Machinery Lubrication magazine published by Noria Corporation
Issue link: https://www.e-digitaleditions.com/i/902206
46 | November - December 2017 | www . machinerylubrication.com PERSPECTIVE ISO 21469-certified products are primarily intended for food-processing plants and applications in which there is incidental contact with food. e U.S. Federal Drug Administration (FDA) provides regulations and good practice recommen- dations regarding pharmaceutical manufacturing e q u ip m e nt a n d lubricants within t h e C o d e o f Federal Regulations (CFR). In 21 CFR 211.65, it states: "Equipment shall be constructed so that surfaces that c ont a c t c omp o - nents, in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements." e document further stipulates: "Any substances required for operation, such as lubricants or coolants, shall not come into contact with components, drug product containers, closures, in-process materials, or drug products so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements." From this information, it can be concluded that machine operation should be free of lubricants in sections or components where exposure to a pharma- ceutical product or its packaging may occur. Keep in mind this regulation does not specify that lubri- cants should not be applied in machinery utilized for pharmaceutical production, but rather that lubricants should not come in contact with the drug product. Moreover, while lubrication routes would not be expected in equipment sections that are exposed to the product or its packaging, it is possible to lubricate isolated machine sections. e FDA's Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients offers additional information on lubricants used in the manufacturing process: "Any substances associated with the operation of equipment, such as lubricants, heating fluids or cool- ants, should not contact intermediates or APIs (Active Pharmaceutical Ingredients) so as to alter the quality of APIs or intermediates beyond the official or other estab- lished specifications. Any deviations from this practice should be evaluated to ensure that there are no detri- mental effects on the material's fitness for use. Wherever possible, food-grade lubricants and oils should be used." is last statement allows for the use of food-grade lubricants in exposed areas of the machine. However, this should be addressed and documented properly. e FDA also permits the use of lubricants in a manufac- turing facility or in isolated machine sections when there is no risk of contact with the pharmaceutical product or its packaging. When a lubricant is needed in an area that is exposed to the drug product, t he poten- tial impact should be analyzed to ensure it will not be detrimental to the product's intended fitness for use. is requirement is stricter than the crite- rion for food-processing machines, which allows a maximum lubricant contam- ination of 10 parts per million. In general, sealed-for-life or non-lubricated components should be the first choice for machinery components. Food-grade lubricants are a good option for isolated production machine components that need lubrication. Of course, proper cleaning and sanitizing practices will be required after the application of lubri- cants within the production area. Lubrication-related Requirements In CFR 21.211, the FDA provides guidance regarding lubrication practices and machine main- tenance used in the manufacturing, processing and packing of pharmaceuticals. It emphasizes the impor- tance of maintaining clean equipment and establishing written procedures, including lubrication procedures. If a lubricant change or lubrication issue could impact product quality, written records are required to be kept relating to the affected product batch. However, routine maintenance such as lubrication does not have specific record-keeping requirements. Lubricant Selection For effective lubricant selection in pharmaceutical facilities, one of the first steps should be to classify machines by the application. For support services equipment not located in the production area and that have no potential contact with production machinery or the product/packaging, it is possible to use H2 lubri- cants, which are not intended for food-grade (incidental contact) applications. ese types of machines would include pumps, compressors, gearboxes and hydraulic systems involved in the supply of water, compressed gases and energy. Most lubricants (non-H1) in the market fulfill H2 requirements, while only a limited IT MUST BE DETERMINED WHETHER THE MACHINERY SHOULD BE LUBRICATED WITH CONVENTIONAL LUBRICANTS OR IF THERE ARE SPECIFIC REQUIREMENTS FOR SELECTING AN APPROPRIATE LUBRICANT. Helpful Resources For more information on this sub- ject, visit the following websites: NSF International www.nsf.org U.S. Federal Drug Administration www.fda.gov U.S. Government Publishing Office www.ecfr.gov