Sanpang 8

Lecture materials_Ratih Dewanti-Hariyadi 3/27/19
Sanitary Design for Building

and Equipment
Lecture material 8
Course : ITP 322 Food Safety and Sanitation
Ratih Dewanti-Hariyadi
Department of Food Science and Technology

Bogor Agricultural University
http://ratihde.staff.ipb.ac.id/
Outline
•  Definition of Sanitary Design

•  Sanitary Standards
•  Classification of Sanitary Standards
•  Sanitary Design in Regulations
•  Sanitary Design for Building and Facility
- 11 Principles
•  Sanitary Design for Machinery and
Equipment
- 10 Principles
2
RDH/ITP/IPB Bogor Agricultural University
RDH/ITP/IPB/2019 1
Demo Version, http://www.verydoc.com and http://www.verypdf.com

Definition
•  Sanitary design is the application of

design techniques that allow cleaning of
all manufacturing assets to be done
appropriately, in time and effective
Controlled Good
+ Clean, dry, Sanitary Effective Food
+ manufacturing + building
traffic of “no gap” and + sanitation =
ingredients practices floor equipment procedures
Safety
3
Sanitary Standards
Several institutions that establish guidance on sanitary design :
•  USDA Through the Food Safety & Inspection Service (FSIS)
develop guidelines for the design of plant, equipment &
machinery and other facilities for meat, poultry, and egg
processing.
•  US FDA develop requirement for cleanability of plant,
machinery and equipment for food processing
Other design standards for plant, machinery and equipment in
food industry are developed by:
•  3-A Sanitary Standards, Inc. (www.3-a.org)
•  the National Sanitation Foundation NSF (www.nsf.org)
•  Underwriters Laboratories (www.ul.org)
•  The European Hygienic Engineering & Design Group, EHEDG
(www.ehedg.org).
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Classification of Sanitary Design

•  Sanitary design for Building : (a) sanitary standard for floor,
wall, ceiling, langit-langit, drainage (b) zoning (c) food
defense standard : site security, fences, cable, ducts and
chest/cupboard
•  Sanitary design for Utility, consists of : water, steam and air
•  Sanitary design for Food Processing Equipment and
Machinery, includes : construction materials, sanitary
welding, maintenance, cleaning, and drainability
•  Sanitary design for Cleaning and Sanitizing (disinfection),
includes : Cleaning In Place (CIP) design, dry cleaning,
Cleaning Out Place (COP), plant cleaning, cleaning
procedure, cleaning validation, chemicals for cleaning and
sanitizing
•  Sanitary design for Personnels, includes : design for
changing room, hand/foot/shoes washing devices and other
design to encourage sanitary habit and practices
5
Sanitary Design in Regulations

•  Buildings and facilities for food processing must be designed
based on sanitary aspects as an effort to guarantee food safety
•  In Indonesia :
-  Minister of Industry Regulation No. 75 / M-IND / PER / 7/2010
on the Guidelines for Good Manufacturing Practices which
includes the requirements for buildings and facility,
construction and layout; structure of the facility, etc.
-  The Regulation of the Head of BPOM RI No HK.
03.1.23.04.12.2206 in 2012 on Good Manufacturing Practices
for Home Industry
-  The Regulation of the Head of the Republic of Indonesia
BPOM, No. HK.03.1.23.12.11.10720, 2011, on the Guidelines
Processing of Powder Infant Formula and Powder Follow-Up
Formula.

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Sanitary Design for Building & Facility

Eleven Principles in Designing Sanitary Building and Facility :
1.  Distinct hygienic zones established in the facility
2.  Control the movement of personnel and materials flows to
reduce hazards
3.  Water accumulation is controlled inside the facility
4.  Room temperature & humidity are controlled
5.  Room air flow & air quality are controlled
6.  Site elements facilitate sanitary conditions
7.  Building envelope facilitates sanitary conditions
8.  Interior spatial design promotes sanitation
9.  Building components & construction that facilitate sanitary
conditions
10. Design of utility systems to prevent contamination).
11.  Sanitation integrated into facility design
7

•  Food processing building or facility has to have a
hygienic zone that is physically separated from other
zones
•  Differentiation of the zones also allow one processing in
a chain to be conducted, while the other has a problem,
is dedicated for processing of allergenic materials, or is
scheduled for cleaning etc.
•  Objective : obtain raw materials and personnels’ traffic
appropriate for the flow of processing while minimizing
the risk of contamination
•  Examples : physical barrier between raw and processed
foods
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To prevent cross contamination
9
2. Control the movement of personnel and materials

flows to reduce hazards
•  Referring to the first principle, when plant is divided

physically into distinct zones, the traffic for materials
and personnel could be designed such that hazards
could be better controlled
•  Traffic of workers, visitors, products, raw materials
and ingredients, packaging materials has to be
designed carefully to assure they move from one zone
to another and avoiding contamination
10
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Flow of ingredient/product
ingredients
End products & distribution

Administration/office
Production area
11

Passive Active
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3. Water accumulation is controlled inside the facility

•  While water is essential for products, processing, and
sanitation, it is also an important threat to food safety
•  Construction of wall, floor, ceilings has to be designed
well to prevent puddle, and shall be designed to
facilitate self-draining and water disposal
•  Therefore, floor has to be made from strong and
durable materials with slope to facilitate draining and
equipped with good drainage
13

3. Water accumulation is controlled inside the facility
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4. Room temperature & humidity are controlled
•  Room temperature and humidity is important in

controlling microbial growth
•  Need to control such that room is cool and dry
•  Ensure that HVAC (heating, ventilation, and air
conditioning) system capable of maintaining
temperature and humidity
•  The engineering division has to assure that HVAC
could control environment (temperature, humidity, air
flow, and air filter) and the plan has to consider that
machines and equipment are running
15

5. Room air flow & air quality are controlled
The HVAC system especially has to assure :
•  air flow will take place from cleaner to less
clean room; e.g. air from raw material zone has
to move in the opposite direction of and exit
the factory directly)
•  air entering processing room is filtered to
control microorganisms
•  supply backup air from outside room to
maintain flow rate and pressure at specific
rooms
•  minimum condensation at open surface
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6. Site elements facilitate sanitary conditions
•  Consideration must be carried out when choosing
location, especially pertaining the availability of yard,
lighting, r thus make it possible to carry out
cleaning, sanitation and maintenance of building and
equipment properly
•  Consideration : access control to and from the location;
especially to protect the plant
•  Starting from the designing to construction, it is
important to carefully consider the security aspects of the
location and personnels, good vehicle management,
lighting and water such that the site is conducive not only
for food safety but also safe and healthy for the workers
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7. Building envelope facilitates sanitary conditions

•  During the designing and construction : assure that all
openings in the building (e.g. door, fans, grids and
other cavity to allow utility channels) are free of
insects and other pests
•  All openings have to be designed such that they :
- do not provide shelters (both inside or outside
building perimeter)
- do not become entry routes for insects and other
pests to the processing room
- facilitate cleaning and inspection
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8. Interior spatial design promotes sanitation
•  The production lines shall be

designed with full
consideration for food
safety
•  Adequate interior space has
to be held to allow
cleaning, sanitizing and
maintenance of the building
components and processing
equipment in accordance
with good procedures
19

9. Building components & construction that facilitate
sanitary conditions
•  In designing building components, it is necessary to pay
attention to prevent locations that could be used as hiding
place, even the source of contamination, for biological,
chemical and physical hazards
•  When choosing building materials,
always sought to use durable materials
and resistant to chemicals for cleaning
agent
•  Attention shall be made especially for
floor surface, wall and ceiling finishing
or coatings, and utility ducts that
penetrates the wall etc.
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10. Design of utility systems to prevent contamination
When designing and constructing utility installation, always
pay attention to prevent the occurrence of hazards
(chemical, biological or physical) by :
•  Assuring that all surfaces can be cleaned to the
appropriate microbiological standard (see principle #1 for
equipment)
•  Choosing and using the appropriate construction
materials
•  Provide access for cleaning, inspection and maintenance
•  Prevent water accumulation
•  Prevent curves, corners or empty spaces that are difficult
to reach and can be a gathering place for contaminants
(dirt and dust)
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11. Sanitation integrated into facility design
•  The design of buildings and facilities

must be equipped with proper
sanitation systems in an integrated
manner (for chemical, physical and
biological hazards)
•  It is necessary to examine carefully
each corners and gap to assure that
the design encourage for good
sanitary practices, such as design of
doors, sink, duct/channels, and other
things located near the walls etc. to
assure accessibility and clean ability
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Sanitary Design for Machinery &

Equipment
Ten Principles in Designing Sanitary Machine/Equipment
1.  Cleanable to a microbiological level
2.  Made of compatible materials
3.  Accessible for inspection, maintenance, cleaning
and sanitation
4.  No product or liquid collection
5.  Hollow areas hermetically sealed
6.  No niches
7.  Sanitary operational performance
8.  Hygienic design of maintenance enclosures
9.  Hygienic compatibility with other plant systems
10. Validated cleaning and sanitizing protocols
23
Sanitary Design for Machinery and

Equipment
1.  Cleanable to a microbiological level
•  Machinery and equipment for the food industry must be

designed and constructed to ensure that cleaning and
sanitation processes can be carried out effectively and
efficiently
•  Cleaning, dismantling, reassembly takes time, cleaning
chemicals, water and energy; so reduced frequency is wanted
•  Continuous processing is a strategy to reduce the residence
time thus microbes do not have enough time to grow and
multiply, therefore requires absence of area on machinery and
equipment where food products can stay for a period of time;
(a) on a connection (tees on a pipe or stubs on a tank) where
sensors (eg temperature, pressure etc.) are installed and (b)
dead areas on the pump, valve (valve) and others
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Equipment
2. Made of Compatible Materials
•  All materials for machinery and equipment must have a
surface that is inert (non-reacting), rust resistant (corrosion
resistant), non-porous and nonabsorbent.
•  AMI (American Meat Institute) Foundation : materials must
obtain approval and be registered with applicable
regulations/standards; for example, registered with the NSF/
ANSI/3A 14159-1 or a newer version.
•  Steel material : most commonly used material. The steel used
is a type of stainless steel (Stainless Steel, SS), SS 300 series
•  Materials not to be used are wood, enamel, uncoated
aluminum and other materials listed in NSF/ANSI /3A 14159-1.
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Equipment
•  If composite materials are used (including plastic), the material must
remain intact without changes in shape, structure and function during
the cleaning and sanitation process. The types of plastic that can be
used are usually set by the authorized institution.
–  US : plastic made from materials allowed : CFR 21 parts 175, 176, 177
–  Indonesia; the types of plastic permitted, among others :
lRegulation No. HK. 03.1.23.07.11.6664 of 2011 (Food Packaging)
•  Painted and / or coated surfaces should not be used as food contact
materials. If this cannot be fulfilled, then the paint and coating must
remain intact and the conditions as food contact material are still
fulfilled
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Equipment
•  Various types of metals used for construction of machinery and food

processing equipment must be compatible with each other
•  The use of seals and O-rings must be designed in such a way as to
minimize the chance of contact with processed food products.
•  The materials used in the construction of machinery / food processing
equipment must be compatible with
- products which are processed
- environmental conditions where the machinery/equipment will be used
- methods and chemicals to be used for cleaning and sanitation.
27
Sanitary Design for Equipment

3. Accessible for inspection, maintenance, cleaning
and sanitation
•  All parts / components of machinery and equipment must be

easily accessible for inspection , maintenance, cleaning and /
or sanitation.
•  This convenience is measured by : an inspection must be able
to be carried out by someone without the help of additional
tools or
•  Machinery and equipment must be easily disassembled; so
cleaning and sanitation operations are easy to do and do not
cause the machine and equipment to wear out quickly.
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Equipment
and sanitation
•  All contact areas with the product (product zone) must be
easily accessible for cleaning, sanitation and inspection
•  If there is unreachable contact surface, it must be able for
disassembly
•  If accessibility and / or disassembly is not possible, the unit as
a whole must be cleaned by the CIP method or; if it is not
possible, with the COP method.
•  Parts attaching to or hanging on equipment / machines are
left in place so that they are easy to clean and prevent
damage or loss (a basket can be used)
29

Equipment
and sanitation
•  If there are machine or chain guards; then the guards must be
designed to be easily separated and if there is a liquid it will be
drained away from the contact surface.
•  If the equipment / machine has a container, the container must be
easy to pick up for cleaning, but it is designed not to be easily lost
and separated from the equipment / machine.
•  All belting systems must also be easily separated; or belt pressure is
easily set to be removed without tools; making it easier to clean all
belt surfaces.
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Equipment
and sanitation
•  All other surfaces (other than food contact surfaces) must

also be easily accessible for cleaning and inspection.
•  Equipment / machine installations must have adequate
floor clearance; i.e 18 inches for each contact area or
product conveyor and 12 inches for equipment / machinery
in general.
•  The equipment / machine is placed at least 30 inches from
the wall/overhead structures and 36 inches from equipment
or other stationary objects
31

Equipment
and sanitation
•  All air lines or pipes, vacuum and product lines and their
parts must be easily removed and separated for cleaning
and sanitation.
•  All air lines or pipes, vacuum and product lines are made of
material that is transparent (or at least semi-transparent)
and meets the food contact surface requirements. Flexible
and transparent channels will facilitate inspection
•  If the equipment / engine has a pneumatic system, the
exhaust is not placed on or close to the food contact
surfaces. Attention also needs to be given to the input lines
(supply lines) of the channel, not to get in or sucked in dirt
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Equipment
4. No product or liquid collection
•  Machines and equipment - including piping systems - must be
designed to be "self-draining", to ensure that food, water and
other liquid products are not left behind and accumulate
•  This self-draining design aims to minimize (i) the chance of
accumulation of residual products or cleaners thus contaminate
food products and (ii) risk of rust especially when there is remain
of liquid food products, cleaning solutions, sanitizers, or rinsing
water on metal surfaces .
•  Microorganisms can also grow and develop in water (puddle),
especially if there are remain of food products trapped in hidden
internal gaps or pockets. Furthermore, any residual liquid that is
left behind and not thoroughly drained also has the potential to
be a source of contaminants.
33

Equipment
5. Hollow areas hermetically sealed
•  All holes or cavities in machinery and equipment for the food

industry must be closed tightly
•  Basins on machinery or equipment must be removed or
permanently closed
•  Bolts, buttons, hangers, covers, junction boxes, plates, etc. must be
welded in such a way that they are part of the surface of the
machine, and do not leave a basin or hole.
•  In principle : minimize the possibility of accumulation or
penetration of liquid (remaining food products) entering into or to
the surface of the machine / equipment, especially when
accumulation occurs imperceptibly (tidak kentara)
•  The existence of a hollow area has to be avoided as early as
possible (at the design stage). If this cannot be avoided; then it
must be closed tightly. 34
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Equipment
6 No Niches (Crack-free and No Gaps)
•  Food processing equipment shall not become

gathering place for microorganisms or food residues :
have to be free of cracks, open connection, gaps, and
dead end
Evaluation of Welding quality
Evaluation when modification of equipment is
made
35

Equipment
6. No Niches (Crack-free and No Gaps)
•  Several important issues pertaining principle no 6 :
-  Maximum surfaces roughness of equipment & machine is 32 -
inch (o.081 m), non-contact surfaces < 125 -inch
-  The corner and inner corners must have a smooth curved
surface with a radius > least 1/8 inch (angle must be >135o)
-  No lap joints without hermetic closures
-  Caulking (mendempul) is not allowed for food contact
surfaces
-  All connections and welding must be polished, smoothed,
impermeable, free of holes, cracks and corrosion.
-  The use of fasteners is not recommended at or above the
product zone. If it has to be to used; the fastening material
must be made of material that meets the requirements as
food contact material. 36
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Equipment
7. Sanitary operational performance
•  During operations, machinery and equipment must have a
sanitary performance : not contribute to conditions that are
not sanitary (e.g.causing the spread of food products to the
environment, the spread of dust, the entry of lubricants etc)
•  Important criteria for evaluation of this principle :
-  Ensure that various buttons/ control panels are easy to
clean and sanitize during engine operation.
-  All pressurized air used to circulate air on the surface of
food products or on food contact surfaces must (i) be
clean (through 0.3 microns filters and (ii) dry.
-  Air must be dry to prevent condensation in the piping
system. Filter unit, to filter air should be placed as close as
possible to the food contact surface.
37

Equipment
7. Sanitary operational performance
•  Important criteria for evaluation of this principle (cont) :
-  no bearings on or above the food contact surface
-  there is a clear separation, between the food contact surface
and non-food contact surface (standard surface roughness)
-  all surfaces adjacent to food contact surfaces are designed
with surface specifications or food contact zones
-  food contact surfaces are made and designed to prevent the
accumulation of residual products during the operation of
machinery and equipment
-  Shafts (poros) installed through the product contact zone
must be equipped with an air gap to prevent contamination of
the product. This air gap will prevent flow of material from the
area of non- food contact to the food contact area. This shaft
problem mainly occurs in mixing equipment (mixer or blender)
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Equipment
8. Hygienic design of maintenance enclosures
•  Hygienic designs for maintenance of protective caps for
components such as electrical panel safety caps, chains,
belts, etc.) and protectors (for buttons, valve handles/
faucets, switches, and human machine interfaces/HMI)
should be considered from the time a machine /
equipment is design and construction
•  Design and construction must ensure that processed
food products, water, or other liquid products will not
splash and penetrate, or accumulate in or on the surface
of the safety cap and /or protector.
•  In addition to consideration of quality and food safety,
this is also closely related to work safety.
39

Equipment
8. Hygienic design of maintenance enclosures
Criteria for evaluating sanitary designs according to this principle:
•  Motor guards, chains, electronic control boxes, bearings are not
placed on open containers or places
•  Control and junction boxes fixed to and/or tied to machinery and
equipment must be tied in ways that remain in accordance with the
principles of sanitary design
•  Utility lines and supply pipes and cables must be separated to
facilitate cleaning & prevent gathering places for dirt
•  Utility lines are installed on the floor (max.12 inch above the floor)
•  Channels and / or pipes to pass material to machinery and
equipment are not placed over the room or open product zone.
•  For safety closures and / or protectors requiring cleaning with
direct washing : ensure that the surface be exposed to water/
cleaners/sanitizers to reach microbiological hygiene standards. 40
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Equipment
9. Hygienic compatibility with other plant systems
•  Various machines and equipment require additional systems, for
example an exhaust system, drainage, or an automatic cleaning
system to function properly.
•  From the start it must be designed so that the integration of
various systems does not increase sanitation risks
•  Technical and detailed considerations need to be given to the
design of the exhaust duct, the ability of the drainage channel to
effectively dispose of effluent, the effectiveness of the CIP
system when integrated with certain machines and equipment
•  The design team needs to complete the checklist, not only a
checklist for the machines and equipment; but also to include
other systems that allow the machine and equipment to function
in the factory system. The principles 1-8 are the basis for
completing this 9th principle.
41

Equipment
10. Validated cleaning and sanitizing protocols
•  Every machine and equipment for the food industry must be
equipped with a valid cleaning and sanitation procedures
•  The design and construction of machinery and equipment must be
carried out by considering cleaning and sanitation procedures.
Protocol validation needs to be done to ensure that cleaning and
sanitation carried out in accordance with the protocol is proven to
be effective and efficient for these machines and equipment.
•  The cleaning procedure needs to clearly state the specifications of
the cleaning chemicals and sanitizer used or recommended, in
accordance with (i) machine and equipment specifications (ii)
operating conditions and (iii) existing environmental requirements.
•  Machinery and food equipment industries need to consult and
collaborate with the food industry/technology experts, especially
food safety experts, when designing, fabricating, constructing and
validating machinery and equipment for the food industry
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Thank You
https://lms.ipb.ac.id/course/view.php?id=137
http ://ratihde.staff.ipb.ac.id7
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Lecture materials_Ratih Dewanti-Hariyadi 3/27/19

Sanitary Design for Building

Department of Food Science and Technology

• Definition of Sanitary Design

Demo Version, http://www.verydoc.com and http://www.verypdf.com

• Sanitary design is the application of

Demo Version, http://www.verydoc.com and http://www.verypdf.com

Classification of Sanitary Design

Sanitary Design in Regulations

Demo Version, http://www.verydoc.com and http://www.verypdf.com

Sanitary Design for Building & Facility

Sanitary Design for Building & Facility

Demo Version, http://www.verydoc.com and http://www.verypdf.com

Sanitary Design for Building & Facility

To prevent cross contamination

Sanitary Design for Building & Facility

2. Control the movement of personnel and materials

• Referring to the first principle, when plant is divided

Demo Version, http://www.verydoc.com and http://www.verypdf.com

Sanitary Design for Building & Facility

2. Control the movement of personnel and materials

End products & distribution

Sanitary Design for Building & Facility

2. Control the movement of personnel and materials

Demo Version, http://www.verydoc.com and http://www.verypdf.com

Sanitary Design for Building & Facility

3. Water accumulation is controlled inside the facility

Sanitary Design for Building & Facility

Demo Version, http://www.verydoc.com and http://www.verypdf.com

Sanitary Design for Building & Facility

• Room temperature and humidity is important in

Sanitary Design for Building & Facility

Demo Version, http://www.verydoc.com and http://www.verypdf.com

Sanitary Design for Building & Facility

Sanitary Design for Building & Facility

7. Building envelope facilitates sanitary conditions

Demo Version, http://www.verydoc.com and http://www.verypdf.com

Sanitary Design for Building & Facility

• The production lines shall be

Sanitary Design for Building & Facility

Demo Version, http://www.verydoc.com and http://www.verypdf.com

Sanitary Design for Building & Facility

Sanitary Design for Building & Facility

• The design of buildings and facilities

Demo Version, http://www.verydoc.com and http://www.verypdf.com

Sanitary Design for Machinery &

Sanitary Design for Machinery and

• Machinery and equipment for the food industry must be

Demo Version, http://www.verydoc.com and http://www.verypdf.com

Sanitary Design for Machinery and

Sanitary Design for Machinery and

Demo Version, http://www.verydoc.com and http://www.verypdf.com

Sanitary Design for Machinery and

• Various types of metals used for construction of machinery and food

Sanitary Design for Equipment

• All parts / components of machinery and equipment must be

Demo Version, http://www.verydoc.com and http://www.verypdf.com

Sanitary Design for Machinery and

Sanitary Design for Machinery and

Demo Version, http://www.verydoc.com and http://www.verypdf.com

Sanitary Design for Machinery and

• All other surfaces (other than food contact surfaces) must

Sanitary Design for Machinery and

•  Definition of Sanitary Design

•  Sanitary design is the application of

•  Referring to the first principle, when plant is divided

•  Room temperature and humidity is important in

•  The production lines shall be

•  The design of buildings and facilities

•  Machinery and equipment for the food industry must be

•  Various types of metals used for construction of machinery and food

•  All parts / components of machinery and equipment must be

•  All other surfaces (other than food contact surfaces) must

•  All holes or cavities in machinery and equipment for the food

•  Food processing equipment shall not become