White Paper

Reduce Operational Costs

With Hygienically-designed Equipment

Contents

1 Introduction

2 Contamination Outbreaks

3 What Defines Hygienic Design?

4 Why Hygienic Design is Critical for Manufacturers of

Food, Beverages and Pharmaceuticals

5 What are the Key Benefits of Investing in

Hygienically-designed Product Inspection Equipment?

6 Cleaning and Sanitization (Hygiene Restoring Processes)

7 Who Sets the Standards?

8 Functional Hygienic Design Criteria for

Product Inspection Equipment

9 Conclusion

10 Annex: Hygienic Design Assessment

 1 Introduction
Reduce Operational Costs with Hygienic Design

Food, beverage and pharmaceutical manufacturers are under increasing consumer and legislative pressure to
ensure product safety and quality. As a result, many rely on checkweighers, metal detectors, vision and x-ray
inspection systems to provide assurance that the products coming off their production lines meet consumer
expectations and are as safe as possible.

Investing in hygienically-designed product inspection equipment is crucial in avoiding cross-contamination and

preventing the growth of microbiological contamination within manufacturing plants. Most responsible companies
already use hygienically qualified equipment. Those who do not follow good hygienic practices may have a lower
initial cost, but their total cost and risk to the consumer is much higher.

This white paper explains why the hygienic design of product inspection equipment is critical and explores the
key benefits of investing in such equipment. It also defines hygienic design and lists various cleaning processes,
before focusing on the functional sanitary design criteria for product inspection equipment and looking at who
sets the standards.

The paper explains that as well as helping manufacturers to ensure the safety of food, beverage and
pharmaceutical products, investing in hygienically-designed product inspection equipment will also lead to
reduced operational costs and increased operational efficiency in the long-term.

2 Contamination Outbreaks
Several serious, high-profile foodborne illness outbreaks have occurred in various parts of the world in recent
years. Inadequate cleaning and sanitizing programs, as well as poor equipment design, construction and
maintenance of plant equipment have been listed as contributing factors in many of these outbreaks.
In the 1960s, for example, Salmonella contamination issues in dry milk products led to more stringent equipment
surveillance in milk drying facilities, and played a role in the development and improvement of 3-A Sanitary
Standards for dry milk processing and handling equipment.

In 2009, an extensive and well-publicised Salmonella Typhimurium outbreak was associated with peanuts.
Investigations revealed that equipment design and maintenance, and cleaning and sanitizing programs were
major causative factors in the outbreak.1 In 2011, another deadly L. monocytogenes outbreak in cantaloupe
melons was caused by equipment that had been inadequately cleaned, poorly maintained and was not of
cleanable design and construction.2

Problems associated with the microbiological contamination of pharmaceutical products have also hit the
headlines. In 2015, for example, the National Institutes of Health (NIH) Clinical Center in the United States sus­
pended operations of its Pharmaceutical Development Section (PDS) after the Food and Drug Administration (FDA)
discovered serious manufacturing problems and lack of compliance with standard operating procedures (SOPs).

1 www.cdc.gov/salmonella/typhimurium/update.html.
2 www.cdc.gov/listeria/outbreaks/cantaloupes-jensen-farms/120811/index.html.

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Reduce Operational Costs with Hygienic Design
 The facility makes products for certain clinical research studies conducted in the hospital and in April that year,
two vials of albumin, used for administering the drug interleukin in experimental studies, were found to have
fungal contamination. Vials made from the same batch were administered to six patients. Among the problems
the FDA identified during its inspection were deficiencies in the physical facility, including flaws in the air handling
system, and operational failures including inadequate quality control, insufficient employee training, and lack of
compliance with SOPs.

As well as endangering the lives of consumers and patients, the repercussions of microbiological outbreaks
include loss of production caused by unplanned downtime and facility shutdowns, as well as lost revenue and
long-term brand damage resulting from adverse publicity, in particular negative social media coverage.

Companies are exposed to the risk of foodborne illness – an expensive challenge. And the liability when linked to
an outbreak is now bigger than ever as the former associate commissioner for foods at the U.S. Food and Drug
Administration (FDA) David Acheson explains, "Thirty years ago if you had a little problem, you were not going to
get discovered. Now the chances of getting caught are significant, and it can be the end of your company."¹

When the Grocery Manufacturers Association surveyed three dozen international companies in 2011, more than
half reported being impacted by a food recall during the previous five years. Eighteen percent of those said the
affect from the recall and lost sales was between $30 million and $99 million; 5% said the financial impact was
$100 million or more. The long-term reputational damage to companies can have an even steeper price tag.¹

Investing in hygienically-designed product inspection equipment can play a key role in preventing contamination
incidents.

3 What Defines Hygienic Design?

Hygienic design aims to allow for easy, cost-effective and reliable cleaning of food and pharmaceutical
manufacturing facilities and their equipment in order to minimize physical, chemical and microbiological
contamination risks. This is achieved by applying hygienic design standards and guidelines throughout a project
cycle from the concept development stage to the construction, fabrication and commissioning.

In the annex to this white paper you will find a Hygienic Design Assessment checklist for your convenience, which
can help planning of projects.

4 Why Hygienic Design is Critical for Manufacturers of Food,

Beverages and Pharmaceuticals
Every year as many as 600 million people, or almost 1 in 10 people in the world, fall ill after consuming
contaminated food, according to the World Health Organization's (WHO) first ever global estimates of the global
burden of foodborne diseases in 2015.²

Microbiological bacteria cause approximately ninety percent of all foodborne illnesses. Bacteria that cause human
illnesses, including disease, are called pathogenic, and those most likely to be found in food include Salmonella,
Listeria, E-coli and Campylobacter.

¹ http://fortune.com/food-contamination/
² http://www.who.int/mediacentre/news/releases/2015/foodborne-disease-estimates/en/

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Reduce Operational Costs with Hygienic Design
 Listeria is the most commonly found bacteria in the food industry and is the food pathogen that has had the
Reduce Operational Costs with Hygienic Design
most impact on improvements in facility hygienic design over the past 30 years. When sanitization practices are
insufficient, Listeria can harbour and thrive in many pieces of equipment used in food processing plants, such as
conveyor belts, slicers, dicers and peelers. Machinery used for packaging products can also harbour and transfer
bacteria to products. When this occurs, scrupulous sanitization must occur to eliminate Listeria.

The primary response to contamination outbreaks has been increased implementation of the Hazard Analysis
and Critical Control Points (HACCP) system and other food safety programs, as well as an increased reliance on
third-party auditing programs. Foodborne illness outbreaks also triggered recent food safety legislative activity,
including the U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA).

The FSMA rules mark a big regulatory shift: one that mandates companies take a more proactive approach to
food safety rather than wait for an outbreak to trigger a frantic clean-up response. Charles Breen, a former FDA
district director who is now a food safety consultant, explains, "Instead of the FDA having to show that firms are
doing something wrong, firms have to show that they're doing something right". The prevention and control of
microbial contamination is also critical for manufacturers of pharmaceutical products to maintain the quality and
safety of medicines. Not only do contaminated drugs pose a health risk to patients, they can also be detrimental
to a company's economics, the environment and regulatory approvals.

5 What are the Key Benefits of Investing in

Hygienically-designed Product Inspection Equipment?
Hygienically-designed product inspection equipment offers food, beverage and pharmaceutical manufacturers
numerous benefits. In addition to helping to protect consumer welfare and companies' brand reputations
by increazing product safety and reducing the risk of recalls, hygienically-designed equipment can help
manufacturers with HACCP, legal and regulatory compliance, as well as result in cost savings and increased
operational efficiency in the long run.

5.1 Regulatory Compliance

Food manufacturers are under increazing pressure to adopt the standards of the Global Food Safety Initiative
(GFSI). Other directives and standards, such as HACCP and Good Manufacturing Practice (GMP) are also
important and designed to help food and pharmaceutical manufacturers make their processes as safe and
transparent as possible.

The primary GFSI-benchmarked food safety schemes include:

• The British Retail Consortium (BRC)
• Food Safety System Certification 22000 (FSSC 22000)
• International Featured Standard (IFS Food)

The primary focus of audits under these GFSI benchmarks is on the overall food safety management system,
including HACCP and related programs. The hygienic design, construction and maintenance of all food equipment
is now more important than ever before and is addressed in a general manner in most regulatory and industry
food safety programs.

The FSSC scheme has the most specific explanation with regards to equipment and provides that food contact
equipment be designed and constructed to facilitate appropriate cleaning; of durable materials; of materials
designed for food use; be impermeable and rust or corrosion-free; and meet established principles of hygienic
design.

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 Hygienically-designed product inspection equipment will also help pharmaceutical manufacturers comply with
GMP, especially FDA 21 CFR Parts 210 and 211, GAMP-4 and FDA 21 CFR Part 11, which are enforced by the
European Medicines Agency (EMEA) in Europe and the Food and Drug Administration (FDA) in the U.S.

6 Cleaning and Sanitization (Hygiene Restoring Processes)

Four main cleaning processes are used in food, beverage and pharmaceutical processing plants today. These are:
• Cleaning Out Of place (COP)
• Cleaning In Place (CIP)
• Manual Cleaning
• Immersion Cleaning

Cleaning Out Of Place (COP)

Cleaning Out Of Place (COP) involves dismantling and cleaning equipment manually. Today this has been
replaced with cleaning in place (CIP) in most parts of the food industry where food is pumped and undergoes
continuous processes. Although some equipment still needs to be dismantled and manually cleaned, wherever
possible, CIP is the preferred choice.

Cleaning In Place (CIP)

Cleaning in Place (CIP) refers to cleaning that takes place without dismantling equipment. It poses less of a
chemical exposure risk to people than COP. CIP can be a very efficient way of cleaning as it tends to be faster,
less labor-intensive – and can thus contribute to lowering the total cost of ownership (TCO) of equipment in the
long run.

CIP is an important component in ensuring product safety in processing plants. Successful cleaning and
sanitizing between production runs avoids potential contamination and products that do not meet quality
standards leaving the manufacturing facility.

Manual Cleaning
Manual cleaning is the universal practice in the pharmaceutical industry. The efficiency of this method of cleaning
depends on the cleaning operators, as well as the concentration of detergent used and the temperature of the
washing liquid. Depending on the nature of the surface and its impermeability manual cleaning means washing,
brushing, rubbing and wiping by hand using suitable, adequately hygienic tools (such as a disposable cloth
impregnated with special surface-sterilizing alcohols) or spraying and rinsing with a pressure cleaner, in the latter
case avoiding direct hand-contact with the surfaces cleaned.

Immersion Cleaning
Immersion cleaning is the process by which the equipment parts to be cleaned are placed into the cleaning
solution so that the cleaning agent fully contacts every surface. This method of cleaning is preferred for processes
which require a long soaking time because of the type of contamination being removed or the shape of the parts
to be cleaned.

Beside the above mentioned four cleaning processes, there is an extra process providing even more protection:

Sanitization
Sanitization aims to achieve an even higher degree of cleanliness and deploys more intense measures such as
the use of disinfectants for the sake of hygienic objects and a hygienic environment. It should however not be
confused with sterilization which makes use of stronger chemicals – or processes such as boiling instruments
or tools in autoclaves. Sterilization aims to eliminate 100% of the microbes (bacteria, viruses, fungal spores)

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Reduce Operational Costs with Hygienic Design
 known to exist. However, a production plant sanitization program may include a sterilization process for certain
Reduce Operational Costs with Hygienic Design
food contacting tools.

6.1 Degrees of Ingress Protection (International Protection)

The Ingress Protection, also referred to as International Protection, (IP) rating system is an internationally
recognized scale that relates to proven "protection of electric enclosures of appliances, machines and installation
materials" against "penetration of solids and liquids". The IP (Ingress Protection or International Protection) rating
system does not define the materials of construction.

Defined in the DIN EN 60529 standard, IP ratings can be identified by the letters IP, followed by two numbers.
These numbers define the amount of protection a piece of equipment has against specified elements and its
ability to resist contamination that could otherwise get inside the equipment and cause it to fail.

The first number refers to the amount of protection an enclosure has against solid matter, such as dust particles,
while the second number defines the level of protection against liquids. The higher the number, the greater the
protection. However, depending on the circumstances IP66 and IP67 may be an exception to this rule as IP66
relates to applying water jets while IP67 relates to immersion in water. IP69 is the highest protection rating
available. It provides protection against ingress of dust and high-temperature, high-pressure water.

The industry and environment, as well as the application where the equipment is being used, dictates which
sanitization level is required and will have a direct influence on how the equipment is designed and constructed.
However, it is the user who has ultimate responsibility for the cleaning and sanitization of the machinery.

Each industry has its own special set of sanitization requirements. In the meat and poultry industry, for example,
where hygiene and cleanliness are paramount, equipment must be able to withstand rigorous high-pressure,
high-temperature wash down procedures. It is important to be aware, however, that although equipment with an
IP69 rating can help to reduce the risk of microbiological contamination of products and limit downtime, it is
not single-handedly sufficient to prevent contamination. Hygienically-designed product inspection equipment
is crucial.

7 Who Sets the Standards?

Worldwide, several organizations are involved in the hygienic design of equipment used for food, beverage and
pharmaceutical processing. The main ones are:
• The European Hygienic Engineering and Design Group (EHEDG)
• The U.S. Food and Drug Administration (FDA)
• The U.S. Department of Agriculture (USDA)
• 3-A Sanitary Standards Inc. (3-A SSI)
• National Sanitation Foundation (NSF) International
• The North American Meat Institute (NAMI)

Despite variation between these organizations with regards to their standards and/or recommendations, they are
in general harmony with food safety intent and the importance of the application of sound principles of hygienic
design and construction.

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EHEDG
Founded in 1989, EHEDG is a consortium of equipment manufacturers, food industries, research institutes
and public health authorities aimed at promoting hygienic design through its guidelines, documents, training
materials and education programs.

EHEDG actively supports European legislation, which requires that the handling, preparation, processing and
packaging of food is done hygienically, using hygienic machinery and in hygienic premises (according to the
Food Hygiene Directive, the Machinery Directive and the Food Contact Materials Directive). EHEDG guidelines
describe how to meet the European Commission's requirements, for example, how to ensure that food contact
surfaces are smooth and drainable, and how to prevent contamination by microorganisms, chemicals and
foreign bodies.

FDA
The FDA, known by its present name since the 1930s, began to exercise modern regulatory functions with the
passage of the 1906 Pure Food and Drugs Act. The FDA is responsible for protecting public health by ensuring
the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, the
nation's food supply, cosmetics, and products that emit radiation.

The FDA Food Safety Modernization Act's (FSMA) Final Rule for Preventive Controls for Human Food sets
requirements for a written food safety plan that includes preventive controls. Measures are required to ensure
that any hazards requiring a preventive control will be minimized or prevented. This includes process, food
allergen and sanitization controls, as well as supply-chain controls and a recall plan.

USDA
In the USA, the USDA has authority for equipment and process in the plants: The United States Department of
Agriculture (USDA) has several mission areas, one of which is food safety. The Food Safety and Inspection
Service (FSIS) is the public health agency in the USDA responsible for ensuring that the nation's commercial
supply of meat, poultry and egg products is safe, wholesome, and correctly labelled and packaged.

The FSIS works with federal, state and local food safety partners to address emerging pathogens, to detect
foodborne hazards, and to prevent foodborne illness. The agency has published a Sanitation Performance
Standards Compliance Guide which references methods already proven to be effective in maintaining sanitary
conditions in meat and poultry establishments.

3-A SSI
3-A SSI, often referred to as 3-A for short, is an independent, not-for-profit corporation dedicated to advancing
hygienic equipment design for the food, beverage and pharmaceutical industries. The corporation formulates
sanitary standards and accepted practices for the sanitary design, fabrication, installation and cleanability of
food equipment or systems used to handle, process and package consumable products where a high degree of
sanitization is required.

These sanitary standards and accepted practices are developed through the cooperative efforts of industry experts,
including regulatory sanitarians, fabricators and processors. 3-A Sanitary Standards in general provide material
specifications, design criteria and other necessary information for equipment types to satisfy public health
concerns.

3-A SSI's goal is to protect consumable products from contamination and to ensure that all product surfaces can
be mechanically cleaned in place (CIP) or easily dismantled for manual cleaning.

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 NSF
Reduce Operational Costs with Hygienic Design
Manufacturers, regulators and consumers look to NSF International for the development of public health
standards and certification programs that help protect the world's food, water, consumer products and
environment. The organization's mission is to protect and improve global human health.

NSF International has been helping businesses in the agriculture, processing, food equipment, restaurant and
retail industries to navigate the food safety and regulatory environment for more than 70 years. Its food safety
and quality services span every link from farm to fork, including certification, testing, training, consulting,
auditing and regulatory compliance. The organization tests and certifies food equipment products for acceptance
across the U.S.A., Europe and other global markets, and provides certification services for equipment used in
food processing. NSF International food equipment standards include requirements for material safety, design,
construction and product performance.

NSF has no direct legal authority over food producing organizations. The "NSF 14159" standard aligns with
the European Norm (EN) NSF 14159, to advance a harmonized sanitary design standard between Europe and
North America. NSF is more oriented towards the process side of the business than the other agencies cited,
providing training and accreditation for HACCP.

NAMI
Created in 2015 through the merger of the American Meat Institute (AMI) and the North American Meat
Association, NAMI is a national trade association that represents companies who process 95 percent of red
meat and 70 percent of turkey products in the U.S. and their suppliers throughout America.

NAMI aims to keep its fingers on the pulse of legislation, regulation and media activities that impact the meat
and poultry industry, and provides rapid updates and analyses to its members to help them stay informed.
The organization also conducts scientific research through its Foundation, which is designed to help meat and
poultry companies improve their plants and their products.

8 Functional Hygienic Design Criteria for

Product Inspection Equipment
In 2002, the North American Meat Institute's (NAMI) Equipment Design Task Force (EDTF) established a list of
10 sanitary design principles aimed at improving food safety by reducing the contamination risk from Listeria in
ready-to-eat meat and poultry products. In 2014, the American Meat Institute Foundation (AMIF) updated these
principles.

To reduce the risk of microbiological contamination outbreaks, all product inspection equipment should be
designed with due consideration to the application, operating environment and cleaning regimes likely to be
encountered, and should adhere to the following 10 principles of sanitary design:

8.1 Cleanability
Food equipment must be constructed to ensure effective and efficient cleaning over its lifespan. Equipment
should be designed to prevent bacterial ingress, survival, growth and reproduction on both product and non-
product contact surfaces. The ability to easily disassemble equipment for cleaning and inspection is important.
Product inspection equipment with smooth surfaces can help to prevent pathogenic microorganism growth by
making sanitization easy.

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 Product inspection equipment is available which meets 3-A Sanitary Standards and is cleanable to a
microbiological level, thereby reducing cleaning times and labor costs.

Favourable Practice Non-Favoured Practice

Smooth finish, free of pock- Surfaces (such as bead-blast)
ets where stray material can that have small pockets invisi-
collect or harbour microbial ble to the naked eye. These
infestation. Easily disassem- indentations can be detected
bled and assembled. by running your thumbnail
across the surface.

8.2 Construction Materials

The construction materials used for product inspection equipment should be completely compatible with the
product, environment, cleaning and sanitizing chemicals, as well as the methods of cleaning and sanitization.
Product contact surfaces must be made from materials which are corrosion resistant, non-toxic and non-
absorbent.

Plated, painted and coated surfaces should not be used for food contact surfaces or for surfaces above product
zone areas. A stainless steel construction is advisable as it is corrosion resistant – whereas uncoated aluminum
should be avoided as it dissolves in harsh wash-down environments.

In addition, plastic-coated belt materials are preferred over cloth as cloth absorbs moisture and can harbour
microorganism growth.

Product inspection equipment is available that is made from compatible materials. For example, metal detection
and x-ray systems exist with fully-welded stainless steel tubular frames which allow water to roll off during
cleaning and help to eliminate bacteria traps on the system.

Favourable Practice Non-Favoured Practice

All stainless and food-grade Use of fabric belts – stray fibres
plastic construction. Plastic wick moisture and microbial
coated belts preferred over material. Use of untreated alu-
cloth. Proper fabrication prac- minium – it dissolves in harsh
tices to prevent corrosion from environments. Sealants in lieu
weld areas. Bolted joints are of gaskets.
properly gasketed.

8.3 Accessibility
All parts of the product inspection equipment should be readily accessible for inspection, maintenance, cleaning
and sanitization without the use of tools. CIP is preferred over COP to avoid time-consuming dismantling and
reassembly.

Designing equipment to increase accessibility for cleaning is vital and will help to reduce downtime by making
cleaning easier and quicker. COP parts should be easily removable by hand or with the use of simple hand
tools, other product contact areas such as catch bins/reject bins should also be easily removable to assist with
cleaning of the equipment. In addition, tool-free belt removal and tensioning is advisable to allow quick and
easy sanitization, service and replacement.

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 Product inspection equipment is available that has been designed specifically to enhance accessibility and can
Reduce Operational Costs with Hygienic Design
be cleaned and sanitized using manual cleaning methods or CIP systems. Such product inspection equipment
also allows for conveyor belts, chains and other components to be easily disassembled to ensure that cleaning
is complete and thorough.

Favourable Practice Non-Favoured Practice

Open construction for Field maintenance requires

cleaning and visual in- tools. Areas are concealed
spection. from cleaning, inspection.
Intuitive field-assembly. Narrow gaps hide areas re-
Tool-less removal of quiring sanitization.
components and high
ground clearance.

8.4 No Liquid Collection

Equipment should be self-draining to ensure that liquid from the product, cleaning process or condensation,
which can harbour and promote the growth of bacteria, does not accumulate, pool or condense on the
equipment. All surfaces should be designed to eliminate water pooling and be self-draining. Framework should be
rounded or inclined at 45 degrees, and flat under surfaces that are difficult to see or clean should be avoided. Belt
tension should be adequate throughout operations to prevent water pooling on belts, and materials used should
be non-absorbent.

Product inspection equipment should be designed to prevent product residues and liquid collection. For
example, x-ray inspection and metal detection systems exist that avoid ledges and horizontal surfaces and
instead have sloped and curved edges to allow water to roll off during cleaning, as well as drainage slots in
catch trays.

Checkweighing systems are available where all frames have tubular designs and horizontal surfaces have been
kept to an absolute minimum, allowing not only water to roll off but also reducing build-up of product particles
or dirt in the first place.

Vision inspection systems are also available where the vision enclosure is mounted on stand-offs, which
minimizes face-to-face contact with the sub-frame. In addition, the sub-frame is designed in a manner that uses
clean design concepts, and is constructed out of round tubing which sheds water and minimizes the pooling of
water on the sub-frame. Furthermore, as there is no access to the internal cavity of the sub-frame, this eliminates
concerns over water being pooled internally.

Favourable Practice Non-Favoured Practice

Predominantly sloping and Concave and flat surfaces,
rounded surfaces. Start or large surfaces with ten-
with the product contact dency to buckle. Pockets
zone and ensure that every- between bearings and con-
thing flows down and away veyors. Frames with large
from there. upper or lower surface ar-
eas that encourage mois-
ture retention.

8.5 Hermetic Sealing

Hollow areas of equipment such as frames and rollers should be eliminated, whenever possible, or permanently
sealed. Bolts, studs, mounting plates, brackets, junction boxes, name plates, end caps, sleeves and other such
items should be continuously welded to the surface of the equipment, not attached via drilled and tapped holes.

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 Hollow areas are not acceptable at or above the product contact zone. Product inspection equipment is
available with hermetically-sealed hollow areas.

Favourable Practice Non-Favoured Practice

All tubing closed-welded. Internal bearings, socket-head
or other fasteners with pock-
ets, hollow pulleys or press-fit
plastic cap assemblies cap-
ping hollow areas.

8.6 No Niches
Equipment parts should be free of niches such as pits, cracks, corrosion, recesses, open seams, gaps, lap seams,
protruding ledges, inside threads, bolt rivets and dead ends. Welds should be flush and free of pits, cracks and
corrosion.

Internal angles should be 135 degrees or greater, and internal radii should be 3mm or greater. Internal angles of
less than 55 degrees should be avoided as the area between the surfaces cannot be seen or cleaned. Press and
shrink fits should not be used as they have inherent gaps and can leak. Fasteners should not be used in or above
the product contact zone as they are harbourage areas. In addition, there should be no exposed threads as these
pose a contamination risk. Flanges should be welded, with gaps in welded seams to allow for free flow of cleaning
solutions. Bolted joints should be gasketed and the gaskets visible to verify their presence. Belt scrapers should not
have lap joints and must be capable of being removed without tools.

Product inspection systems are available with no niches. For example, x-ray systems and metal detectors exist that
are designed to eliminate cavities and bacterial traps.

Favourable Practice Non-Favoured Practice

Minimum contact be- Pockets allowing product
tween support surfaces. buildup. Unsealed gaps
Smooth surfaces with between assemblies.
large enough radii to help Fasteners and threads in
cleaning. All seams with the product contact area.
a smooth high quality
weld.

8.7 Operational Performance

During normal operations, the product inspection equipment must perform so that it does not contribute to
unsanitary conditions or the harbourage and growth of bacteria. The characteristics of the product being produced
will have the greatest impact on the equipment's operational construction specifications. Avoidance of spillage
and the effective separation of product contact and non-contact zones are of paramount importance.

To ensure hygienic operation and minimize the possible spread of contamination, it is essential that the design
also takes into account components and parts that will be touched by the operator who will almost certainly
have been in contact with the product. Buttons on control panels should be easily cleanable so as not to create
microbial harbourage.

The same applies to handles of safeguards (covers) and any other part or component that will be touched by the
operator. Bearings should not be present in or above the product contact zone areas.

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 The conveyor and other equipment parts should be designed to minimize product build-up.
Reduce Operational Costs with Hygienic Design
Product inspection equipment is available which is designed for sanitary operational performance.

Favourable Practice Non-Favoured Practice

Drives and bearings are well- Bearings in the product zone
removed from the product or internal to pulleys. User in-
contact zone. Proper separa- terfaces or buttons that re-
tion of product contact and quire protection during clean-
non-contact areas using ing. Use of non-sanitary
guides. guides for product contact
zone separation.

8.8 Maintenance Enclosures

Product inspection equipment maintenance enclosures and human machine interfaces (HMIs) such as push
buttons, valve handles, switches and touchscreens should be designed to ensure that product residue or
water does not penetrate or accumulate in or on the enclosure or interface. In addition, the physical design of
the enclosures should be sloped or pitched to avoid use as a storage area or residue accumulation point. A
special control function to temporarily disable the touchscreen during cleaning is advantageous as it prevents
misoperation.

Drives, chain guards, electrical control boxes and sealed bearings should not be located over open product
zones. Control and junction boxes should be fastened to the frame in a manner consistent with the sanitary
design principles. Power and network supply lines should be well above floor level and connections to and from
the control cabinet should be firmly affixed and able to withstand direct cleaning and environment sanitization
processes. Maintenance enclosures in direct wash down areas should be IP rated and suitable for exposure to
water and chemicals used in cleaning and sanitization.

Product inspection equipment is available with hygienically-designed maintenance enclosures. In addition, many
systems have cable trays which have been incorporated not only to allow easier access to cables, but also to keep
cables off the floor which otherwise can gather dust and provide another location for bacteria to breed.

Favourable Practice Non-Favoured Practice

Sealed touchscreen HMI with Operator reaches over con-
no protruding buttons. Control veyor, or HMI extends across
cabinet has a sanitary design conveyor. Enclosures and
with a sloping top surface. IP HMI are lower IP rating than
rating of all connections to machine components. Drive
and from the cabinet ade- assemblies are part of the
quate to withstand sanitiza- product zone.
tion process.

8.9 Hygienic Compatibility

Product inspection equipment should be designed to ensure hygienic compatibility with other equipment and
systems, such as electrical, hydraulics, steam, air and water.

Equipment interfaces and connections to all electrical, mechanical, pneumatic and mounting interfaces need to be
defined to enable integration into the production line, environment and sanitary processes. Access for maintenance,
plant cleaning and sanitization processes need to be known. Product characteristics and how they will flow into
and out of the product inspection equipment need to be taken into account. Specific biological contamination risks
must also be identified and taken into account during construction design.

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 Product inspection equipment is available which is hygienically compatible with other plant systems.
Furthermore, checkweighers, x-ray systems and metal detectors exist that incorporate hygienic management of
electric cables, trunking and pneumatic services.

Favourable Practice Non-Favoured Practice

A document defining the spe- A document with just a ge-
cific equipment provided neric drawing of a machine
along with the customer in- type, without instruction on
terfaces for all utilities and integration fundamentals and
communications, mainte- hygienic compatibility.
nance, product transfers, and
product segregation.

8.10 Cleaning Validation

The procedures prescribed for cleaning and sanitization must be clearly written, designed and proven to be effective
and efficient. Chemicals recommended for cleaning and sanitization must be compatible with the equipment
and the manufacturing environment, and must be capable of removing product residue as non-aggressively as
possible.

Product inspection equipment suppliers must consider the cleaning and maintenance of the machine at the start of
the design, not as an afterthought.

Questions for manufacturers to consider include:

• What needs to be cleaned and how (CIP/COP)?
• Which cleaning process should be used and are there restrictions on sensitive components?
• What cleaning and sanitization protocols are provided by the equipment supplier?
• What maintenance tasks are required after cleaning and sanitization?

Product inspection equipment is available which is designed in line with cleaning protocols. For example, well-
designed x-ray pipeline systems exist which incorporate CIP procedures. CIP provides for a flush-out of the
pipework with hot cleaning fluid at the end of a production run, with no need to disassemble the manifold or
disconnect the pipework. For sterile applications, an aseptic manifold is available. This design incorporates a set
of double O-ring seals on either side of the x-ray window section, where it connects to the stainless-steel manifold.
The design allows for CIP, and steam can be passed through the system to kill any micro-organisms present,
without the need to dismantle the manifold assembly.

Favourable Practice Non-Favoured Practice

A planned sanitization proto- Sanitization instructions that
col that addresses the spe- do not consider the type of
cific equipment, for the cus- equipment, or the environ-
tomer to incorporate into the ment in which the equipment
plant sanitization process. will be placed.

White Paper 13
Reduce Operational Costs with Hygienic Design
 9 Conclusion
Reduce Operational Costs with Hygienic Design

As food, beverage and pharmaceutical recalls become more frequent and costly, and safety laws become
increasingly stringent, it is important that all product inspection equipment not only performs well, but is designed
to prevent bacterial growth and facilitate proper cleaning.

Hygienically-designed equipment can play a key role in reducing the risk of microbiological contamination
outbreaks and can also aid regulatory and HACCP compliance. However, as this white paper shows, investing in
equipment that is built with hygienic principles in mind offers manufacturers several additional long-term benefits,
including reduced overall operating and maintenance costs and increased operational efficiency.

14 White Paper
Reduce Operational Costs with Hygienic Design
10 Annex: Hygienic Design Assessment
Checklist for your use – a tool for critical review of product inspection equipment conveyor and components by
functional areas.
Conveyors
……Easily disassembled/assembled for CIP/COP
……Surfaces with relief pattern to prevent belt
adhesion
……Drives external to the product contact area
and separated by barrier or distance
……No exposed threads
……Plastic coated or monolithic belt materials
preferred over cloth
Frames
……Minimize tube in favor of solid, where
practical
……Internal angles 135° or greater
……Sloped surfaces to minimize material
accumulation
……Welds closed, complete, free of pits,
occlusions, spatter, and discoloration
……Blind-holes with standoffs for any bolted
attachment
……Minimize horizontal surfaces
Bolted Joints
……Minimize bolted joints in favor of one-piece,
or weldments
……Gaskets visible for inspection, proper
position, and function
……Minimize surface area between bolted parts
……No fasteners with recessed heads
Clamps
……Easy to use to support cleaning
……Open construction to allow cleaning
……Minimize contact area between surfaces to
support cleaning
……No traps or niches that collect debris
User Interfaces
……Accessible without reaching over the product
contact zone where practical
……Minimum IP69k rating
……No buttons, niches, or traps that collect
debris
……Positioned outside the product contact zone
where practical
Floor Interface
……No exposed threads
……Adjustable to permit proper installation
……Minimize points of contact
……Minimize horizontal surfaces facing the floor
……Horizontal surfaces far enough from floor to
support cleaning
Rejectors
……Clean air source provided
……Filtered and dried air
……Rejectors over the product contact zone
should meet "Zone 1" requirements
Transfers and Guides
……Easily removed, disassembled, and
assembled for cleaning – COP or CIP
……Easily adjusted to encourage proper use
……Design for "Zone 1" if there is direct product
contact
Sensors
……IP rated appropriately for the environment
……No niches or traps that collect debris
……Removed from product contact zone
Cable and Conduit
……Cable appropriate for environment and power
rating
……Interfaces to enclosures IP rated for the
environment
……Open cable preferred over conduit to prevent
water entrapment
……Wires and cables loosely supported in open
rack to permit thorough cleaning
Materials, Protection, Finish
……Materials must be compatible with the user's
products and suitable for the user's cleaning/
sanitization practices
……Devices with electrical enclosures have IP
ratings sufficient for the environment
……Surface finishes of machine/equipment
should be appropriate for the zones where
used
White Paper 15
Reduce Operational Costs with Hygienic Design
 About Mettler-Toledo Product Inspection:
The Product Inspection Division of METTLER TOLEDO is a leader in the field of automated inspection technology.
Our solutions increase process efficiency for manufacturers while supporting compliance with industry standards
and regulations. Our systems also deliver improved product quality which helps to protect the welfare of
consumers and reputation of manufacturers.

Checkweighing Metal Detection X-ray Inspection Vision Inspection

Disclaimer:
Information contained in this publication is provided "as is" and without warranty. METTLER TOLEDO disclaims all
warranties, express or implied, and makes no warranty regarding the accuracy or applicability of the information
contained in this publication, and is therefore explicitly not responsible for any damage, injury or death resulting
from the use of or reliance on the information.

No part of this publication may be reproduced or distributed for any purpose without written permission from
METTLER TOLEDO.

© 2016 METTLER TOLEDO. All rights reserved. Subject to technical changes.

www.mt.com/pi
For more information

Mettler-Toledo GmbH
CH-8606 Greifensee, Switzerland
Tel: +41 44 944 22 11
E-Mail: product.inspection@mt.com
Website: www.mt.com/contact

Subject to technical changes

© 07/2016 Mettler-Toledo GmbH
Global Marcom Switzerland