Essential Elements of Sanitation in the Beverage Industry

8 Essential Elements of Sanitation in the Beverage Industry Martha Hudak-Roos and Bruce Ferree CONTENTS Introduction Why Are There Sanitation Needs? What Are the Current and Future Regulatory Components of a Sanitation Program? GMPs Bottled Water Juice Regulations Other Regulations Summary What Tools Are Used by the Beverage Industry Today in FulÞlling Its Sanitation Program Needs? Cleaning and Sanitizing Procedures Other Sanitation Elements Master Sanitation Schedule How Is the EfÞcacy of the Program VeriÞed? Case Studies for Beverages Conclusion INTRODUCTION Sanitation is an essential element for any food processor but is especially crucial for beverage processors. Key elements in sanitation include: TX110_book Page 175 Tuesday, May 6, 2003 9:21 AM © 2003 by CRC Press LLC Why are there sanitation needs? What are the current and future regulatory components of a sanitation program? What tools are used by the beverage industry today in fulÞlling its sanitation program needs? How is the efÞcacy of the program veriÞed? Examples of these key elements will be illustrated with case studies. By following basic principles and incorporating important components such as management commitment, training, and resources into the sanitation pro- gram, beverage manufacturers can maintain the efÞcacy of their sanitation programs, resulting in high-quality, safe beverages that meet reasonable shelf life expectations. WHY ARE THERE SANITATION NEEDS? The word sanitation is derived from the Latin “sanitas,” which means health. Sanitation in the food industry has been applied to the process of creating and maintaining a wholesome environment in which to make safe food. It is a broad-based program — encompassing in today’s food industry a large portion of what are considered “prerequisite” or “universal” food safety program elements. These are program elements that are plant wide, as opposed to the Hazard Analysis and Critical Control Point (HACCP) system, which identiÞes speciÞc process steps as the essential or critical control points. These universal programs are the second level of the food safety pyramid (Figure 8.1), with management commitment as the base and HACCP and continuous quality improvement as the next layer and the pinnacle, respectively. FIGURE 8.1 Food safety and quality pyramid. MANAGEMENT COMMITMENT PREREQUISITE PROGRAMS HACCP CONTINUOUS QUALITY IMPROVEMENT TRAINING EDUCATION TX110_book Page 176 Tuesday, May 6, 2003 9:21 AM © 2003 by CRC Press LLC Sanitation covers water, air, employee hygiene, equipment cleanliness, equipment maintenance, facility design and condition, pest control, chemical control, and a host of other plant-wide needs. By their very nature, sanitation programs fulÞll the moral and legal obligations to create and maintain hygienic practices that keep a facility, equipment, and hence the food clean and wholesome. Companies that have failed in their sanitation programs have gone down in the annals of history and in the stock market. The recalls involving Hudson Industries and Bil Mar Foods could have been somewhat mitigated with enhanced sanitation programs. Outside of the safe food aspects of sanitation, a clean environment can increase product quality and shelf life. Reduced yeast and mold in the product and in the environment are key goals of sanitation, and these organisms affect the quality of products as well. As a broad-based program within any plant’s food safety system, sani- tation must have training, education, and documentation as key elements. It is unfortunate that we do not require “certiÞed” sanitation managers in the industry. In many cases, it is difÞcult to get a sanitation crew together. Sanitation is typically performed during the night shift and involves very inhospitable environments. The members of the sanitation crew are truly the unsung heroes of the food safety system. WHAT ARE THE CURRENT AND FUTURE REGULATORY COMPONENTS OF A SANITATION PROGRAM? The basic sanitation regulation for the beverage industry begins with 21 Code of Federal Regulations Part 110, also known as “Current Good Manufacturing Practices.” For those beverage manufacturers involved in international trade, hygiene standards are found in the Codex Alimentarius Commission’s “General Principles of Food Hygiene.” These two docu- ments list comparable considerations in producing safe, wholesome bev- erages in a sanitary environment. The Good Manufacturing Practices (GMPs) deÞne the regulatory expec- tations for sanitation. For a beverage processor, the beginning step in sani- tation is the process of identifying how these expectations are met. We suggest a table format such as Table 8.1. In this table, the left column is the Food and Drug Administration (FDA) provision and the middle column is the GMP text as spelled out in 21 CFR 110. The last column is where the plant/facility can list the procedures or programs that are used to cover the regulatory need. Such a matrix can identify any GMP area that is not fully addressed. It can also help to consolidate procedures, if you Þnd within the matrix many TX110_book Page 177 Tuesday, May 6, 2003 9:21 AM © 2003 by CRC Press LLC TABLE 8.1 U.S. FDA GMP Matrix Example GMP Item Regulatory Guidance Food Safety Program 110.10 Personnel The plant management shall take all reasonable measures and precautions to ensure the following. (a) Disease Control Any person who, by medical examination or supervisory observation, is shown to have, or appears to have, an illness, open lesion, including boils, sores, or infected wounds, or any other abnormal source of microbial contamination by which there is a reasonable possibility of food, food-contact surfaces, or food-packaging materials becoming contaminated, shall be excluded from any operations which may be expected to result in such contamination until the condition is corrected. Personnel shall be instructed to report such health conditions to their supervisors. (b) Cleanliness All persons working in direct contact with food, food-contact surfaces, and food-packaging materials shall conform to hygienic practices while on duty to the extent necessary to protect against contamination of food. The methods for maintaining cleanliness include, but are not limited to: (1) Wearing outer garments suitable to the operation in a manner that protects against the contamination of food, food-contact surfaces, or food-packaging materials. (2) Maintaining adequate personal cleanliness. (3) Washing hands thoroughly (and sanitizing if necessary to protect against contamination with undesirable microorganisms) in an adequate handwashing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated. TX110_book Page 178 Tuesday, May 6, 2003 9:21 AM © 2003 by CRC Press LLC procedures that are addressing the same need. For international compa- nies, the Codex General Principles of Food Hygiene are analogous to the FDA GMPs and are an excellent resource as the base reference for any company’s sanitation program. GMP S The General Provisions within the GMPs start with one of the most important aspects of hygiene, personnel hygiene. Plant management must have a pro- gram in place to ensure that personnel are healthy and not likely to be the source of abnormal microbial contamination. Also, personnel working with food or packaging must maintain a degree of cleanliness that includes clean outer garments, good personal hygiene, and adequate handwashing. Jewelry is not permitted. Gloves, if used, must be intact, clean, and in sanitary condition, as well as made from an impervious material. Hair restraints are required. Storage of personal items is limited to areas other than where food is exposed or equipment and utensils are washed. Personal habits are also regulated: no gum chewing, eating food, drinking beverages, or using tobacco where food is exposed or equipment is washed. Finally, the regulatory guid- ance concludes with the statement, “…taking necessary precautions to pro- tect against contamination of food, food-contact surfaces, or food packaging materials with microorganisms or foreign substances including, but not lim- (4) Removing all insecure jewelry and other objects that might fall into food, equipment, or containers, and removing hand jewelry that cannot be adequately sanitized during periods in which food is manipulated by hand. If such hand jewelry cannot be removed, it may be covered by material which can be maintained in an intact, clean, and sanitary condition and which effectively protects against the contamination by these objects of the food, food-contact surfaces, or food-packaging materials. (5) Maintaining gloves, if they are used in food handling, in an intact, clean, and sanitary condition. The gloves should be of an impermeable material. TABLE 8.1 (CONTINUED) U.S. FDA GMP Matrix Example GMP Item Regulatory Guidance Food Safety Program TX110_book Page 179 Tuesday, May 6, 2003 9:21 AM © 2003 by CRC Press LLC ited to, perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin.” The General Provisions also cover education and training. The guidance suggests that personnel responsible for identifying sanitation failures or food contamination should have a background of education or experience to provide a level of competency necessary for the production of safe food. Food handlers should receive (in the authors’ opinion, must receive) appro- priate training in proper food handling techniques and food protection prin- ciples and should be informed of the dangers of poor personal hygiene and unsanitary practices. Supervisors, according to the GMPs, are responsible for ensuring compliance. The grounds of the manufacturing site should allow for proper storage of equipment and removal of waste. Weeds and grass should be kept cut, and the yard, roads, etc., maintained. Reducing pest harborage and attractants is part of this requirement: drainage and waste disposal must be adequate. All unused process piping must be stored up off the ground. The building also must be under control. SufÞcient space for equipment and storage must be available. The design of the facility must be effective to permit proper precautions for reducing the potential for contamination: i.e., location, time, partition, airßow, and enclosed systems. Included in this section of the GMPs is the requirement to protect food in outdoor bulk fermentation vessels by coverage, controlling areas over the tanks, checking on a regular basis for pests, and skimming. Building Controls go on to cover ßoors, walls, ceilings (construction, materials, cleanliness), lighting, ventilation, and screening for pests. For sanitary operations, the GMPs require that the building and equipment be maintained in a sanitary condition. Cleaning compounds and sanitizing agents must be safe and adequate for use. ( Note: the GMPs do not deÞne acceptable cleaning and sanitizing compounds. These are deÞned in 21 CFR Part 178.) Toxic compounds must be controlled so as not to contaminate food, contact surfaces, or packaging. Pest control is required within this section as well. Sanitary operations also include the cleaning and sanitizing of food contact surfaces. Sanitary Facilities and Controls covers water supply, plumbing, sewage, and toilets. Processors who use boilers to create steam should become famil- iar with this section as well as Part 173 Subpart D — Secondary Direct Food Additives, SpeciÞc Usage Additives. Finally, this section covers handwashing. Good handwashing includes hot water, sanitary towels, and refuse receptacles for waste towels. Signs that indicate that hands must be washed and how to wash must be posted and must be understood easily by the staff. Fixtures with foot- or knee- activated pedals that are designed to protect against recontamination of clean hands are also important. TX110_book Page 180 Tuesday, May 6, 2003 9:21 AM © 2003 by CRC Press LLC Equipment and Utensils are part of the GMPs. According to the regula- tion, “The design, construction, and use of equipment and utensils shall preclude the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants. All equipment should be installed and maintained as to facilitate the cleaning of equipment and all adjacent areas.” This section covers aspects important to the beverage indus- try such as smooth welds and the cleanliness of holding, conveying, and manufacturing systems (closed and automated). It covers equipment instru- mentation (thermometers, pH, acidity, etc.) and the need to accurately and adequately maintain these devices. This is an important section for review. Production and Process Controls covers operations. This section has some key elements, including “Appropriate quality-control operations shall be employed to ensure that food is suitable for human consumption and that food packaging materials are safe and suitable” and “Overall sanitation of the plant shall be under the supervision of one or more competent individuals assigned responsibility for this function.” There are three areas speciÞc to this section: Raw Materials, Manufacturing Operations, and Warehousing. The Raw Materials section requires that raw materials be inspected, segre- gated, or otherwise handled to ensure that they are clean and suitable for processing. This section also requires that water used for washing or rinsing be safe and of sanitary quality. Where water is reused for washing, it cannot increase the level of contamination of the food. In today’s manufacturing environments, water reuse (recycling) is a key element in food sanitation. The Codex Committee on Food Hygiene has developed a text on the safe reuse of water that can be found on the Codex Web site. Those in the beverage industry must be cognizant of water safety issues, including Cryptosporidium (chlorine resistant), Giardia , and other protozoa. Rinsing and sanitizing equipment right before use with chlorinated water might not provide for safe food contact surfaces. Other points of interest within Raw Materials include: “Material scheduled for rework shall be identiÞed as such.” Check your rework protocols to ensure that they meet this re- quirement. “Liquid materials received and stored in bulk shall be held in a manner that protects against contamination.” Liquid bulk items in bulk containers can be protected from contam- ination by ensuring proper ventilation and by reviewing the con- dition of agitators routinely. Protection from contamination also means that CIP (clean-in-place) and product loops in distribution systems cannot be cross-connected. This is especially important in the beverage industry where most items are cleaned with CIP TX110_book Page 181 Tuesday, May 6, 2003 9:21 AM © 2003 by CRC Press LLC systems. Also, review temperature controls on bulk holding tanks to ensure that the product can be and is adequately held to pre- vent growth of microorganisms. The section on Manufacturing Operations requires that equipment and containers be maintained in an acceptable condition. Food manufacturing must be conducted to minimize contamination and growth of microorgan- isms, and therefore processors should monitor time, temperature, humidity, a w , pH, pressure, and ßow rate. Manufacturing operations such as freezing, dehydration, heat processing, acidiÞcation, and refrigeration should be monitored to ensure that mechanical breakdowns, time delays, temperature ßuctuations, and other factors do not contribute to contamination of the food. Food shall be protected from metal by using sieves, traps, magnets, metal detectors, etc. Metal is not the only type of foreign material found in food. Your operations must ensure that controls are in place to adequately protect the consumer from objects such as stones, rubber, plastic, glass, etc. Manufacturing Operations continues on to describe various require- ments of speciÞc process steps: washing, peeling, trimming; heat blanch- ing; batters and breaders; Þlling, assembling, packaging; dry products; and acid and acidiÞed products. Finally, the section on Warehousing requires that food be stored and transported under conditions that protect food against physical contamina- tion and microbial contamination as well as against deterioration of the food and container. Natural or unavoidable defects that occur at low levels that are not hazardous to health are covered within this section. Current defect action levels (pesticides, etc.) are not listed in this section, but reference is made to them. It is important to note that the mixing of food containing defects above the current defect action level with another lot of food is not per- mitted and renders the Þnal food adulterated, regardless of the defect level of the Þnal food. B OTTLED W ATER Second on our path down Regulatory Lane are the Drinking Water regulations, 21 CFR Part 129. Again, comparable international standards exist in the Codex Alimentarius. “Processing and Bottling of Bottled Drinking Water” describes the general provisions and the conditions for buildings and facilities, equipment, and production and process controls. This section does not sup- plant 21 CFR Part 110 but is in addition to it. SpeciÞc requirements of this regulation include the separation of the bottling room from other plant oper- ations or storage by tight walls, ceilings, and self-closing doors. Conveyor TX110_book Page 182 Tuesday, May 6, 2003 9:21 AM © 2003 by CRC Press LLC openings shall not exceed the size required to permit passage of containers. Washing and sanitizing of bottles shall be performed in an enclosed room. Cleaning and sanitizing solutions utilized by the plant shall be sampled and tested by the plant as often as necessary to ensure adequate performance in the cleaning and sanitizing operations. Records of these tests are required to be maintained, including a record of the intensity and duration of the agent’s contact with the surface. Record retention for this industry is 2 years. J UICE R EGULATIONS In February 2002, the new Juice HACCP regulations (21 CFR Part 120) were implemented. Within these regulations are speciÞc requirements for sanitation: sanitation controls, monitoring, and records. Again, this regulation is in addition to Part 110. Under the new regulations, each processor must have and implement Sanitation Standard Operating Procedures (SSOPs). SSOPs must address sanitation conditions and practices before, during, and after processing. SpeciÞc SSOPs must address: 1. Water — the safety of the water that comes into contact with the food including ice 2. Condition and cleanliness of food contact surfaces, including uten- sils and gloves 3. Prevention of cross contamination from unsanitary objects to food, packaging, and contact surfaces 4. Maintenance of handwashing, hand sanitizing, and toilet facilities 5. Protection of food packaging and contact surfaces from adultera- tion with lubricants, fuel, pesticides, cleaning compounds, sanitiz- ing agents, condensates, and other chemical, physical, and biological contaminants 6. Proper labeling, storage, and use of toxic compounds 7. Control of employee health conditions that could result in micro- biological contamination of food, packaging, and contact surfaces 8. Exclusion of pests SSOPs must be monitored during processing with sufÞcient frequency to ensure conformance with 21 CFR Part 110. The regulations require that corrective actions be made in a timely manner. Your facility must ensure that corrections are taken, are timely, and are documented. Corrective actions only go so far, and when a problem is repetitive (twice is a repetition), preventive measures should also be evaluated and implemented. These pre- ventive measures should also be documented. TX110_book Page 183 Tuesday, May 6, 2003 9:21 AM © 2003 by CRC Press LLC Juice regulations require that SSOP records of monitoring and corrective actions shall be retained for 1 year for refrigerated (perishable) and 2 years for frozen or shelf stable products. Note that this is different from bottled water. Records shall include: the name of the processor, location, date, time, signature, and if appropriate the product/production code. O THER R EGULATIONS Many other regulations impact beverage companies. The Environmental Protec- tion Agency (EPA) has regulations that cover the registration of chemicals (clean- ers, sanitizers, etc.), and some requirements exist for containment barriers around large volumes of chemicals (for example, bulk storage of chemicals used in CIP processes). EPA also regulates processing water and wastewater. Already men- tioned were FDA’s parts 173 and 178 that govern boiler additives and sanitizers. FDA has other regulations that could impact your sanitation program. State and local requirements should not be forgotten, particularly as they relate to liquids and solid waste. In a sanitation environment where large volumes of liquid and solid waste are created, these regulations are paramount to a good sanitation program. Monitoring the biological oxygen demand (BOD) of your wastewater, recycling chemical drums and barrels, etc. are all part of this process. S UMMARY What has been covered so far is not intended to be an all-encompassing survey of regulations. The goal of this discussion is to encourage processors to be regulation watchers. Read the regulations; outline your program against them. Read regulations that do not pertain to you — these give you a good idea of what other industry expectations are. For example, you might not be manufacturing bottled water, but your FDA investigator knows those regu- lations and hopes that you comply with the “higher standard.” The SSOP requirements for juice are very similar to those for seafood. If you were aware of these regulations back in ’96, you would not be surprised now. There is good information within the regulations that can be used as the base for your program. WHAT TOOLS ARE USED BY THE BEVERAGE INDUSTRY TODAY IN FULFILLING ITS SANITATION PROGRAM NEEDS? C LEANING AND S ANITIZING One major aspect of sanitation is cleaning. First, decide how you will clean a particular surface or piece of equipment. Wet or dry? Dry cleanups are TX110_book Page 184 Tuesday, May 6, 2003 9:21 AM © 2003 by CRC Press LLC [...]... company In trying to determine the source of the yeast growing in the beverage (and these were some hearty yeast cells — living even after 200ûF heat treatment), an air duct was discovered that resembled the surface of the moon — or worse, a mushroom farm — because of the amount of yeast growth on it The intensity of the yeast and dirt substrate growing in the duct had, in some places, almost Þlled the. .. is found Other types of chemicals can be used within the cleaning program — acid to remove scale buildup, fogging with acid, etc The most important key to cleaning in the beverage industry is the CIP system Designed to replace mechanical (manual) scrubbing with laminar ßow of the chemicals via a pump, this type of cleaning was made for the tanks and long, hard pipes common to the beverage industry CIP... program, sanitation is essential, and employees in this area would beneÞt from the support and resources of a continuing education program In designing and maintaining the sanitation program, keep a few key points in mind: 1 Be a regulatory watcher 2 A beverage sanitation program has numerous needs, but the CIP and Þlling area are two key essential elements (as are air and water) 3 Document your sanitation. .. may have become contaminated Maintenance programs must be in place to ensure that these items are routine and are documented Many plants have a preventive maintenance program for food safety to address these critical needs Finally, the sanitation program cannot ignore the special needs of the beverage industry The production of most types of beverages involves Þlters of some type These must be checked... have application and merit in designing a sound sanitation program A good sanitation program relies on trained, educated, skillful, and knowledgeable sanitation staff One of the difÞculties in establishing and maintaining a sound sanitation program is the lack of good education and training for sanitation managers No certiÞcation program or continuing education program for sanitation personnel exists... unsatisfactory reading In either case, there are a variety of ATP tests/types of bacterial swabbing methods that can be used As long as the testing allows for the efÞcacy of the procedures to be veriÞed and continuous improvement to be made, either will be adequate Another good veriÞcation tool for sanitation programs is the use of environmental swabbing or sponging to determine whether pathogenic microorganisms,... sample is found The purpose of environmental testing is to conÞrm that your routine sanitation program is capable of removing pathogens and keeping them out of the facility When a positive result is noted, corrective actions should include: 1 Immediate recleaning of the area to prove that it can be cleaned and pathogen free 2 Routine sampling of the area to prove that it can be maintained clean and... violations of integrated pest management principles (attractants, exclusions), should be available Supporting programs — locker cleaning program, break room cleanliness, building integrity, grounds, dumpsters, etc — should be integrated into the pest control program Next, check the maintenance department The preventive maintenance aspects of the equipment directly impact the cleanliness of the facility... important Chlorine, iodine, quaternary ammonia, and acid sanitizers are all used in the industry The selection of the sanitizer is based on the target microorganisms and the cost Be aware that sanitizers (chlorine and acid) can eat away at paint and equipment surfaces, causing a loss in equipment life Again, a common application is quaternary ammonia, with the use of an acid-based sanitizer intermittently... 3 Review of the routine sanitation procedures for that area CASE STUDIES FOR BEVERAGES The critical sanitation issue for beverages is post-pasteurization contamination This includes contamination of the pasteurized product as well as any © 2003 by CRC Press LLC TX110_book Page 191 Tuesday, May 6, 2003 9:21 AM ingredients added to the pasteurized liquid (vitamins, purees pasteurized in another facility, . commitment, training, and resources into the sanitation pro- gram, beverage manufacturers can maintain the efÞcacy of their sanitation programs, resulting in high-quality,. address these critical needs. Finally, the sanitation program cannot ignore the special needs of the beverage industry. The production of most types of beverages