Pathogen Environment Monitoring and · PDF fileOctober 2011 Anett Winkler 2 Hygienic Zoning...
Transcript of Pathogen Environment Monitoring and · PDF fileOctober 2011 Anett Winkler 2 Hygienic Zoning...
1
Pathogen Environment Monitoring and
Zoning
October 2011
Anett Winkler
2
Hygienic Zoning and Environmental Monitoring –
• Salmonella
• Review the concept of Hygienic Zoning of food
plants
• Identification of different zones
• Controls of cross contamination
• Monitoring of the controls using PEM
• Examples of Environmental monitoring programs
Salmonella
(vegetative)
Importance – dry foods
Beyond CCP controls
Incidences of Salmonella outbreaks
Number of organisms needed to cause disease
7
Controlling cross contamination
Zoning
a) Review the concept of Hygienic Zoning of food plants
b) Identification of different zones
c) Controls of cross contamination
Pathogen Environmental Monitoring (PEM
a) Monitoring of the controls using Environmental Monitoring
b) Examples of Environmental monitoring programs
8
Zoning – QP 6.4-03
Note: This QP does not address zoning for other
purposes, e.g. allergen controls.
Controls of allergen cross contamination are discussed in
conjunction with sanitation measures including relevant QP,
and captured in HACCP Form J (plant lay out where this
point is also considered)
… apply during the
receipt,
storage,
processing and
packaging of products
Zoning Principles for Prevention of (microbial) Cross
Contamination
9
Zoning refers to the segregation of areas of the facility based
on
(physical) barriers,
cleaning procedures,
employee practices and
control of movement of people, equipment and materials
necessary to protect products from potential microbiological
hazards originating from the manufacturing environment and
its surroundings.
Scope more descriptive:
Zoning – QP 6.4-03
10
Focus on appropriate controls
at the interfaces and movements between areas where the
microbial profile changes such as between cooked and raw
product…
to protect product, raw materials and packaging during their
movement from one area to another in a facility,
to protect the processing environment where exposed product
and materials might become contaminated from higher risk areas
of the factory
Zoning – QP 6.4-03
11
Zoning – QP 6.4-03
Valid for all productions:
A documented risk assessment shall be conducted to
understand and identify how zoning programs and related
controls should be employed.
Supporting materials
Checklist (Table 2)
Form J (plant lay out) - HACCP
Responsibilities clearly defined:
Plant Quality is responsible to ensure the risk assessment
is performed,
Corporate Food Safety and Corporate Sanitation will
provide the technical support,
Corporate Microbiology will approve the Hygienic Zoning
assessment
12
Provides a
Protocol for Conducting a Hygienic Zoning
Assessment
in 6 Steps
Zoning – QP 6.4-03
Steps 1-4 provide more details to perform an adequate
risk assessment:
Usage of Table 1 for product susceptibilities,
Product exposure & other processing factors (e.g.
movements),
Risks related to non-manufacturing rooms (e.g. rest
rooms)
13
Zoning – QP 6.4-03
Step 5 defines the zones / classification of areas:
A - Non-manufacturing zone (still requires application of
basic hygiene requirements), e.g. rest rooms, offices
B - Raw zone/Limited processed zone, may also include
emergency exit to outside, roof access, rest rooms in
production
C - Controlled zone for manufacturing product of low to
medium susceptibility (product susceptibility 2 - 3) which can
be exposed to the environment and the operators
D - High control zone for manufacturing product which
supports growth (mainly susceptibility 1)
14
Step 6
Identify and implement necessary controls
Examples of controls are provided in Section 5
(former Section 4)
Zoning – QP 6.4-03
Table 1 also includes numerical ranking based on product
characteristics such as water activity, pH, formulation, etc,
finished products are ranked according to the following
criteria:
1 - pathogen grow and / or spoilage may grow
2 - spoilage may grow and/or pathogen may survive
3 - low risk (no growth)
15
Zoning – QP 6.4-03
Table 1 examples:
“Cheese Products, RTE (Natural Cheese, Cream Cheese,
Process Cheese), Cream Cheese Bars”
Risk of Pathogens: YES / Risk of Spoilage: YES / Product Risk:
1 or 2
“Confections/Chocolate & Chocolate compound enrobed
biscuits/wafers/cookies/cakes”
Risk of Pathogens: YES / Risk of Spoilage: NO / Product Risk: 2
“Cookies, Crackers, Snack Mixes, Brownies, without
sensitive ingredients”, “Caramels”
Risk of Pathogens: NO / Risk of Spoilage: NO / Product Risk: 3
16
Risk of Pathogens in confectionery products with fillings & enrobings containing
sensitive ingredients (see HACCP Standard Section 14 for definition!) due to
long term survival in those products
low infective dose in those products
Note: For some fillings, where aw>0.6 the spoilage risks
due to potential of osmophilic yeast growth has to be
evaluated (based on formulation, challenge testing…)
Examples: Barny filling, jam fillings, fig paste fillings
Zoning – QP 6.4-03
17
Examples of commonly handled raw agricultural materials are
Raw Milk
Raw Meat
Cocoa beans
Nuts / Seeds
Flour
Dried Fruits / Spices / Herbs
Since microbiological analyses results cannot be used to ensure safe
products, segregation of areas where (raw agricultural) materials are
handled that are likely to be contaminated is very important in order
to prevent any cross contamination of pathogens in processing areas
for finished products!
considered highly contaminated
contamination level of these is
quite low, around 1%
(Salmonella)
Zoning – QP 6.4-03
18
WHITE
ZONE
SANITIZZATO
INGRESSO
RED
ZONE
NEUTRAL
ZONE
E
EE
Fruit filling
preparation Finished product
warehouse
Raw flour reception
Dough preparation,
open system
Area A Area C
Example: Old Plant
Zoning – QP 6.4-03
19
point of sampling for Salmonella PEM
cocoa beans cleaning area; cocoa nuts roasting area deposited sweets production line Shok-1;
"A" zone "C" zone deposited sweets extruder Shok-3;
pralines production line ShPF -24;
deposited sweets production line Shok-2
MARKING:
metal detector
magnet; sieve
7
79
37
12
24 3
28
10 131614
4
8 9
56
21
3
2 1
11
15
19
31
Plant layout (third floor)
МD
17
№2№1
ShPF- 24
20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95 100 11010515
МD
42
LTS-6
Shok- 2
Shok - 1
МD
МDpalletizer
Shok-3
Marking:
А2 - all raw materials for sweet production (floor 4)
- people flow
- rejects (rubbish, remnants of raw and packing materials, sanitary waste)
В - additional materials palletizing system (1, 2, 3 floors)
31
32
3334
35
36
37
3839
40
Finished product
warehouse
Dough preparation
Fruit filling preparation
Finished
goods
warehouse
Product Flow
Chocolate depositing
Raw flour
reception
Raw material
warehouse
New Plant
Zoning – QP 6.4-03
20
Dough Preparation (handling of flour, seeds, nuts)
in separate floor / room of production building
dedicated people working there
dedicated tools available (also for cleaning)
separate raw material deliveries (no common lifts, forklifts –
warehouses)
separate air filtration systems
separate drain systems
Procedure in place for maintenance people / visitors to
prevent contamination of other processing areas
Preparation of Fillings in dough preparation area
Flour dust distribution near to post-baking area
Shared Washing Room for equipment used in dough
preparation & fillings
Zoning – QP 6.4-03
21
How Organisms Adhere to surfaces
22
Treated and
untreated ceramic
Image from http://www.flooring.com.hk/safe-walk.htm
Mild Steel Image from http://pubs.sciepub.com/ajmse/1/3/1/
23
24
PEM – QP 6.3-05
PEM is a verification activity of effective zoning in
place, i.e. implemented zoning measures are preventing /
minimizing microbial cross contamination.
Therefore, samples shall be taken during production &
are not meant to be a verification of cleaning practices!
Normally, sampling is performed after at least 3h
production runs.
25
This policy focuses on two specific pathogens (Salmonella
spp. and Listeria monocytogenes) and indicator
organisms which predict their presence in the processing
environment.
This program shall also enable detection of potential
pathogen harborage areas, in processing environments,
including pilot plants.
The program focuses on areas where pathogens are not likely
to occur, i.e. in production areas after kill steps, e.g. after
baking.
PEM – QP 6.3-05
26
Samples produced in R&D and plant laboratories are
not subject to facility PEM, must undergo finished
product testing prior to external consumer testing.
Pilot plants are required to implement PEM
programs if producing product for consumption
purposes.
PEM – QP 6.3-05
27
What are the pathogens of concern in dry
processing, especially biscuits /
confectionery / snacks / candies ?
Currently, based on outbreaks,
Salmonella is recognized as major and
only pathogen of relevance in those foods.
PEM – QP 6.3-05
28
Therefore, sampling plans in biscuits, confectionery, snacks, candies are concentrating on Salmonella.
Note: In dry processing there are no other
microorganisms known that would allow to conclude the
presence of Salmonella at those points (also called
“indicators”).
Therefore, PEM samples have to be analyzed for
Salmonella!
PEM – QP 6.3-05
29
Focus (harborage) areas in dry
productions
Generally, these productions provide
optimal growth temperatures (warm areas)
and
plenty of nutrients…but
they would not provide the water necessary
for growth!
PEM – QP 6.3-05
30
Focus areas in dry productions cont.
processing areas after kill step where where water is used & open to environment, e.g. for
cooling (cooling tunnel condensation pipes), cleaning (brushes of floor cleaning machines), hand washing, sanitation – include all drains in program!
areas of high traffic, e.g. people, raw materials, equipment (movable containers) – wheels of movable containers can be included
PEM – QP 6.3-05
31
Zone 4
Remote areas outside of the procesing area: Hallways, doors coolers, cafeteria…
Zone 3 Remote non-product contact areas within the
processing area room: Floors, walls, drains, leg supports, wheeled items,
forklifts…
Zone 2
Product Contact Surfaces: Conveyors, filling equip., pipes, storage vessels, utensils/scrapers/tools,
hands…
Zone 1
Non-product contact surfaces: Exterior of equipment, control panels/buttons, aprons, gloves, tables…
PEM – QP 6.3-05
Examples
Control Button Handle (intake jam)
Zone 2 Zone 3
Footbridge Floor under sink
Pooling possible Pooling possible
PEM – QP 6.3-05
33
Pooling is used to cover more sampling points without
increasing the number of analyses.
Only pool one zone: do not pool Zone 2 and Zone 3 swabs:
• Zone 2: up to 5 swabs from one area can be pooled for
one analysis
• Zone 3: up to 5 sponges/swabs can be pooled
Note: Do not pool drains with other Zone 3 samples.
Drains can be pooled with other drains of the same area
PEM – QP 6.3-05
34
CONCLUSIONS
• Post lethal step contamination
can occur through harbourage
• Steps taken to ensure prevention
of cross contamination
• Largely based on physical
segregation
• Monitored by routine
environmental testing