Sanitary Equipment Design
With food safety becoming a top priority, the cleanability of equipment and the professionalism and status of personnel are emerging as industry flashpoint.
Change is easy to talk about, but hard to effect; and agreeing on changes equipment suppliers need to make in sanitary design can fall victim to inertia or outright resistance. But change is coming, with the faltering steps taken nine years ago turning into a gallop.
Sloped surfaces, polished welds, tool-less disassembly-the new generation of processing machines and other contact points are being designed first and foremost with sanitation in mind, not as an afterthought. The gospel of hygiene gathered believers throughout the last decade, and the Salmonella poisoning linked to Peanut Corporation of America in January 2009 pushed many more acolytes to the sanitary-design faith. High-risk foods such as ready-to-eat meats and raw salads no longer are the only focus. Clean-in-place systems are becoming common in formerly dry environments such as bakeries as equipment fabricators, prodded by their biggest food clients, graft hygienic solutions from multiple processes onto their machinery.
Joe Stout, global director of product protection and hygienic design at Kraft Foods Inc., helped shape the 10 principles of sanitary equipment design developed by a task force of the American Meat Institute in the early 2000s. More recently, he helped draft similar design principles for low-moisture foods (see related story on page 44). Hygiene experts from seven major manufacturers have waged an awareness and public-dialogue campaign over the last two years, drawing ever larger and more enthusiastic crowds of machine builders and other food companies. A February workshop was oversubscribed, with a June follow-up in Chicago expected to draw another capacity crowd. Ten industry trade groups are helping to fund the workshops.
The grassroots sanitary-design effort began when Suzanne Tortorelli, a microbiologist at Campbell Soup Co., attended an allergen control workshop in 2008 and suggested forming an ad hoc group with Kevin Farnum, director-sanitation center of excellence & engineering at General Mills Inc. With the assistance of Ecolab Inc., representatives from Kraft, ConAgra, Heinz, Kellogg and Sara Lee joined them at the 3M Innovation Center in the Twin Cities to discuss common concerns and map strategies to address them. Sanitation by design topped the priority list, followed by staff training and advocating for higher organizational status for corporate sanitarians.
The group sought common ground in their own equipment-cleaning objectives in hopes of streamlining their specifications to help equipment suppliers develop broadly acceptable designs. Cleanability is the top priority, but affordability also is an issue. The consensus is that over-designed machines that add cost and make it difficult for small machine shops to compete are to be avoided. Advocacy of washdown-ready equipment is generating some pushback from the bread and buns side of baking, where wet clean-up raises the likelihood of yeast and mold growth.
Besides the workshops and presentations to industry groups, task force members are engaged in outreach to major suppliers. Kraft’s Stout traveled to Dublin, OH, to meet with engineers for Peerless mixers, while Campbell’s Tortorelli visited CMC America, another mixer fabricator. Suppliers also are being invited to food plants to give them a better idea of the sanitation challenges and operating realities of food manufacturing. Checklists have been developed for each of the sanitary design principles; equipment makers are encouraged to conduct a self-evaluation to identify areas where their machines may be deficient.
One example is CFS Americas, the Frisco, TX, division of Kempten, Germany-based CFS. At last year’s Worldwide Food Expo in Chicago, the firm introduced GigaSlicer, a machine designed with both hygiene and increased throughput in mind, according to Richard Steck, business unit leader. The drives and electronics associated with a bigger, more complex slicer are a bad fit with high-pressure washdown, so engineers created a clear split between the product zone and drive zone. Attention was paid to detail: the clockwise motion of the previous slicer was reversed, explains Steck, so that shaved debris accumulates on the operator side of the unit, not in a hard-to-access area. Sealed joints, rounded edges and elimination of niches received as much attention as higher slicing speeds. Tool-less removal of belts and knives is part of the redesign.
Linde Gas’ line of cryogenic freezers began the sanitary-redesign process three years ago, with the first revamped unit reaching market in late 2008. Welds have replaced bolts between modular units of five models so far, and bearings and other moving parts are isolated from food-contact areas, much like CFS’s slicers. CIP is an option on some of the freezers, which are smaller and require less stainless steel than the systems they replaced, according to Mark Ewig, food & beverage market development team leader in Linde’s Chicago office.
The firm is based near London, and engineers considered a number of sanitary standards, including dairy’s 3A, the European hygienic standard EHEDG, NSF International’ s guidelines and the AMI principles. While the changes sought to address broad sanitary objectives and reduce the time, labor and water needed to clean, the specifics were driven by the requirements of customers such as Kraft, Cargill and Keystone Foods. “Those companies take sanitation to a new level and are saying, ‘This is what is important to us,’” says Ewig. “We spent about a year in due diligence” with key accounts.
Satisfying broad principles is easier than addressing specific standards, as international suppliers can attest. A condenser coil used on dearation vessels sold in Europe by Tetra Pak Inc. meets EHEDG hygienic standards but can’t pass muster under 3A because it can’t be visually inspected. Likewise, one of the better hygienic fittings available are specified by Deutsches Institut fur Normung, but DIN fittings can’t be used in US dairies because no European manufacturer has sought 3A certification. Tetra Pak substitutes tri-clamps on those applications, explains Craig Reinhart, quality control manager in the firm’s Vernon Hills, IL, headquarters.
“Depending on the processor, there are different levels of sanitary concerns,” adds Reinhart, with large manufacturers looking for higher levels of sanitary design. There also are tradeoffs depending on the product type: juice processing doesn’t require the same level of risk management as dairy, and using the most hygienic valve might pose challenges and disrupt the process. “It’s always a question of balancing risk level,” says Reinhart.
Hartland, WI-based Dorner Manufacturing Inc. periodically sends its engineers for recertification under BISSC, which is administered by AIB International. “It’s a bare-minimum floor, and it’s taken a pretty big hit because of PCA,” allows Dorner’s John Kuhnz, food marketing manager, “but it still has a pulse.”
Dorner studied a range of sanitary standards when engineering food-grade conveyors introduced three years ago, and its base unit was designed around BISSC. Those conveyors won’t tolerate high-pressure washdown and don’t support tool-less disassembly, but if microbes or allergens aren’t an issue in an area of the plant, food companies “are relying on the robustness of their sanitary processes” to wipe down noncritical conveyors while investing in high-end units in risky areas.
Allergen concerns were a game-changer in bakeries because removal requires wet cleaning, “and the equipment wasn’t designed for that,” adds Miller. For equipment suppliers working in multiple segments of the industry, the switch to washdown was taken in stride, but smaller machine builders are struggling with the change. Those are the companies that can most benefit from the low-moisture sanitation principles, he suggests.
Product handling downstream of ovens is receiving serious reevaluation in bakery production. Kellogg’s Cary, NC, plant, a former Austin Quality Foods facility that produced peanut-butter sandwich crackers, was caught up in the PCA recall. Peanut paste is added post-baking, and the capping machines that place the cracker on the filling became contaminated with salmonella. The 50 truckloads of product that were destroyed were a small part of the loss: the plant itself shut down for a three-month cleaning, with lost production costs running into tens of millions of dollars.
The incident created instant interest for a new depositing/capping system from Franz Haas Machinery of America Inc., Richmond, VA. The system features equipment from Haas along with a creamer from Mondomix and a capper from Houdijk Holland. The flight bar and chain on conventional sandwiching systems make thorough sanitation impossible, according to Rick Parrish, Haas’s director-sales and marketing. The new system has an open and hygienic design, is CIP-ready and uses stainless as its material of construction. Polished welds and other hygienic features sometimes work against the efficiency of production equipment, Parrish notes, but “from the oven to the end of the line, 3A standards and washdown are the trend” in baking equipment, he believes.
The fourth installation is being commissioned in Kraft’s Beijing, China, cookie plant. Throughput issues need to be addressed, but the system is “light years ahead” of existing technology in terms of sanitation, says Al Koch, global engineering director for Kraft’s Nabisco division. “It’s a quantum leap and proves sanitary design and installation doesn’t have to cost a lot of money.”
Food companies are sensitive to those concerns. Reaching a consensus on sanitary design “is a way for us to get our act together and be more uniform in our specs,” says General Mills’ Farnum “That’s going to help in factory acceptance tests.”
His task force is developing calculations for the lifecycle cost of sanitizing equipment. The intent is to arm specifying engineers with the information so they will consider design and installation when calculating a machine’s total cost of ownership.
In-house training and awareness also are a focus. Kraft created an 18-month sanitarian certification program. It concludes with an 800-question test. About 85 engineers and other professionals have been certified, and their knowledge of sanitary design and other fundamentals is viewed as a significant asset.
Company executives’ attitudes also are changing. Campbell Soup is creating the position of corporate sanitarian, a change Tortorelli believes will elevate sanitation’s status and improve overall food safety. “Sanitation is affecting our business,” she says. “Sanitation is going to be key in the modernization of cGMP,” the section of the federal food code dealing with good manufacturing practices.
General Mills alum Thomas Imholte wrote “Engineering for Food Safety and Sanitation” in 1987, and the book remains relevant. “We still pass out the book to our new engineers when we train them,” says Farnum. “But once we train them, they leave for another assignment. It’s relatively easy to train, but it’s hard to get people who have a passion for sanitation.”
Instead of approaching sanitation as the end of production, the task force hopes to get food companies to view it as the beginning. And even before it’s cleaned, equipment needs to be designed to accommodate the process.
For more information:
Dwight Wagaman, Baker Perkins Inc., 616-784-3111, dwight.wagaman@bakerperkinsgroup.com
Brad Neil, CFS Americas, 214-618-1100, brad.neil@cfs.com
John Kuhnz, Dorner Manufacturing, 262-369-1332, john.kuhnz@dorner.com
Rick Parrish, Franz Haas Machinery of America Inc., 804-222-6022, rparrish@haasusa.com
Mark Ewig, Linde Gas, 312-559-3698, mark.ewig@linde.com
Gabe Miller, Sani-Matic Inc., 608-332-3471, gabem@sanimatic.com
Craig Reinhart, Tetra Pak Inc., 847-955-6294, craig.reinhart@tetrapak.com
1. Cleanable. Equipment should be constructed to be cleanable to a GMP, product hazard (microbiological, chemical, physical), and quality level that is validated and verified by active monitoring programs.
2. Made of Compatible Materials. Materials used for equipment construction must be compatible with the product, environment, and proposed cleaning methods.
3. Accessible for Inspection, Maintenance, Cleaning and Sanitation. When needed, equipment should be easily disassembled for sanitation without requiring special tools.
4. No Liquid Collection. No stagnant product build-up or liquid collection areas. Equipment should be self-draining to assure that residues do not accumulate or pool on the equipment.
5. Hollow Areas Eliminated or Sealed. Hollow areas of equipment must be eliminated whenever possible or permanently sealed. Items such as bolts, studs, mounting plates, brackets, junction boxes, nameplates, end caps and sleeves should be continuously welded to the surface and not attached via drilled and tapped holes.
6. No Niches (e.g., no pits, cracks, corrosion, crevices, recesses, open seams, gaps, lap seams, protruding ledges, inside threads, bolt rivets, or dead ends). Welds should be ground and polished smooth.
7. Sanitary Operational Performance. During normal operations, the equipment must perform so it does not contribute to unsanitary conditions or the harborage and growth of bacteria.
7.1. Hygienic Design of Maintenance Enclosures. Human/machine interfaces such as push buttons, valve handles, switches and touch screens, must be designed to ensure product and other residues (including liquid) do not penetrate or accumulate in or on the enclosure or interface.
7.2. Hygiene Compatibility with Other Plant Systems. Equipment design should ensure hygienic compatibility with other equipment and systems, such as electrical, hydraulic, steam, air and water systems.
8. Validated Cleaning and Sanitizing Protocols. Procedures for cleaning and sanitation must be clearly written, designed and proven effective and efficient. Chemicals recommended for cleaning and sanitation must be compatible with the equipment and the manufacturing environment.
9. Separate Processes Wherever Possible. Dissimilar processes in plants or on single line or equipment should be properly separated to prevent cross contamination based on a risk assessment. – i.e. raw from RTE.
10. Meet Personnel Hygiene and Sanitation Requirements. All plant personnel, contractors and visitors must be trained and required to follow plant hygienic and sanitation requirements – no exceptions.
Accessibility for high-pressure washdown is a key design consideration for new slicing and packaging equipment engineered for ready-to-eat meat production. Source: CFS Americas.
Conveyors can double as work surfaces in some food production systems, increasing the need for thorough cleaning of microbes and allergenic proteins. Source: Dorner Manufacturing Inc.
Sloped surfaces, polished welds, tool-less disassembly-the new generation of processing machines and other contact points are being designed first and foremost with sanitation in mind, not as an afterthought. The gospel of hygiene gathered believers throughout the last decade, and the Salmonella poisoning linked to Peanut Corporation of America in January 2009 pushed many more acolytes to the sanitary-design faith. High-risk foods such as ready-to-eat meats and raw salads no longer are the only focus. Clean-in-place systems are becoming common in formerly dry environments such as bakeries as equipment fabricators, prodded by their biggest food clients, graft hygienic solutions from multiple processes onto their machinery.
Joe Stout, global director of product protection and hygienic design at Kraft Foods Inc., helped shape the 10 principles of sanitary equipment design developed by a task force of the American Meat Institute in the early 2000s. More recently, he helped draft similar design principles for low-moisture foods (see related story on page 44). Hygiene experts from seven major manufacturers have waged an awareness and public-dialogue campaign over the last two years, drawing ever larger and more enthusiastic crowds of machine builders and other food companies. A February workshop was oversubscribed, with a June follow-up in Chicago expected to draw another capacity crowd. Ten industry trade groups are helping to fund the workshops.
The grassroots sanitary-design effort began when Suzanne Tortorelli, a microbiologist at Campbell Soup Co., attended an allergen control workshop in 2008 and suggested forming an ad hoc group with Kevin Farnum, director-sanitation center of excellence & engineering at General Mills Inc. With the assistance of Ecolab Inc., representatives from Kraft, ConAgra, Heinz, Kellogg and Sara Lee joined them at the 3M Innovation Center in the Twin Cities to discuss common concerns and map strategies to address them. Sanitation by design topped the priority list, followed by staff training and advocating for higher organizational status for corporate sanitarians.
The group sought common ground in their own equipment-cleaning objectives in hopes of streamlining their specifications to help equipment suppliers develop broadly acceptable designs. Cleanability is the top priority, but affordability also is an issue. The consensus is that over-designed machines that add cost and make it difficult for small machine shops to compete are to be avoided. Advocacy of washdown-ready equipment is generating some pushback from the bread and buns side of baking, where wet clean-up raises the likelihood of yeast and mold growth.
Besides the workshops and presentations to industry groups, task force members are engaged in outreach to major suppliers. Kraft’s Stout traveled to Dublin, OH, to meet with engineers for Peerless mixers, while Campbell’s Tortorelli visited CMC America, another mixer fabricator. Suppliers also are being invited to food plants to give them a better idea of the sanitation challenges and operating realities of food manufacturing. Checklists have been developed for each of the sanitary design principles; equipment makers are encouraged to conduct a self-evaluation to identify areas where their machines may be deficient.
Sanitizing foams and high-pressure washdowns are coming into play in dry-food production, creating the need for more robust equipment. Source: Dorner Manufacturing Inc.
Long, winding road
Re-engineering production machinery is time consuming and costly, as the experience in the meat segment shows. Slicing machines are particularly vulnerable to cross contamination, and suppliers have spent years designing acceptable solutions.One example is CFS Americas, the Frisco, TX, division of Kempten, Germany-based CFS. At last year’s Worldwide Food Expo in Chicago, the firm introduced GigaSlicer, a machine designed with both hygiene and increased throughput in mind, according to Richard Steck, business unit leader. The drives and electronics associated with a bigger, more complex slicer are a bad fit with high-pressure washdown, so engineers created a clear split between the product zone and drive zone. Attention was paid to detail: the clockwise motion of the previous slicer was reversed, explains Steck, so that shaved debris accumulates on the operator side of the unit, not in a hard-to-access area. Sealed joints, rounded edges and elimination of niches received as much attention as higher slicing speeds. Tool-less removal of belts and knives is part of the redesign.
Linde Gas’ line of cryogenic freezers began the sanitary-redesign process three years ago, with the first revamped unit reaching market in late 2008. Welds have replaced bolts between modular units of five models so far, and bearings and other moving parts are isolated from food-contact areas, much like CFS’s slicers. CIP is an option on some of the freezers, which are smaller and require less stainless steel than the systems they replaced, according to Mark Ewig, food & beverage market development team leader in Linde’s Chicago office.
The firm is based near London, and engineers considered a number of sanitary standards, including dairy’s 3A, the European hygienic standard EHEDG, NSF International’ s guidelines and the AMI principles. While the changes sought to address broad sanitary objectives and reduce the time, labor and water needed to clean, the specifics were driven by the requirements of customers such as Kraft, Cargill and Keystone Foods. “Those companies take sanitation to a new level and are saying, ‘This is what is important to us,’” says Ewig. “We spent about a year in due diligence” with key accounts.
Satisfying broad principles is easier than addressing specific standards, as international suppliers can attest. A condenser coil used on dearation vessels sold in Europe by Tetra Pak Inc. meets EHEDG hygienic standards but can’t pass muster under 3A because it can’t be visually inspected. Likewise, one of the better hygienic fittings available are specified by Deutsches Institut fur Normung, but DIN fittings can’t be used in US dairies because no European manufacturer has sought 3A certification. Tetra Pak substitutes tri-clamps on those applications, explains Craig Reinhart, quality control manager in the firm’s Vernon Hills, IL, headquarters.
“Depending on the processor, there are different levels of sanitary concerns,” adds Reinhart, with large manufacturers looking for higher levels of sanitary design. There also are tradeoffs depending on the product type: juice processing doesn’t require the same level of risk management as dairy, and using the most hygienic valve might pose challenges and disrupt the process. “It’s always a question of balancing risk level,” says Reinhart.
Ingersoll Rand’s Jason Grizzi peers at a cutaway of the firm’s two-stage, oil-free VFD compressor. Some food companies have made oil-free compressors their standard because of food-contamination concerns.
Compromized relevance
The baking counterpart to 3A is BISSC (Baking Industry Sanitary Standards Committee), a 61-year-old guidance almost as old as 3A. While 3A standards have undergone a third-party verification upgrade in recent years, BISSC hasn’t kept current with the times, points out Gabe Miller, senior applications engineer at Sani-Matic Inc., Madison, WI. For instance, BISSC allows threaded-bolt passages, a design discouraged because the area can harbor bacteria.Hartland, WI-based Dorner Manufacturing Inc. periodically sends its engineers for recertification under BISSC, which is administered by AIB International. “It’s a bare-minimum floor, and it’s taken a pretty big hit because of PCA,” allows Dorner’s John Kuhnz, food marketing manager, “but it still has a pulse.”
Dorner studied a range of sanitary standards when engineering food-grade conveyors introduced three years ago, and its base unit was designed around BISSC. Those conveyors won’t tolerate high-pressure washdown and don’t support tool-less disassembly, but if microbes or allergens aren’t an issue in an area of the plant, food companies “are relying on the robustness of their sanitary processes” to wipe down noncritical conveyors while investing in high-end units in risky areas.
Allergen concerns were a game-changer in bakeries because removal requires wet cleaning, “and the equipment wasn’t designed for that,” adds Miller. For equipment suppliers working in multiple segments of the industry, the switch to washdown was taken in stride, but smaller machine builders are struggling with the change. Those are the companies that can most benefit from the low-moisture sanitation principles, he suggests.
Product handling downstream of ovens is receiving serious reevaluation in bakery production. Kellogg’s Cary, NC, plant, a former Austin Quality Foods facility that produced peanut-butter sandwich crackers, was caught up in the PCA recall. Peanut paste is added post-baking, and the capping machines that place the cracker on the filling became contaminated with salmonella. The 50 truckloads of product that were destroyed were a small part of the loss: the plant itself shut down for a three-month cleaning, with lost production costs running into tens of millions of dollars.
The incident created instant interest for a new depositing/capping system from Franz Haas Machinery of America Inc., Richmond, VA. The system features equipment from Haas along with a creamer from Mondomix and a capper from Houdijk Holland. The flight bar and chain on conventional sandwiching systems make thorough sanitation impossible, according to Rick Parrish, Haas’s director-sales and marketing. The new system has an open and hygienic design, is CIP-ready and uses stainless as its material of construction. Polished welds and other hygienic features sometimes work against the efficiency of production equipment, Parrish notes, but “from the oven to the end of the line, 3A standards and washdown are the trend” in baking equipment, he believes.
The fourth installation is being commissioned in Kraft’s Beijing, China, cookie plant. Throughput issues need to be addressed, but the system is “light years ahead” of existing technology in terms of sanitation, says Al Koch, global engineering director for Kraft’s Nabisco division. “It’s a quantum leap and proves sanitary design and installation doesn’t have to cost a lot of money.”
Spacers that create clearance between utility piping and wall surfaces are becoming common food plant features, allowing cleaning crews to thoroughly sanitize work areas.
Attitude readjustment
In the mid-‘90s, Baker Perkins devised a manual of best hygienic practices for grain-foods machinery. Now the UK-based equipment supplier is revisiting its designs and determining what re-engineering is necessary to meet food companies’ new expectations. “Salmonella in peanut butter awakened people to the fact that there are microbial hazards,” comments Dan Christie, technical director in Baker Perkins’ Grand Rapids, MI, office. The challenge is to adopt an open design and allow tool-less disassembly to meet North American demands without adding unnecessary costs that would burden manufacturers in other markets.Food companies are sensitive to those concerns. Reaching a consensus on sanitary design “is a way for us to get our act together and be more uniform in our specs,” says General Mills’ Farnum “That’s going to help in factory acceptance tests.”
His task force is developing calculations for the lifecycle cost of sanitizing equipment. The intent is to arm specifying engineers with the information so they will consider design and installation when calculating a machine’s total cost of ownership.
In-house training and awareness also are a focus. Kraft created an 18-month sanitarian certification program. It concludes with an 800-question test. About 85 engineers and other professionals have been certified, and their knowledge of sanitary design and other fundamentals is viewed as a significant asset.
Company executives’ attitudes also are changing. Campbell Soup is creating the position of corporate sanitarian, a change Tortorelli believes will elevate sanitation’s status and improve overall food safety. “Sanitation is affecting our business,” she says. “Sanitation is going to be key in the modernization of cGMP,” the section of the federal food code dealing with good manufacturing practices.
General Mills alum Thomas Imholte wrote “Engineering for Food Safety and Sanitation” in 1987, and the book remains relevant. “We still pass out the book to our new engineers when we train them,” says Farnum. “But once we train them, they leave for another assignment. It’s relatively easy to train, but it’s hard to get people who have a passion for sanitation.”
Instead of approaching sanitation as the end of production, the task force hopes to get food companies to view it as the beginning. And even before it’s cleaned, equipment needs to be designed to accommodate the process.
For more information:
Dwight Wagaman, Baker Perkins Inc., 616-784-3111, dwight.wagaman@bakerperkinsgroup.com
Brad Neil, CFS Americas, 214-618-1100, brad.neil@cfs.com
John Kuhnz, Dorner Manufacturing, 262-369-1332, john.kuhnz@dorner.com
Rick Parrish, Franz Haas Machinery of America Inc., 804-222-6022, rparrish@haasusa.com
Mark Ewig, Linde Gas, 312-559-3698, mark.ewig@linde.com
Gabe Miller, Sani-Matic Inc., 608-332-3471, gabem@sanimatic.com
Craig Reinhart, Tetra Pak Inc., 847-955-6294, craig.reinhart@tetrapak.com
Sanitary design principles for dry food manufacture
With some minor tweaks and the addition of two guidelines for facility separation and personnel hygiene, a leadership group of major food companies developed a list of 12 sanitation principles for equipment suppliers to consider when designing machines. Except for some minor streamlining, the principles amplify sanitary design principles put forward in 2003 by a task force of the American Meat Industry. The design imperatives follow.1. Cleanable. Equipment should be constructed to be cleanable to a GMP, product hazard (microbiological, chemical, physical), and quality level that is validated and verified by active monitoring programs.
2. Made of Compatible Materials. Materials used for equipment construction must be compatible with the product, environment, and proposed cleaning methods.
3. Accessible for Inspection, Maintenance, Cleaning and Sanitation. When needed, equipment should be easily disassembled for sanitation without requiring special tools.
4. No Liquid Collection. No stagnant product build-up or liquid collection areas. Equipment should be self-draining to assure that residues do not accumulate or pool on the equipment.
5. Hollow Areas Eliminated or Sealed. Hollow areas of equipment must be eliminated whenever possible or permanently sealed. Items such as bolts, studs, mounting plates, brackets, junction boxes, nameplates, end caps and sleeves should be continuously welded to the surface and not attached via drilled and tapped holes.
6. No Niches (e.g., no pits, cracks, corrosion, crevices, recesses, open seams, gaps, lap seams, protruding ledges, inside threads, bolt rivets, or dead ends). Welds should be ground and polished smooth.
7. Sanitary Operational Performance. During normal operations, the equipment must perform so it does not contribute to unsanitary conditions or the harborage and growth of bacteria.
7.1. Hygienic Design of Maintenance Enclosures. Human/machine interfaces such as push buttons, valve handles, switches and touch screens, must be designed to ensure product and other residues (including liquid) do not penetrate or accumulate in or on the enclosure or interface.
7.2. Hygiene Compatibility with Other Plant Systems. Equipment design should ensure hygienic compatibility with other equipment and systems, such as electrical, hydraulic, steam, air and water systems.
8. Validated Cleaning and Sanitizing Protocols. Procedures for cleaning and sanitation must be clearly written, designed and proven effective and efficient. Chemicals recommended for cleaning and sanitation must be compatible with the equipment and the manufacturing environment.
9. Separate Processes Wherever Possible. Dissimilar processes in plants or on single line or equipment should be properly separated to prevent cross contamination based on a risk assessment. – i.e. raw from RTE.
10. Meet Personnel Hygiene and Sanitation Requirements. All plant personnel, contractors and visitors must be trained and required to follow plant hygienic and sanitation requirements – no exceptions.
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