall be conducted in a manner that protects againstthe contamination of food, food-contact surfaces, or food packaging materials.Maintenance: The first part of this GMP requirement says that not only your building, butalso everything in the facility must be kept in a sanitary condition to prevent the food thatyou receive, process or store from getting contaminated.The control strategies that we reviewed earlier for the maintenance of your facility, itsequipment, and your employee’s practices in Modules 3, 4, 5 and 6 are included in theGMP to make sure that you can maintain your facility in a sanitary condition. To complywith this part of the GMP you also need to have procedures to clean and sanitize thoseparts of your facility that may not come in direct contact with food, but may eventuallylead 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 waythat 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 sanitizeequipment and utensils will not contaminate any food in your facility. For example, thisis why it is necessary to remove all food products from the area before you begin yourcleaning procedures.
  34. 34. module 7 • page 33 of 44Sanitation of Food Contact SurfacesGMP Requirement: Sanitation of food contact surfaces. All food contact surfaces, in-cluding utensils and food contact surfaces of equipment, shall be cleaned as frequentlyas 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 directcontact with food during handling, processing, or storage.Frequency of Cleaning: This GMP requirement says that all food contact surfaces mustbe cleaned as frequently as necessary to prevent contamination. There is no rule fordeciding 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 shouldbe cleaned at a minimum of once a day depending on the food being processed. In somecases equipment and utensils may need to be cleaned after every use. Also, if a piece ofequipment is accidently contaminated by the plant environment itself, it would need to becleaned. For example, if someone uses a high pressure hose to clean the floor, and thewater from the dirty floor splashes onto cleaned food contact surfaces, those food contactsurfaces 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 ontheir processing activities, the types of equipment used, and most importantly on the foodthat is being processed. For example, if you are processing a ready-to-eat product (a foodthat will not be cooked before it is eaten) then cleaning and sanitizing may need to bedone more frequently to prevent these foods from being contaminated by harmful bacterialike Listeria.
  35. 35. module 7 • page 34 of 44Special Requirements for Low MoistureFoods and Wet ProcessingGMP Requirement: Food contact surfaces used for manufacturing or holding lowmoisture food shall be in a dry, sanitary condition at the time of use. When thesurfaces are wet-cleaned, they shall, when necessary, be sanitized and thoroughly driedbefore subsequent use.GMP Requirement: In wet processing, when cleaning is necessary to protect againstthe introduction of microorganisms into food, all food contact surfaces shall becleaned and sanitized before use and after any interruption during which thefood contact surfaces may have become contaminated. Where equipment and uten-sils are used in a continuous production operation, the utensils and food contactsurfaces 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 decideboth 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 driedfoods that have a low amount of moisture. Because there is not enough water available inthese 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. Thispart of the GMP requires that equipment, utensils or other items that come in contact withthese foods must be dry to prevent these foods from absorbing moisture. It also statesthat 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 sanitizeequipment, utensils and any other food contact surface before it is used and after anyinterruption in processing activities that could have caused them to get contaminated. Forcontinuous operations, the GMP requires processors to use good judgment to decide howoften it is necessary to clean and sanitize equipment to prevent contamination.
  36. 36. module 7 • page 35 of 44Non-Food Contact Surfaces of EquipmentGMP Requirement: Non-food contact surfaces of equipment used in operation of foodplants 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. Thisrequirement is included because of the potential for dirty water and harmful bacteria orother microorganisms to be easily transferred to the parts of the equipment that do comein contact with food when it is being used.Each operation must evaluate the equipment that they use and determine how and whennon-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 sametime. For large pieces of processing machinery it may be necessary to clean or sanitizefood contact surfaces once or more per day, but other parts that do not come in directcontact with food may only need to be cleaned and sanitized every few days or once perweek, depending on how they are used and the likelihood of contamination.
  37. 37. module 7 • page 36 of 44Storage of Cleaned Equipment & SingleService ArticlesGMP 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 shallbe handled, dispensed, used, and disposed of in a manner that protects againstcontamination of food or food contact surfaces.These two parts of the GMP are included to make sure that equipment, utensils, and otherfood contact surfaces are stored properly after they are cleaned and sanitized so that theydo not become contaminated before they are used. Disposable or single-use items mustalso 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 workactivities or the plant environment. At a minimum, cleaned items should never be storedon the floor, which is likely to be the dirtiest part of the plant. Cleaned items should bestored 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 launderedlinens to be stored at a minimum of 6 inches above the floor. Items that have been wetcleaned should be stored in a dry environment, turned upside down or otherwise allowedto drain and protected from dust.
  38. 38. module 7 • page 37 of 44Equipment StorageGMP 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.
  39. 39. module 7 • page 38 of 44What You Can DoTo meet the general GMP requirements for cleaning and sanitizing food contact surfaces,equipment, utensils, and non-food contact surfaces in the plant environment as necessaryyou 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.
  40. 40. module 7 • page 39 of 44How To MonitorPeriodic checks of the condition of thefacility, equipment and utensils shouldbe conducted as described in Modules3, 4, 5 and 6 to make sure that theyare in acceptable condition. Cleaningand sanitizing activities should be rou-tinely checked to be sure that they areconducted properly and at the propertime as described in your sanitationprocedure. This may include monitor-ing the proper use of detergents andcleaning aids, sanitizers, and cleaningand sanitizing procedures. Additionalperiodic checks using monitoring toolsfor cleanliness and/or tests for specifictypes of bacteria should be conductedas needed or required by regulationsfor certain types of food products. Although the current GMP does not require monitoringrecords, you may want to keep a record of the results of your observations for your ownuse. If any corrections are necessary to correct problems, those actions should also benoted on a written record.
  41. 41. module 7 • page 40 of 44Use Safe and Effective Cleaners andSanitizersGMP Requirement: Sanitizing agents shall be adequate and safe under conditions ofuse. Any facility, procedure, or machine is acceptable for cleaning and sanitizing equipmentand utensils if it is established that the facility, procedure, or machine will routinely renderequipment and utensils clean and provide adequate cleaning and sanitizing treatment.GMP Requirement: Substances used in cleaning and sanitizing. Cleaning compoundsand sanitizing agents used in cleaning and sanitizing procedures shall be freefrom undesirable microorganisms and shall be safe and adequate under the con-ditions of use. Compliance with this requirement may be verified by any effective meansincluding purchase of these substances under a supplier’s guarantee or certification, orexamination 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 thatthe products that you are using are acceptable and free of contamination from undesirablemicroorganisms.
  42. 42. module 7 • page 41 of 44Use Safe and Effective Cleaners and SanitizersUse 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, andon 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 sanitizersin Part 180 of Title 40 of the Code of Federal Regulations. This regulation describes EPAtolernace 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 atthe top of the screen to return to this module.FDA-Approved Sanitizers in 21 CFR Part 178 EPA-Tolerance Exemptions 40 CFR Part 180Use Effective Procedures: These GMP requirements also say that the procedures,equipment or service that is used for cleaning and sanitizing must be acceptable, andthat you need assurance that they will routinely provide adequate cleaning and sanitiz-ing. Standard cleaning and sanitizing procedures identified in reference information fromgovernment, university, or trade associations should be acceptable if implemented prop-erly. One such standard procedure was provided earlier in this Module. When using specialsanitizing 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.
  43. 43. module 7 • page 42 of 44What You Can DoTo meet the GMP requirements to use safe and effective cleaning and sanitizing agentsthat 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 MonitorKeep appropriate records from your supplier to show that the cleaning and sanitizingchemicals 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 teststrips to confirm that you have the appropriate sanitizer concentration each time thatsanitizing solutions are prepared. Although the current GMP does not require monitoringrecords, you may want to keep a record of the results of your observations for your ownuse. If any corrections are necessary to correct problems, those actions should also benoted on a written record.
  44. 44. module 7 • page 43 of 44Checklist Questions for GMP Requirementsin Module 7In Module 7 we reviewed the GMP requirements for: the sanitary condition of the buildingand facilities; selecting and using cleaning and sanitizing chemicals; proper cleaning andsanitizing procedures for food contact surfaces, equipment, utensils and facilities; and theproper storage and handling of cleaned and sanitized equipment and utensils. We havecompiled 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 theseGMP 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 ResourcesCleaning 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?
  45. 45. 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?
  46. 46. module 7 • page 44 of 44Check Your KnowledgeThis 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 answerswhile 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. Clickon the answer you think is correct. You will see a text box that will tell you if this answeris correct or wrong and why. When you find the correct answer, be sure to write down thequestion 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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