pathogen environment monitoring and · pdf fileoctober 2011 anett winkler 2 hygienic zoning...

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Pathogen Environment Monitoring and

Zoning

October 2011

Anett Winkler

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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

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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

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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

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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:


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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


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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

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Provides a

Protocol for Conducting a Hygienic Zoning

Assessment

in 6 Steps


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)

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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)

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Step 6

Identify and implement necessary controls

Examples of controls are provided in Section 5

(former Section 4)


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)

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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

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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


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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)


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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


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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

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79

37

12

24 3

28

10 131614

4

8 9

56

21

3

2 1

11

15

19

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Plant layout (third floor)

МD

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№2№1

ShPF- 24

20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95 100 11010515

МD

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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)

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32

3334

35

36

37

3839

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Finished product

warehouse

Dough preparation

Fruit filling preparation

Finished

goods

warehouse

Product Flow

Chocolate depositing

Raw flour

reception

Raw material

warehouse

New Plant


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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


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How Organisms Adhere to surfaces

http://firstlook.pnas.org/wp-content/uploads/2013/03/flagella.jpg

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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/

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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.

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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

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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

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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

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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

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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

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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

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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

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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

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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

pathogen environment monitoring and · pdf fileoctober 2011 anett winkler 2 hygienic zoning...

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