Different Lubricants Approved For Pharmaceutical Machine Use
It is beneficial to lubricate pharmaceutical machinery from time to time. Lubrication during manufacturing minimizes the friction between different parts of the machines. This is important as friction can cause heating which may adversely affect the pharmaceutical product. Lubrication also helps reduce the tendency of parts to rust and decreases load in the machine. The lubricants for pharmaceutical machinery are generally made of natural organic oils as synthetic ones can cause reaction with products and are therefore not permitted.
There are several machines that are commonly used by in pharmaceutical industry that have moving parts that require regular lubrication. Examples include the colloid mill, coating machine, tablet press, packing machine and rapid mixer granulator. A common issue is that lubricants can leak and ultimately may inadvertently come into contact with the product and cause contamination. In sterile environments, the lubricant can be a source of microbial contamination, and if such lubricant infiltrates the product there is a high probability that it will compromise both its quality and efficacy.
In order to prevent risk of compromising pharmaceutical products, lubricants used in machinery must meet the necessary regulatory guidelines -- only food-grade lubricant oil is permitted and it must have ISO21469 certification. Manufacturers are also required to have their products pass the National Sanitation Fouondation (NSF) H1 registration. The H1 category is one of three categories of lubricant:
- H1 Lubricant – food grade lubricants used for equipment with high chance of contact or mixing with the food or drug product. It must contain ingredients that are listed in the 21CFR part 178:3570.
- H2 Lubricant – these lubricants are used for parts that are not exposed to the product. The lubricants must not contain any heavy metal like arsenic, lead or cadmium.
- H3 Lubricant – lubricants that are edible and soluble and are usually used in transportation equipment.
Synthetic food grade lubricants that contain polyalphaolefin or polyalkylene oils may be used when manufacturing at an extreme temperature. Silicon oil that has high viscosity may also be used.
Food grade oils are very similar to the more normal synthetic oils in their properties -- they can reduce friction and control rusting of machinery. Food grade oil has the advantage that a certain percentage is tolerated in the food or drug product. See FDA guidelines Sec. 178.3570 Lubricants with incidental food contact - http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/...].
The international standard applicable to lubricants in the pharmaceutical industry is ISO21469; it goes beyond NSF H1 requirements in that it requires manufacturers to meet particular hygiene standards for the formulation, manufacture, use and handling processes of lubricants that may have incidental product contact. ISO21469 certification requires lubricant manufacturers to develop a hygiene strategy and to consider chemical, physical and biological hazards in the context of the lubricant end use. Four essential elements are required to maintain annual certification:
- An initial formulary and labelling review of the ingredients in the lubricant
- Annual testing of certified product
- A complete risk assessment for all products certified
- Annual production facility audit.
Before Using Food Grade Lubricants equipment users should check the following:
- The Material Safety Data Sheet (MSDS)
- Testing of the lubricant for disburden
- The Ingredients should comply with the 21 CFR part 178:3570
- The lubricant has a current Certificate of Analysis
- Lubricants must not have an expired use by date.
LFA Tablet Presses offers a full range of food grade grease, lubricants and cleaning products. All of these are produce by industry leader Ambersil. If you need anything from the Ambersil rage but are not able to find it on our site please do let us know.