Lubricants are used to minimize the faction between the moving surfaces of the machines. Fraction may cause the heating of the moving parts. It also helps to minimize the load on the machine and rust. Generally lubricants are prepared with organic and synthetic compound those are not permitted in pharmaceuticals.
There are many moving parts in compression machine, packing machines, coating machine, colloid mill, rapid mixer granulator etc. those are required to be lubricated time to time. Leakage of lubricants is a major problem in pharmaceutical manufacturing that can cause the contamination in drug products. In sterile production this lubricant may cause microbial contamination in product. There is a chance of mixing the lubricants with the products that is not acceptable by the regulatory agencies. Therefore, a suitable lubricant is required for pharmaceutical manufacturing machines. Food grade lubrication oils are used for lubrication in pharmaceuticals those are permitted by regulatory agencies. These lubricant must have ISO21469 certification and manufacturer must have National Sanitation Foundation (NSF) H1 registration for the product.
Generally synthetic food grade pharmaceutical lubricants contain polyalphaolefin oil (PAO) or polyalkylene (PAG) and can be used at extreme temperatures also. Silicon oils with high viscosity are also used.
Food grade oils are similar to the synthetic lubricants in lubrication, fraction reduction, rust control and other properties. These also have an extra advantage of incidental contact with drug products. 21 CFR part 175 Section178:3570 - Lubricants with incidental food contact has a list of food grade oils to use as lubricants and their permitted percentage in food and drug materials.
ISO21469 - Lubricants with incidental product contact - Hygiene requirements has hygiene requirements and the handling of the lubricants during the incidental contact with the food and drug products. Information for use, packing, labelling and other requirements for an international standard lubricant is also specified in this part.
Different Grades of Lubricants:
According to United States Department of Agriculture (USDA), lubricants have following three categories.
A. H1 Lubricants: These are food grade lubricants and used for lubricating the equipments where are chances of contact with food or drug products. These lubricants must contain the ingredients listed in 21CFR part 178:3570.
B. H2 Lubricants: These are used to lubricate the parts of machines those do not have chance of contact with product. The ingredients for these lubricants are not listed but should not contain heavy metals like lead, cadmium and arsenic.
C. H3 Lubricants: These are edible oils those are soluble and used in transportation equipments like trolleys.
Following things should be verified before using the food grade lubricants:
1. Material Safety Data Sheet (MSDS) for pharmaceutical lubricants should be available.
2. Chemical composition of the pharmaceutical lubricants should be according to the 21 CFR part 178:3570.
3. Certificate of Analysis must be available for the purchased lot.
4. Pharmaceutical lubricants should be tested for disburden.
5. Pharmaceutical lubricants should not be expired because it may come in contact with product.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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