Presentation at the 3 rd SAFOODNET seminar

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Joanna Johnston
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Hygienic design of processing equipment Integration / Zoning Food Production Engineering

A systematic way of combining hygienic entities into a hygienic facility This may be a

hygienic system, and can be for example a part, an assembly, a module, a line, or a

1 Hygienic design of processing equipment Integration / Zoning Food Production Engineering Integrated Approach to hygienic design What is an integrated approach to hygienic design? A systematic way of combining hygienic entities into a hygienic facility This may be a new design or reassignment of existing entities An entity is a component part of a hygienic system, and can be for example a part, an assembly, a module, a line, or a factory 2 Food Production Engineering, National Food Institute, Technical University of Denmark 1 (10)

2 Integrated Approach to hygienic design The facility must conform to all specified requirements Can originate from eg. legislation, users, product quality, safety Definition of Hygienic Integration : The process of combining or arranging two or more entities to work together while eliminating or minimizing hygiene risks. The integrated approach also includes determining specifications for product flow, control strategy, automation, maintenance, change management, training of personnel etc. 3 Food Production Engineering, National Food Institute, Technical University of Denmark Integration guideline The European Hygienic Engineering and Design Group (EHEDG) guideline on Hygienic Systems Integration (HSI) The HSI guideline has the task of linking and supporting currently available guidelines on hygienic design which are made for specific eguipment and hygienic tests and can be viewed as vertical guidelines The HSI guideline is classed as a horizontal guideline It is a completely new approach, and does not replace either EN or HACCP standards 4 Food Production Engineering, National Food Institute, Technical University of Denmark 2 (10)

3 Nomenclature 1 Hygienic Entity: An essential component part of a hygienic system Part: A one piece item a single material: a pipe, screw, shaft, spring, plate, elastomeric seal or flange. (= the fundamental building block for integration) Module: A combination of parts such as a coupling, floor or valve that accomplishes a new specific function Unit: A combination of modules such as a centrifuge, or fryer Any automation, the instructions and specifications necessary to establish and maintain the specified level of hygienic performance 5 Food Production Engineering, National Food Institute, Technical University of Denmark Nomenclature 2 Process Line: An arrangement of units, modules and/or parts that can produce a completed or intermediate food product, such as beer, cheese, flavours, enzymes, spices, hamburgers, packed food, ice creams etc. Factory: An arrangement of process lines, units, modules, and/or parts designed to manufacture a product: personnel, perimeters, buildings, process equipment, utility supplies and systems for management, zoning, maintenance, storage, pest management, cleaning etc. 6 Food Production Engineering, National Food Institute, Technical University of Denmark 3 (10)

4 Nomenclature 3 Hygiene Zone: A permanent area with restrictions on access and egress of material, personnel and equipment, in which a defined level of hygiene and care is maintained. Transfer Zone: A barrier/treatment zone that allows people and/or materials to pass from one zone to another without compromising the status of the higher hygiene/care zone Static dead zone: An area of equipment where transport, especially drainage, is permanently inadequate for safe food production. 7 Food Production Engineering, National Food Institute, Technical University of Denmark Nomenclature 4 Dynamic dead zone: An area of equipment where transport/drainage may temporarily become inadequate for safe food production, as a result of the operational positioning of valves or other moveable parts. Applies only to systems involving solids or fluids under flow Domain: A transient operational boundary with a given operational cleanliness status inside it, a section of the process equipment to be managed as sterile or clean or empty for a period of time 8 Food Production Engineering, National Food Institute, Technical University of Denmark 4 (10)

5 Nomenclature 5 Hygiene Barrier: A hygienic entity, typically at the module or unit level, which separates and protects the hygienic integrity of a hygienic domain/zone from that of a domain/zone of a lower hygienic standard. Hygiene Status: The hygiene and readiness status of equipment, for example, sterile, pasteurised, clean, clean and sterile, clean and pasteurised, clean and empty, clean and full, dirty, cleaning, sterilizing, pasteurising, opened, under maintenance. 9 Food Production Engineering, National Food Institute, Technical University of Denmark Nomenclature 6 Containment: The total physical hygienic or aseptic boundary of an environmentally managed domain/zone, of a building, room, cabinet, or isolator. Can include transfer zones, differential air pressure systems and the seals, thermal barriers at physical penetrations for piping, light fittings, cables, ducts, vents and drains Hygienic Maintenance: The continual assurance of hygienic food production by replacement or adjustment of entities of a system prior to any hygiene failure. Replacement entities must be original parts, or have been validated to give satisfactory hygiene performance 10 Food Production Engineering, National Food Institute, Technical University of Denmark 5 (10)

6 Nomenclature 7 Design Change: Any alteration of any hygienic entity within a food production system (procedure, part, module, unit, process line, specification, formulation, personnel, building, document, etc.), including any substitution where the hygienic entity is not replaced by an exact copy, potentially causing hazards to food safety or quality. Change Management: A documented procedure in which all design changes are documented and reviewed by a multifunctional team. This team must use an HACCP or similar risk assessment study to manage safely any proposed or enforced alteration in parts of a food production hygienic system. 11 Food Production Engineering, National Food Institute, Technical University of Denmark A single integration step At each integration action entities must have at least a prospective validation identifying probable failure modes Hygienic integration should be carried out on a modular basis, with entities that have passed the functional requirement for integration Instructions must cover: installation, operation, cleaning, sterilization (if applicable) and maintenance Concurrency with design and validation activities other than those concerned with hygiene is a prerequisite! 12 Food Production Engineering, National Food Institute, Technical University of Denmark 6 (10)

7 Why follow a systematic approach? What happens when we do not follow a systematic approach? We create hazards, which could be do to for example The way equipment is operated, e.g. leaving a valve on a branch closed creating a dead end Lack of having change management Lacking up to date documentation with regard to installation, automation, operation, maintenance and cleaning Lack of proving the operation and performance of equipment before routine use The spatial arrangement of equipment 13 Food Production Engineering, National Food Institute, Technical University of Denmark Flow diagram the need for zoning Flow diagram Food Production Engineering, National Food Institute, Technical University of Denmark 7 (10)

8 What is zoning? Zoning is a part of a total concept to prevent contamination Zoning means that we divided and setup boundaries Zoning requires division in to areas having a well defined function and risk level Zoning requires knowledge concerning product, process and handlings which leads to prevention Zones are ineffective without proper guidance, training and the right attitudes 15 Food Production Engineering, National Food Institute, Technical University of Denmark Procedures for zoning 1 Ask these basic questions before introducing zones What must be prevented from entering the area? What is the most appropriate preventive measure? It is inappropriate to introduce zoning for some of these reasons It seems a popular or modern idea Other companies do it to To establish this to try to force operators to comply to GMP 16 Food Production Engineering, National Food Institute, Technical University of Denmark 8 (10)

9 Procedures for zoning 2 The correct and systematic approach is the following Establish a multi disciplinary team Decide on the necessary level of product protection Integrate with HACCP, GMP etc. Involve all relevant parties actively in the process In existing plants, study all connections, doorways etc. In new plants, make the plan before construction starts Identify all details concerning hygienic design of installations Plan all associated routines and plan training 17 Food Production Engineering, National Food Institute, Technical University of Denmark Zoning and layout important points Plan for the future Make sure there is enough space and e.g. light Equipment personnel Care for the detail necessary in the work situation otherwise you cannot expect people to produce quality products 18 Food Production Engineering, National Food Institute, Technical University of Denmark 9 (10)

10 The importance of a Master Plan Every plant shall have and updated master plan containing all pipe connections All access ways All paths where product and / or personnel moves The plan must be review minimum every year Future planning must relate to the master plan A contamination of a product, may be much easier to track if all connections etc are known When a plant is changed the plan must change accordingly 19 Food Production Engineering, National Food Institute, Technical University of Denmark 10 (10)

Hygienic Design a prerequisite for HACCP EHEDG a Guiding Authority

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