Lubricants in the GMP and HACCP Surrounding

GMP News No. 665

GMP News
23 January 2006

Lubricants in the GMP and HACCP Surrounding

All production machines in the pharmaceutical and food industry need lubrication. Generally, pharmaceutical products should not come into contact with lubricants. However, in practice the contact cannot always be avoided. Therefore, the international standard ISO 21469 was created, which lays down requirements on "Lubricants with Incidental Product Contact"

In spring 2006, this standard will be published officially as an European and International standard. As part of the standards published by the official Technical Committees ISO/TC 199 "Safety of Machinery" and CEN/TC 114 "Safety of Machinery", it should also be seen in connection with the machinery guidelines. Since the standard EN 1672-2 demands for technically unavoidable incidental product contact the usage of so called food-grade lubricants, they are now defined in ISO 21469. 
New in ISO 21469 is that, apart from the ingredients listed in 21 CFR § 178.3570, further ingredients can be used on the condition that they have an official authorisation as food ingredients. 
It remains unclear in how far the American certifier organization, NSF, which holds a monopoly position in the registration of NSF H1 lubricants, will accept this. As a certification organisation that is even recognised by the WHO, NSF certificates provide a high safety standard based on great accuracy, which is reflected in the factors time, costs and flexibility. 
Another novelty is that the HACCP concept is implemented with regard to lubricants. Representing a chemical risk themselves, they cannot maintain the quality standards when used inappropriately. An essential element is the approval for existing ingredients, which - in contrast to common industrial lubricants - must not in any case represent a health risk. It is also made sure that smell and taste of the pharmaceutical product or food product is not affected in case of contamination. 
All in all, this is a very important international standard offering safety to the manufacturers and users of pharmaceutical and food machinery by defining which criteria have to be fulfilled by lubricants if occasional product contact cannot be avoided. Here, consumer protection comes first.

Dr Luciana Husfeld
Klueber Lubrication Munich KG

International Standardization Organization

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