Yearbook 2013/2014 - ehedg

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European Hygienic Engineering & Design Group Practical considerations for cleaning validation Hein Timmerman, Diversey, part of Sealed Air, Amsterdam, the Netherlands, e-mail: hein.timmerman@sealedair.com, www.diversey.com The European Hygienic Engineering & Design Group (EHEDG) subgroup Cleaning Validation, chaired by Professor Rudolf Schmitt of HES-SO in Switzerland, is working on a new guideline pertaining to cleaning validation expected to be published in <strong>2014</strong>. Cleaning and/or disinfection validation is defined as ‘obtaining documented evidence that cleaning and/or disinfection processes are consistently effective at reaching a predefined level of hygiene, if properly implemented on equipment and production environment and used as intended.’ In contrast, cleaning verification is defined as ‘the application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure is or has been operating as intended.’ Verification is sometimes described as the documented evidence showing that an assigned entity continues to meet the required (hygiene) specifications. According to International Standards Organisation (ISO) 22000, verification is the ‘confirmation through the provision of objective evidence that specified requirements have been fulfilled.’ The goal of developing the new EHEDG guideline is to provide a complete validation approach suitable for equipment manufacturers, cleaning product and equipment manufacturers and all industrial food producers, from smalland medium-sized enterprises (SME) to multinational companies. Cleaning validation is a documented process that shows evidence demonstrating that the cleaning methods that have been found applicable and acceptable for a process/product, achieve consistently the required levels of cleanliness. The objective of the cleaning validation is to demonstrate the effectiveness of the cleaning procedures in the removal of product residues, degraded products, preservatives, allergens, and/or cleaning, disinfecting, cross- contamination and enzymatic agents that can post a risk to the consumer of manufactured food products. Together, validating cleaning, assuring a validation standard and achieving consistent results is a topic of high priority in the food processing industry. Cleaning validation is used to show proof that the cleaning system consistently performs as expected and provides scientific data that the system consistently meets predetermined specifications for the residuals. However, when starting a new Greenfield plant, the integration of a validation approach from the design phase is a good base from which to achieve the required result. When an existing plant or line requires an effective and validated cleaning program, a huge amount of effort will be needed. More than 80 percent of cleaning procedures and methods executed on a daily basis in the food industry are not validated and are poorly documented. Lack of cleaning validation can be one of the root causes of food safety incidents as it relates to underperforming cleaning routines. The validation of process lines is more than the lineup of single equipment. Implementation of a new validation plan will require a holistic approach. Validation can absorb a huge amount of a dedicated team’s time and will have an economic impact on the manufacturing operation. Finding the balance between a theoretical and academic-proven method and the practical realisation of the validation plan will require good insights in current available technologies and their practicality on the plant floor. In addition, a simple engineered line modification, such as the changing of a pump type or the addition of a valve or new instrument, can necessitate a new validation of the entire process line. Validation requires a deep understanding of all elements involved in the cleaning result, such as the importance of design and development for an effective program; the principles and calculations of residue limits for a wide variety of residue types; routes of administration; and dosage types the selection of available analytical methods, along with appropriate levels of analytical method validation. It also requires a knowledge base about the selection of sampling methods and sampling sites, along with proper selection of blanks and controls using the appropriate strategies and documentation for sampling recovery studies; the presence of a cleaning validation master plan and/or policy components; the appropriate documentation for cleaning validation protocols and reports; the tools used for monitoring, verification and revalidation; and validation maintenance for validated cleaning processes.
84 Practical considerations for cleaning validation The new EHEDG guideline will demonstrate a practical approach that takes into account all of the needed steps to come to a validated cleaning. The partnership between the food operator and cleaning chemicals suppliers and optimisation of related services is essential to assure a focused and professional validation approach. However, it will be a crucial task to define a balanced strategy in grouping cleaning activities and simplifying the validation work to keep the validation implementation a task that will not disrupt the company’s efficiency. SMART SAFETY Thanks to smart automation, the new Tetra Alcip CIP unit uses exactly the right temperature, amount of water, detergent concentration and cleaning time to achieve uncompromising food safety. While cutting the consumption of water by 21% and chemicals by 6%. And delivering unique flexibility to meet every CIP need. All at the lowest operational cost. Certified equipment conforming to the guidelines of EHEDG, of which Tetra Pak is an active member. www.tetrapak.com Tetra Pak, , ProTeCTs WhAT’s good and Tetra Alcip are trademarks belonging to the Tetra Pak group.
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EHEDG Yearbook 2013/2014 European H
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European Hygienic Engineering & Des
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4 Contents EHEDG Guidelines 154 EHE
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12 EHEDG Company and Institute memb
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14 EHEDG Company and Institute memb
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18 Legal requirements for hygienic
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22 The importance of hygienic desig
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24 The importance of hygienic desig
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Page 33 and 34: 32 Particle and VOC emissions, chem
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Page 45 and 46: 44 Hygienic design of floor drainag
Page 47 and 48: 46 Hygienic design of floor drainag
Page 49 and 50: 48 Hygienic design of high performa
Page 53 and 54: 52 Performance testing of air filte
Page 57 and 58: 56 Spray cleaning systems in food p
Page 59 and 60: 58 Spray cleaning systems in food p
Page 63 and 64: 62 Environmentally friendly water b
Page 65 and 66: 64 Environmentally friendly water b
Page 69 and 70: 68 Flow behaviour of liquid jets im
Page 73 and 74: 72 Optimisation of tank cleaning Th
Page 75 and 76: 74 Optimisation of tank cleaning Re
Page 79 and 80: 78 Effective tank and vessel cleani
Page 81 and 82: 80 Effective tank and vessel cleani
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Page 87 and 88: 86 Integrated hygienic tamper-free
Page 89 and 90: 88 Damage scenarios for valves: Ide
Page 91 and 92: 90 Damage scenarios for valves: Ide
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Page 112 and 113: A cleaner, healthier future. Cleani
Page 114 and 115: Examination of food allergen remova
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Page 122 and 123: Cleanability test of a hygienic des
Page 124 and 125: Aspects of compounding rubber mater
Page 126 and 127: New developments for upgrading stai
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Page 130 and 131: International Hygienic Study Award
Page 132 and 133: EHEDG Regional Sections 131 MEXICO
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EHEDG Regional Sections 133 In Octo
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EHEDG Regional Sections 135 EHEDG D
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EHEDG Regional Sections 137 EHEDG G
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EHEDG Regional Sections 139 Members
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EHEDG Regional Sections 141 EHEDG L
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EHEDG Regional Sections 143 Beside
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EHEDG Regional Sections 145 To prom
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EHEDG Regional Sections 147 EHEDG R
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EHEDG Regional Sections 149 and adv
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EHEDG Regional Sections 151 Transla
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EHEDG Regional Sections 153 EHEDG U
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EHEDG Guidelines 155 Doc. 7. A meth
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EHEDG Guidelines 157 Doc. 18. Passi
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EHEDG Guidelines 159 Doc. 28. Safe
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EHEDG Guidelines 161 Doc. 37. Hygie
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EHEDG Subgroups 165 design, selecti
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EHEDG Subgroups 167 Given a clean s
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EHEDG Subgroups 169 • Doc. 26 Hyg
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EHEDG Subgroups 171 It will address
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EHEDG Subgroups 173 EHEDG Subgroup
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EHEDG Subgroups 175 Chairman: Andy
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EHEDG Subgroups 177 EHEDG Subgroup
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EHEDG Secretariat Lyoner Strasse 18
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