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The Lubricant that Pharmaceuticals Trust

Pharmaceutical plants have machineries that have many moving parts and these require lubricants to work properly. These range from hydraulics, gear boxes, bearings and chains to vacuum pumps and compressors.

Lubricants used in the pharmaceuticals must meet basic requirements like wear protection, good lubricity, long life etc. This requirements help avoid high friction and rapid wear on the compounds. Lubricants based on pre fluorinated polyether oils and PTFE are particularly suited for clean room applications. They offer good wear protection and are chemically resistant to sterilization techniques employed in clean rooms.

Another area of concern is lubricant leakage. Lubricants do not discriminate against materials with which they come into contact, so contamination control is a major issue in pharmaceuticals. This is the main reason why food grade lubricants are essential in pharmaceuticals. Standard lubricants are mixes of base oils and chemical additives, many of which harm human health if ingested. Food grade lubricants use additive types that are more benign. A good food grade lubricant will use synthetic base oils such as PFO, which offers long oil life.

Lubricants used for pharmaceutical must have NSF H1 registration and ISO 21469 certification. The NSF - H1 registration has established itself as an international standard for lubricants used in the food industry. This is based on the US guidelines of sec.21 CFR of the FDA regulations. The NSF international carries out assessment and approval process. The NSF registered products are listed in White book.

Meanwhile, ISO 21469:2006 specifies the hygiene requirements for the formulation, manufacture, use and handling of lubricants which, during manufacture and processing can come in to incidental contact with products used in food, pharmaceuticals, cosmetics, tobacco or animal feeding stuff industries.

Pharmaceutical plants should consider the following when using food grade lubricants:

  1. Ensure the availability of MSDS of the lubricant.
  2. Ensure the availability of chemical composition of the lubricant (Cross check with 21 CFR 178-3750 lubricants list for incidental food contact).
  3. Pharmaceutical manufacturer must have quality agreements with supplier.
  4. Ensure each lot comes with certificate of analysis and they must contain approved substances.
  5. Lubricants must be tested for sterility once they are sterilized and enter sterile facilities (In case of sterile applications).
  6. When food grade lubricants come to contact with products like oral solids their expiration date must be considered.
  7. In solid dosage forms, lot-to-lot consistency of the received product must be analyzed for microbial load.

Pharmaceuticals should use only the highest quality lubricant. The Industrial Lubricant Store’s food-grade lubricants are 100% OEM compatible and formulated specifically for each type of industrial equipment being used in the food services industry. Composed of the highest quality synthesized hydrocarbon fluids available, these special blends offer extended life and protect against wear, rust, and corrosion. Check out our product offerings at http://www.theindustriallubricantstore.com/food-grade-lubricants.

About the Author
Randy Renick
Randy Renick has a Bachelor's degree from LSU. He is an STLE Certified Lubrication Specialist and has a 29 year work history in Industrial Lubrication. He is currently a Lubricant Consultant at The Industrial Lubricant Store.

All lubricants along with their images and logos on this website are trademarks of their respective manufacturers. TheIndustrialLubricantStore.com makes no claims of special affiliation with or special sanctions by the original manufacturers or their respective trademarks. The appearance of those names is not intended to imply that TheIndustrialLubricantStore.com is an authorized dealer or distributor of these manufacturers.