Stephen Sumerlin Noria HACCP LE
Managing Risk with Food-Grade Lubricants and the HACCP Program Stephen Sumerlin Noria Corporation
Agenda • • • • • •
The challenge Th h ll Background and history Food-grade lubricant performance Food-grade lubricant classifications Contamination and hazard control Gain HACCP success
The Challenge For food, F f d b beverage, cosmetic, ti pharmaceutical h ti l and d any other company which manufactures products that will be directly consumed or used by people, people processes must be highly scrutinized for cleanliness, contamination, sanitation and quality. For this reason, these companies have a particularly difficult task when it comes to lubrication; not just the task of lubricating correctly, but i determining in d t i i which hi h lubricant l bi t to t use and d where. h
Background and History Food-grade lubricants were formerly regulated by the U.S. Department of Agriculture (USDA) and the Food Safety and Inspection Service Division (FSIS) The prior approval program was eliminated in 1998 (FSIS). 1998. Today, food-grade lubricants are registered by the National Sanitation Foundation (NSF), where lubricant suppliers submit formulation ingredients and NSF verifies that the ingredients are included in the approved list (FDA-Title 21) and no testing is performed. Approved lubricants can be branded with the NSF logo and an approved lubricants list can be found at www.nsf.org/usda.listings.asp. Lubriplate
Background and History In the 1960s, the U.S. National Aeronautics and Space Administration (NASA) developed a strategic program that adopted traditional inspection techniq techniques es with ith a science-based food safety system. The program uses a proactive and preventive method for identifying risk by inspecting and examining any production point or “critical control point” for food contamination risk. The program was adopted and known as the Hazard Analysis and Critical Control Point (HACCP) program. FDA
Food-Grade Lubricant P f Performance As with any other lubricants, food-grade lubricants must meet the performance needs of equipment by providing metal-to-metal t lt t l separation ti and d remaining i i odorless, d l tasteless and physiologically inert. Food-grade lubricants also must be formulated to withstand product contamination contamination, such as sugar sugar, dust dust, chemicals, etc., and have a built-in anti-microbial to fend off the risk of bacteria formation in wet environments like meat packaging.
Food-Grade Lubricant P f Performance Additives – What are they? • Organic and inorganic compounds dissolved or suspended (as solids) in the oil • Can represent from 0.1% to 30% of formulated oil volume • Monitoring additive health is an important goal of oil analysis
Additives’ Role…
SAIT, JCF
Food-Grade Lubricant P f Performance
Common Additives and their Functions
DT
Food-Grade Lubricant Cl Classifications ifi i
LW, Lubecon, GT
Food-Grade Lubricant Cl Classifications ifi i In order for food-grade lubricants to be classified in one of the three mentioned categories, they must comply with certain FDA codes within Title 21, such as: – 21.CFR 178.3570: Allowed ingredients for the manufacture of H1 lubricants – 21.CFR 178.3620: White mineral oil as a component of non-food articles intended for use in contact with food – 21.CFR 172.878: USP mineral oil for direct contact with food – 21.CFR 172.882: Synthetic Iso-paraffinic hydrocarbons – 21.CFR 182: Substances generally recognized as safe
Even though the H1 classified food-grade lubricants are manufactured with the ideology of incidental contact with food, the allowable lubricant contamination constituted by the FDA is 10 parts per million.
FDA
Contamination and Hazard C Control l Lubricant contamination can be held to a minimum with proactive plans and proper maintenance practices. Maintenance personnel p p should be aware of the liabilities associated with lubricant contamination. To effectively control lubricant contamination risk, certain guidelines d l can be b followed, f ll d such h as: • • • •
Ensure all leaks are contained and addressed Ensure over-greasing is limited Use containment devices such as grease caps, if allowed Top up and filtration equipment should be clean and well Top-up maintained
Contamination and Hazard C Control l The HACCP has been a success in monitoring g and controlling g food and beverage industry contamination risk, and is now being used in cosmetic and pharmaceutical industries. In the U.S., the HACCP is in compliance with and regulated by 21 CFR 120/123. To develop and implement a successful HACCP program, there are seven principles to assist in that respect. They are as follows: Principle 1 – Conduct a hazard analysis: Plants determine the food safety hazards and identify the preventive measures the plant can apply to control these hazards. Principle 2 – Identify critical control points: A critical control point (CCP) is a point, step or procedure in a food process at which control can be applied and, as a result, a food safety hazard can be prevented, eliminated or reduced to an acceptable level. A food safety hazard is any biological, chemical or physical property that may cause a food to be unsafe for human consumption. FDA
Contamination and Hazard C Control l Principle 3 – Establish critical limits for each critical control point: A critical limit is the maximum or minimum value to which a physical, biological or chemical hazard must be controlled at a critical control point to prevent, eliminate or reduce to an acceptable level. Principle 4 – Establish critical control point monitoring requirements: Monitoring activities are necessary to ensure that the process is under control at each critical control point. FSIS is requiring that each monitoring procedure and its frequency be listed in the HACCP plan. Principle 5 – Establish corrective actions: These are actions to be taken when monitoring indicates a deviation from an established critical limit limit. The final rule requires a plant’s HACCP plan to identify the corrective actions to be taken if a critical limit is not met. Corrective actions are intended to ensure that no product injurious to health or otherwise adulterated as a result of the deviation enters commerce. FDA
Contamination and Hazard C Control l Principle 6 – Establish recordkeeping g procedures: The HACCP regulation g requires that all plants maintain certain documents, including its hazard analysis and written HACCP plan, and records documenting the monitoring of critical control points, critical limits, verification activities and the handling of processing deviations. deviations Principle 7 – Establish procedures for ensuring the HACCP system is working as intended: Validation ensures that the plans do what they were designed to do; that is, they are successful in ensuring the production of safe product. Plants will be required to validate their own HACCP plans. FSIS will not approve HACCP plans in advance, but will review them for conformance with the final rule. rule The seven principles of the HACCP are included in the ISO 22000 standard. ISO 22000 is an industrial-specific risk management system for any type of food processing and marketing, which can be closely incorporated with a quality management system. FDA
Gain HACCP Success There are fundamental steps you can take to increase the success of a HACCP program program, such as: •Create concise lubrication tasks/procedures and perform any equipment i t modifications difi ti necessary tto complete l t th these ttasks k •Ensure the highest level of cleanliness inside and outside of equipment is achieved using contamination control techniques •Lubricant Identification System to help with lubricant crosscontamination resulting in premature failures •Keep the HACCP program up to date with constant refinement and document all successes and failures refinement,
Gain HACCP Success Contamination Control – Seals play a vital role in lubricant contamination issues
Gain HACCP Success Lubricant Identification System – Helps prevent cross-contamination failures
Cross-contamination can cause premature equipment failure due to incompatibility. Food-grade lubricants pose a large risk for cross-contamination f il failures d due tto th the ffactt that many H1 lubricants are not compatible with H2 and d H3 llubricants. bi t GT
Questions? [email protected]
Agenda • • • • • •
The challenge Th h ll Background and history Food-grade lubricant performance Food-grade lubricant classifications Contamination and hazard control Gain HACCP success
The Challenge For food, F f d b beverage, cosmetic, ti pharmaceutical h ti l and d any other company which manufactures products that will be directly consumed or used by people, people processes must be highly scrutinized for cleanliness, contamination, sanitation and quality. For this reason, these companies have a particularly difficult task when it comes to lubrication; not just the task of lubricating correctly, but i determining in d t i i which hi h lubricant l bi t to t use and d where. h
Background and History Food-grade lubricants were formerly regulated by the U.S. Department of Agriculture (USDA) and the Food Safety and Inspection Service Division (FSIS) The prior approval program was eliminated in 1998 (FSIS). 1998. Today, food-grade lubricants are registered by the National Sanitation Foundation (NSF), where lubricant suppliers submit formulation ingredients and NSF verifies that the ingredients are included in the approved list (FDA-Title 21) and no testing is performed. Approved lubricants can be branded with the NSF logo and an approved lubricants list can be found at www.nsf.org/usda.listings.asp. Lubriplate
Background and History In the 1960s, the U.S. National Aeronautics and Space Administration (NASA) developed a strategic program that adopted traditional inspection techniq techniques es with ith a science-based food safety system. The program uses a proactive and preventive method for identifying risk by inspecting and examining any production point or “critical control point” for food contamination risk. The program was adopted and known as the Hazard Analysis and Critical Control Point (HACCP) program. FDA
Food-Grade Lubricant P f Performance As with any other lubricants, food-grade lubricants must meet the performance needs of equipment by providing metal-to-metal t lt t l separation ti and d remaining i i odorless, d l tasteless and physiologically inert. Food-grade lubricants also must be formulated to withstand product contamination contamination, such as sugar sugar, dust dust, chemicals, etc., and have a built-in anti-microbial to fend off the risk of bacteria formation in wet environments like meat packaging.
Food-Grade Lubricant P f Performance Additives – What are they? • Organic and inorganic compounds dissolved or suspended (as solids) in the oil • Can represent from 0.1% to 30% of formulated oil volume • Monitoring additive health is an important goal of oil analysis
Additives’ Role…
SAIT, JCF
Food-Grade Lubricant P f Performance
Common Additives and their Functions
DT
Food-Grade Lubricant Cl Classifications ifi i
LW, Lubecon, GT
Food-Grade Lubricant Cl Classifications ifi i In order for food-grade lubricants to be classified in one of the three mentioned categories, they must comply with certain FDA codes within Title 21, such as: – 21.CFR 178.3570: Allowed ingredients for the manufacture of H1 lubricants – 21.CFR 178.3620: White mineral oil as a component of non-food articles intended for use in contact with food – 21.CFR 172.878: USP mineral oil for direct contact with food – 21.CFR 172.882: Synthetic Iso-paraffinic hydrocarbons – 21.CFR 182: Substances generally recognized as safe
Even though the H1 classified food-grade lubricants are manufactured with the ideology of incidental contact with food, the allowable lubricant contamination constituted by the FDA is 10 parts per million.
FDA
Contamination and Hazard C Control l Lubricant contamination can be held to a minimum with proactive plans and proper maintenance practices. Maintenance personnel p p should be aware of the liabilities associated with lubricant contamination. To effectively control lubricant contamination risk, certain guidelines d l can be b followed, f ll d such h as: • • • •
Ensure all leaks are contained and addressed Ensure over-greasing is limited Use containment devices such as grease caps, if allowed Top up and filtration equipment should be clean and well Top-up maintained
Contamination and Hazard C Control l The HACCP has been a success in monitoring g and controlling g food and beverage industry contamination risk, and is now being used in cosmetic and pharmaceutical industries. In the U.S., the HACCP is in compliance with and regulated by 21 CFR 120/123. To develop and implement a successful HACCP program, there are seven principles to assist in that respect. They are as follows: Principle 1 – Conduct a hazard analysis: Plants determine the food safety hazards and identify the preventive measures the plant can apply to control these hazards. Principle 2 – Identify critical control points: A critical control point (CCP) is a point, step or procedure in a food process at which control can be applied and, as a result, a food safety hazard can be prevented, eliminated or reduced to an acceptable level. A food safety hazard is any biological, chemical or physical property that may cause a food to be unsafe for human consumption. FDA
Contamination and Hazard C Control l Principle 3 – Establish critical limits for each critical control point: A critical limit is the maximum or minimum value to which a physical, biological or chemical hazard must be controlled at a critical control point to prevent, eliminate or reduce to an acceptable level. Principle 4 – Establish critical control point monitoring requirements: Monitoring activities are necessary to ensure that the process is under control at each critical control point. FSIS is requiring that each monitoring procedure and its frequency be listed in the HACCP plan. Principle 5 – Establish corrective actions: These are actions to be taken when monitoring indicates a deviation from an established critical limit limit. The final rule requires a plant’s HACCP plan to identify the corrective actions to be taken if a critical limit is not met. Corrective actions are intended to ensure that no product injurious to health or otherwise adulterated as a result of the deviation enters commerce. FDA
Contamination and Hazard C Control l Principle 6 – Establish recordkeeping g procedures: The HACCP regulation g requires that all plants maintain certain documents, including its hazard analysis and written HACCP plan, and records documenting the monitoring of critical control points, critical limits, verification activities and the handling of processing deviations. deviations Principle 7 – Establish procedures for ensuring the HACCP system is working as intended: Validation ensures that the plans do what they were designed to do; that is, they are successful in ensuring the production of safe product. Plants will be required to validate their own HACCP plans. FSIS will not approve HACCP plans in advance, but will review them for conformance with the final rule. rule The seven principles of the HACCP are included in the ISO 22000 standard. ISO 22000 is an industrial-specific risk management system for any type of food processing and marketing, which can be closely incorporated with a quality management system. FDA
Gain HACCP Success There are fundamental steps you can take to increase the success of a HACCP program program, such as: •Create concise lubrication tasks/procedures and perform any equipment i t modifications difi ti necessary tto complete l t th these ttasks k •Ensure the highest level of cleanliness inside and outside of equipment is achieved using contamination control techniques •Lubricant Identification System to help with lubricant crosscontamination resulting in premature failures •Keep the HACCP program up to date with constant refinement and document all successes and failures refinement,
Gain HACCP Success Contamination Control – Seals play a vital role in lubricant contamination issues
Gain HACCP Success Lubricant Identification System – Helps prevent cross-contamination failures
Cross-contamination can cause premature equipment failure due to incompatibility. Food-grade lubricants pose a large risk for cross-contamination f il failures d due tto th the ffactt that many H1 lubricants are not compatible with H2 and d H3 llubricants. bi t GT
Questions? [email protected]
