Lubricant is a substance introduced to reduce friction and wear between moving surfaces of a machinery.Friction causes heat,so lubricants reduce heat by carrying away the moving surface of the machinery and cool its components.Lubricants also helps to maintain machine parts rust and corrosion free.
Industrial lubricants are prepared from either organic or synthetic compounds.Most of the organic lubricants are prepared from chemical compounds through a number of chemical processing using some additives.Typically lubricants contains 90% base oil (most often petroleum fractions called mineral oils) and less than 10% additives. Vegetable oils or synthetic liquids such as hydrogenated poly olefin's,esters,fluorocarbons and many others are some times used as base oils.The key role of additives used in lubricants is to increase the viscosity of lubricants and reduce oxidation and contamination.Some common additives are antioxidants,anti foaming agents,rust - corrosion inhibitors,metal deactivator's etc.
Lubrication challenges in Pharmaceuticals
Machineries used in pharmaceuticals have many moving parts that require lubricants,to maintain reliable and efficient operation.These range from hydraulics,gear boxes,bearings and chains to vacuum pumps and compressors.Some major lubricants related issues in pharmaceuticals are discussed below.
- Lubricants used in the pharmaceuticals must meet basic requirements like wear protection,good lubricity,long life etc.If lubrication is insufficient or lubricant is not suitable for the application high friction and rapid wear on the compounds may occur.This is quite undesirable in pharmaceuticals because in a clean room the minute wear particle will contaminate the ambient air.(lubricants based on pre fluorinated poly ether 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).
- Lubricant leakage is a major headache in pharmaceuticals because if incidental contact occurs,they do not discriminate against materials with which they come in to contact,so contamination control is a major issue in pharmaceuticals.Hence the usage of lubricants are technically unavoidable pharmaceutical manufacturers are insisted to use food grade lubricants to reduce the contamination risks,because 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.
Food grade lubricants
Food grade lubricants are suitable for incidental contact with food and pharmaceuticals. They are not intended for human consumption or for contact with skin or mucous membrane.Food grade lubricants composed in such a way that if applicable,technically unavoidable residues in the processed product are innocuous for health,taste and odour, and they do not have any other adverse effect on the product.
A food grade lubricant performs in the same way as other lubricant.It provide protection against wear,friction,corrosion and oxidation,dissipates heat and transfer power.It is compatible with rubber and other safety materials as well as provide a safety effect in some cases.
Food grade lubricants categories
The lubricant types of food grade applications are broken in to categories based on the likely hood they will contact with food.The USDA created the original food grade designations H1,H2 and H3,which is the current terminology used.
H1 Lubricants are food - grade lubricants used in food processing environments where there is some possibility of incidental food contact.Lubricant formulations may only be composed of one or more approved base stocks,additives and thickeners listed in 21 CFR 178.3750
H2 Lubricants are lubricants used on equipments and machine parts in locations where there is no possibility that the lubricants or lubricated surface contacts food.Because there is not the risk of contacting food,H2 lubricants do not have the list of acceptable ingredients.they cannot,however,contain intentionally heavy metals such as antimony,arsenic,cadmium,lead,mercury or selenium.Also ingredients must not include substances that are carcinogens,mutagens,teratogens or mineral acids.
H3 Lubricants are also known as soluble or edible oil, are used to clean and prevent rust on hooks, trolly's and similar equipment.
Lubricants for pharmaceutical use 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.The H1 registration is based on the US guidelines of sec.21 CFR of the FDA regulations.The USFDA has determined qualitative and quantitative ingredients to be used in lubricants for food industry.The assessment and approval process is carried out by the NSF international.The NSF registered products are listed in White book.The standard H1 describes products,which are to be used where incidental contact with food is possible.
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.
H1 Lubricants are food - grade lubricants used in food processing environments where there is some possibility of incidental food contact.Lubricant formulations may only be composed of one or more approved base stocks,additives and thickeners listed in 21 CFR 178.3750
H2 Lubricants are lubricants used on equipments and machine parts in locations where there is no possibility that the lubricants or lubricated surface contacts food.Because there is not the risk of contacting food,H2 lubricants do not have the list of acceptable ingredients.they cannot,however,contain intentionally heavy metals such as antimony,arsenic,cadmium,lead,mercury or selenium.Also ingredients must not include substances that are carcinogens,mutagens,teratogens or mineral acids.
H3 Lubricants are also known as soluble or edible oil, are used to clean and prevent rust on hooks, trolly's and similar equipment.
Lubricants for pharmaceutical use 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.The H1 registration is based on the US guidelines of sec.21 CFR of the FDA regulations.The USFDA has determined qualitative and quantitative ingredients to be used in lubricants for food industry.The assessment and approval process is carried out by the NSF international.The NSF registered products are listed in White book.The standard H1 describes products,which are to be used where incidental contact with food is possible.
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.
When you are using food grade lubricants in pharmaceuticals ensure the following
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 come 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.
