Many factors impact a machine’s performance to produce quality, accurate and timely products. One is the lubricants used in the machine’s moving parts, mainly for reducing friction in moving parts and preventing over-temperature problems.
Like other industries, lubricants in pharmaceutical industries are used as a maintenance tool. However, to qualify lubricants for pharma applications, they must fulfil specific requirements to prevent contamination and product quality compromise.
It is common and necessary to use food-grade lubricants for the machine used in pharma product processing. Because food-grade lubricants contain inherited properties specific to pharmaceutical industries, these particular qualities cannot be provided by other grades of lubricants. Food-grade lubricants are also permitted by reputed regulatory bodies to be used in pharma organizations.
What is a food Grade Lubricant?
A lubricant is a substance added to reduce friction between moving parts such as chains and gears. They help reduce heat (due to friction) and damage to moving parts due to overheating.
A food-grade lubricant is any industrial-grade lubricant that is safe for processes or machinery where items consumable by humans and animals are processed, and there is a chance that the lubricant can accidentally come in direct contact with the product. The food-grade lubricant does not harm the product or change its physical or chemical properties.
For the pharma industry, lubricant must be of food grade. Because food-grade lubricant is made up of chemicals and materials, it does not cause harm or contaminate pharma products if there is any accidental contact between the product and moving parts.
Some processing machines can also face the problem of lubricant leakage, where the lubricant escapes the applied part and enters the product area, increasing the chance of interacting lubricant with the product. In this case, a food-grade lubricant prevents contaminating and disturbing a product's quality.
Characteristics of a food grade lubricant
There are no specialized characteristics described for a food-grade lubricant in pharma industries. However, the United States FDA states two properties that must be applied in pharma applications, which are stated below.
· The lubricant must be odorless and tasteless to prevent changing physical properties of pharma products. The lubricant must also be colorless to prevent changing the color or appearance of any spots on the pharma product.
· The volume of base oil mineral oil) should not be greater than ten parts per millimetre (ppm).
· In addition to the above requirements, the lubricant must be registered as H1 or ISO 21469.
Where food grade lubricant does is used?
Most modern machine manufacturers are building machines that use no or minimum amount of lubricant, especially for those machines where the product comes in direct contact with the machine’s moving parts, such as tablet compression machines. However, lubricant is still required for some machines for the reasons mentioned initially.
For these machines or parts of the machine, a food-grade lubricant H1 or ISO 24169 must be used where there is a chance of direct contact with the product and machine part.
Some scenarios where H1 and non-H1 grade lubricants are used in the pharma industry are mentioned below.
· For machines or equipment not located in the production area, such as in the utility or technical area, where it is impossible that a product might come in contact with the machine, non-H1 grade lubricant can be used.
· A compressed line, where there is a chance of acc...
(All Rights Reserved)