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Presentation at the 3Presentation at the 3rdrd SAFOODNET seminarSAFOODNET seminarStSt OlavOlav’’ss HotelHotel,, TallinnTallinn, Estonia, Estonia;; MayMay 446, 20096, 2009
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Food Production Engineering
Hygienic design of processing
equipment
Integration / Zoning
2 Food Production Engineering, National Food Institute, Technical University of Denmark
Integrated Approach to hygienic design
•What is an integrated approach to hygienic design?
–A systematic way of combining hygienic entities into a hygienicfacility
•This may be a new design or reassignment of existing entities
–An entity is a component part of a hygienic system, and canbe for example a part, an assembly, a module, a line, or afactory
Presentation at the 3Presentation at the 3rdrd SAFOODNET seminarSAFOODNET seminarStSt OlavOlav’’ss HotelHotel,, TallinnTallinn, Estonia, Estonia;; MayMay 446, 20096, 2009
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3 Food Production Engineering, National Food Institute, Technical University of Denmark
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.
4 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 EN16722 or HACCP standards
Presentation at the 3Presentation at the 3rdrd SAFOODNET seminarSAFOODNET seminarStSt OlavOlav’’ss HotelHotel,, TallinnTallinn, Estonia, Estonia;; MayMay 446, 20096, 2009
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5 Food Production Engineering, National Food Institute, Technical University of Denmark
Nomenclature –1
•Hygienic Entity: An essential component part of a hygienic system
–Part: A onepiece item a single material: a pipe, screw, shaft,
spring, plate, elastomeric seal or flange. (= the fundamental
buildingblock 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
© EHEDG
6 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.© EHEDG
Presentation at the 3Presentation at the 3rdrd SAFOODNET seminarSAFOODNET seminarStSt OlavOlav’’ss HotelHotel,, TallinnTallinn, Estonia, Estonia;; MayMay 446, 20096, 2009
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7 Food Production Engineering, National Food Institute, Technical University of Denmark
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 deadzone: An area of equipment where transport,
especially drainage, is permanently inadequate for safe food
production.© EHEDG
8 Food Production Engineering, National Food Institute, Technical University of Denmark
Nomenclature –4
•Dynamic deadzone: 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© EHEDG
Presentation at the 3Presentation at the 3rdrd SAFOODNET seminarSAFOODNET seminarStSt OlavOlav’’ss HotelHotel,, TallinnTallinn, Estonia, Estonia;; MayMay 446, 20096, 2009
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9 Food Production Engineering, National Food Institute, Technical University of Denmark
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.© EHEDG
10 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© EHEDG
Presentation at the 3Presentation at the 3rdrd SAFOODNET seminarSAFOODNET seminarStSt OlavOlav’’ss HotelHotel,, TallinnTallinn, Estonia, Estonia;; MayMay 446, 20096, 2009
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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.
© EHEDG
12 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! © EHEDG
Presentation at the 3Presentation at the 3rdrd SAFOODNET seminarSAFOODNET seminarStSt OlavOlav’’ss HotelHotel,, TallinnTallinn, Estonia, Estonia;; MayMay 446, 20096, 2009
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13 Food Production Engineering, National Food Institute, Technical University of Denmark
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
14 Food Production Engineering, National Food Institute, Technical University of Denmark
Flow diagram –the need for zoning
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Presentation at the 3Presentation at the 3rdrd SAFOODNET seminarSAFOODNET seminarStSt OlavOlav’’ss HotelHotel,, TallinnTallinn, Estonia, Estonia;; MayMay 446, 20096, 2009
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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
16 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
Presentation at the 3Presentation at the 3rdrd SAFOODNET seminarSAFOODNET seminarStSt OlavOlav’’ss HotelHotel,, TallinnTallinn, Estonia, Estonia;; MayMay 446, 20096, 2009
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17 Food Production Engineering, National Food Institute, Technical University of Denmark
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
18 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
Presentation at the 3Presentation at the 3rdrd SAFOODNET seminarSAFOODNET seminarStSt OlavOlav’’ss HotelHotel,, TallinnTallinn, Estonia, Estonia;; MayMay 446, 20096, 2009
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19 Food Production Engineering, National Food Institute, Technical University of Denmark
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