IDM | Technology/IT Sterile Filtration from the Point of View of the HACCP Concept Part 1. Basics Author: Thomas Huber, Lifescience Systeme Engineer, Parker Kaarst Germany, Extension: phone: +49(0)2131-4016-9482 * fax : +49(0)2131-4016-5482, Mobile: +49 (0)173-2877133, email: thomas.huber@parker.com Last year, it has been found increasingly that auditors deal more and more with the subject of sterile filtration of products and technical gases in audits. This is reason enough to put more focus on the subject. What is the basis of these controls? What is the purpose? How can companies prepare for this? Food producers must observe special hygiene rules. The producers will be liable if customers suffer any damage from ingestion of their products. This not only applies in case of tort, which is to be controlled by the "fooddefense" measures stipulated in IFS6. Equally, the food entrepreneur bears full responsibility for health-hazardous and/ or disgusting conditions of its products – no matter the fault. For example, this is the case if it does not meet its product observation obligations or only does so insufficiently. It is obligated to observe its products and production so that it will recognise unknown dangers as well and ensure remedy. The consequences of product observation errors can become expensive. A production manager may be personally liable with his private assets if he accepts product defects by, e.g., not using functional filtration. If an audit finds deviations from limits without the corresponding corrective measures being taken, this constitutes gross negligence by omissions. These risks may be minimised by food manufacturers 26 · 10 2016 | international-dairy.com by consistently following the HACCP (Hazard Analysis and Critical Control Point) concept. In this, the subject of sterile filtration of products and technical gases is relevant that has been particularly focused on by auditors in the recent time. A danger analysis according to the Codex Alimentarius is part of the HACCP concept. Critical control points (CCPs) in the production process must be recognised and potential negative impairments of the consumer removed by suitable Evaluation Probability Probability of discovery Severity 1 Very low: error is unlikely, the error has not occurred in comparable processes Control measures prevent errors Very low: no effect for consumers noticeable 2 Low: process under control, error occurs very rarely/only in theory Control measures usually lead to the error being discovered Low: slight feeling of discomfort 3 Medium: error occurs occasionally according to experience Control measures may discover the error Medium: doctor required 4 High: error occurs often, process not under control Control measures rarely discover the error High: more severe illness/ damage to health 5 Very high: error nearly unavoidable No control measures introduced, control measures will not find the error Critical: severe health damage to death Table 1 (Source: Daniela Palm - SGS Fresenius GmbH, HACCP/IFS, 6 November 2012)
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