5_1_Advanced Hygienic Design_Physical Design

Processing Engineering School For training purposes only
Physical Hygienic
D i
Design
Advanced Hygienic Design
Processing Engineering School
Tetra Pak Internal

TG/0508
Physical hygienic design
Internal
Stefan Åkesson / TPPS Research & Technology, 2008
Tetra Pak Internal

TG/0508
UCCD Plant and Lines
Tetra Pak Processing Systems AB > Order Fulfilment Capital Equipment
Internal
Tetra Pak Internal

TG/0508
What to consider....
Legal demands related to hygiene – food safety;
 hygienic
yg design
g acc to standards
 be possible to clean, with what, when and how
 correct material in food contact
 production parameters related to the product
Internal
Tetra Pak Internal

TG/0508
Physical Hygienic
D i
Design
Zoning
Tetra Pak Internal

TG/0508
Building elements
Layout, installation, and construction details will influence the
overall quality level of the finished product. Where at all
possible, consideration should be given to this;
 Floors
 Drains & gutters
 Walls
 Ceiling
 Doorways
Surroundings...
Internal
Tetra Pak Internal

TG/0508

Drainage
 Drainage is often neglected and badly constructed. Equipment should not be
l
located
t d di
directly
tl over d
drainage
i channels
h l as thi
this may restrict
t i t access ffor cleaning.
l i
 Discharges from equipment, however, should be fed directly into drains to avoid floor
flooding.
 Satisfactory drainage can be achieved only if adequate falls to drainage points are
provided.
id d
 Volume of water and floor finish are important factors to consider.
 The drainage system should flow in the reverse direction of production (i.e. from high
to low risk) and, whenever possible, backflow from low-risk to high risk areas should
b iimpossible.
be ibl
Internal
Tetra Pak Internal

TG/0508
Processing area requirements

 Providing adequate ventilation in production areas to minimise odours
and vapours and to prevent airborne contamination of food-contact
areas.
 Provide enough air changes per hour to maintain a stable clean air
quality,
 Maintain, if applicable, positive air pressures to protect against
contamination from outside air.
 Control air flows between processing areas to protect against cross
contamination.
 Provide clean sources of air, temperature and humidity controlled to
preventt condensation,
d ti
 Preventing entry of pests, using screens or other means.
 Route traffic from areas of higher hygiene to areas of lower hygiene.
Internal
Tetra Pak Internal

TG/0508
Product transfer
 All product transfer pipes should be installed in such a way that fluid is allowed
to drain.
 Avoid “dead ends”. If they do occur in the installation, the ratio of length-to-
diameter should not be more than 1,5:1.
 All dead ends should be cleanable and heat sterilisable (Cold spot). Piping
should be as straightforward as possible.
 Connections and piping between pieces of equipment should be permanent.
permanent
Rubber or plastic hoses should be avoided. Unnecessary changes in elevation
should be avoided so that air or liquid traps are not created.
 Pipes should run in separate accessible gangways (pipe trains). Measures
shall
h ll b
be ttaken
k tto allow
ll ffor expansion
i or contraction
t ti
 Pipes that pass through the ceilings or walls should pass through a protection
pipe section at the point of traverse to allow for expansion or contraction. The
pipes can enter the process area through the ceiling or open trays fixed to
walls or columns should be used.
Internal
Tetra Pak Internal

TG/0508
Physical Hygienic Design- zoning

Passage of Personnel or Material outside the
production building
Passage of Personnel or Material inside the

production building
Product handling or CIP

(dry or controlled wet)
Processing of product (controlled wet)
Special application or special filling machine

equipment,
i t nott needed
d d ffor Tetra
T t PakP k Aseptic
A ti filling
filli
machines (dry or controlled wet)
Air Locks (air overpressure) for passage of

personnel and/or material
Hygienic zoning can be a way to

avoid cross contamination of
allergens from other factory
areas.
Internal
Tetra Pak Internal

TG/0508
Zoning should be used as a preventive

measure as part in the total hygiene
measure,
concept.
Basic Hygiene Zone (Green), (Black)
T i l areas are ffound

Typical d iin th
the warehouse
h or
incoming material reception areas. The milk
reception area is also included in this zone.
Medium Hygiene Zone (Amber), (White)
Typical areas are where closed equipment with

much higher hygienic requirements inside the
equipment is operated.
High Hygiene Zone (Red) (White/White)

Typical areas are where processed products are
exposed and vulnerable to process environmental
influences for recontamination.
Internal
Tetra Pak Internal

TG/0508
Zoning philosophy
As zoning classifications define different level of hygienic

requirements, the applicable zone has to be identified. Need of
zoning related to the cost vs benefit.
The different zones can be further classified, if applicable, into dry and wet
processing areas.
Adequate barriers,
barriers both physical and virtual
virtual, must be installed to every potential
vector to prevent cross-contamination of potential and significant pollution.
A zone can also be specially classified for special applications and extraordinary
high hygienic requirements like e.g.
e g in baby food processing lines or special
machine equipment demands.
Internal
Tetra Pak Internal

TG/0508
Physical Hygienic
D i
Design
Material in food contact
Tetra Pak Internal

TG/0508
Material in food contact – in focus today;

y migration
g
 Plastic & rubber

– Approved migration level of allowed substances
– Plasticisers and anti-oxidants
 Metal
– Metal ions
– Radiation
 Lubricant
– Grease & oil
Internal
Tetra Pak Internal

TG/0508
Material in food contact – What to use & whyy to use it
 Your experience?
– Stainless steel
– Rubber seals & gaskets
– Plastic
– Ceramics
– Glass
– Other
Internal
Tetra Pak Internal

TG/0508
What to consider designing

g g lines & p
plants.
Correct material used for material in food contact;

• stainless steel quality suitable for the
food to be processed
• elastomers and plastics quality suitable for the food to
b processed,
be d EU reg. 1935/2004 or FDA
• correct surface finish (US & EHEDG 0,8μm)
Internal
Tetra Pak Internal

TG/0508

 Corrosion resistant
 Non toxic
 Non absorbent (except when technically or functionally
unavoidable)
 Surfaces of materials and coatings shall be durable, without
breaks, resistant to cracking, chipping, flaking, and abrasion,
and prevent penetration of unwanted matter while used as
intended.
 Not transfer undesirable odor, color, or taint to the food.
 Not contribute to contamination of the food nor have any
adverse effect on the food.
 The manufacturing process selected must guarantee that the
finished product will comply with the mentioned requirements
above.
Internal
Tetra Pak Internal

TG/0508

Stainless steel
 corrosion resistance
 strength
 durability
 ability to be readily cleaned and sterilised
 impart neither color nor flavor to foodstuffs and beverages
 Austenitic
A i i stainless
i l steels:
l minimum,
i i ffor ffood
d contact applications,
li i 16%
chromium and 6% nickel. Austenitic grades with varying amounts of
chromium and nickel, sometimes with other elements (e.g. molybdenum,
copper), are used for particular applications.
 Austeno-ferritic
Austeno ferritic steels
steels, also known as Duplex steels: Contain 21 21-28%
28%
chromium, 0-4.5% molybdenum, 3.5-8% nickel, 0.05-0.3% nitrogen and
up to 1% tungsten. These stainless steels may be used in contact with
aggressive foodstuffs as they have a very high resistance to corrosion
caused by,y for example,
p saline solutions at high g temperatures.
p
Internal
Tetra Pak Internal

TG/0508
Physical Hygienic Design
Stainless steel qualities;

Alloy Cost Index
304 1.0
For most food applications 304L or
316L is fine when: 316 1.5
Properly Fabricated 317 2.1
Properly Installed
2003 1.5
Properly Operated & Maintained
2205 2.0
For those applications where 304L or 2507 2.7
316L is marginal:
marginal
6XN 4.9
Lean Duplex – 2304, 2101, 2003
Duplex – 2205, SMO 954 22 11.4
S
Super A
Austenitic
t iti – 6%-Mo
6% M ffamily
il
C276 11.6
Nickel Base
Internal
Tetra Pak Internal

TG/0508

Stainless steel, surface;
The Ra value is an average not found to effect cleanability, 0,8μm in US none in EU.
The topography is an more important factor.
Surfaces with the same Ra value

can have different shapes
Internal
Tetra Pak Internal

TG/0508

Stainless steel, corrosion;
Stainless steels all possess a high resistance to

corrosion. This resistance is conferred by the naturally
occurring chromium - rich oxide film which is always
present on the surface of stainless steel
steel.
Corrosion is the process whereby material is chemically
dissolved and typically oxidized.
The actual process of corrosion is electrochemical and
can be quite complex and must obey the laws of
electricity
Internal
Tetra Pak Internal

TG/0508
Material in food contact - corrosion
Most common corrosion types within the

food industry:
 Halide Ion Pitting (Chlorine)

 C i C
Crevice Corrosion
i
 Stress Corrosion Cracking (SCC)
 Microbiologically Induced Corrosion (MIC)
Halide Pitting Crevice SCC MIC General

Internal
Tetra Pak Internal

TG/0508
Material in food contact -

corrosion
Halide Ion Pitting

 Requires presence of halide ions
(Chlorine, Fluorine, etc).
 Typically found in;
 - Cleaners / Sanitizers
 - Product (Salt)
 - Water
W t with ith hi
high
h content
t t chlorine
hl i iions
 Always in the presence of moisture
 Concentrated by Evaporation
 Low pH < 5
 Accelerated by elevated temperature
 Once initiated results in perforation in a
few days – several weeks
 Not significantly delayed by wall thickness
 Can not be arrested, rinsing / flushing not
effective
 Repairable only by metal removal ! Grind
down to fresh metal
Internal
Tetra Pak Internal

TG/0508
Material in food contact – corrosion ((Diploma

p work))
“Roughing”;
Type of corrosion mainly found below 60 dgr C. A red
surface easy to remove, even with a cloth of paper.
Main content hematite Fe2O3.
Electrochemical process may be caused by
impurities in water or additives in detergents.
“Blackness”;
Type of corrosion mainly found above 60 dgr C. A
black surface hard to remove even when scratching.
Surface contained hematite but also magnetite
Fe3O4.
Electrochemical process may be caused by
impurities in water, additives in detergents or
substances containing P or S.
Internal
Tetra Pak Internal

TG/0508
Passivation
A way to improve corrosion stability
Real passivation;
• High cons of acid 20-30% HNO3
• High temperature approx 60 dgr C
• Long
gppenetration time approx
pp 0,5-1
, h
Detergent suppliers often use a low cons. version with citric acid.
Internal
Tetra Pak Internal

TG/0508

Stainless steel, migration;
Studies on the migration of iron, chromium, nickel, manganese, molybdenum,

cobalt and wolfram from austenitic stainless steel into the food have shown that
the migration of the metal ions, into an average daily diet, is negligible compared
with the natural contents of these elements in foodstuffs.
E
Example
l ffrom the
th DTU project,
j t test
t t result,
lt fermented
f t d milk:
ilk
Sample Fe Cr Mn Co Ni Mo W (µg/kg)
Skim milk 0,22 <1 23 4 17 40 <1
Stabilizer, protein powder 5,7 23 54 14 68 1020 <1
Starter culture, acidophilus 1,4 21 3290 8 19 17 <1
Fermented product 0,25 <1 23 4 13 52 <1
Internal
Tetra Pak Internal

TG/0508
Internal
Tetra Pak Internal

TG/0508

Coatings (Diploma work)
Main constitute of fouling
 Type A, 65–115 degrees.

– 50-60% proteins, 30-40% minerals, 4-8% fat.
– White and spongy consistence. Main protein part is B-Lg.
 Type B, above 115 degrees.
– 60-70% minerals, 20-30% proteins, 4-8% fat.
– Grey and brittle consistence. Main protein part is casein.
Denaturation of B-Lg
B Lg
Aggregation of B-Lg
Deposition of minerals
Van der Waals forces
Lewis Acid-Base forces
El t t ti forces
Electrostatic f
Surface energy
1  cos   LLW  2  L L   2  SLW  LLW 
α
  S L   S L   180  
Internal
Tetra Pak Internal

TG/0508

Production
run 2
2 (e2 22 (g) on 2 (j) 1 2
Production
run 3
3 (f (i) 2 3 on 3 (k) e 1 3 (l) 3
Before the test
After the test
Internal
Tetra Pak Internal

TG/0508
Coating Thickn Manufact Country Material Reduced Increased Resistant Recommended

ess urer Occurrence Cleanability against the for further
of fouling chemicals of testing
the CIP-
Process
Xxxx App. X USA Fluoro- NO YES NO YES

200 polymer
**
nm
Sputtered <100 Y Denmark Titanium NO NO NO NO
TiO2 di id
dioxide
nm
Xxxx App. Z Sweden Fluoro- NO POSSIBLY YES YES
100 polymer
**
μm
SiO2 <100 W Germany Silicon NO NO POSSIBLY NO
dioxide
nm
Internal
Tetra Pak Internal

TG/0508
Material with a Tetra Pak article number

vs
Material without a Tetra Pak article number
What to specify
p y in p
purchase order?
Inspect & verify…?
Who is the owner of the material?
Use of Article declaration; Certificate of compliance
Internal
Tetra Pak Internal

TG/0508
Physical Hygienic
D i
Design
Hygienic risks - Contamination
Tetra Pak Internal

TG/0508
Contamination
In order to secure food safety,

y, it is important
p to
reduce hygienic risks to prevent contamination,
caused by;
 microbiological causes
 chemical causes
 physical, foreign bodies arising from machinery, or
other sources
 etc
Internal
Tetra Pak Internal

TG/0508
Contamination

Microbiological contamination;
High infection risk area
The degree to which the environment of the filling room is controlled strongly
impacts the quality and the shelf life of the product. Areas that are considered as
high infection areas include:
 Rooms where processing equipment for sour milk products or milk powder
processing equipment is installed
 Rooms where bottle washing equipment is installed
 Rooms with strong air currents
 Rooms with traffic to and from other areas of the production facility
 Rooms with high humidity, such as the room where the processor is installed,
or any area where steam or hot water is discharged during pre
pre-sterilisation
sterilisation
and/or production
 Areas where unnecessary activities, especially those that produce dust,
are performed
 Inadequate filtration for HVAC systems and/or poor air quality control.
control
Internal
Tetra Pak Internal

TG/0508
Contamination
Microbiological causes
 Bacteria
 Moulds
 Yeast
 Etc
Internal
Tetra Pak Internal

TG/0508
Contamination
Bacteria characteristic properties

Bacteria,
Highly varied group. The normal bacterium is rod-shaped, 1x2 μm, i.e. about 10 times
smaller than all other microorganisms.
microorganisms bacteria of approx.
approx 00.55 μm are often found in water
water.
All bacteria are to be considered as hard particles.
Most bacteria grow best in the range from 25 to 40°C,

and at a pH of about 7.
More than 90% of all bacteria live on organic material.

material
Extreme forms exist which are capable of growing on
salts and carbon dioxide.
Internal
Tetra Pak Internal

TG/0508
Contamination
Bacteria, health risk and food

spoilage;
The most common organisms that spoil low

low-
acid food. A few of these are foodborne
pathogens.
Some spoil high-acid food
food, although none of
these are food pathogens.
Internal
Tetra Pak Internal

TG/0508
Contamination
Physical
y hygienic
yg design
g
Bacteria,, special
p characteristics,,
gram negative;
 The Gram negative,
g which have a veryy
thin cell wall and occur only as
vegetative cells. This group contains the
great majority which are able to multiply at
refrigeration temperatures.
 Very low resistance to desiccation,
chemicals and heat.
 Highly variable radiation resistance
resistance,
although never extremely high.
 Usually spread by water.
Internal
Tetra Pak Internal

TG/0508
Contamination
Bacteria, special characteristics, gram

positive;
iti
 The Gram positive group, which has a thick, rigid cell wall.
By far the majority occur only as vegetative cells.
 A small number of gram positive microorganisms can
sometimes occur as spores.
 Often withstands desiccation. Low resistance to heat and
chemicals.
chemicals
 A few have extremely high resistance to radiation.
 Extremely high resistance to desiccation, chemicals
and heat.
heat
 The radiation resistance is occasionally very high.
 Usually spread by air, but also by water.
Internal
Tetra Pak Internal
SÅ/0507
Tetra Pak Internal

TG/0508
Contamination
Bacteria, pathogene, E
E-coli,
coli, example;
Internal
Tetra Pak Internal
SÅ/0507
Tetra Pak Internal

TG/0508
Contamination

Fungi
Two basic forms exist:
Yeasts, which are unicellular, oval or round.
Moulds, which grow in a branched, filamentous form.
• Yeasts and moulds grow best within the range from 20 to
30°C, and at pH 6-7. All grow on organic material.
• Yeast is most common organisms that spoil high-acid
food. There are no food pathogens.
• Moulds mayy spoil
p high-acid
g food.
• A small number of fungi are carcinogenic or allergenic.
• Yeasts and moulds can also spoil low-acid food.
Internal
Tetra Pak Internal

TG/0508
Contamination
Fungi; yeast & mould
All have a very thick cell wall

wall. The majority can occur
both in vegetative form and as spores.
In its vegetative form, exhibits low to medium resistance
to desiccation,
desiccation chemicals and heat.
heat
Most fungal spores are very resistant to desiccation.
Some also exhibit high resistance to chemicals and
heat.
Fungi have relatively high resistance to radiation.
By far the majority of fungal spores are suited to be
spread by air.
Internal
Tetra Pak Internal

TG/0508
Allergenes – list of food stuff
Ingredients referred to in Article 6(3a), (10) and (11), DIRECTIVE 2003/89/EC

• Cereals containing gluten ( i.e. wheat, rye, barley, oats, spelt, kamut or their hybridised strains) and products
thereof
• Crustaceans
C and
d products
d thereof
h f
• Eggs and products thereof
• Fish and products thereof
• Peanuts and products thereof
• Soybeans
So beans and prod
products
cts thereof
• Milk and products thereof (including lactose)
• Nuts i. e. Almond (Amygdalus communis L.), Hazelnut (Corylus avellana), Walnut (Juglans regia), Cashew
(Anacardium occidentale), Pecan nut (Carya illinoiesis (Wangenh.) K. Koch), Brazil nut (Bertholletia excelsa),
Pistachio nut (Pistacia vera), Macadamia nut and Queensland nut (Macadamia ternifolia) and products thereof
• Celery
C l and
d products
d t ththereoff
• Mustard and products thereof
• Sesame seeds and products thereof
• Sulphur dioxide and sulphites at concentrations of more than 10 mg/kg or 10 mg/litre expressed as SO2.’
Internal
Tetra Pak Internal

TG/0508
Contamination
Avoid spreading
p g the contamination – don’t use high
g
pressure equipment during external cleaning.
Internal
Tetra Pak Internal

TG/0508
Contamination

How to handle microbiological contamination;
• Correct time/temp relation to reduce or kill the bacteria (type of
product & wanted product quality)
Avoid recontamination by
y hygienic
yg design
g & GMP;
• Tightness of couplings
• Openings to atmosphere
• Condense
• Quality of additives & service media
• Type of filling machine
• Storage & transport
• Correct operation
• Correct maintenance & spare parts
Internal
Tetra Pak Internal

TG/0508
Contamination
Chemical causes, examples;
Migration from plastics

Migration from rubber
Lubricants
Detergents
Food additives
Additives in steam
Pesticides
Internal
Tetra Pak Internal

TG/0508
Contamination

Migration of chemicals, rubber & plastic:
Example , production of hot NBR; An emulsifier,
emulsifier various butadiene monomers,
monomers
radical generating activators, and a catalyst are added to polymerization vessels.
Within the vessel, water serves as the reaction medium. The tanks are heated to
30°C-40°C to facilitate the polymerization reaction and to promote branch
formation in the polymer. Because several monomers capable of propagation the
reaction are involved in the production of nitrile rubber, the composition of each
polymer can vary.
It is usually permitted to react for 5 to 12 hours. Polymerization is allowed to
proceed to ~70% conversion before a “shortstop”
shortstop agent is added to react with the
remaining free radicals. Once the resultant latex has “short stopped”, the
unreacted monomers are removed through a steam in a slurry stripper. Recovery
of unreacted monomers is close to 100%. After monomer recovery, latex is sent
through a series of filters to remove unwanted solids and then sent to the blending
tanks where it is stabilized with an antioxidant. The yielded polymer latex is
coagulated using calcium chloride, aluminium sulphate, and other coagulating
agents in an aluminium tank.
Allowed substances are listed. The material must be inert,

acc to the legislation (allowed migration). Internal
Tetra Pak Internal

TG/0508
Food safety – Material in Food Contact

Characteristics
EPDM;
Resistant to most fluids in the food industry.
Resistant to ozone.
Temperature range: -40°C °C to +150°C.
°C
Is attacked by organic and non-organic oils and fats.
NBR;
Resistant to fluids like oil and grease.
grease
Sufficiently resistant to diluted lye and diluted nitric acid.
Temperature range: -40°C to +100°C.
Is attacked by ozone.
HNBR;
Most characteristics as NBR.
Temperature up to +140°C.
More resistant to wear than NBR.NBR
Internal
Tetra Pak Internal

TG/0508
Food safety – Material in Food Contact

Characteristics
FPM;
FPM
Often used when other elastomers are unsuitable.
Resistant to ozone and chemicals.
T
Temperature
t range: -20°C
20°C tto +200°C
+200°C.
Is attacked by fluids like water, steam, lye, acid and alcohols – if they are hot.
MVQ (silicone);
Resistant to ozone
ozone, alcohols
alcohols, glycols and most fluids used in the food industry
industry.
Temperature range: -50°C to +230°C.
Is attacked by steam, inorganic acids, mineral oils and most organic solvents.
PTFE;
Often used as ”cover” for O-rings of EPDM.
Resistant to almost all fluids.
Temperature range: -30°C
30 C to +200°C
+200 C.
Not elastic – tendency to compression set.
Internal
Tetra Pak Internal

TG/0508
Contamination
Lubricants
 Only NSF approved ”Food Grade” lubricant type H1 is allowed
 In EU lubricant in food contact is not allowed. In US the allowed amount of

lubricant in food contact is 10mg/L
 Shell is the only company with a production process of ”Food Grade” oils totally
separated
t d from
f production
d ti off non ffoodd grade
d oils.
il
NSF “white list” don’t justify use in direct or indirect food contact
Internal
Tetra Pak Internal

TG/0508
Contamination
Detergents
Detergents must not contaminate product,
hygienic design
design.
Detergents must be flushed out with water
after cleaning.
Only detergents for food premises are allowed
to be used.
Secure your design by a Hygienic Risk

Assessment
Internal
Tetra Pak Internal

TG/0508
Contamination
Chemicals used in detergents:
Surfactants to 'cut' grease and to wet surfaces

Abrasives to scour
Substances to modify pH or to affect performance or stability
of other ingredients, acids for descaling or caustics to destroy
dirt
Water softeners are used to counteract the effect of
"hardness" ions on other ingredients
Oxidants (oxidizers) for bleaching and destruction of dirt
Non-surfactants materials that keep dirt in suspension
Enzyme to digest proteins, fats, or carbohydrates in dirt or to
modify fabric feel
Ingredients that modify the foaming properties of the
cleaning surfactants, to either stabilize or counteract foam
Internal
Tetra Pak Internal
SÅ/0507
Tetra Pak Internal

TG/0508
Contamination
Physical contamination - Foreign bodies

bodies, examples;
Metal
Ceramics
Glass
Rubber
Plastic
Paper & board
Insects
Soil & dirt during maintenance
Internal
Tetra Pak Internal

TG/0508
Contamination
D t ti
Detection
Metal
Stainless steel objects mainly found due to break down or abnormal wear
of machines
Normally removed by electro magnet before filling
Glass, plastic & rubber
Avoid glass & plastic in your design, if not possible use “non breakable”
material
Glass, plastic & rubber can be detected by special scanners, expensive
eq.
Use correct torq
torque
e when
hen tightening and use
se correct gasket material
Internal
Tetra Pak Internal

TG/0508
Contamination

Other contamination
Good Manufacturing Practice

Use good quality additives
When necessary use filters,
separators, etc to remove
contaminants
Internal
Tetra Pak Internal

TG/0508
Contamination
Have you been involved in any case of contamination?
Internal
Tetra Pak Internal

TG/0508
Physical Hygienic
D i
Design
Integration of equipment - considerations
Tetra Pak Internal

TG/0508
What to consider designing lines & plants.
Pipe support
• pipe slope rec
rec. 3°
3
• expansion aid used, risk of tension
• valve clusters not used as support of pipes,
risk of tension – intercrystallic
y corrosion
Positioning/layout
• building and other premises acc. to Codex principles
• hygiene zones with transfer barriers (air pressure,
air filter quality, PPE, etc)
• possible to inspect and maintain equipment
• possible to clean equipment externally (non food area)
• insulation properly mounted and suitably sealed Internal
Tetra Pak Internal

TG/0508

g g lines & p
plants.
Utilities
• culinary steam quality in food contact
• potable water quality in food contact and
f cleaning
for l i purpose
• cooling media, indirect contact with food
• sanitary compressed air in food contact
(filter quality
quality, oil and condense free)
• air used for ventilation (zoning - filter quality)
Internal
Tetra Pak Internal

TG/0508

g g lines & p
plants.
Components selected suitable for the food to be processed
• material approved
pp for food contact
• withstand temperature (process, HW sterilisation, steam or other)
• hygienic connection not causing dead ends or misalignment
• installation direction not causing dead ends
• need of barrier of steam or hot condensate (correct temp & flow)
• T-pipes, correct CIP flow
• drainable, no product residues in pockets (fill with water not air)
• positive pumps cleanable (by-pass valve)
• masking of feed-back signals, forced control, etc (control system
must not affect hygienic design)
• instrumentation and sampling devices shall comply with the
relevant design parameters
Internal
Tetra Pak Internal

TG/0508
Selection of components
p –p
product & CIP
 Hygienic, designed for the food stuff

 Temperature
 Viscosity
 Particles or fibres
 Fat content
 pH
 Detergent or steriliser to be used
 Aseptic vs non-aseptic design....ESL?
Internal
Tetra Pak Internal

TG/0508
Physical Hygienic
D i
Design
Joining of equipment
Tetra Pak Internal

TG/0508
Installation

Couplings:
Avoid over compression, insufficient compression,
misalignment and metal to metal.
SMS or Clamp or DIN 11864, aseptic coupling.
Internal
Tetra Pak Internal

TG/0508
Installation
What to consider...
H gienic welds
Hygienic elds
• approved certified welder
• suitable weldingg method with correct p
parameter settings
g
• orbital welding preferred –tungsten electrodes and inert gas,
rec O2 level 30 – 40 ppm
• pipe alignments
• inspection and approval of welds (visual, video scope)
Internal
Tetra Pak Internal

TG/0508
Installation
Photos from customer inspection on site,

40% of the welds not approved....
Internal
Tetra Pak Internal

TG/0508
Installation
How to…welding
g
Welding standard to be used BS EN ISO 5817:2007

Class C + additional demands
Welding method shall be qualified
Welder shall be qualified
Internal
Tetra Pak Internal

TG/0508
Installation
Weld log,
g example;
p
Internal
Tetra Pak Internal

TG/0508
Installation
What to…welding
g
Welders passport and inspection of welds!
 According to BS EN ISO 5817:2007 Class C and additional demands.
 Welders inspection shall be documented and signed.
 According to D&B MS 096
NDE (non
( destructive
d t ti evaluation)
l ti ) = NDT ((non d
destructive
t ti ttesting)
ti )
 VT Visual test ISO 5817 class C and additional demands

– Surface control
 PT Penetrant test EN 1289
– Surface control
 RT Radiographic test
– Volumetric control
Internal
Tetra Pak Internal

TG/0508
Installation

Welding standards
EN ISO 3834-2 Quality requirements for fusion welding of metallic

materials - Comprehensive quality requirements
EN ISO 14731 Welding coordination - Tasks and responsibilities
EN 287-1 Qualification test of welders - Fusion welding
EN 1418 Welding personnel - Approval testing of welding
operators for fusion welding and resistance weld
setters for fully mechanized and automatic welding
of metallic materials
SO 15607
EN ISO 560 Specification
Spec cat o anda d qualification
qua cat o o of welding
ed g
procedures for metallic materials - General rules
EN ISO 15614-1 Specification and qualification of welding procedures
for metallic materials - Welding procedure test
ISO-2553 Welded, brazed and soldered joints - Symbolic
representation on drawings
EN ISO 5817 Welding - Fusion-welded joints in steel, nickel,
titanium and their alloys (beam welding excluded) -
Quality levels for imperfections Welding - Fusion-
welded joints in steel, nickel, titanium and their alloys
(b
(beam welding
ldi excluded)
l d d) QQuality
lit levels
l l for
f
imperfections
Internal
Tetra Pak Internal

TG/0508
Physical Hygienic
D i
Design
Other considerations
Tetra Pak Internal

TG/0508
To consider – for customer maintenance
 Preventive vs corrective maintenance

 Access to maintenance
 Risk of contamination during maintenance
 Maintenance intervals
 MTBF
 Spare parts
 Technical Service maintenance contract
Internal
Tetra Pak Internal

TG/0508
Other criteria to consider, indirect hygienic;

 Safety aspects for personnel and machines
 Pressure
 Potentially explosive atmosphere
 Inert gas, N2
 Electrical protection, EMC, IP, etc
 Communication interface
 Environmental impact
Internal
Tetra Pak Internal

TG/0508
Everything
y g taken care of…?
Cleaning;
Cleaning
g is not a way
y to correct improper
p p hygienic
yg design.
g
Internal
Tetra Pak Internal

TG/0508

Cleaning – CIP
The design has ”correct” cleanability, when the stipulated cleanness
requirements are fulfilled by the selected cleaning method.
Parameters to consider:
 Type of detergent to be used
 Concentration of detergent
 Use of disinfectant
 Water quality
 Flow/pressure of cleaning liquid
 Temperature of cleaning liquid
 Cl
Cleaning
i circuits
i it and
d no. off objects
bj t per circuit
i it
 Handling of rinse liquid
 Separate cleaning system for raw and
t t d production
treated d ti area
The cleaning result must be verified. Internal
Tetra Pak Internal

TG/0508
Physical Hygienic
D i
Design
Excersises
Tetra Pak Internal

TG/0508
Selection of material
What hygienic design parameters do you need
g up
to consider setting pap
production line for
 Tomato ketchup
 Cream
 Fruit juice with fibre and seeds
...and what about CIP?
Internal
Tetra Pak Internal

TG/0508
Hygienic integration of equipment

Discussion; hygienic and safe food production, what to consider and why?
 Existing building & equipment

 Selection of suitable components & design correct functionality
 Putting equipment in place
 Joining equipment
 Communication, between existing and new equipment
 Manual interactions
 ...other
TP actions vs inform customer about findings & their consequences

consequences.
Check up on site.
Internal
Tetra Pak Internal

TG/0508

5_1_Advanced Hygienic Design_Physical Design

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

5_1_Advanced Hygienic Design_Physical Design

Uploaded by

Copyright:

Available Formats

Processing Engineering School For training purposes only

Tetra Pak Internal

Physical hygienic design

Tetra Pak Internal

Physical hygienic design

UCCD Plant and Lines

Tetra Pak Processing Systems AB > Order Fulfilment Capital Equipment

Tetra Pak Internal

Physical hygienic design

Legal demands related to hygiene – food safety;

Tetra Pak Internal

Tetra Pak Internal

Physical hygienic design

Tetra Pak Internal

Physical hygienic design

Tetra Pak Internal

Physical hygienic design

Processing area requirements

Tetra Pak Internal

Physical hygienic design

Tetra Pak Internal

Physical Hygienic Design- zoning

Passage of Personnel or Material inside the

Product handling or CIP

Processing of product (controlled wet)

Special application or special filling machine

Air Locks (air overpressure) for passage of

Hygienic zoning can be a way to

Tetra Pak Internal

Physical Hygienic Design- zoning

Zoning should be used as a preventive

Basic Hygiene Zone (Green), (Black)

T i l areas are ffound

Medium Hygiene Zone (Amber), (White)

Typical areas are where closed equipment with

High Hygiene Zone (Red) (White/White)

Tetra Pak Internal

Physical Hygienic Design- zoning

As zoning classifications define different level of hygienic

Tetra Pak Internal

Tetra Pak Internal

Physical hygienic design

Material in food contact – in focus today;

 Plastic & rubber

Tetra Pak Internal

Physical hygienic design

Material in food contact – What to use & whyy to use it

Tetra Pak Internal

Physical hygienic design

What to consider designing

Correct material used for material in food contact;

Tetra Pak Internal

Physical hygienic design

Material in food contact

Tetra Pak Internal

Physical hygienic design

Material in food contact

Tetra Pak Internal

Physical Hygienic Design

Stainless steel qualities;

Tetra Pak Internal

Physical hygienic design

Material in food contact

Surfaces with the same Ra value