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Lubricants are used to reduce friction between the moving surfaces of machines. Fractions can heat moving parts. It also helps reduce the load and rust on the machine. Generally, lubricants are prepared with organic and synthetic compounds that are not approved in pharmaceuticals.
Compression machines, packing machines, coating machines, colloid mills, rapid mixer granulators, etc. have many moving parts. They need to be lubricated from time to time. Leakage of lubricants is a major problem in pharmaceutical manufacturing that can cause contamination in drug products.
In sterile production, this lubricant can cause microbial contamination of the product. There is scope for mixing lubricants with products that are not acceptable by regulatory agencies.
Therefore, a suitable lubricant is required for pharmaceutical manufacturing machines. Food grade lubricating oils are used for lubrication in pharmaceuticals that are approved by regulatory agencies. These lubricants must have ISO21469 certification and the manufacturer must have National Sanitation Foundation (NSF) H1 registration for the product.
Typically, synthetic food grade pharmaceutical lubricants contain polyalphaolefin oil (PAO) or polyalkylene (PAG) and can be used at extreme temperatures. Silicone oil with high viscosity is also used.
Food grade oils are similar to synthetic lubricants in lubrication, friction reduction, rust control and other properties. They also have an added benefit of incidental contact with drug products. 21 CFR Part 175 Section 178:3570 – Lists food grade oils for use as lubricants in incidental food contact lubricants and their permitted percentages in food and drug ingredients.
ISO21469 – Contact of lubricants with incidental products – hygiene requirements Contains hygiene requirements and handling of lubricants during incidental contact with food and drug products. Information on usage, packing, labeling and other requirements of an international standard lubricant is also specified in this section.
