EHEDG Glossary

Version 2004/04.G01

This document replaces the “Definitions of expressions relevant to hygienic

processing and plant design” dated May 1991, amended Dec 1993 and Dec 2003.

The definitions are presented to provide uniform general interpretation of the terms,
phrases and expressions used in EHEDG guideline documents and publications.
Where relevant, definitions established by official standards bodies have been
adopted. Some of these definitions may be qualified for use in specific guideline
documents.

A
Aseptic equipment

Hygienically designed equipment that is sterilisable and is impermeable to micro-

organisms to maintain its aseptic status.

Aseptic process

A process using equipment sterilized before use, and which, in running conditions, is
protected against recontamination by micro-organisms.

See also Ultra-clean process

Accessible (see Easily accessible)

B
Bioaerosol

Dispersed biological agents in a gaseous environment. (BS EN ISO 14698-1:2003)

Biocontamination

Contamination of materials, devices, individuals, surfaces, liquids, gases or air with

viable particles. (BS EN ISO 14698-1:2003)

Biofilms

A microbial consortium adhering to a surface.

NOTE: these are frequently but not in every case embedded in extra-cellular
polymeric substances.

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C
CCP (critical control point)

A step at which control can be applied and is essential to prevent or eliminate a food
safety hazard or reduce it to an acceptable level. (Codex)

CIP (cleaning-in-place)

Automated wet cleaning system of a line and/or individual equipment in a closed

circuit without dismantling.

NOTE: CIP efficiency depends on 5T's – time, temperature, titration, turbulence and
technology. CIP can be done in a dry area, the aim being that the design precludes
any water passing into the environment.

Cleanability

The suitability of equipment to be freed from soil easily.

See also Comparative cleanability

Cleaning

The removal of soil, food residues, dirt, grease or other objectionable matter. (Codex)

Cleanroom

Room in which the concentration of airborne particles is controlled, and which is

constructed and used in a manner to minimize the introduction, generation, and
retention of particles inside the room, and in which other relevant parameters e.g.
temperature, humidity, and pressure, are controlled as necessary. (BS EN ISO
14698-1 :2003)

Coatings

The result of a process where a different material is deposited to create a new

surface. (3-A)

Commercial sterilization (see Sterilization )

Comparative cleanability

The cleanability of equipment relative to a reference.

Conditions for intended use

- in relation to equipment and parts or other elements e.g. of building, and not
in the context of product and consumer

All normal or reasonably anticipated operating conditions, including those of cleaning.

These should set limits for variables such as time, temperature and concentration

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Contaminant

Any biological or chemical agent, foreign matter or other substance not intentionally
added to food, which may compromise food safety or suitability. (Codex)

Contamination

The introduction or occurrence of a contaminant in food or food environment.

Controlled environment (see Zoning)

Control measure

Any action and activity that can be used to prevent or eliminate a food safety hazard
or reduce it to an acceptable level. (Codex)

NOTE: In a broader sense, should also cover measures to have under control points
necessary for assuring non-safety attributes are maintained at an acceptable level.
(see also preventive action)

COP (cleaning-out-of-place) – (see also Wet cleaning)

Manual cleaning of dismantled equipment.

NOTE: The main part of the installation may remain fixed in a position but parts may
be removed to another point for cleaning.

Corrective action

Any action to be taken when the results of monitoring at the CCP indicate a loss of
control. (Codex)

NOTE: Action taken to eliminate or reduce the causes of nonconformity, defect or

other undesirable situation after a deviation has been detected, in order to minimize
or prevent its recurrence. Every control point in a Quality Monitoring system must
include the corrective action to be taken in case of deviation.

Crevice

A crack with an opening accessible to contaminants.

For example a narrow opening or fissure either in the bulk of a material or between
two closely fitting components, such as a flange and its gasket. Typically, a crevice
has a depth more than 20 times the width of its opening. Crevices may not only
harbour soils and micro-organisms and be inaccessible to cleaning agents, but may
also cause accelerated corrosion of the bulk material, rapidly increasing the size of
the crevice.

D
Diaphragm
A thin sheet of material forming a non-porous partition, such as between a
pressurized medium and the measuring sensor.

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Disinfectant

A chemical that is used after cleaning for killing a certain proportion/type of viable
micro-organisms remaining on the surface.

NOTE: A disinfectant is not expected to kill all micro-organisms of any type, including
spores (see also sterilization). Nevertheless in the USA it is defined as an agent
that will kill 100% of infectious fungi and vegetative bacteria although it will not
necessarily kill bacterial spores on inanimate surfaces.

Disinfection

The reduction, by means of chemical agents and/or physical methods, of the number
of micro-organisms in the environment, to a level that does not compromise food
safety or suitability. (Codex)

NOTE: disinfection according to BSI 5283: the destruction of micro-organisms, but

not usually bacterial spores. Disinfection does not necessarily kill all micro-
organisms, but reduces them to a level acceptable for a defined purpose e.g. a level
which is harmful neither to health nor to the quality of perishable food. Specifically in
USA, the terms sanitizer and sanitization are more commonly used in the food
industry (see sanitizer/sanitization)

Dry-cleaning

Cleaning which does not involve any use of water, a technique which can be used as
a preventive measure to reduce risks of microbial development in equipment and in
the environment. It also reduces risk of contamination with e.g. residues of aged or
modified product. Mostly done manually using brushes and/or vacuum cleaners.

E
Easily or Readily Accessible

A location that can be safely reached by a personnel from the floor, platform, or other
permanent work area. (3-A)

Easily or Readily removable

Quickly separated from the equipment with the use of simple hand tools if necessary.
The latter are implements normally used by fitters, operating and cleaning personnel
such as a screwdriver, a wrench or hammer. (3-A)

F
Food hygiene

All conditions and measures necessary to ensure the safety and suitability of food at
all stages of the food chain. (Codex)

Food safety

Assurance that food will not cause harm to the consumer when it is prepared and/or
eaten according to its intended use. (Codex)

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Food suitability

Assurance that food is acceptable for human consumption according to its intended
use. (Codex)

NOTE: This word is now more and more preferred to ‘wholesomeness’.

G
GHP (Good hygiene practices)

Measures applicable throughout the food chain (including primary production through
to the final consumer), to achieve the goal of ensuring that food is safe and suitable
for human consumption. GHPs are a subset of GMPs.

GLP (Good laboratory practices)

The means by which laboratory work is planned, performed, monitored and recorded
to ensure accuracy and reliability of results, safety and efficiency in the laboratory.

GMP (Good manufacturing practices)

All procedures, processes, practices and activities aimed at ensuring that the quality
and safety objectives are met consistently. GMP's should apply throughout the
supply chain for food. Application of GMP is a prerequisite for any HACCP study.
(see HACCP)

NOTE: GHPs are a subset of GMPs.

H
HACCP (Hazard Analysis Critical Control Point)

A system which identifies, evaluates and controls hazards that are significant for food
safety. (Codex)

NOTE: A HACCP study must be performed during the development of new products
and processes, covering thus new equipment, and when changes are made on
existing lines or to products. All CCP's identified must be monitored and corrective
action taken in case of deviation.

Hazard

A biological, chemical or physical agent in, or condition of, food with the potential to
cause an adverse health effect. (Codex)

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Hazard analysis

The process of collecting and evaluating information on hazards and conditions

leading to their presence to decide which are significant for food safety and therefore
should be addressed in the HACCP plan. (Codex)

NOTE: Hazard analysis is a crucial step in the implementation of an HACCP plan.

Must not be confused with risk analysis.

High care areas (see Zoning)

Hollow body

Void spaces, inaccessible to cleaning, which may become sources of contamination

Hygiene (see Food hygiene)

Hygiene areas – low, medium and high (see Zoning)

Hygienic equipment class I

Equipment that can be cleaned in-place and can be freed from soil without
dismantling.

Hygienic equipment class II

Equipment that is cleanable after dismantling and can be freed from soil after
reassembly.

Hygienic Integration

The process of combining or arranging two or more entities to work together for a
hygienic purpose.

I
Intended conditions of Use (see Conditions for intended use)

In-place cleanability (see also CIP)

The suitability to be easily cleaned without dismantling.

L
Low (Basic) care areas (see Zoning)

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M
Manual cleaning

Removal of soil when the equipment is partially or totally disassembled.

Mechanical cleaning
Shall denote cleaning, solely by circulation and/or flowing chemical detergent
solutions and water rinses onto and over the surfaces to be cleaned, by mechanical
means.

Medium care areas (see Zoning)

Membrane

A thin, flexible sheet of material forming a porous partition which may allow the slow
transfer of a liquid through it, such as cell-wall of a micro-organism.

Microbial impermeability
The ability of equipment to prevent the ingress of bacteria, yeasts and moulds from
the outside (environment) to the inside (product area).

Micro-organisms (pathogenic)

Micro-organisms that can cause disease/illness in humans and animals.

NOTE: Distinguish from indicator micro-organisms, whose presence indicate a failure

of a GHP. The number present is assumed to be related to the probability of
contamination of a product with a pathogen.

See also Relevant micro-organisms

Monitoring
The act of conducting a planned sequence of observations or measurements of
control parameters to assess whether a CCP is under control.

N
Non-absorbent materials

Materials which, under the intended conditions of use, do not internally retain
substances with which they come into contact.

Non-product contact surfaces

(See also Product contact surfaces)

All exposed surfaces other than those in contact – or potential – contact with product.

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Non-toxic construction materials

Materials which, under intended conditions of use, do not release toxic substances.

P
Pasteurization

A microbiocidal heat treatment aimed at reducing the number of any harmful micro-
organisms, if present, to a level at which they do not constitute a significant health
hazard.

NOTE: pasteurization applies to equipment as well as to food.

Product contact surfaces

All equipment surfaces that intentionally or unintentionally (e.g. due to splashing)

come in contact with the product, or from which product or condensate may drain,
drop or be drawn into the main product or container, including surfaces (e.g.
unsterilised packaging) that may indirectly cross-contaminate product contact
surfaces or containers.

NOTE: A risk analysis can help to define areas of potential cross-contamination.

R
Relevant micro-organisms
Micro-organisms able to contaminate, multiply or survive in the product and be
harmful to the consumer or product quality

Removable (see Easily or Readily removable)

Risk
A function of the probability of an adverse health effect and the severity of that effect,
consequential to a hazard(s) in food. (Codex)

Risk is 'the potential for the occurrence of unacceptable food safety deviations' but
may be extended to cover quality deviations.

NOTE: In Codex terminology 'risk' pertains to public health issues. It relates to safety
and not to quality related matters.

Risk analysis

A process consisting of three components: risk assessment, risk management and

risk communication. (Codex)

NOTE: Whereas Hazard analysis is under the responsibility of food

manufacturers, Risk analysis is a public health matter.

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Risk Assessment

Risk assessment is the scientific part of the risk analysis process in which the
hazards and risk factors are identified and the risk is calculated.

Apart from an end point calculation of risk, the risk model developed can be of value
in determining the parts of the chain which contribute most to risk or to investigate
the effect of changes in practices or processes throughout the chain on the risk level.

Risk assessment contains 4 elements:

- hazard identification which identifies particular hazards or contaminants in a

product or process

- exposure assessment which estimates the intake/exposure of the hazard by the

consumer

- hazard characterization which relates exposure to the hazard with a public

health effect (illness/ death) frequently by assessing the dose-response
relationship

- risk characterization which calculates the risk from the exposure (intake) and
dose-response estimate (effect).

Risk Management

Risk management is an evaluation of the acceptability of the risk posed and the
implementation of measures to reduce this risk if necessary.

Risk Communication

Risk communication involves transparent communication between the risk assessors

(scientists) and the risk managers (regulators, industry, government agencies etc.).
The results of risk assessment and risk management should be communicated more
widely to the relevant stakeholders, including consumers.

Risk zone (see Zoning)

S
Sanitation (USA)

Equivalent to hygiene in general terminology for the food industry.

Sanitizing or Sanitization (USA)

A process applied to a cleaned surface capable of reducing the numbers of the most
resistant human pathogens by at least 5 log10 reductions (99.999%) to 7 log10
reductions (99.99999%) by applying accumulated hot water, hot air, or steam, or by
applying an EPA-registered sanitizer according to label directions. Sanitizing may be
effected by mechanical or manual methods using hot water, steam, or an approved
sanitizer.

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Sanitizer (USA)

A substance that reduces the microbial contaminants on inanimate surfaces to levels

that are considered safe for public health. According to the official food contact
surface sanitizer test, a sanitizer is a chemical that reduces the microbial
contamination of two standard organisms, Staphylococcus aureus and Escherichia
coli, by 99.999% or 5 logs in 30 seconds, at 25°C. Non-food contact sanitizers must
reduce contamination by 99.9% or 3 logs in 5 minutes.

Soil

Any remaining, undesirable material in the equipment or process environment. It may

or may not contain micro-organisms.

Solutions

Water and/or those homogeneous mixtures of cleaning agents and/or disinfectants

and water used for flushing, cleaning, rinsing and disinfection

Splash contact surfaces

Non-product contact surfaces that during normal use are subject to accumulation of
soil and which require routine cleaning to avoid soil to drop or to be drawn into the
main product or container.

Sterilization

A process aimed at removing or killing all forms of micro-organisms, including

bacterial spores.

NOTE 1: In the US, commercial sterilization refers to the inactivation of all organisms
of significance to public health and the absence of spoilage under normal conditions
of storage.

NOTE 2: In the UK, still used to denote disinfection.

NOTE 3: Sterilization can equally apply to treatment of food.

Sterilization-in-Place

Sterilization without dismantling

Surface rupture

Breaking or tearing of a surface commonly the result of impact from a shot- or bead-
blasting medium. Under magnification the damage to the surface will generally
appear like fish scales, the openings under which face forwards the source of the
shot or beads. These areas can harbour soils and micro-organisms and be difficult to
clean.

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Surface treatment

A process whereby chemical or mechanical properties of the existing surface are

altered.

U
Ultra-clean process

A process using equipment disinfected before use, and which, in running conditions,
is protected against recontamination by micro-organisms that may harm the safety
and suitability of the specific product that is made.

NOTE: Measures for initial reduction of microbial load and against recontamination
can be less stringent than those applied for an aseptic process. Ultra clean or
Aseptic refers more to the process line and not the environment.

V
Validation

Obtaining evidence that the elements of the HACCP plan are effective. (Codex)

The obtaining of evidence that the food hygiene control measures selected to control
a specific hazard(s) in a specific food(s) are capable of controlling the hazard to the
level specified. (provisional Codex)

NOTE: In the context of ISO 9000-2000, this process is named qualification.

Validation is used in a much broader sense e.g. for validation of cleaning. Validation,
in general, intends to establish documented evidence, that a specific process will
consistently meet its predetermined objectives
In the case of a cleaning process: the objective is that the next batch of product,
which will be processed in the cleaned equipment, does not become contaminated
from any microbiological and chemical sources, foreign material or environmental
residues, having potential affect on the food contact surfaces

Verification
The application of methods, procedures, tests and other evaluations, in addition to
monitoring to determine compliance with the HACCP plan. (Codex)

NOTE: In the context of ISO 9000-2000, this process is named validation, a situation
that may lead to some confusion.
In a wider sense can represent: Activities, including auditing, reviewing, inspecting,
challenging, testing, checking etc., that demonstrate whether items, processes,
services or documents conform to specified requirements for quality, especially food
safety e.g. as seen in the HACCP plan.

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W
Wet cleaning
(Cleaning-out-of-place as opposed to CIP – see specifically CIP)

Can refer to cleaning of equipment or processing environment. Cleaning procedure

carried out only when product is not exposed and using methods that limit amount of
water applied and its spread. The main aim of wet cleaning is to remove soil that may
or may not contain micro-organisms.

NOTE: The objectives are basically to use as little water as possible and to be as dry
as possible rapidly after cleaning. This is a procedure specifically intended to reduce
risks of build-up of environmental Listeria monocytogenes populations in ice cream,
cheese and refrigerated product process areas.
Also referred to as Controlled wet cleaning.

Z
Zoning

The physical or visual division of the plant into sub-areas, leading to the segregation
of different activities with different hygiene levels.

Related terms and explanations. The following are proposals for use in EHEDG.

Controlled environment refers to all zoning but may relate more to the high hygiene
case.

Zoning cannot be defined for all plants and processes in black and white as there will
always be local influences that play a role. Most important is that zoning fits into the
overall plan of prevention with respect requirements of process and safety of
consumers.

High hygiene = high care or high risk

IDF states: a critical hygienic area within the plant where products and ingredients
vulnerable to contamination and/or microbial growth are processed, treated, handled
or stored.
An area within a plant's zoning plan where the following products and ingredients are
processed or stored – either those destined for a highly susceptible consumer group,
being instant in nature or ready for consumption, or those which will be handled in a
refrigerated supply chain and which are susceptible to growth of pathogenic micro-
organisms such as Listeria monocytogenes.

Note: The term “high risk area” could also be used for a zone where there is a high
concentration of pathogens e.g. in fresh meat and chicken, raw cocoa bean, fresh
raw milk and vegetable areas. These areas present a high risk for other process
areas and there should be adequate barriers to stop spread of pathogens.

High hygiene is equivalent for food to clean room.

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Medium hygiene = medium care or medium risk

Can be a process area for products, susceptible to contamination but where the
consumer group is not especially sensitive and where also no further growth is
possible in the product in the supply chain. Can also be the intermediate area leading
into the high hygiene zone but where access is only across certain barriers.

Low (Basic) hygiene = Low care or low risk

Low (basic) relative to others but where minimal GHP must be applied
Low (basic) hygiene areas can be sub-divided as proposed in EHEDG Doc. 26 on
dry materials.

An area where products are not susceptible to contamination and are protected in
their final packages. Can also be an area where raw materials are handled before
being subjected e.g to a thermal process step (a CCP).

Examples

Related to cleaning for total zoning, some examples are given in the table below but
these are certainly only guidelines. Each establishment must make its own
zoning plans based on product and consumer group, local influences and
legislation.

Sample zoning plan in relation to cleaning :

High hygiene Medium hygiene Low (Basic)

hygiene

Few cases e.g. Bottling areas Fresh/raw milk

(Controlled) wet Chilled pasta UHT filling reception
cleaning production Areas for ice- Mix preparation
cream and frozen prior to
food filling pasteurization
/assembly
Infant formula filling Filling of dry soups, Warehouses
Dry cleaning area coffee, chocolate
moulding

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References :

(1) 3-A Standards Organisation, http://www.3-a.org

(2) British Standards Institute. BS EN ISO 14698-1:2003 : Cleanrooms and

associated controlled environments. Biocontamination control. General
principles and methods. (http://bsonline.techindex.co.uk)

(3) British Standards Institute. BS 5283:1986 :Glossary of terms relating to

disinfectants (http://bsonline.techindex.co.uk)

(4) Codex CAC/RCP1- 1969, Rev. 3-1997, Amd. (1999) Recommended

International Code of Practice : General principles of Food Hygiene including
Annex on HACCP System. Downloadable version at :
ftp://ftp.fao.org/codex/standard/en/cxp_001e.pdf

(5) EHEDG Doc 26. Hygienic Engineering of Plants for the Processing of Dry
Particulate Materials, November 2003

(6) EN ISO 9000:2000. Quality Management systems. Fundamentals and

Vocabulary.

(7) IDF. International Dairy Federation/Fédération International de Laiterie,

Diamant Building, Boulevard Auguste Reyers 80, 1030 Brussels
www.fil-idf.org

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