Food grade oil in pharmaceutical industry

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 accidental contact with the product, requires an H1-grade lubricant. For example, in the case of a blowing machine, where compressed air is used to blow containers before filling, H1 grade lubricant must be used.

·        For conveyors or other types of belts that have the potential to contact products, an H1-grade lubricant must be used.

Types of food grade lubricant

For food-grade lubricants, three categories are used in the pharmaceutical industry. These are H1, H2 & H3. The National Sanitation Foundation, a non-profit organization involved in product testing and certification for non-food items such as lubricants, developed this standard. Let’s briefly look at the description of these lubricants.

H1

H1 lubricants are used where accidental product contact can occur with the lubricant used in the machine. These lubricant types do not contain any odour or taste and cannot chemically react with the product.

Examples of pharma machines where H1 lubricant is used include tablet compression machines, conveyors, belts and mixers.

H2

H2 lubricants are at a lower grade of food grade than H1 lubricants. The H2 lubricant cannot be used where direct contact with the product is possible. For a lubricant to be registered as H2, it is forbidden to use dangerous materials and chemicals such as carcinogens, mutagens or heavy metals.

H3

H3 lubricants are commonly known as edible oils because humans can safely consume them. These lubricants are also used in the manufacturing of food-grade products and items.

In pharma applications, they are commonly used for cleaning machines after or before a product or batch has been completed. Because oil has a natural tendency to resist and remove rust, it is possible that some traces of oils remain in the machine during cleaning. The benefit of using H3 lubricant for cleaning is that If some traces remain and they come in contact with the pharma product, there would be no or little damage to the pharma product.

What are the regulatory and standards requirement for food grade lubricant?

When selecting a lubricant, fulfilling regulatory requirements is mandatory. Some of the common regulations are as follows.

United States Food & Drug Administration – FDA

There are no specific requirements for lubricants in the United States – FDA. However, it also states the following requirements.

The 21 CFR 211: The United States FDA specifies requirements in section 65, namely “Equipment Construction”. It states that lubricant shall not come in contact with the drug product. However, if un-avoidable and possible, use food-grade lubricant.

The 21 CFR 178 section 3570 specifies attributes for a lubricant that may accidentally come in contact with a pharma product. Accordingly, the lubricant shall be safely used for pharma processing equipment such as manufacturing, packaging, transporting or holding.

The lubricant must be prepared from one or more than the following

       o Substance safe for use in food

       o Substance used with prior sanction or approval

       o Substance identified in 21 CFR 178.3570, paragraph (a)3

The lubricant can only be used according to following applications

       o Protective anti-rust film

       o Release agents on gaskets

       o Lubricant for machine parts

       o Exposure of lubricant part to product

The ISO 21469

The International Standardization Organization – ISO 21469:2006 Safety of machinery — Lubricants with incidental product contact — Hygiene requirements is an ISO standard for lubricants. Almost all pharma manufacturing regulatory bodies recognize ISO 24169 as a safe lubricant for accidental contact with the product.

As mentioned in the title, this standard is only applicable for a lubricant that accidentally comes in product contact and cannot be applied to areas or machines where there is no possibility of product contact. Examples include Compressors and Air Handling Units.

ISO 21469 standardizes requirements for the formulation, manufacturing and handling of lubricants that can accidentally come in contact with the product. Some key areas of these standards are underValidating formulation on-site during production

Ensure that packaging is accurate and according to regulations

Essential testing of the manufacturing product must be performed so that accurate formulation can be achieved

The ISO 21469, helps to mitigate risks related to formulation and manufacturing during production and storage, by

·        Ensuring that H1 formulation has not been altered.

·        Ensures that product constituents are according to labels.

·        It ensures that there are adequate arrangements to prevent the product from contamination and mix-up with other products during manufacturing.

·        It ensures that Good manufacturing practices are followed during the entire production stage – from raw material to manufacturing and dispatching to the target location for distribution.

·        Preventing contamination due to dirt, moisture and foreign particles when the product is stored in storage or warehouse

·        It also ensures that there are no abrupt or major temperature variations during the entire period of storage,

·        The storage conditions should be appropriate.

·        The lubricant must not be stored beyond its expiry date. Expired lubricant must be discarded appropriately, considering environmental and drug regulatory regulations.

·        During transportation, the product does not face any damage, tampering or change in its formulation and packaging. It must be delivered at the exact condition and accurate formulation.

Applications of food grade lubricants

An example of a lubricant system in pharma equipment is a table compression machine. It consists of a set of punches that rotates around a turret at high speed. Since these mechanical punches rotate at high speed, they often become overheated and cause damage to the product. Overheating also affects the mechanical part's performance and reduces its life.

To prevent overheating, food-grade lubricant is used. A lubricant is contained in a small tank inside the machine, and the pump automatically pumps the lubricant to the punches. Depending on the machine and process requirements, the pump can be configured for lubricant quantity and timing.

Since pharma tablets are continuously produced, and the product will likely come in contact with the lubricant, food-grade lubricants are used.

About the Author

Muhammad Asim Niazi has a vast experience of about 11 years in a Pharmaceutical company. During his tenure he worked in their different departments and had been part of many initiatives within the company. He now uses his experience and skill to write interested content for audiences at PharmaSources.com.