Our health is the most precious thing we have - to protect it, the production of food and pharmaceutical products has been subject to strict regulations for many decades. This is also true with regard to the lubricants used. ISO 21469 is the first international standard for lubricants, providing unambiguous hygiene requirements on the formulation, manufacture and use of lubricants where incidental contact with the product being manufactured or processed cannot be excluded. With the ISO 21469 certification, Klüber Lubrication supports its customers in the food-processing and pharmaceutical industries in their efforts to comply with the stringent hygiene requirements necessary in these sectors.
Klüber Lubrication was one of the first companies in Europe, and the first in North America, to be certified according to ISO 21469. Devised by NSF (National Sanitation Foundation, USA), the certification programme is currently the most taxing and comprehensive one for H1 food-grade lubricants.
Klüber Lubrication had manufactured its H1 lubricants to maximum standards also before ISO 21469, however, the advantages the new certification has for its customers is explained by Helga Thomas, Market Manager Pharmaceutical Industry, and Martina Bohnsack, Quality Management Officer, who prepared and oversaw the Klüber Lubrication certification process.
Helga Thomas: An important aspect is the fact that the standard is valid worldwide. The wish to have an international standard for the manufacture of H1 lubricants had been expressed by our food and pharmaceutical customers for quite some time. The ISO certification means we can offer them this kind of manufacturing assurance for the Klüber Lubrication range of H1 lubricants, one of the largest ranges of H1 lubricants available around the world.
Martina Bohnsack: What is new and immensely important in context with this standard is that the lubrication issue is considered as a whole, and that the lubricant manufacturer is assessed accordingly: it is not only the lubricant and its ingredients that are taken into account but also the way the lubricant is made, handled, packed and stored. The certification process consists of four parts: formulation review, risk assessment for the whole production process, audit, sampling and testing. This means that the customer can be assured that H1 lubricants from Klüber Lubrication are manufactured to high hygiene standards. During the NSF certification audit, the entire Klüber Lubrication production process was examined - from the delivery of raw materials to manufacture, filling and dispatch. This ensures that the lubricant does not contact other substances such as cleaning agents or foreign machine process materials. Even the packaging materials are subjected to review to determine if they are suitable for use in the food and pharmaceutical sectors.
Helga Thomas: ISO 21469 covers the whole life cycle of the lubricant. It requires Klüber Lubrication, as the manufacturer, to analyse the hygiene aspects that arise from handling a lubrication product, and to instruct the user accordingly. Of course we cannot dictate to our customers how to precisely use lubricants, but we can and do offer consulting and support that go far beyond the normal scope of product recommendation. This starts with determination of the optimum lubricant quantity for each friction point - in practice operators often want to be certain of reliability and tend to lubricate excessively. We also advise customers on the most suitable application method, for example where precise metering by grease gun or tube nozzle is preferable to manual application by spatula etc. It is generally recommended to store the lubricants near the lubrication points, in a place where they are easy to see by the operating staff thus maintaining awareness regarding the importance of correct lubrication.
The add-on service KlüberAssetSupport offered by Klüber Lubrication supports the pharmaceutical, food and cosmetics industries in many other important issues. It includes risk analyses in lubrication audits to identify all critical control points (HACCP = Hazard Analyses and Critical Control Points) and workshops on the subject of lubrication familiarise staff with all aspects of lubrication. For example, in just one week we performed a complete HACCP lubrication audit at a customer and identified all lubrication points, prepared all lubrication charts and provided the customer with on-site assistance for implementing the actions required.
Martina Bohnsack: Our customers in the food and pharmaceutical industries work under strict legal requirements. The GMP (Good Manufacturing Practice) guidelines, for example, stipulate that all substances required in the production process be documented. It must be proven that these substances are manufactured under controlled conditions. Our certification means that we can effectively support our customers in this respect.
Focus on product responsibility
Support for customers: the range of lubricants for food-processing and pharmaceutical industries from Klüber Lubrication meets the international standard