RESEARCH &

DEVELOPMENT
Quality and Food Safety

Zoning and Hygiene

Requirements and Measures

Observations from Internal Audits

 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept
 Agenda:
Definition of zoning concept
Introduction
Approach according zones
Requirements of defined zones related to
buildings
Corresponding measures related to flow
Observations and examples from internal audits
Conclusions

Susanne Wagner Internal Audit 2

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Definition of the zoning concept

 Zoning is the segregation of areas with the objective to
protect the environment, process and product from
unwanted contamination like dust, foreign materials and
micro-organisms.
 For each zone different requirements are defined for
building, surrounding, people, movement of goods.
 The principle of zoning is based on the fact that raw
materials come in from the “dirty” outside and are
converted in different steps (zones) in clean, packed end-
products.
 Flow will therefore be from dirty to clean, where both the
start (raw materials warehouse) and the end (end-product
warehouse) are low care.

Susanne Wagner Internal Audit 3

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Definition of zoning concept – basic requirements

 3 zones have been defined:
 Low : the zone which has direct contact to the outside
 Medium: the zone where the raw material or product is exposed to
the surrounding.
 High : the zone where the product is exposed to the surrounding and
after which the hazards present are not reduced.
 In addition a transfer zone is defined, as any zone or area within a
zone, used to prepare movement of goods or persons from one
zone to the other.
 Zoning always increases only one step, thus you can not go from
a low zone to a high zone or vice-versa.
 The internal of equipment can also be categorised (e.g. tetra filling
chamber is high care), and can therefore define the zone of the
surrounding (medium care).

Susanne Wagner Internal Audit 4

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Definition of zoning concept

Outside

Transfer TZ TZ Transfer
Low Medium High Medium
zone zone
Internal dirty Internal clean Exposed Exposed, Exposed Internal clean
To be
Dirty Clean heattreated

Non-processed Packed

Susanne Wagner Internal Audit 5

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Definition of the zoning concept

 Zoning as part of the total hygiene concept
 Facilities/Utilities - Design
 Materials
 Equipment/Utensils - Design
 Applied technology
 Personnel hygiene
 Personnel training
 HACCP concept
 Verification of hygiene concept (e.g. environmental
sampling)

Susanne Wagner Internal Audit 6

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept - Approach

 General considerations on zoning
 Principles and classification

 Realisation of the zoning concept

 Target orientated approach:
• Characterisation of product
• Determination of consumer group
What level of hygiene to be applied?

Susanne Wagner Internal Audit 7

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept - Approach

 Risk study:
• Risk analyses
• Risk assessment
What to be prevented?

 Preventive measures:
Zoning – a tool in terms of prevention by
product type

Susanne Wagner Internal Audit 8

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept – Requirements

 Buildings
 Floors
 Drains
 Walls
 Doors
 Windows
 Ceiling/Roof
 Utilities
 Air treatment
 Equipment/Installation

Susanne Wagner Internal Audit 9

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept - Requirements

 Floors

Low care Transfer zone Medium care High care

- solid concrete - see low care - no concrete, tiles with closed - preferably no tiles, waterproof
joints, waterproof layer (e.g. layer i.e. epoxy resin
epoxy resin)
- no open gaps/joints - smooth surfaces - smooth sealed surfaces, no
cracks

- smooth connections, no - see low care - smooth wall-floor connections, - see medium care
open joints no ledges at least 10 cm high
contoured junction

Susanne Wagner Internal Audit 10

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept – Examples

 Floors
High care area:
Smooth surface, curved
wall floor connection in a
tipping area for canning
line – Nutricia Kasdorf
(Argentine).

Susanne Wagner Internal Audit 11

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept – Examples

 Floors
High care area:
Smooth surface, curved
wall floor connection in a
canning area – Nutricia
Indonesia, Jakarta
(Indonesia).

Susanne Wagner Internal Audit 12

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept - Requirements

 Drains
Low care Transfer zone Medium care High care
- generally trapped, no - see low care - trapped open or closable - closable drains (only to be
direct connection to stainless steel drains with bas- opened by hand)
sewage system kets
- no open joints between - no open joints between floor - no open joints between floor
floor and drain and drain and drain
- sewage system not flowing
from low to high care zone
- suitable capacity to avoid - no open drainage channel
flooding of surrounding allowed area to be kept as
dry as possible
- wet processing: drainage - dry and wet processing: pref-
channels allowed with suitable erably dry drains, however
capacity and sufficient slope, drains, trapped and with sani-
finally trapped tation solution acceptable

Susanne Wagner Internal Audit 13

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept – Examples

 Drains

Dry area – low care: Closable
drain, smooth and sealed floor-
drain connection in warehouse
area – Nutricia Wuxi (China).
Susanne Wagner
Fred Bauer
Wet area – medium care: Trapped
drain with basket, smooth, sealed
floor-drain connection in wet
preparation – Milupa Fulda
(Germany).
Internal Audit 14
Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept - Requirements

 Walls
Low care
- smooth bricks, concrete - see low care
(not porous) painted,
metal, panel cladding –
avoidance of corrugated
iron cladding, closed
connections, joints
- no specific requirements
for appendages
- penetration sites tightly - see low care
closed to outside
Transfer zone Medium care
- preferably claddings in dry ar-
eas
- preferably smooth, washable,
tiles in wet areas
- closed joints, sealed gaps
- finishes to be waterproof, not
designed to allow accumula-
tion of water behind cladding
pharmaceutical look:
- walls without ledges or spaces, - no straight edges (floor/wall)
appendages are built up the
walls
- penetration sites tightly closed
in particular to areas of less
care
High care
- see medium care
- smooth well maintained fin-
ish, no gaps
- see medium care
- preferably appendages
in/behind walls in areas with
formation of dust (e.g. pack-
ing, dumping)
pharmaceutical look:
- no tiles allowed
- penetration sites tightly
closed generally also within
different areas of high care

Susanne Wagner Internal Audit 15

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept - Examples

 Walls/connection/penetration sites

High care area: Epoxy resin covered Medium care area: Epoxy resin
surfaces, smooth curved wall/equipment- floor and sandwich panel wall with
floor connection in spray dryer area – smooth curved connection, slurry
Milupa, Fulda (Germany). preparation – Unitech, Auckland
(New Zealand).
Susanne Wagner Internal Audit 16
Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept - Examples

 Walls/penetration sites
High care area: Sandwich panel wall, smooth
and tight sealing of penetration sites in dry
dumping area of IMF plant – Nutricia Polska,
Opole (Poland).

Susanne Wagner Internal Audit 17

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept - Requirements

 Ceilings/lighting
Low care Transfer zone Medium care High care
- preferably no wooden - see low care - constructions/appendages - smooth cleanable ceilings,
construction, water- round edges, no hollow profiles preferably no open append-
proof painted wooden ages
rafter allowed
- preferably no windows - see low care - see low care
in roof
dry process area: dry process area:
- preferable lowered ceiling - straight concealed lowered
above open process, walkable ceilings
dry/wet process areas:
- lowered ceiling not recom-
mended where risk of conden-
sation
- shattered proof light - shatter proof lights, closed - lighting integrated in ceilings
bulbs; open cases al- cases
lowed
pharmaceutical look:
- lighting integrated in ceiling

Susanne Wagner Internal Audit 18

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept - Examples

 Ceilings/lighting
2003 2004

High care area: Left picture – prior reconstruction: Dumping area for canning line
located in raw material warehouse facilities, open appendages, window front,
ceiling/roof constructed from corrugated iron plate.
Right picture – same area after reconstruction: Smooth finish of ceiling and wall,
lowered ceiling therefore no appendages, integrated lighting.
Nutricia Kasdorf (Argentina).
Susanne Wagner Internal Audit 19
Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept - Requirements

 Doors
Low care Transfer zone Medium care High care
- no special requirements, - doors from transfer to - doors from medium to high - no wooden doors
no glass in doors medium care area: care area: non-wooden
plastic covered wood
allowed
- all doors kept closed as - see low care - doors are opening into the - no direct connection to out-
far as possible, rapid lower care zone side (also to roof areas) be-
closing systems for ex- side emergency/explosion
ternal doors doors
- large doors equipped - double door/sluice system to
with personnel small outside
doors or adjacent per-
sonnel doors
pharmaceutical look:
- no ledge around doors

Susanne Wagner Internal Audit 20

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept - Examples

 Doors
Low care area: Fast moving roller
door from the anteroom (sluice) of
the warehouse shipment area to
outside equipped with an air
curtain and an adjacent personnel
door. Support Arceburgo (Brazil).

Susanne Wagner Internal Audit 21

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept - Examples

 Doors
High-medium care area: Automatic fast
moving roller door separating the medium
care transfer zone from high care area.
Nutricia Kasdorf (Argentina).

Susanne Wagner Internal Audit 22

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept - Requirements

 Windows

Low care Transfer zone Medium care High care

- preferable no windows - see low care - see low care - see low care
- shatterproof glass - shatterproof glass, no wooden - see medium care
frames
- preferable closed, open - no windows, which can be
window to be equipped opened
with insect screens
- windows preferable to be in-
tegrated into the walls, no
ledges

Susanne Wagner Internal Audit 23

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept - Examples

 Windows
High care area: No windows to outside, windows
to areas of lower level integrated into the walls –
no ledges. Nutricia Kasdorf (Argentina).

Susanne Wagner Internal Audit 24

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety
Zoning concept – Requirements
 Air treatment
Low care Transfer zone Medium care High care
no direct product contact:
- standard ventilation - no direct air inlets from outside
- standard filtration (e.g. dust - filtration level in areas without
filter, EU3) open product EU7
- dry raw material handling area - preferably air conditioned
air conditioned
- cotton air supply preferable in - see medium care
non dusty areas; otherwise
combination of continuous op-
eration and regular cleaning
pharmaceutical look : - preferably slight overpressure - overpressure from high to
- ventilation due to from medium to low medium care zones
overpressure in me-
dium care zone
direct product contact:
- filtered air supply in process-
ing areas (e.g. packaging,
drum drying) and for trans-
port/cooling
- quality EU9 : in general
- quality EU10 : for IMF starter
due to Enterobacter sakazakii

Susanne Wagner Internal Audit 25

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept - Examples

 Air treatment

High care area: Ventilation of the drum drying area and ancillary facilities for air
supply. Nutricia Polska, Opole (Poland).

Susanne Wagner Internal Audit 26

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept - Requirements

 Equipment/installations/tools
Low care Transfer zone Medium care
- for inspection glasses glass
procedure to be implemented
pharmaceutical look:
- open vertical electrical cable
installations
High care
- see medium care
- lines with exposed product
covered, breakage procedure
for acrylic covers should be
available
- equipment stainless steel in-
side (product contact surface)
and preferably outside, po-
rous/flaking materials not al-
lowed
- machinery with low mainte-
nance demand preferable
(e.g. lubrication, abrasion)
- only essential equipment, in-
stallations (e.g. cable shafts,
pipe work)
- preferably open vertical elec-
trical cable installations

Susanne Wagner Internal Audit 27

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept –
 Equipment

2002 2004

Medium care area: Lactose dumping area for wet preparation. Nutricia Macroom
(Ireland).
Susanne Wagner Internal Audit 28
Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept – Examples

2003 2004

High care area: Tipping for canning line.

Nutricia Kasdorf (Argentina).

Susanne Wagner Internal Audit 29

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept – Corresponding measures

 Personnel hygiene
 Protective clothing
 Hygiene measures
 Social facilities: changing rooms, toilets, recreation areas
 Passages
 Personnel
 Authorisation
 Transfer/Movements
 Materials/Product
 Tool/Equipment
 Waste

Susanne Wagner Internal Audit 30

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept – Corresponding measures

 Protective clothing – staff, contractors, visitors
Low care Transfer zone Medium care High care
- company clothing to be - see low care - change of clothing mandatory - preferably change of clothes
worn, contractors in- - closed at neck, long sleeved, or additional overall
cluded (preferably dis- closed wrists, light coloured, - see medium care
tinguishable from own preferably no external pockets - preferably distinguishable
staff) - preferably distinguishable from from clothing in medium care
clothing in low care areas areas
- shoes provided for - change to authorised - additional shoe change or
safety reasons shoes/boots mandatory application of overshoes
- visitors: at least overshoes mandatory
mandatory
- headdress generally - headdress recom- - hairnets mandatory - hairnets mandatory
recommended mended, depending - beard net when handling open - facial mask when handling
on task hairnets man- product, mouth protection open product mandatory
datory (e.g. de-boxing, when handling powders for
sorting) working safety reasons
- gloves preferably applied for - gloves mandatory when han-
working safety reasons dling open product for hy-
giene reasons
- jewellery policy for work- - jewellery policy for - jewellery policy in terms of hy- - no jewellery
ing safety reasons working safety and gienic aspects
foreign matter reasons

Susanne Wagner Internal Audit 31

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept - Examples

 Protective clothing
High care areas: Distinct
coloured clothing for
different high care working
areas.
Left picture: Complete
overalls and mouth
protection in tablet
compacting.
Right picture: Overalls in
wet preparation for ECN,
defined as high care area
according to Chinese
pharmaceutical
requirements.
Nutricia Pharmaceuticals,
Wuxi (China).

Susanne Wagner Internal Audit 32

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety
Zoning concept - Examples
 Protective clothing

Low care area – character of
transfer zone in jar factory:
Protective clothing, hairnet at
sorting line. Nutricia Polska,
Opole (Poland).
Susanne Wagner
Fred Bauer
Medium care area: Overalls in
dumping for wet preparation.
Sari Husada, Klaten
(Indonesia).
Internal Audit
Workshop 2004
High care area: Overalls
in canning line for IMF.
Third party: Addtop,
Jiankou, Fujian (China).
33
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept – Corresponding measures

 Hygiene measures
Low care Transfer zone Medium care High care
Hand washing: Hand washing: Hand washing: Hand washing:
- recommended - recommended on - mandatory when entering - mandatory when entering
- not necessary at each regular basis - not necessary for passages
transfer from outside to from border line of transfer
inside zone and back
- recommended after dis-
posal of waste
Hand sanitation: Hand sanitation: Hand sanitation: Hand sanitation:
- no requirement - see low care - see low care - mandatory
Footwear washing: Footwear washing: Footwear washing: Footwear washing:
- no requirement - see low care - acceptable in wet processing - generally not to be applied,
- not recommended in dry proc- shoe change or overshoes
essing preferred

Susanne Wagner Internal Audit 34

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept - Examples

 Hygiene measures

High care area: Shoe change in

Medium care area: Transfer sluice from
transfer zone from dry
warehouse to high care area. Nutricia
dumping/blending area to
Kasdorf (Argentina).
corresponding washing room for
utensils/tools. Nutricia Auckland
(New Zealand).

Susanne Wagner Internal Audit 35

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept – Corresponding measures

 Social facilities
Low care
- changing facilities to be - see low care
available
- canteen/recreation area - see low care
to be available
- working coats, jackets
preferably to be put off
prior entry
- in case of common can-
teen this is mandatory
Transfer zone Medium care
- changing facilities together
with personnel working in less
critical areas possible
- preferably routing within the
changing facilities
- access to toilets preferably via
changing facilities
- in case of direct access work-
ing coats, jackets to be put off
prior entry
- canteen/recreation area to-
gether with personnel working
in less critical areas possible
- working coats, jackets put off
prior entry mandatory
- in case of common canteen
designated hooks/storage fa-
cilities
High care
- either separate changing fa-
cilities for staff working in
high care area or additional
facilities to the common ones
to be available
- routing within the changing
facilities to be available
- no direct access to toilets
only via changing facilities
- no direct access to can-
teen/recreation area only via
changing facilities

Susanne Wagner Internal Audit 36

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept – Examples

 Social facilities – Changing rooms

Changing facilities with routing:

Room with lockers for private
belongings – washing/shower room
– changing room with working
clothes; designated footwear is
available. Nutricia Krotoszyn
(Poland).

Susanne Wagner Internal Audit 37

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept – Examples

 Social facilities – Changing rooms

Shoe change area with lockers prior

entering the high care area. Drying facility
for boots. Milupa Colmar (France).

Susanne Wagner Internal Audit 38

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept – Examples

 Social facilities – Toilets
External toilet outside the premises for truck
drivers. Support Arceburgo (Brazil).

Susanne Wagner Internal Audit 39

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept – Corresponding measures

 Passages - personnel
Low care Transfer zone Medium care High care
- people are allowed to go - walking routes defined - walking routes defined within - walking routes defined within
from low care to outside within the building-low the medium care areas i.e. the high care area i.e. staff
and visa versa care areas i.e. staff staff not allowed to go to lower not allowed to go to lower
serving the transfer care areas and back or to high care areas and back without
areas not allowed to care areas without precautions precautions, only authorised
go outside routing
- specified doorways

Susanne Wagner Internal Audit 40

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept – Corresponding measures

 Passages - authorisation
Low care Transfer zone Medium care High care
Authorisation for staff
- authorisation needed - see low care - see low care - authorisation of named and
supervised staff
- depending on task - basic medical examination and - extended medical examina-
basic medical exami- supervision mandatory tion and supervision manda-
nation and supervision tory (e.g. stool test 4 x per
(e.g. task: sorting, de- year)
boxing)
Authorisation for suppliers/contractors and visitors
- authorisation needed - see low care - see low care - authorisation of named and,
- designated walking supervised suppliers/contrac-
routes tors
- designated walking routes
- information on hygiene re- - information on the special
quirements hygiene requirements of high
- questionnaire on health status care areas
- questionnaire on health
status
- visitors to be accompa- - see low care - see low care - see low care
nied - visits reduced to a minimum,
preferably visitor’s corridor

Susanne Wagner Internal Audit 41

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept – corresponding measures

 Transfer/Movements – materials, product

Low care Transfer zone Medium care High care

- automatic (roller) doors
to outside
- all wooden palettes al- - change from wooden
lowed
- automatic door to transfer zone - sluice system/interlock with
automatic doors
- conveyor trap doors
- preferably no wooden pallets in - only designated plastic pal-
pallet to plastic pallet exposed product areas ettes
or into pallet shoe
- in wet dumping no direct con-
tact of wooden pallets with sur-
faces e.g. pallet shoe or
placement on plastic pallets
- selected clean wooden pallets
in dry dumping areas accept-
able (for product to be heat
treated)

Susanne Wagner Internal Audit 42

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept - Examples

 Transfer/Movements – materials, product: pallets
Medium care/transfer zone to high care:
Pallet turner applied for changing from
wooden to plastic pallets. Nutricia Kasdorf
(Argentina).

Susanne Wagner Internal Audit 43

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept - Examples

 Transfer/Movements – materials, product: pallets

Medium care: Pallet shoe

applied for pallets with
packaging material
transported to filling lines.
Nutricia Zoetermeer (The
Netherlands).

Susanne Wagner Internal Audit 44

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept – corresponding measures

 Transfer/Movements – materials, product
Low care Transfer zone Medium care High care
- removal of terti- - preferable removal of the sec- - only essential material to be
ary/transport packag- ondary packaging prior trans- transferred to high care
ing (e.g. shrink foil) port to high care
- dust removal from sur-
faces
- remaining raw/packaging ma-
terial to be stored in medium
care
- if return to warehouse (low
care area) sufficient protective
measures to be applied i.e.
similar way back e.g. wrapping
and relocation from dedicated
plastic pallets
- semi-finished products in tote- - semi-finished products pref-
bins/silos stored at least in erably stored in high care (i.e.
medium care designated storage areas)
- semi-finished products in big
bags – storage in low care:
additional transport/protection
foil to be applied; transfer back
to areas of higher care in ac-
cordance with the require-
ments for raw materials

Susanne Wagner Internal Audit 45

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept - Examples

 Transfer/Movements – materials, product: pallets
Medium care/transfer zone to
high care: De-boxing and
sanitation of in-liner surface of
25 kg-raw material bags prior
conveying through sluice to
high care dry dumping station.
Addtop Int, Jiangkou – third
party blender and packer for
Nutricia Qiqihar (China).

Susanne Wagner Internal Audit 46

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept - Examples

 Transfer/Movements – materials, product: pallets
High care/transfer zone and prepared batch
storage – pharmaceutical standard: Transfer
of raw materials into approved bags for wet
preparation ECN. Nutricia Wuxi (China).

Susanne Wagner Internal Audit 47

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept – corresponding measures

 Transfer/Movements – tools, equipment
Low care Transfer zone Medium care High care
- dedicated forklift trucks - dedicated forklift - dedicated driven fork lift trucks - no driven forklift trucks: pref-
allow to go from outside trucks within the build- within the medium care areas erably manually handled,
to low care ing for low care areas and allowed to go to border stainless steel fork lifters
line of transfer zone
pharmaceutical look:
- no forklift trucks
- cleaning procedure for fork lift trucks designated to defined areas
- re-charging in separate, - re-charging not in production
ventilated areas areas to be solved
- covered canopy for
loading/unloading of
trucks
- closed transport system
for inter-factory trans-
port
- designated tools for use and cleaning in the various processing areas
- only authorised tool kits (from - only authorised and station-
TD) ary tool kits (from TD)

Susanne Wagner Internal Audit 48

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept - Examples

 Transfer/Movement – tools, equipment

2001 2002

Inter-factory transport: Lorries for the transport of raw materials and semi-finished
products. The open system is being replaced step by step by a closed system protected
against adverse weather effects. Nutricia Polska, Opole (Poland).

Susanne Wagner Internal Audit 49

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept - Examples

 Transfer/Movement – tools, equipment

Medium care: Foil transporter for the foil

supply of Tetra-packaging machines.
Nutricia Zoetermeer (The Netherlands).

Susanne Wagner Internal Audit 50

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept - Examples

 Transfer/Movement – tools, equipment

High care: Designated tools used at High care: Designated cleaning

the filling. Support Arceburgo tools in the agglomeration
(Brazil). department. Milupa Colmar
(France).
Susanne Wagner Internal Audit 51
Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept – corresponding measures

 Transfer/Movements – waste

Low care Transfer zone Medium care High care

- waste containers designated to defined area and corresponding cleaning procedure
- crossing routes of waste and material/product to be avoided
- at least one zone or a sluice - treatment of waste separated
needed between medium care from processes either by
zone and outside for removal physical measures or by time
of waste e.g. waste compactors to be
avoided, removal of dust from
collector systems after pro-
duction stop
- designated vacuum cleaners to defined areas

Susanne Wagner Internal Audit 52

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept - Conclusions

 Approach to zoning in practice

risk assessment as to – product

target state
– consumer
assessment of existing – buildings actual state
– flow

assessment of improved state

against target state
- improvements of buildings
- adjustment of flows

- verification of - implementation of
conducted preventive hygienic
activities measures

Susanne Wagner Internal Audit 53

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept - Conclusions

 Principle of flow of products, personnel and waste
Low care Transfer zone Medium care High care

flow of raw material flow of waste flow of personnel

Susanne Wagner Internal Audit 54

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept - Conclusions

 Principle of flow of products, personnel and waste
High care Medium care Transfer zone Low care

flow of finished goods flow of waste flow of personnel

Susanne Wagner Internal Audit 55

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept - Conclusions

 Principle of a lay out: ideal factory

Access corridor prior changing

Canteen, recreation area Changing facilities Technical facilities,

workshop

Access corridor after changing

High care
changing

L M H M L
Susanne Wagner Internal Audit 56
Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Thank you for your attention.

Enjoy the workshop.

Susanne Wagner Internal Audit 57

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept - Annex

 Principles of flow in practice
 Realisation in spray drying plants:
• Low care and Transfer zone
• silo areas, raw material/packaging material warehouse
• Medium care
• weighing, wet preparation, evaporation
• High care
• spray drying, fluid bed, packaging (big bags, tote-bins)
• Medium care
• sluice to warehouse (partially realised)
• Low care
• big bag or tote bin warehouse

Susanne Wagner Internal Audit 58

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept - Conclusions

 Principles of flow in practice
 Realisation in drum drying plants:
• Low care and Transfer zone
• silo areas, raw material/packaging material warehouse, mill
• Medium care
• weighing, wet preparation, slurry preparation
• High care
• drum drying, possibly intermediate storage, blending,
primary packaging
• Medium care
• secondary packaging (partially realised), sluice to
warehouse (partially realised)
• Low care
• palletising, storage of finished product

Susanne Wagner Internal Audit 59

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept - Annex

 Principles of flow in practice
 Realisation in blending plants:
• Low care and Transfer zone
• raw material/packaging material warehouse
• Medium care
• transfer of raw materials and packaging materials (de-boxing,
de-palletising of raw materials/packaging materials)
• High care
• weighing of ingredients, blending, intermediate storage,
primary packaging (partially also secondary packaging)
• Medium care
• secondary packaging (partially realised), sluice to warehouse
(partially realised)
• Low care
• palletising, storage of finished product

Susanne Wagner Internal Audit 60

Fred Bauer Workshop 2004
 RESEARCH &
DEVELOPMENT
Quality and Food Safety

Zoning concept - Annex

 Principles of flow in practice
 Realisation in jar food and wet ECN plants:
• Low care
• raw material/packaging material warehouse, de-palletising of
glass-ware, washing of raw materials
• Transfer zone
• transfer of raw materials/packaging materials (de-boxing, de-
palletising), sorting, peeing, blanching, washing of glass-ware
• Medium care
• weighing of ingredients, mixing, intermediate storage, primary
filling/packaging, heat treatment
• High care: aseptic filling
• labelling/secondary packaging, sluice to warehouse
• Low care
• palletising, storage of finished product

Susanne Wagner Internal Audit 61

Fred Bauer Workshop 2004