Food Grade Lubricants|Pharmaceutical Industries

Lubricants are used to reduce the friction between different moving parts of the machines in pharmaceutical industries. Different types of machines like filling machines, granulation equipment, compression machines, coating machines, blistering machines, etc. are used in pharmaceutical industries and all machines require proper lubrication for smooth work.

In pharmaceutical industries, conventional lubricants are not safe to use so the concept of food-grade lubricants was introduced because in the food industry, the same food-grade lubricants are used.

As the name indicates it is food-grade and is not harmful.

Food-grade lubricants have the same functions as other lubricants but these lubricants meet regulatory requirements to use in the pharmaceutical industry.

Topic to Discuss

In this article we will discuss following

Properties Of Food Grade Lubricant.

  • Why Food Grade?
  • Classification
    • H1 Lubricants
    • H2 Lubricants
    • H3 Lubricants
  • Formulation of Food Grade Lubricants
    • Base Materials
    • Additives
  • Test For Lubricants
  • Authorities and Regulations

Properties Of Food Grade Lubricant

  • A good food-grade lubricant should possess the following properties
  • Should reduce friction
  • Should transfer power
  • Should be tasteless
  • Physiologically inert
  • Odourless
  • Should be resistant to water
  • Should be resistant to oxidation
  • Prevent wear and tear
  • Compatible with machine parts.
  • Food grade lubricants used in the pharmaceutical industry should be of good quality because they may have to bear heavy load as in case of compression machine parts and should be suitable for dusty environments like for granulation area machines because in pharmaceutical industries usually  powder are processed  and may adhere to the machine parts, especially in OSD area.

Why Good Grade?

  • As pharmaceutical industries use different types of machines and for smooth machines running proper lubrication is required.
  • Sometimes there are chances of lubrication leakage and it may accidentally come in contact with product so lubricants used for these machines should be of food-grade quality.

Classification Of Food Grade Lubricants

Lubricants were originally classified by the United State Department of Agriculture(USDA) and later on it was taken up by National Sanitation Foundation (NSF)

  • Food grade lubricants are classified into the following
    • H1 Lubricants
    • H2 Lubricants
    • H3 Lubricants

H1 Lubricants

  • H1 are the lubricants which are used for those machine parts which are in direct contact with the product and where there are chances of accidental lubricant contact with the product.
  • It does not mean that we can freely mix H1 lubricants with the product but it has an allowable limit usually 10 parts per million.
  • H1 lubricants are also known as Incidental lubricants.
  • For lubricants to be H1 grade or food grade mean that all the ingredients for  H1 Lubricants are in the approved list of FDA and meet requirements of CFR 21 178.3570

H2 Lubricants

  • H2 are the lubricants which are used for those machine parts which are not in contact with the product.
  • Mean for those parts where there are no chances of lubrication mixing with the product.
  • H2 lubricants should not contain carcinogenic materials or heavy metals.

H3 Lubricants

  • H3 lubricants are edible oils.
  • These are soluble lubricants.
  •  H3 lubricants are used to prevent rust.
  • H3 lubricants contain materials which meet specific guidelines of  21 CFR.

Also Read:

GMP vs cGMP and 21 CFR.

Formulation of Food Grade Lubricants

  • Food grade lubricants consist of following two main components
  • Base Materials
  • Additives

Base Materials

  • Commonly used base materials for food-grade lubricants are as follow
  • Mineral Oil / White Oil
  • PAO
  • Silicon Oil
  • Esters


  • Commonly used additives  for food-grade lubricants are as follow
  • Anti-foam agents
  • Anti-wear agents 
  • Antioxidants agents
  • Surfactants
  • Viscosity Modifiers
  • Corrosion Inhibitors

Test For Lubricants

  • Usually, the following tests are performed for food-grade lubricants 
  • Viscosity
  • Density

Authorities and Regulations

  • Following bodies and regulations regulate the food-grade lubricants
  • USDA 
  • FDA 21CFR
  • National Sanitation Foundation (NSF)
  • ISO 21469
  • ISO 22000
  • Modern machines for pharmaceutical industries are designed in such a way that requires no lubrication or a very small quantity of lubricant is required to the parts where there are chances of product contact.
  • FDA provides regulations and Good manufacturing practices for equipment manufacturers and lubricant manufacturers.
  • 21CFR 211.65 states that equipment should be manufactured in such a way that product contact parts should not change the safety and quality of the drug product.
  • It also states that any lubricant should not come in direct contact with drug products or the in process materials and should not change or affect the quality of drug product.
  • From the above statement,we can see that the product contact parts should be free of lubricant.
  • FDA Good manufacturing practices for API states that any lubricant should not come in direct contact with API and when it is required to use a lubricant then use food-grade lubricants.
  • The above statement does not mention that the use of lubricants is prohibited rather it states that lubricants should not come in contact with drug products and always use a food-grade lubricant.

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