Over the past few years, pharmaceutical industry equipment has increasingly used food-grade lubricants. While food-grade lubricants are beneficial, there are other issues to consider.
New pharmaceutical production equipment generally requires little or even no lubricant, especially machinery on pharmaceutical manufacturing and packaging lines. However, machines near the production line may require lubrication if they have chains or moving assemblies. Lubricants recommended by equipment manufacturers may not be H1 food-grade lubricants or certified to ISO21469. We must therefore determine whether conventional lubricants can be used in the machinery and, if they cannot, what requirements the necessary lubricants must meet.
Lubricant requirements
Selecting the appropriate lubricant requires consideration of the load, rotational speed, viscosity requirements of the lubricated component or machine, and the lubrication method. Once these factors are determined, it’s time to consider additional requirements, such as whether food grade is required. Although food-grade lubricants are widely used in pharmaceutical equipment, H1 food-grade or ISO21469 standard-certified lubricants are mainly used on food processing equipment that may have incidental contact with food.
The U.S. Food and Drug Administration has regulations and recommendations on good practices for pharmaceutical manufacturing equipment and lubricants mentioned in U.S. federal regulations. 21CFR 211.65 states: “Surfaces of equipment that come into contact with drug product ingredients, intermediate materials, or drug products should be nonreactive, nonadditive, and nonadsorbent that will not alter the safety, composition, concentration, quality, or purity of the drug product or cause them to exceed official or established standards.
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The document also reads: "Substances required for operation, such as lubricants, coolants, etc., cannot enter the equipment and must not come into contact with pharmaceutical containers, sealing items, intermediate materials or pharmaceuticals to ensure that the safety, composition, concentration, quality or purity of the pharmaceuticals remain unchanged."
Therefore, it can be concluded that lubricants should not be used in production equipment or components that may come into contact with pharmaceuticals and packaging bags. It should be noted that this regulation does not prohibit the use of lubricants in all pharmaceutical equipment, but we should avoid lubricants coming into contact with pharmaceuticals. If the lubrication point is not on equipment that comes into contact with drugs or packaging, then the lubrication point may be located on independent equipment.
The U.S. Food and Drug Administration's Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients states additional information on lubricants required in the manufacturing process: "Lubricants, heating or cooling media, etc. required for equipment should be avoided from direct contact with the intermediate product or drug substance to avoid affecting the quality of the intermediate product or drug substance. Any violation of this provision should be evaluated to ensure that there is no negative impact on the suitability of the substance for effect. Where possible, food grade lubricants and oils should be used."
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The above information recommends the use of food-grade lubricants in areas of equipment where incidental contact with pharmaceuticals may occur. However, this recommendation needs to be effectively addressed and formally documented. The U.S. Food and Drug Administration allows lubricants to be used in production equipment or in separate machine parts where contact with drugs or packaging is unlikely.
If lubricants are required to be used on equipment that may come into contact with pharmaceutical products, the potential effects should be analyzed to ensure that the lubricant does not negatively affect the suitability of the product. Compared with the requirements for food processing equipment, this requirement is more stringent. The contamination concentration of the lubricant must not exceed 10ppm.
Generally speaking, permanently sealed components and components that do not require lubrication are the first choice for mechanical components. Food-grade lubricants are an excellent choice for individual production equipment components that require lubrication. However, after lubricants are used in production areas, proper cleaning and disinfection are required.
In CFR 21.211, the U.S. Food and Drug Administration provides guidance on lubricant use and equipment maintenance during pharmaceutical production, processing, and packaging. The document emphasizes keeping equipment clean and establishing written procedures, including lubrication procedures. If an oil change or lubricant problem could affect product quality, records of the affected product batches should be created and retained. However, routine maintenance such as lubrication generally has no special record-retention requirements.
Lubricant selection
To select lubricants effectively for pharmaceutical equipment, first classify the equipment. Auxiliary equipment outside production areas, as well as auxiliary equipment that does not come into contact with production equipment, products, or packaging, should use H2 lubricants, which are not food grade. Such equipment includes pumps, compressors, gearboxes, and hydraulic systems supplying water, compressed gases, and power. Most non-H1 lubricants on the market can meet H2 requirements, but only a small proportion of lubricating oils have formal H2 certification.
If the compressed air pipeline of production equipment needs lubrication, then using H1 grade lubricant is a good choice.
Machines or components located in production areas but with physical barriers to products and packaging areas do not have special requirements when selecting lubricants. However, food-grade lubricants may better optimize the safety and maintenance measures of production equipment.
For components such as chutes, chains, drive belts, etc. that may come into contact with pharmaceuticals or packaging, further analysis is recommended to determine the true lubrication needs of the component. Determine whether these components must be lubricated, and if so, determine the appropriate type of lubricant, method and frequency of lubrication. For example, chains can be lubricated with oil, grease, or dry spray.
Clean rooms may require sterilizing tools as well as sterilizing equipment components. If these tools and components require lubrication, the lubricant must not only be food grade, but must also have been previously heat treated in a sterilizer or sterilized by gamma irradiation. In this case, additional performance requirements such as oxidation resistance, chemical resistance, and radiation resistance need to be considered when selecting lubricants. Special storage and handling procedures should also be taken into consideration.
Where possible, switching to permanently sealed and lubrication-free components can reduce the lubrication burden and prevent potential contact. Equipment and components used in the pharmaceutical industry are generally smaller than those in other industries and tend to operate in controlled environments. These favorable conditions support the transition to permanently sealed and lubrication-free components. Equipment in production areas is recommended to adopt these components, and using them throughout all equipment would also be beneficial.
Under certain circumstances, ISO21469 certified lubricants are superior to H1 food grade lubricants. Although both lubricants are suitable for equipment or components that may have incidental contact with products, ISO21469 certified lubricants "reflect the level of quality control in the preparation, production, distribution, and storage of lubricants to ensure that the lubricants meet the highest hygiene standards." Both lubricants are NSF certified.
Finally, ensure that established change management procedures are followed and that records of lubricant status, analysis, selection, and actions are maintained. If you would like some official advice and interpretation of regulations, please contact the relevant organization. The U.S. Food and Drug Administration's Division of Drug Information can also provide further assistance.
(Excerpt from the May 2018 issue of Lubricating Oil Information magazine.)