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Validation of cleaning and erosscontact 141 8.3 SAMPLING TO VALIDATE CLEANING Sampling must ensure recovery of allergen resiclues from the equipment surface or from final product, and the level of recovery and repeatability has to be sufficient to meet the eriteria set to define cleaning as effective Where samples are taken, when they are taken and how they are taken can influence the outcome of a validation study ~ a negative test result may be the consequence of poor sampling technique or cross-contaminants not being homageneously dispersed through out the sample, or due to samples being taken from a point where allergen residue is unlikely. The stage at which samples are taken during the cleaning process is significant. If the aim is to demonstrate a comparative decline in allergen residues removed during cleaning, samples need (o be taken at suitable time intervals from the onset of cleaning, Samples taken at intervals throughout a clean ean be used to demonstrate that allergen residues are not held up within a system and subsequently released at a later stage of the clean Besides taking samples to show the efficacy of cleaning, samples taken before cleaning in be used to confirm that the sampling and testing methods are capable of recovering and detecting allergen residues, isc. positive controls, Sampling points will be dependent on the equipment and cleaning process that is being validated, Sampling pointsare selected to challenge the efficacy of cleaning, targeting difficult to clean areas and areas that present opportunity for significant cross-cantact. Selection of sampling points is best done in consultation with engineers and operatives who are familiar with the process. They will have knowledge of the movement of product through the system and points that are difficult to clean or may retain or hold up product. They will also be aware oF access points, how to use them and the type of sample that it is possible to take, 8.3.1 Rinse samples - rinse waters, wash waters or purging/flushing materials Samples of rinse water are taken when there is no other way to access the equipment, for example CIP systems or connecting pipe work, Wash water, particularly if is reeycled or part ofa common washing point for utensils or trays, could be a vehicle for cross-contamination, and should be included in the sampling programme. In isolation, a single sample of final rinse water in which the allergen is below the pre- defined acceptable level is not sufficient to validate the efficacy of cleaning. It does not provide any information about whether allergen residues have been removed or the level of allergen residues remaining on the equipment. However, if'a pre-wash rinse can be sampled, se waters can be sampled from the onset of cleaning, then at intervals through to the final rinse water and these samples show a declining level of allergen, by implication the level remaining on the equipment has been reduced. Sampling of rinse water for subsequent verification of cleaning may then be justified, In acleaning validation study on CIP equipment used to prepare peanut slurry for flavouring intermediates (Stephan er al., 2004), detection of the allergen in the pre-rinse water confirmed that the sampling and measurement approach were working (equivalent to a positive control). This gave confidence in the sampling and analytical method particularly when, as expected, the allergen was not detected in rinse waters following subsequent alkaline and acid washes and not in the final product (see Table 8.2). 142 Management of Food Allergens Table 8.2 Analysis of rinse water samples and first final product afer @ clean for the presence of peanut General protein Stage in cleaning ELISA result for Bradford Coomassie process peanut (1ug/mL) Plus, Piereo (1ig/mt) Result Rinse water Prewash 985-1379" 85.9-917.68 Positive Alter alkaline cleaning ND ND Negative ‘After acidic cleaning ND ND Negative Product Final product after clean ND-1.1¢ NDP Negative Data from Stephon a al. (2004. IND, not detected the rage from 4 cleans, 3 samples pe leon © the final product after clean was an arial mix of water and maltodextrin, sad not contain protein «mg/kg, peanut was detected ofr only one run and was raced back fo an application error dung the manufacturing process Collecting rinse water samples is not always easy or reproducible. It may involve sampling from a fast-maving stream of sometimes hat water. Once the sample has been collected, it needs to-be chilled or frozen and analysed as soon as possible as the allergen may be unstable in water due to seclimentation of microbial growth and lost before it can be tested. Rinse or wash water samples known to contain cleaning fuids may affect the method of analysis, limiting the validity of such samples. In a study of a tray washer as a possible source of cross-contact, samples of wash Water containing 1% alkaline Foam detergent were taken for testing (Arrowsmith and Brown, 2006). Tests using a positive control sample in the presence of this concentration of detergent gave a false-negative result (see Table 8.3). Alternative sampling points were required to confirm that tray washing was not a route of cross-contamination. In dry manufacturing environments, cleaning may be by flushing or purging a system with a dry, inert material such as flour, diatomaceous earth, salt or starch. Removal of allergen residues can be followed by sampling the purging materials after known volumes have passed. through the system. Data that show a dectine in the level of the allergen until it reaches the pre-defined acceptable level or below demonstrate the efficacy of cleaning. Table 8.4 shows declining levels of soya when whey was used to purge the system of a soya product (Helle, 2005). Table 8.3. An example of interference of « cleaning Mid in a wash water sample on the result of on an ELISA allergen test for prawns. ELISA result for Test mar tropomyosin (11g/mL) Prawn extract diluted to 5 1ag prowny/mL 0.08 Prawn exkact diluted to 5 11g prawn/ml in the presence 2ll0Q of 1% alkaline foom cleaning fluid Prawn exkact diluted to 10 1g prawn/mL 021 Prawn extract diluted io 10 1g prawn/ml in the presence

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