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Sterilisation - Articles and news items

Hygienic design requirements for components in hygienic and sterile processes

Issue 6 2011  •  4 January 2012  •  Ulf Thiessen and Matthias Schäfer, EHEDG Subgroup Valves

The major objective of hygienic design is to avoid product contamination by microbes, particles and chemicals. European legislation (i.e. the Machinery Directive) is forcing machinery suppliers to design their machines which are used in the production of food, pharmaceuticals and cosmetics according to some so-called hygienic design criteria. The common objective of these criteria is to make a machine CIP (Cleaning In Place) cleanable. The design of sealings is one of the major aspects of hygienic design. Sealing design shall avoid accumulation of soil and microbes and therefore has to be ‘gap free’ under all operation conditions. Even very small gaps and crevices can harbour a big number of microbes and can be the source of product contamination. Machinery and piping design shall make sure that all surfaces in contact with the product can be cleaned with a defined CIP procedure unless the machine or piping systems is foreseen to be dismantled for cleaning. So-called dead legs which are areas not sufficiently covered by the CIP stream have to be considered as difficult to clean and represent an extreme hygienic risk.

All manufacturers of equipment used in the production of foodstuffs in the European Union are committed to following the basic hygienic design requirements defined in chapter 2.1 of the EU Machinery Directive. Therefore, hygienic design of food processing equipment is regulated by law in all countries of the European Union. These legal requirements also apply to all machinery and plants for the production of cosmetics and pharmaceuticals1. In recent years, a variety of directives, codes, guidelines and recommendations explaining, discussing and specifying hygienic design requirements in detail have been published2-4.

Testing the effectiveness of packaging sterilisation: Truth or faith?

Issue 3 2010, Past issues  •  30 June 2010  •  Jan Bruecklmeier, Senior Aseptic Specialist, Nestlé

The effectiveness of packaging sterilisation devices in an aseptic filling system is often tested during start up and validation of the system. Some publications even classify the different aseptic filling systems with their average logarithmic reduction rate (ALR). According to different publications, the testing seems to be quite easy and the result is a precise parameter, characterising the process. But is this the truth?

 

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