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Functional Hygienic
D i
Design
Advanced Hygienic Design
Processing Engineering School

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Functional hygienic design

C t t
Content
 Why
y & When
 Production Demands
 CIP recipes
 CIP systems
 CIP parameters
t
 Operational Qualification

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Wh & When
Why Wh
Functional Hygienic Design

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Functional hygienic design

Why?
y
Legal demands related to hygiene;

 Hygienic design, possible to clean

– Machine Directive, 2006/42/EC( Annex 1, paragraph 2.1)
 Hygiene risk assessment (according to…)
– Food processing machinery. Hygiene requirements EN 1672-2:2005
– Sa
Safety
e y of
o machinery.
ac e y Hygiene
yg e e requirements
equ e e s for o thee des
design
g oof machinery
ac e y
EN ISO14159:2002

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Functional hygienic design

When?

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Functional Hygienic
D i
Design
Production Demands

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Food processing

Anything special?

 Sequencing
 Automatic interactions
 Manual interactions
 Phase logics
 Alarm handling

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Food processing
Water hammer
Manual interference with sensors
Cleaning of tank outlets without pressure
Unique
q Valve Seat Cleaning g
Manual override
Possible to bypass manual overrides...
Calibration
Feed-back levels, Control levels, Mechanisation level
More?
M ?

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Phase Logics

The phase logic part of the

phase contains the program
code for the state diagram,
where the control and
status signals are interfaced
to the surroundings.
The relationship of the
states in a phase is shown
in the diagram below. No
other relations are allowed.
It is only possible to be in
one state at the time.

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Interlocks and Running Faults

Interlock
Interlock is a summary of conditions e.g. cleaning
phase running, production phase running etc and other
conditions that will prevent a phase from starting.
RunningFault
RunningFault is a summary of conditions e.g. valve
fault, motor fault and other faults that will prevent a
phase from starting or if the phase is running, enter
held state. The RunningFault is also evaluated before
restart of a phase.

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General automation
General

 If any control module that affects the phase is set in manual mode,
the phase shall be interlocked. The interlock shall be possible to
b
bypass b
by authorized
th i d user.
 Changed parameters shall take immediate effect in the program.
 Alarm and hold functions must exist in phases if abnormal process
events occur.

Logging

 All alarms must be logged.

gg
 All operator interactions must be logged with type of interaction,
time and operator identity.
 Parameters changed from UI must be logged with parameter
name description
name, description, time
time, old value
value, new value and operator
identity.

Access levels

 It must be possible to configure authorization on all buttons and

input fields during design. If change in configuration has to be
made in later stage, the system should be able to run full Internal
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production without any disturbance.

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Production demands

Performance on filling/emptying

 Water in product etc

 Foreign material contamination
 Product sequencing
 Product change
– Hygienic level of CIP/SIP (air introduction)
– water plug/product-to-product
– CIP/SIP
Traceability
T bilit d
demands
d
Automation error control

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Physical reality to Functional design

Tank – Line – Tank (compact valve cluster)
Destination
tanks
Sources

Flush 1

Flush 1
These distances
must be very short

7
8
2
CIP Return
Flush 2 Production
line

Reclaim

Drain
Drain Line valve

Flush 3
Flush 3
Flush 3
3
5
Parameter name
1. FillToDrainAmount (emptying, source tank)
2. FlushToDrainAmount ((emptying,
p y g, source tank))
3. FillToDestAmount (production)
5. FlushToDestAmount (production)
7. FillToTankAmount (filling, dest tank)
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Flushes

 Flush 1
 Flush 2
 Flush 3
 Affecting hygiene if not working properly
 Filli
Filling and
d flushing
fl hi off allll pipes
i shall
h ll b
be b
basedd on
amount. In parallel a timer will run. When either the
amount or time is attained, the filling or flushing is
finalised. Alarm when timer is attained.

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Mix Phases – seen inside the pipe…

e of liquids
Pre Flush Flush Final
rinse rinse

ProductB Flow

Mixture
ProductA ProductA
Drain

Drain

Drain
Reclaim

Reclaim

Reclaim

Reclaim
CIP Desti-
Product Product Product
nation
Return Tank 2 Tank 1 Tank 1

+12 -12 +9 -9 +11 -11 6 4

Parameter name (Numbers used in picture)

1. FillToDrainAmount (emptying, source tank)
2 FlushToDrainAmount (emptying
2. (emptying, source tank)
3. FillToDestAmount (production)
4. FillToReclaimAmount (production)
5. FlushToDestAmount (production)
6. FlushToReclaimAmount (production)
7. FillToTankAmount (filling, dest tank)
8. FlushToTankAmount (filling, dest tank)
9. MixZone Amount (+ value to tank 1, - value to tank 2)
11. FillMixZoneToDestAmount (+ value to dest 1, - value to dest 2)
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12. FlushMixZoneToDestAmount (+ value to dest 1, - value to dest 2) AHD & AM / 2013

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Material Separation / Traceability

Levels of material separation:
1. After production status cleaned should be reached. The product
rest is “pushed”
pushed out from line during cleaning sequence.
sequence
2. After production status flushed should be reached. Production
finished with a flush.
3
3. No flushes between batches and product is pushed to last
running storage tank. It is similar to a product change on a
pasteurizer where the product is pushed to the last running storage
tank. Typical for queuing of batches on the production line.
4
4. No flushes
N fl h b t
between b t h
batches and
d product
d t is
i pushed
h d to
t “new”
“ ”
selected storage tank. Is the lowest level and most common in
reception lines since it is nearly always the same product with the
same characteristics at product intake. Product in line (from last
batch) is pushed to tank in next running batch.
batch

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Traceability levels

For the four alternatives of material separation there

are corresponding traceability levels. Meaning, the
visualization on the traceability tree will vary depending
on the material separation philosophy.

Example
If products from several road tankers are received
through the same reception line without flushing or
cleaning between
between, there are two volumes moving
through the line every time there is a product change.

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Traceability level 3

Batch 1 completed C01C01 C01C02

Road tanker at R01X01 has unloaded

and the product A is stored in storage R01X01
A

tank C01C01. No flush afterwards. A

R01W01

Reclaim

Batch 2 started
C01C01 C01C02

Road tanker at R01X01 is unloading

with product B and push A forward.
A
Product A will be delivered to C01C01 R01X01

even if C01C02 isi selected

l t d to
t run with
ith B
R01W01
product B. B A

Reclaim

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Traceability level 3
C01C01 C01C02

Batch 2 mix zone to reclaim

A
Road tanker at R01X01 is unloading with R01X01

product B and push A forward. Product B

R01W01

A is delivered to C01C01 and mix zone B B A

is going to reclaim before activating

C01C02.
Reclaim

C01C01 C01C02

A B
Batch 2 in full production R01X01

Road tanker at R01X01 is unloading g B

R01W01

with product B and delivers to C01C02. B

Conclusion:
Reclaim

If no reclaim it is possible to send mixzone to either tank A or B. This is

controlled by the parameter in the production phase. Otherwise the
mixzone have to go to drain. Internal
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Production demands for the HRA

Necessary to check

 Water in product
 Product/CIP safety – solutions & interlocks
 Foreign material contamination
 Product sequencing
 Product change
g
 Traceability demands
 Automation error control – phase logics
 Interface to external equipment
 Critical control points

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Exercise – Safest solution

1. Assess hygienic risks related to possible malfunction of the

5 solutions
11. Mibi
Mibi,
2. Chemical contamination,
3. Foreign objects

2. How to secure correct functionality?

1. Limitations, prerequisites, validations
2. Where to document in Workflow?
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Production
PFS for Production VG10&Line Stepp RUNNING
procedure:
HELD
Idle
WaitForSource
Description FillToDest
Cleaning pressure, Flush 2 and cleaning return FillToReclaim
functionality. The design element is located after Production
p
a valve cluster with non mixproof connections. ProdToDest
Automation system must check that the correct ProdToReclaim
proximity switches are activated when different FlushToDest G02Q0002 G02Q0002
paths are selected. Also the proximity switches G02Q0001 (2-3 seconds delay)
that should not be activated have to be G02Q0003 (5-6 seconds delay)
controlled. All functions are started from the Deactivation
deactivate G02Q0003
control room.
deactivate G02Q0001 (2-3 seconds
delay)
A pushbutton box with 3 buttons is needed deactivate G02Q0002 (5-6 seconds
Button 1 = Confirmation of performed connection delay)
for production “Production Request” (G01BG001) FlushToReclaim G02Q0002 G02Q0002
G02Q0001
Q ((2-3 seconds delay)
y)
Button 2 = Confirmation of performed connection
G02Q0003 (5-6 seconds delay)
for CIP of line 1 “CIP Request, line 1” V01BG001) Deactivation
Button 3 = Confirmation of performed connection deactivate G02Q0003
for CIP of line 2 “CIP Request, line 2”(V01BG501) deactivate G02Q0001 (2-3 seconds
delay)
deactivate G02Q0002 (5-6 seconds
d l )
delay)
FlushToDrain G02Q0002 G02Q0002
CIP Line 1 G02Q0001 (2-3 seconds delay)
G02Q0003 (5-6 seconds delay)
Line 2 Deactivation
Line 1 deactivate G02Q0003
deactivate
deact vate G02Q0001
G0 Q000 (2-3 ( 3 seconds
seco ds
delay)
deactivate G02Q0002 (5-6 seconds
delay)
Draining Internal
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PFS for Production VG10

Cleaning procedure:
Activations during cleaning of Line 1
Step RUNNING HELD

Idle
CIP (Cleaning)

Drain G02Q0003 G02Q0003

Flip
p sequence
q
Completed

Step Step description RUNNING

No.

Flip01 Flip 01 with pressure

Flip02 Flip 02 with pressure

Flip10 Flip 10 depressurise Deactivate CIP Pressure Pump,

Deactivate CIP Return Pump

Flip11 Flip 11 without pressure G02Q0003

Flip12 Flip 12 without pressure G02Q0002

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Functional Hygienic
D i
Design
CIP Recipes

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Cleaning demands
Dependent on previous production
Product
P d t
–Proteins, fat
–Adhesiveness, cohesiveness, stickiness
Production parameters
–Time
–Temperature
Temperature

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Cleaning demands
Dependent on new production

Need of CIP
Need of disinfection Hot Water
Need of disinfection Chemical
Need of sanitary air in pipe&tank systems

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Recipe exercise

How is drained or not drained after CIP affecting

g
hygiene?
Pipes remain filled with water after CIP to prevent
contamination
i i or to avoid id pitting
i i corrosion?
i ?
Pipes remaining filled with water after CIP will create
an extra mixphase to handle during filling of the line
With an empty pipe there is no mix phase, hence
product can go directly to the destination
destination.
More?

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Cleaning sequence
Pre-rinsing
with water at 50-60°C, to remove sugar and melt any fats. The
temperature should not exceed 60°C in order to avoid denaturing of the
proteins,
t i which
hi h th
then b
become much h more diffi
difficult
lt tto clean.
l
Cleaning with an alkaline detergent
to remove proteins and fats.
Rinsing with water
to remove any residues of the alkaline detergent.
Cleaning with an acidic detergent
to dissolve mineral salts and the deposits left by hard water. This is
repeated as often as necessary, depending on whether the surfaces
are hot or cold, the type of food and the water quality.
Rinsing with water
to remove any residues of the acidic detergent.
(Sterilisation or disinfection)
to kill bacterias or or other living organisms to a certain level
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Standard Recipes
Program 1 Program 2 Program 3
Caustic recipe Acid recipe Caustic & Acid recipe

Program 4 Program 5 Program 6

Acid & Caustic recipe Caustic & Acid & Caustic Caustic & HotWater
recipe disinfection recipe

Program 7 Program 8 Program 9

Caustic & Acid & HotWater Acid & Caustic & HotWater Caustic & Chemical
disinfection recipe disinfection recipe Disinfection recipe

Program 10 Program 11 Program 12

Caustic & Acid & Chemical Chemical Disinfection recipe Final Rinse
Disinfection recipe

Program 13 Program 14 Program 15

HotWater disinfection recipe One solution recipe

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Recipe exercise (Cleaning Handbook)

Design
g a CIP recipe
p for

 Milk reception line

 Soft water
ater (no deposits)

Decide

 Necessary steps
 Temperatures

 Times

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Recipe exercise (Cleaning Handbook)

Design
g a CIP recipe
p for

 Milk pasteuriser line

– Including Separator & homogeniser
 Soft water (no deposits)

Decide

 Necessary steps
 Temperatures

 Times

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Functional Hygienic
D i
Design
CIP systems

Security level
NN/MMYY

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CIP Systems

Single use systems

• Single path (without circulation)
• Single-use (with circulation)
•Decentralised CIP systems (satellite systems)

Re-use system
• Centralised CIP systems (recovery systems)

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Tetra Alcip

CIP liquid
q – Single
g path/single
p g use

Single path Single use/re-use

Advantages
Advantages
Always new CIP liquids
Reduced consumptions
Inexpensive investment
Less load on waste water
system
Disadvantages
Disadvantages
High running cost
More expensive investment
High environmental load

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Centralised CIP

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Decentralised CIP

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Centralised or decentralised
CIP systems?

Centralised Decentralised
• Advantages • Advantages
– One control – Could be shorter p
piping
p g
– Handling of CIP liquids – Low losses of energy
at one location – Raw and processed separated
– Handling of product recovery
at one location
– Recovery of chemicals • Disadvantages
– One PLC at each CIP station
• Disadvantages – Detergent tanks in production
– Long piping – No recovery of chemicals
– Higher
g losses of energy
gy – Difficult recovery of product
– Two stations needed for raw
and processed

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Routing of liquid – detergent tank/

b l
balance tank
t k

Detergent tank Balance tank

• Advantages • Advantages
– Shorter cleaning times for large – Only a small cleaning volumes needed
objects.
bj t – Dirty liquid could be sent to drain
• Disadvantages • Disadvantages
– When an object with lots of – Foaming might create problem in
impurity is cleaned, the whole a small balance tank
tank volume needs to be – Large
L objects
bj t might
i ht create
t llong cleaning
l i
replaced times

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Cleaning Demands for the HRA

Necessary to check

 Correct recipe & chemicals

 Product/CIP safety – solutions & interlocks
 CIP liquid quality
 Need of draining & sanitary air
 Report/validation demands
 Automation error control – phase logics
 Interface
I t f to
t external
t l equipment
i t during
d i CIP
 Interface to external equipment during disinfection

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Exercise – Tank CIP

1. Assess hygienic risks related to the tank CIP for the 3

solutions
11. Mibi
Mibi,
2. Chemical contamination,
3. Foreign objects

2. How to avoid found risks?

1. Limitations, prerequisites, validations
2. Where to document in Workflow/Technical File?
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Functional Hygienic
D i
Design
CIP parameters

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Why all these CIP parameters

Connecting
gpphysical
y reality
y to functionality
y
Securing correct recipe performance
Object oriented optimization
Achieving handling of mix phases
A hi i expected
Achieving t d performance
f

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CIP STATION QT Turb

CT

NCSD FCMT
CCSD
ACSD FCA
RWCSD
CDCSD
CIP Line
- Temperature
- Conductivity
C

PRTSD=
CIP Circuit
PRCSD= Recovery
WWTSD=
WWCSD
Drain Caust Chem
Neutr FW Acid RW
ic

CIP Line
- Pump Speed
-Flow Control
FTTA
CL Parameters CC Parameters FTTMT
AcidCondSortDelay (ACSD) FillCircleAmount (FCA)
CausticCondSortDelay (CCSD) FillCircleMaxTime (FCMT)
RinseWCondSortDelay (RWCSD)
FillToTankAmount (FTTA)
ProRecTurbSortDelay (PRTSD)
ProRecCondSortDelay (PRCSD)
FillToTankMaxTime (FTTMT)
WhiteWaterCondSortDelay (WWCSD)
WhiteWaterTurbSortDelay (WWTSD)
ChemDesCondSortDelay (CDCSD) Internal
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NeutrCondSortDelay (NCSD)

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CIP RETURN - MIX PHASES

Final Final Intermediate Pre-rinse Water
rinse rinse rinse
13

8 8 5 4 5 4
1 1 2
2
Chemical Caustic Product
Disinfectant
Acid 7 6 7 6
9 9 9 9
3

Drain
Drain

Drain

Drain

Drain

Drain
Chem Acid Caustic Product
tank tank tank Recovery

Rinse Rinse Neutrali Neutrali Neutrali Neutrali White White

water water sation sation sation sation water water
tank tank
16 14 11 12 15

CL Parameters
P t CC Parameters 11 12
1. AcidCondSortLimit 11. MixZoneBackupAmount
2. CausticCondSortLimit 12. MixZoneBackupTime
3. RinseWCondSortLimit 13. PlugAmount
4. ProRecTurbSortLimit 14. AcidToDrainTime
5. ProRecCondSortLimit 15. CausticToDrainTime
6. WhiteWaterTurbSortLimit 16. ChemDisToDrainTime
7. WhiteWaterCondSortLimit
Internal
8. ChemDisCondSortLimit AHD & AM / 2013
9. NeutrCondSortLimit

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CIP Return Distribution

 Depending on the options selected different levels of

instrumentation and Automation will be required.
 For each destination a different volume parameter
will be required
 Interface segregation
g g is taken care of by
y Automation

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CIP Supply Distribution

 There are normally 4 different valve

options available, each with added
levels of protection

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CIP Return CT/TE + FS

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CIP Return CT/TE + FS

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CIP Return Distribution

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CIP Return Distribution

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Functional Hygienic
D i
Design
Operational Qualification

Security level
NN/MMYY

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Functional hygienic design

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Operational qualification

Ensure that CIP system works as expected

 Check for leakages and possible malfunction

 Make sure that all valves and pumps operates as planned
 Make sure the automation works properly, Interlocks, Running
faults etc
 Make sure that spray devices are working properly to ensure
total coverage of cleaning solution in the tanks
 All cleaning parameters must be monitored and recorded
properly (flow rate,
rate concentration,
concentration temp,
temp time etc)
 See Cleaning Validation

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Findings

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Findings

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Findings

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Summary of findings

Aseptic transfer
• Valves on aseptic transfer line not properly cleaned
• Sand deposit found in aseptic tank
• High level in the aseptic tank during cleaning 1400
litres remaining during the first drainage
• Low concentration alarm during alkal cleaning, 3000
litres remaining in tank at the end of cleaning
• Alkali and acid solution mixed in aseptic tank
• Sample of final rinse water still contained 0,3% alkali

Root cause?

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Customer View

Energy Emissions

Raw materials

Salaries Products

Capital

Cleaning solution
Product losses Water losses
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Plant Completion Procedure

Commissioning Tests

 Demonstration that the plant serves its basic intended purpose;

i.e. is ready for commercial production
Performance Tests

 Demonstrates that the plant attains the agreed Performance Criteria

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 Tests run under commercial operation of the plant

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Performance Exercise

 Which are typical commissioning criteria for a CIP station?

 Which could be typical performance criteria for a CIP station?

 Which are your suggestions for KPI’s for a CIP station?

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