Novartis Pharma ATEX Guide Version November 03

Novartis Pharma AG
Global Pharma HSE & BCP
Novartis Pharma ATEX Guide
A guide for the implementation of the

EU ATEX Directives in
Novartis Pharma AG
Novartis Pharma ATEX Guide, Version November 03.doc © SWISSI 2003

Novartis Pharma AG
Preface
ATEX 95 and 137 are two safety Directives of the European Union, named after the French
“ATmosphere EXplosive”.
Directive 94/9/EC of 23. March 1994 (ATEX 95, “Machine”, “Equipment” Directive) provides the
technical requirements to be applied to equipment intended for use in potentially explosive atmos-
phere. Thus equipment has to fulfill certain specification dependant on the use in explosion zones.
Directive 99/92/EC of 16. December 1999 (ATEX 137) lays down minimum requirements for im-
proving the safety and health protection of workers from explosive atmospheres. It requires classi-
fying work places where explosive atmosphere may occur in order to ensure protection against ex-
plosion.
New equipment must meet the requirements as from July 2003. Existing or second-hand equipment
is permissible if justified by appropriate risk assessment. If the user imports equipment from outside
the EU, he is required to meet the requirement of the Directive.
The Pharma Global HSE & BCP Management Meeting of June 03 decided to elaborate a Guide
supporting the implementation of ATEX 137 of the ChemOps / PharmOps sites in the European
Union. However, the principles of managing safety in areas with explosive atmospheres are gener-
ally applicable. The aim was to make optimal use of the safety standards and tools that are already
successfully implemented and applied within Novartis Pharma to avoid duplication of work.
We have asked the Swiss Safety Institute to elaborate such a Guide with us. The latter has also de-
veloped the Novartis Standards in this area. It is intended to supplement the Guide with further ex-
amples. Please feel free to submit examples to be included in the Guide. Likewise, any suggestions
and comments are welcomed.
Pharma Global HSE & BCP
October 2003

Novartis Pharma AG
Introduction................................................................................................................................... 1
Requirements ................................................................................................................................. 2
Target Date......................................................................................................................................
.................................................................................................................................... 2
Are you concerned? ....................................................................................................................... 3

How to implement the directive?……………………………………………………………..……...4
Annex 1 Explosive Atmospheres .............................................................................................. 5

1.1 Fuels and oxidizers..................................................................................................... 5
1.2 Flammable Gases ....................................................................................................... 5
1.3 Flammable Vapor....................................................................................................... 5
1.4 Combustible Powder .................................................................................................. 5
1.5 Hybrid Mixtures ........................................................................................................ 5
1.6 Aerosols, Mist ............................................................................................................ 6
Annex 2 Prevention of the formation of Explosive Atmospheres............................................ 7

2.1 Substitution of flammable or combustible substances .............................................. 7
2.2 Closed Handling......................................................................................................... 7
2.3 Ventilation.................................................................................................................. 7
2.4 Evacuation.................................................................................................................. 7
2.5 Inerting ....................................................................................................................... 7
Annex 3 Ex-Zones .................................................................................................................... 9

3.1 Special considerations concerning Zones 0 and 20 ................................................. 10
3.2 Ex-Zones in inerted equipment................................................................................ 10
3.3 Factors influencing the extent of Ex-Zones outside equipment .............................. 10
Annex 4 Ignition Sources........................................................................................................ 12

Explosive atmosphere ...................................................................................................... 12
4.1 Open Flames............................................................................................................. 12
4.2 Electrical Sparks ....................................................................................................... 13
4.3 Classified Equipment ............................................................................................... 13
4.4 Mechanical Sparks ................................................................................................... 13
4.5 Hot Surfaces ............................................................................................................. 14
4.6 Static Electricity........................................................................................................ 14
4.7 Chemical Reactions.................................................................................................. 14
Annex 5 Mitigation of explosion effects ................................................................................ 15

Novartis Pharma AG
5.1 Explosion pressure resistant construction ............................................................... 15
5.2 Explosion relief venting ........................................................................................... 15
5.3 Explosion Suppression ............................................................................................. 15
5.4 Explosion Isolation .................................................................................................. 15
5.5 Safety Compartments............................................................................................... 16
5.6 Hazard Zones........................................................................................................... 16
Annex 6 Documentation (Explosion Protection Document) ................................................. 17
Annex 7 Safety Management.................................................................................................. 19

7.1 Training and Instruction .......................................................................................... 19
7.2 Marking Ex-Zones ................................................................................................... 19
7.3 Preventive Maintenance ........................................................................................... 19
7.4 Work Permit System ................................................................................................ 19
7.5 Surveillance and Audits............................................................................................ 19
7.6 Management of Change........................................................................................... 19
7.7 Emergency Management .......................................................................................... 20
Annex 8 References................................................................................................................. 21
Annex 9 Examples .................................................................................................................. 22

9.1 Storage room for flammable liquids ........................................................................ 22
9.2 Sieving on an Oscillation Sieve: ............................................................................... 25

Novartis Pharma AG
Novartis Pharma ATEX Guide
Introduction
This Guide supports the implementation of the European Directive 1999/92/EC (ATEX137). It ap-
plies to all sites of NOVARTIS PHARMA in Europe. However, the general principles of managing
safety in areas with explosive atmospheres are applicable also in other regions.
The non-binding guide provides support in fulfilling the requirements of the Directive taking into
consideration concepts and tools that are traditionally applied in NOVARTIS PHARMA, such as
• ZHA Risk analyses
• the Worksheets to Guidance Note 3.1
• Evaluation of the Hazards in the Work Area according to Guidance Notes “Assignment of
Health Protection Measures for the Handling of Hazardous Substances” and “Workplace Health
Risks Assessment”
Thus it does not set new internal standards of it own; rather it shows how to combine established
rules and NOVARTIS working practice in order to fulfill the European Directive.
The main part of the Guide is a procedure to implement the directive. It is intentionally short, but
contains many references to some more extensive annexes, which you might wish to read when fol-
lowing the proposed procedure.
Requirements
Directive 1999/92/EC is addressed to employers operating establishments where explosive atmos-
pheres occur. It defines the following minimum requirements in order to improve the safety and
health of workers potentially at risk from explosive atmospheres:
• An explosion protection concept must be established to employees working in such areas.
• The concept must be based on a risk assessment and take into consideration the following priori-
ties:
1. Prevention of the formation of explosive atmospheres
2. Elimination of ignition sources
3. Mitigation of detrimental effects of an explosion
• The concept must be implemented and enforced
• The concept must be documented in an explosion protection document
The worksheets that support the implementation of NOVARTIS Guidance Note 3.1 provide a basis
for safety concepts that are in compliance with this EU directive. One should notice however, that for
a complex plant, the worksheets for each apparatus must be applied, and a separate safety concept
must be developed for equipment where there is no worksheet.
Where safety concepts are based on worksheets it is sufficient to refer to those in the explosion pro-
tection document (see Annex 6) and to add the details that are described in the worksheets in a ge-
neric way (e.g. details such as certificates of electric devices must be enclosed or specifications of
conductive footwear etc.)
Novartis Pharma ATEX Guide, Version November 03.doc © SWISSI 2003 page 1 of 27
Novartis Pharma AG
Target Date
The directive has come into force on June 30th, 2003. It must be implemented as follows:
Establishments in use The directive must be implemented until June 30th, 2006. Electrical
before June 30th, 2003: equipment must not be recertified, unless risk analysis shows that it
did not fulfill the requirement for Ex-Zones existing before June
30th, 2003
Establishments coming The directive must be implemented before operating the establish-
use after June 30th, ment. Electrical equipment must comply with EU directive 94/9/EG
2003:
Establishments being The directive must be implemented before operating the modified or
modified or extended extended establishment. Certification of equipment by a notified
after June 30th, 2003: body is required for use in Zones 0 and 20 and where electrical
equipment is involved. In all other cases, the certification can be
made by specialists employed or contracted by NOVARTIS.
Novartis Pharma AG
Are you concerned?

The directive applies to all establishments in EU countries1 where employees are exposed to a risk
due to explosive atmospheres. Excluded from the directive are:
• Areas for and during the medical treatment of patients
• Gas burners in house-hold scale
• Manufacture, handling, storage and transport of unstable substances
• Use of means of transport (e.g. car, train, ships etc.) except those intended for use in explosive
atmospheres (e.g. forklifts)
If any of the following conditions apply, your area may be subject to the directive and you should
further follow the procedure in chapter “How to implement the Directive”:
• There are permanently or temporary explosive atmospheres2 in your area of responsibility.
• You are handling flammable gas (pressurized or liquefied) in production scale (e.g. several cylin-
ders connected at a time).
• You are handling or processing flammable liquids at temperatures higher than the flashpoint mi-
nus a safety margin of 5°C.
• You are spraying combustible liquids.
• You are handling combustible powders, i.e. your area of responsibility is subject to Guidance
Note 3.1
Quantities that represent no hazard to human life are not subject to the directive. There is however
no clearly defined quantity limit in the ATEX directive.
Areas, where flammable liquids are handled in household- or laboratory scale, i.e. in containers be-
low 10L, should take precautions against explosions, such as limitation of container size depending
on the solvent properties, non-smoking rules, precautions against static discharges. However, the
definition of Ex-Zones and a formal explosion document are not required.
Pilot production or operations in large scale fume cupboards with vessels and containers above 50L
must be further assessed.
1
) Notice that other European countries (e.g. Switzerland) have harmonized their legislation with the EU, such that
similar requirements apply.
2
) see Annex 1
Novartis Pharma AG
How to implement the Directive?

1 Are you concerned ? NO STOP
YES
see Annex 1 2 Analyze the likelihood and the extension of the hazardous
areas with explosive atmospheres, both in normal opera-
tion and in case of credible malfunctions or equipment fail-
ures, taking into consideration, e.g.
• ventilation
• operations involving open handling
• inerting
see Annex 2 3 Eliminate explosive atmospheres as far as possible (e.g. by

ventilation, closed handling etc.)
YES No Explosion
4 Explosive atmospheres reliably eliminated ? Risk
NO à 10
see Annex 3 5 Define Ex-Zones
Risk Assessment
The explosion risk must be
see Annex 4 6 Analyze the likelihood and the effectiveness of ignition
identified in a systematic
sources, both in normal operation and in case of credible way [9]. As the exposure to
malfunctions or equipment failures, taking into considera- substances forming explo-
tion, e.g. sive atmospheres – at least
• Potential ignition energy / temperature of the source regarding those outside
• Flammability of the explosive atmosphere, as given by containers and equipment –
characteristics such as MIE, MIT, AIT, GLT. often has also adverse health
effects, it is recommended
to integrate the explosion
see Annex 4 7 Eliminate ignition sources, e.g. by risk assessment in the
• organizational measures such as: no-smoking, hot “Workplace Health Risks
work permit system, Assessment” or in overall
• using only equipment that is certified for the respective ZHA Process Risk Analy-
ses.
Zone
• reducing velocities of mechanical parts, etc.
YES Ignition Risk

see Annex 4 8 Ignition sources reliably eliminated to the extent required
under control
by the respective Ex-Zones ?
à 10
NO
see Annex 5 9 Provide protective or mitigating measures to protect em-
ployees against the effects of a possible explosion.
see Annex 6 10 Compile the explosion protection document, describing the

basis of safety (explosion protection concept)
11 Conduct an explosion protection audit in new plants to

check the full implementation of the explosion protection
concept. Document findings, conclusion and follow-up ac-
tions.
see Annex 7 12 Ensure the permanent reliability of the explosion protection

concept, e.g. by appropriate organizational measures.
References: see Annex 8

Examples: see Annex 9
Novartis Pharma AG
Annex 1 Explosive Atmospheres
1.1 Fuels and oxidizers

An explosive atmosphere consists of fuel and an oxidizing medium. In most cases, the fuel is some
organic combustible material and the oxidizing medium is oxygen (air). However, one should notice
that explosive mixtures are also formed with other combinations.
Fuels (examples) Oxidizers (examples)

flammable gases air
flammable vapour explosive oxygen
combustible powder atmosphere nitrogendioxide
metal powder dinitrogenoxide
combustible aerosol chlorine
combustible mist fluorine
1.2 Flammable Gases

Flammable gases mixed with air can be ignited if the concentration is in the explosion range. The ex-
plosion range lies between the lower explosion limit (LEL) and the upper explosion limit (UEL). The
minimum ignition energy may be lower than 1mJ, i.e. explosive mixtures with flammable gases are
extremely highly flammable. The values can be taken from literature [10].
1.3 Flammable Vapor

Vapors mixed with air can be ignited if the concentration is in the explosion range. The explosion
range lies between the lower explosion limit (LEL) and the upper explosion limit (UEL). Like flam-
mable gases, flammable vapors con be ignited even by very weak ignition sources. The values can be
taken from literature.
The temperature at which the vapor pressure of a combustible liquid is sufficient to produce a flam-
mable mixture with air is called the lower explosion point. This temperature is only slight higher
than the flashpoint of the material, measured in a closed cup. Therefore, when combustible liquids
are handled below the flashpoint(determined in a closed apparatus) no explosive mixture with air
can be formed.
1.4 Combustible Powder

Almost all organic powders can be ignited if they are dispersed in air (dust clouds) in a concentration
between approx. 15 and 6000 g/m3. Exceptions are e.g. Organic materials with high halogen con-
tent.
The minimum ignition energy of raised powder (dust) is in the order of 1 to 10‘000mJ. However,
some powders form dust clouds that can be ignited with energies of less than 1mJ.
On should notice that many powders release flammable decomposition gases when exposed to tem-
peratures where thermal decomposition is induced.
1.5 Hybrid Mixtures

Mixtures of air, combustible powder (dust) and flammable vapor or gas are called hybrid mixtures.
It is important to notice that such mixtures cane be ignited even when the individual concentrations
Novartis Pharma AG
of the dust one hand and the vapor (or gas) on the other hand are below the lower explosive limit!
The ignition energy of hybrid mixtures is mainly determined by the ignition energy of the vapor
(gas), which is by 1-4 orders of magnitude lower that that of the powder (dust). This dangerous ef-
fect can occur if the vapor (gas) concentration is as low as 25% of the LEL. Therefore hybrid mix-
tures may be formed in presence of flammable liquids at temperatures as low as 30°C below the
flashpoint of the liquid.
1.6 Aerosols, Mist

Explosive atmospheres involving combustible liquids may also be formed at temperatures far below
the flashpoint of the liquid, if the liquid is dispersed in small droplets (aerosols, mist). Such mixtures
can be ignited and can lead to explosions similar to dust explosions.
Novartis Pharma AG
Annex 2 Prevention of the formation of Explosive Atmospheres
2.1 Substitution of flammable or combustible substances

In view of achieving inherent safety, substitution of flammable or combustible substances by non-
combustible materials would be highly desirable, however, in practice this is rarely possible.
2.2 Closed Handling

Handling flammable or combustible substances inside closed containments such a vessels, hoppers
and receivers, which are connected with leak-proof pipes, ducts and where necessary with rubber
compensators will prevent the formation of explosive atmospheres in the work area, where the elimi-
nation of ignition sources (see below) is more difficult than inside the equipment.
The concept of closed handling comprises also the replacement of open sampling points (e.g. open
may ways) by special sampling devices that allow closed sampling.
2.3 Ventilation
By adequate ventilation, preferably at the source, flammable substances can be removed from the
working area und thus the formation of explosive atmospheres can be prevented or at least the ex-
tension of the dangerous area can be significantly reduced.
However one should notice that the ventilation system itself (including the filters and fans) is an area
where explosive atmospheres may be formed and therefore is subject to the directive.
The design of a ventilation concept in areas where explosive atmospheres could occur is quite a chal-
lenge: From point of view of explosion protection (and industrial hygiene) the air flow should always
be directed towards the possible source of the flammable material (e.g. an open man way). This im-
plies that production rooms should have a slightly lower pressure than the access corridors. However
from point of view of product quality, the airflow should be just in the opposite direction in order to
avoid contamination of pharmaceutical products with contaminants form outside.
A detailed description of the impact of ventilation systems on the extent of Ex-Zones is given in [7].
2.4 Evacuation
Working under reduced pressure will reduce the explosion risk. Firstly, the energy required to ignite
explosive mixtures at reduced pressure is much higher than at normal pressure, and below approx.
100 mbar no ignition is possible with ignition sources occurring in practice. Secondly, the possible
impact of an explosion starting at reduced pressure will be reduced, as the maximum explosion pres-
sure will decrease proportionally the initial pressure.
2.5 Inerting
By operating under inert gas (e.g. nitrogen), the formation of explosive mixtures can be avoided. In-
erting can avoid explosions of dusts, vapours and hybrid mixtures, but not decomposition or smoul-
dering of powder deposits.
• The level of residual oxygen should not exceed the experimentally determined Limiting Oxygen
Concentration of the respective explosive mixture, taking into consideration a safety margin of
2%.
• Inerting must be ensured in all locations and during all process phases where explosive mixtures
could be formed and relevant ignition sources can not be safely excluded.
• Inerting must be carried out according to validated procedures. A standard method [12] is
evacuation followed by refilling with inert gas. The number of necessary evacuation cycles de-
Novartis Pharma AG
pends on the residual pressure after evacuation, the residual oxygen content in the inert gas and
the permitted residual oxygen concentration. An alternative - less preferable - method is flushing
with inert gas.
• Where highly reliable inerting is required, the oxygen concentration must be monitored, prefera-
bly by oxygen meters. Monitoring the nitrogen flow after validation with an oxygen meter is a -
less reliable - alternative.
The operating manual for inerted plants must include instructions for the prevention of accidents due
to asphyxiation (e.g. when cleaning out the equipment, on control rounds, at discharge points).
Novartis Pharma AG
Annex 3 Ex-Zones
Where the formation of explosive atmospheres can not be reliably and permanently excluded, the
respective hazardous area has to be designated as an Ex-Zone, according to the following definitions:
Ex-Zone 0 An area in which a hazardous explosive atmosphere formed by vapor or gas in
air is present
− continuously or
− for long periods or
− frequently
air is likely to occur in normal operation.
air is not likely to occur in normal operation, and if it does occur, it will exist
for a short period only.
Ex-Zone 20 An area in which a hazardous explosive atmosphere formed by a dust cloud in
air is present
− continuously or
− for long periods or
− frequently
Dust layers of unknown or excessive thickness may be formed. Dust layers on
their own do not constitute a zone 20.
Ex-Zone 21 An area in which a hazardous explosive atmosphere formed by a dust cloud in
air is likely to occur in normal operation. Layers of combustible dust will in
general be present.
Ex-Zone 22 An area in which either
− a hazardous explosive atmosphere formed by a dust cloud in air is not
likely to occur in normal operation, and if it does occur, it will exist for
a short period only.
− accumulations or layers of combustible dust are present.
In general the Ex Zones 0, 1, 2 and 20, 21, 22 are found in the following areas. Inert gas blanketing
or natural or active ventilation that ensures a sufficient dilution of the combustible component could
justify classification in a less hazardous zone.
Zone 0 • inside containers, reactors and pipes containing flammable vapors (i.e.
liquids above their flashpoint)
• where open handling of flammable liquids occurs permanently or for long
periods (degreasing stations)
• in vent lines of containers, reactors and pipes containing flammable va-
pors
Zone 1 • inside pipes normally filled with liquids above their flashpoint
• adjacent to zone 0 where there is no separation (wall, siphon)
• at manholes of reactors containing flammable vapors
• at outlet points of venting or breathing lines of containers and reactors
containing flammable vapors
• at filling stations open handling of flammable liquids occurs
• in trenches and sumps below Zone 0 areas
Zone 2 • adjacent to zone 1 where there is no separation (wall, siphon)
• at outlet points of pressure relief systems of containers and reactors con-
taining flammable vapors and gases
• where spillages of flammable liquids or gases could occur
• around flanges and blind flanges of pipes containing flammable liquids or
gases
• around couplings of hoses, pipes and vapor return lines where flammable
Novartis Pharma AG
liquids are transferred

• in and around locations where flammable liquids or gases are stored
Zone 20 • inside silos, containers, reactors, dryers, mixers and ducts where combus-
tible powder is handled in explosive concentrations
• where open handling of combustible powder occurs permanently or for
long periods
• in vent lines of containers, reactors and pipes containing combustible
powder up to the filter
Zone 21 • adjacent to zone 20 where there is no separation
• at openings for filling combustible powder into containers or reactors
• at unloading chutes of containers for combustible powder
• at outlet points of venting or breathing lines of containers and reactors
containing combustible powder
• inside silos, containers, reactors, dryers, mixers and ducts where combus-
tible powder is normally handled below or above explosive concentra-
tions, i.e. where explosive concentrations prevail only for short time
Zone 22 • adjacent to zone 21 where there is no separation
• where layers of combustible powder could be raised to form an explosive
atmosphere
• where spillages of combustible powder could produce dust clouds
• in vent lines of containers, reactors and pipes containing combustible
powder on the clean air side of the filter
3.1 Special considerations concerning Zones 0 and 20

As a rule, no permanent explosive mixture, i.e. Zone 0 or 20, is tolerated outside equipment (e.g.
outside vessels, containers, pipes and ventilation ducts), first due to the health hazards associated
with chemical substances: The exposure limits for most combustible media are in general much lower
than the lower explosive limits. Second, because it is - in most cases - impossible to reliably eliminate
even very rare ignition sources - as required in permanent Ex-Zones 0 and 20
3.2 Ex-Zones in inerted equipment

Inert gas blanketing is the most frequent method to eliminate explosive atmospheres. Containers and
other areas that had to be classified as Zone 0 or 20 without inerting can be classified as Zone 1 or
21, respectively, if the inert conditions are permanently and reliably [8] controlled.
3.3 Factors influencing the extent of Ex-Zones outside equipment

• The Source of flammable substances
o Quantity, concentration and release rate
With increasing quantity, concentration and release rate of the flammable substance the
extent of a potential explosive atmosphere will increase. The release of a flammable sub-
stance (vapor, gas) depends on
§ the size of the leak/opening
§ the pressure und which the flammable substance is processed
§ the viscosity of the substance
• (Secondary) Containment
The dispersion of explosive atmospheres is effectively limited by continuous walls, whereas
doors, windows etc. are to be considered as sources for the adjacent area.
• Physical properties of the flammable substance
o Density: Powders and high density vapors and gases will preferably be dispersed along the
floor, whereas light gases such as hydrogen will accumulate below the ceiling.
Novartis Pharma AG
o Temperature: With increasing temperature the vapor pressure of the hazardous substance
will increase and the density will decrease its density and viscosity.
o Viscosity: Highly viscous media will have a lower release rate and thus produce a smaller
explosive volume compare to low viscous media having otherwise the same properties.
o Explosion range: Substance with having a low Lower Explosive Limit (LEL) will in gen-
eral lead to larger explosive volumes
• Ventilation
By effective ventilation the formation of explosive atmospheres can be prevented or their extent
and persistence can be significantly reduced. See [7]
Novartis Pharma AG
Annex 4 Ignition Sources

Ignition sources have to be systematically identified and then eliminated to the extent as defined in
the table below:
The assessment of ignitions sources includes
• Likelihood, frequency and duration of occurrence
• Energy in relation to the minimum ignition energy of the explosive mixture to be expected
Explosive atmosphere
occurs continuously or for long

is likely to occur in normal op-
eration; if it occurs it will exist
is not likely during normal op-
only for a short period
periods or frequently
does not occur
eration
Zone none 2/22 1/21 0/20
Ignition source ò ò ò ò
A. occurs during normal operation
B. does not occur during normal operation but

only as a result of rare malfunctions
C. does not occur during normal operation but

only as a result of very rare malfunctions
D. does not occur
acceptable
not acceptable
The following types of ignition sources are considered systematically:
4.1 Open Flames

Open flames are very powerful ignition sources that can ignite all kinds of explosive mixtures. In ex-
zones welding is therefore permitted only if precautions as defined in the work permit form are
taken. Non-smoking rules have strictly to be followed.
Novartis Pharma AG
Where open flames are part of the process (e.g. gas flames in spray driers, combustion units in off-gas
incineration units), these must be location outside ex-zones, and measures must be take to avoid the
transfer of embers from these unit into ex-zones.
4.2 Electrical Sparks

Electrical sparks are avoided by ensuring proper mounting and maintenance of electrical installa-
tions. In ex-zones, only classified electrical equipment must be used, unless a respective work permit
allowing the used of other equipment for a specified period of time under defined precautions.
4.3 Classified Equipment

According to EU directive 94/9/EG, equipment is classified into the following categories:
Category G 1: for Zones 0,1 and 2 for mixtures of gas, vapor or mist with air
Category D 1: for Zones 20, 21 and 22 for mixtures of dust with air
Category G 2: for Zones 1 and 2 for mixtures of gas, vapor or mist with air
Category D 2: for Zones 21 and 22 if designed for mixtures of dust with air
Category G 3: for Zone 2 for mixtures of gas, vapor or mist with air
Category G 3: for Zone 22 if designed for mixtures of dust with air
In new installations, electrical equipment should therefore be used in hazardous places only if it com-
plies with the relevant standards.
Example of an Ex-Label (some parts of this general structure do not apply in all Zones):
II G 2 EEx ib IIC T3
Lagel of the notified body,
Gas Group, reflects MSG

see EN 50015-21, 50028
Temperature Class, indi-

Equipment Group (II for
Equipment category, see
cates maximum surface
T1=450°C; T2=300°C;
T3=200°C; T4=135°C;
G for gas/vapor; D for
and graphic Ex-Label
T5=100°C; T6=85°C
the process industry)
Protection type,
temperature:
and 50039
and MIC
above
dust
4.4 Mechanical Sparks

Mechanical sparks are caused by friction or impact. Maintenance work (cutting, drilling) in ex-zones
is therefore only permitted if the formation of explosive mixtures during the work is excluded by ap-
propriate organizational measures, to be specified in the respective work permit system. Equipment
with moving mechanical parts (e.g. fans, conveyors) in ex-zones must be specially classified. While
relative velocities between moving below 1m/s produced no dangerous mechanical sparks, there is
always an ignition risk above 10m/s. Between 1 and 10m/s there is an ignition risk if the minimum
ignition temperature MIT is lower than the following values depending on the minimum ignition en-
ergy MIE3.
MIE (mJ) <3 3-10 10-30 30-100 100-300 300-1000 >1000
MIT (°C) any <500 <465 <430 <395 <360 <325
3) determined with inductance
Novartis Pharma AG
4.5 Hot Surfaces

The maximum temperature of surfaces in ex-zones must not exceed either of the following values,
depending on the type of explosive atmosphere that is involved:
• gases: - 0.8 times the auto-ignition temperature of the gas in °C

(the factor 0.8 does not apply for Zones 1 and 2, this safety factor is al-
ready taken into consideration in the T-classes as listed in 4.3)
• vapors: - 0.8 times the auto-ignition temperature of the respective liquid in °C
(DIN 51794) (the factor 0.8 does not apply for Zones 1 and 2, this safety
factor is already taken into consideration in the T-classes as listed in 4.3)
• dusts: - the self-ignition temperature of a dust layer with a thickness representative
for the process (the maximum being the self ignition temperature of a 5mm
layer – 75°C) AND
- 2/3 of the minimum ignition temperature of the dust cloud in °C (measured
in a Godbert-Grenwald-Test)
In processes involving moving mechanical parts, the formation of hot spots by friction must be
avoided e.g. by regular maintenance, lubrication, active cooling or temperature control for bearings.
See also T-Classes (section 4.3).
4.6 Static Electricity

Hazardous static discharges are avoided by properly grounding/earthing all conductive equipment,
including mobile items (hoppers, funnels, shovels, trolleys). Where flammable gases, vapors or dusts
having a minimum energy below 30mJ are handled, plant operators have to wear antistatic shoes and
must be grounded via conductive floors.
Because non-conductive items can not be grounded/earthed and therefore charge may accumulate on
such items, non-conductive surfaces in Ex-Zones 0, 1, 20* and 21* are eliminated or limited in size:
Zone 0 Zone 1 Zone 20 Zone 21
Maximum area of non-conductive surfaces (cm2) 25 100 *250 *500
Maximum area of non-conductive surfaces sur- 25 400 *1000 *2000
rounded by a grounded conductive frame (cm2)
Maximum area of bent non-conductive surfaces, e.g. as above as above *as above *as above
collars (applies to largest parallel projection)
Maximum diameter of non-conductive elongated 3 30 - -
structures (pipes, cables) (mm)
*) only if the minimum ignition energy is <3mJ
Charge can be accumulated on non-conductive liquids or powders. Therefore special precautions are
required to avoid ignition of explosive atmospheres where such materials are handled. If the bulk re-
sistivity of a powder is >1010Ohm⋅m discharges between a pile of such a powder to the earthed wall
of the container may occur (cone discharges, see worksheets to GN 3.1)
4.7 Chemical Reactions

Self-ignition of dust layers is the most frequent type of chemical reaction that could lead to dust or
vapour explosions. Heaps or layers of powders must therefore never be exposed to temperature near
the self-ignition temperature. Where powders are exposed to mechanical or thermal impact (milling,
drying) that could result in smoldering fires, precautions must be taken to avoid that smoldering
lumps are not transferred into ex-zoned areas.
Novartis Pharma AG
Annex 5 Mitigation of explosion effects
Design of protective measures must be made on the basis of safety data (K-values) by specialists
following acknowledged codes. As a standard, design should be made for K values up to 299 bar
ms-1. Lower specifications are allowed, provided it is shown that only products with K-values up
to the design value are handled. Effects of solvent in the mixture on the K-value are to be consid-
ered.- The design documentation must be available.
5.1 Explosion pressure resistant construction

An explosion pressure resistant apparatus is designed in accordance with a pressure vessel code. Such
an apparatus will sustain an internal explosion without permanent deformation and without damage
due to material fatigue of components.
A less expensive option is the explosion pressure shock-resistant construction. In this case the appa-
ratus is designed to sustain the pressure of an internal explosion without rupture; however, small,
localized deformations may appear which are permanent. A special test is required after an explosion
to determine whether the apparatus can be reused without repair.
5.2 Explosion relief venting

A relief vent permits part of the pressure generated by an explosion to be vented to the open either
directly or via relief ducts. The apparatus must have sufficient mechanical strength to withstand the
reduced explosion pressure without being ruptured or deformed. Relief venting into a working room
is not permitted, or requires special discharge equipment (quenching tubes). With this mode of pro-
tection, problems with regard to toxicity and to environmental pollution may arise.
It must be ensured that the relief device is indeed the weakest part of the system. The required pres-
sure shock resistance has to be ensured by the supplier of the apparatus either by acknowledged
model calculation or experimentally.
Special attention has to be given to the strength of door latches and sight glasses and to sufficient
strength of the connection between the top of the drier and mobile product containers that are in-
serted into the fixed part for operation.
Old equipment is often not sufficiently pressure shock resistant for standard design. Nevertheless,
relief venting can be designed and installed even for such systems by qualified specialists.
5.3 Explosion Suppression

Pressure sensors will detect a beginning explosion in a very early stage and activate the injection of a
suitable extinguishing medium, thus suppressing the explosion before the pressure can reach a dan-
gerous level.
Suppression systems consist of sensors, a central control unit, emergency power from batteries, HRD
(high rate discharge) extinguishers and nozzles. Integrated systems are commercially available. As a
rule, 2 sensors are combined in a duo circuit to avoid false activations.
The HRD cylinders contain an extinguishing powder on the base of ammonium phosphate, under a
nitrogen propellant pressure of 60 bar or 120 bar. The powder is released through rapid action
valves, which are activated electronically.
5.4 Explosion Isolation

Particular attention should be given to explosion isolation measures against the propagation of an
explosion up- and downstream. Some filters, in particular cassette filters withstand, a dust explosion
on the dust side and act as flame arrestors to the clean air side. When using this as protective ele-
ment, respective test certificates should be available.
Novartis Pharma AG
5.5 Safety Compartments

Small equipment may be installed in a room where during operation and possible formation of ex-
plosive atmospheres, no operators are present (remote control). The safety compartment must be suf-
ficiently large such that the explosion pressure to be expected will cause no damage to the walls.
Combustible material, except for the processed substance must be removed from the safety com-
partment.
This protection concept is applicable only, where no flammable vapours are involved.
5.6 Hazard Zones

Around small equipment (e.g. up to volumes of 200L) hazard zones (typical extension 3-5m) may be
defined, where during operation and possible formation of explosive atmospheres, no operators are
present. As in this approach small explosions in the room are possible, it must be sufficiently large
such that the explosion pressure to be expected will cause no damage to the walls. The hazard zones
must be designed such that areas outside are safe Combustible material, except for the processed sub-
stance must be removed from hazard zones.
This protection concept is applicable only, where no flammable vapors are involved.
Novartis Pharma AG
Annex 6 Documentation (Explosion Protection Document)
The recommended layout given below for an explosion protection document follows ref [3].
It is important to notice that reference to existing documents (e.g. management manuals, corporate
and divisional guidelines, manuals of equipment and SOPs) can and shall be made where possible. A
hierarchical structure (site/plant/equipment) will reduce paperwork, as topics treated on a higher
level can be referenced to in equipment-specific documents. Example: The site emergency organiza-
tion must not be described in detail in the documents for each plant.
Header Information
• Identification Code
• Version
• Company, Site, Plant, Equipment, Area
• Names of author and person in charge of approval
• Date of creation / modification
General Site Safety Management
• Safety Management System
• ESHA Organization, in particular on site level
• Emergency organization, in particular on site level
• Safety relevant infrastructure (e.g. nitrogen supply)
Organization
• Organization chart (plant)
• Responsibilities
• Staff, Qualification
Buildings and topography
Documentation of the buildings and topography may be in graphic form: e.g.
• location plan
• layout plan
• building or plant ventilation
Specification of the process step and activities to be assessed
• The process can be described in the following ways:
• textual description
• process flow chart and
• layout plan.
• The outline of the process should contain all information that is important for explosion pro-
tection.
• Description of the operational steps including
• overview of design and operational data (e.g. temperature, pressure, volume, throughput, ro-
tational speed, equipment)
• startup and shutdown
• cleaning
• maintenance
• process or product changes
Flammable substances
• identification (name)
• quantity
• safety data
Novartis Pharma AG
Review of the possible hazards

This section states the results of the risk assessment discussing
• the possibility of hazardous places' occurring (zoning) and
• the possible sources of ignition
• the possible effects of an explosion
for
• normal operation
• startup and shutdown
• cleaning
• maintenance
process or product changes
Safety Concept
This chapter is based on the risk assessment and describes the resulting choice of safety measures.
• Technical measures
• Avoid the occurrence of explosive atmospheres, e.g.
o inerting
o ventilation
o working below flashpoints
• Avoid the occurrence of effective sources of ignition, e.g.
o Use of equipment classified for the use in ex-zones (fixed and mobile items): specify cate-
gory, temperature class, type of protection, explosion group
o earthing, grounding bonding to avoid static discharges
o conductive footwear or gloves to avoid static discharges
o Lightning protection
• Avoid or mitigate hazardous effects e.g
o Explosion-resistant design
o Explosion relief
o Explosion suppression
o Explosion decoupling
• Organisational measures, including the respective responsibilities e.g.
o operating instructions
o operator training
o servicing and maintenance
o permit-to-work systems
o management of change
o escape routes
o alarm and emergency organization
o emergency installations
Annexes
The annexes may contain e.g.
• EC type-examination certificates
• safety datasheets
• operating instructions for plant or equipment
However, it may also consist only of references indicating where this information is to found in the
company records.
A template is enclosed to this guide.
Novartis Pharma AG
Annex 7 Safety Management
7.1 Training and Instruction

Employees involved in activities in ex-zones (e.g. operators, maintenance staff, contractors) must be
clearly instructed in the rules that apply in ex-zones. In particular they must be familiar with the or-
ganizational measures taken to avoid ignitions sources, measures to be taken in case of process devia-
tions and in case of an emergency. Pre-campaign meetings, regular safety meetings or instructions,
safety workshops are possible measures to transfer and maintain the necessary know-how.
7.2 Marking Ex-Zones

Ex-Zones have to be clearly marked in the plant. The official sign is a yel-
low triangle with black frame and the letters “Ex” inside. The EU-member Ex
states may define additional requirements.
7.3 Preventive Maintenance

Preventive maintenance is an important contribution to plant safety. It ensures that equipment and
control units function reliably and according the specification. Preventive maintenance is particularly
important for safety critical devices (SAMACO), such as oxygen sensors, gas detectors, temperature
alarms, as well as for systems, which are in place to mitigate explosion effects, such as explosion sup-
pression systems.
7.4 Work Permit System

In order to safely carry out non-routine work in areas, where explosive atmospheres may occur, a
work permit system must be implemented. The work permit system shall ensure that
• Workers and contractors are aware of the risk associated with the work to be carried out and
take the necessary precautions, in particular with respect to introducing potential ignition sources
into Ex-Zones
• Responsibilities before during and after completion of the work are clearly assigned
• Persons affected by the work are appropriately in formed
• Equipment or systems on which the work is done are safely isolated
Work Permits shall be given in written form.
7.5 Surveillance and Audits

The technical and organizational safety measures must be controlled on a regular basis, e.g. on plant
tours by the plant manger or supervisor. Findings must be documented and necessary corrective ac-
tion must be done in due time.
Independent and competent external auditors should do more fundamental audits. Findings must be
documented and corrections be made based on a follow-up action plan.
7.6 Management of Change

Changes in the process or modification in the plant require an update of the explosion risk analysis
and a revision of the explosion protection document. There should be a formal procedure in place for
changes, which ensures that the necessary updates in the protection concepts are implemented before
starting the changed process or using the modified equipment.
Novartis Pharma AG
7.7 Emergency Management

Alarm- and emergency plans must be in place to ensure, that in case of a fire or explosion, the emer-
gency forces are alarmed immediately and that injured persons benefit from competent medical treat-
ment as fast as possible.
Novartis Pharma AG
Annex 8 References
1. ATEX 137: Directive 1999/92/EC of the European Parliament and the council of December 16,
1999 on minimum requirements for improving the safety and health protection of workers poten-
tially at risk from explosive atmospheres.
2. ATEX 95: Directive 94/9/EC of the European Parliament and the council of March 23, 1994 on
the approximation of the laws of the Member States concerning equipment and protective sys-
tems intended for use in potentially explosive atmospheres.
3. Guidelines on the application of council directive 94/9/ec of 23 march 1994 on the approxima-
tion of the laws of the member states concerning equipment and protective systems intended for
use in potentially explosive atmospheres
4. EN 13461: Non-electrical equipment for potentially explosive atmospheres, January 2002
5. EN 50015-21: Electrical equipment for potentially explosive atmospheres
6. EN 1127: Explosive Atmospheres - Explosion prevention and protection - Basic Concepts, 1997
7. EN 60079-10: Electrical equipment for use in explosive atmospheres, part 10: Classification of
hazardous areas
8. IEC 61508- Functional safety of electrical/electronic/programmable safety related systems
1998/2000
9. RASE: Methodology for the Risk Assessment of Unit Operations and Equipment for Use in Po-
tentially Explosive Atmospheres; EU Project No: SMT4-CT97-2169; March 2000
10. K.Nabert, G.Schön: "Sicherheitstechnische Kennzahlen", Deutscher Eichverlag, Berlin 1963 and
Supplements up to 1990.
11. Schweizerische Unfallversicherungsgesellschaft SUVA: Merkblatt 2153 "Explosionsschutz", 2003
12. ESCIS Booklet Nr. 3: "Inerting", 1994
Novartis Pharma AG
Annex 9 Examples
9.1 Storage room for flammable liquids

In a storage room, flammable liquids are kept for laboratory use. The inventory consists of:
• 6 100L-drums containing acetone, toluene, hexane, methanol, ethanol and diethylether.
• A safety cupboard containing about 15-25 bottles (glass and plastic) with up to 2Liters of various
other flammable and combustible liquids.
The room is ventilated with an exchange rate of 4/hour. It is also equipped with a gas detector that
will trigger an alarm, when 25% of the LEL is reached (calibrated for propane).
Flammable liquids are removed from the room either by taking out bottles from the cupboard or by
filling portable containers such as metal or plastic cans. There is no NOVARTIS Standard Safety
Concept for this case; therefore the risk assessment is made:
Safety Data: (see [10])

Name Qty Flpt AIT LEL MIE ?
(kg) (°C) (°C) (mJ) (Om)
Ethanol 100 12 425 3.5% 106
Methanol 100 11 455 5.5% 0.14 106
Diethylether 100 <-20 170 1.7% 0.19 1013
Hexane 100 <-20 240 1.2% 0.24 1013
Toluene 100 6 535 1.2% 1013
Acetone 100 -19 540 2.5% 1.15 105
x
Zone 0
Zone 1
1m
Zone 2
1m
Risk Assessment
Areas where explosive atmospheres may occur (Ex-Zones)
Novartis Pharma AG
During normal operation, explosive atmospheres are formed

• permanently or for log periods inside drums and cans.
• when employees are filling cans with flammable liquids from drums.
• in the trip tray below the drums, as inevitable some drops of flammable liquid will fall
there after each transfer operation.
• when the cover is removed from the bung hole and is replaced by a valve.
The following rare malfunctions or operator errors will also lead to explosive mixtures:
• Opening the valve before inserting the flexible tube into the can.
• Leaving the valve open after transfer
• Leak of the valve or of the flexible hose
• A leak of a bottle inside the safety cupboard will also lead to an explosive atmosphere.
The following very rare malfunctions will lead to an explosive atmosphere:
• A leak in a drum causing a pool in the entire room
• Breaking a glass bottle when transferring it from the cupboard into the safety bucket.
The persistence and extension of these explosive mixtures is limited by the permanent venti-
lation of the room. The formation of the explosive atmosphere will be detected in an early
stage and the fire brigade will be alarmed.
Novartis Pharma AG
Ignition Source Occur- Ex- Remark

rence Zone
Smoking D 1, 2 Non-smoking rule strictly en- 1
forced
Welding, cutting D 1, 2 Only allowed based on work 2
permits
Electric light switch D 2 Certified for zone 2, T4 3
Electric spark (lamp) D 2 Certified for zone 2, T3 4
Gas detector D 2 Certified for zone 1, T4 5
Hot surface (lamp) D 2 Certified for zone 2, T3, Di- 6
ethylether requires T4
Heating D 2 This is a water heating, the 7
maximum temperature is inher-
ently limited to 100°C
Mechanical sparks (falling metal C 1 Coincidence of an explosive mix- 8
objects) ture and a falling object is
unlikely
Spark discharge from ungrounded B 1 Lab technicians have no safety 9
operator to earth shoes
Spark discharge from ungrounded C 1 Grounding cable and clap are 10
can to earth ready for use
Brush discharge from plastic cans A 1 Plastic cans up to 10L are still in 11
use
Brush discharge from flexible plas- D 1 Dimension of tube (diameter 12
tic tube 6mm) not sufficient to cause
hazardous discharges
Brush discharge from non- B 0 Experience shows (car tanks) 13
conductive liquid to can that vapour concentration are
above UEL where theses dis-
charges occur
Zone none 2/22 1/21 0/20

Ignition Source ò ò ò ò
6 11 13
A Occurs during normal operation
9
B Does not occur during normal operation but only
as a result of rare malfunctions
8,10
C Does not occur during normal operation but only
as a result of very rare malfunctions
1,2,3,4, 1,2,11
D Does not occur 5,7,
Conclusion:
In addition to the existing safety concept: the following measures must be taken:
1. Lab technicians must be properly grounded during operation.
2. Plastic cans must be banned
3. The lamp must be replaced by one fulfilling requirements of Zone 2. As an alternative, limiting
Zone 2 to the lower part of the room is an option (line “x”)
Novartis Pharma AG
9.2 Sieving on an Oscillation Sieve:

A tablet mixture is sieved using an oscillation sieve. The solid is manually loaded into the receiver
from 20L Plastic bags. After sieving, the powder is fed into 50L Metal drums with plastic bags inside.
The room is not yet classified as Ex-Zone, because no flammable liquids are handled.
Safety relevant information:
a) Equipment:
The sieve has been in use for 8 years, no certificate according to ATEX is available.
There is no interlock preventing to run die sieve without any powder loaded.
b) Tablet mixture:
The tablet mixture does not contain any flammable solvent. The NOVARTIS Basis Data Set is avail-
able. The reference can be made to the respective test report (see page 26).
Risk Assessment and Safety Concept
The Safety Concept of Worksheets 4.1 (Sieve) and 5.1 (Filter) to Guidance Note 3.1 is fully imple-
mented. Instead of the detailed risk assessment, reference is made to the implementation list of these
Worksheets (the example for the sieve is shown below).
Based on the Test data, the powder is classified into Risk Group B.
Implementation of required Safety Measures (Numbers refer to the Worksheet 4.1)
1 The mechanical integrity of the sieve is regularly checked within the SAMACO program
2 The action to be taken in case of blockage is described in in SOP 415-03.
3 Ex Zones have been assigned, see page 27
The electrical equipment is not formally certified for the use in Ex-Zones. It is however
dust tight (Sieve control panel and motor IP 65, fan IP 54). Furthermore, surface tem-
peratures above 50°C (i.e. temperatures at which surface can not be touched for long du-
ration with unprotected hand have never been observed. The surface temperature of the
drives of the sieve and of the fan have been measured after 1h under full load: Values of
38°C for the sieve and of 32°C for the fan were observed. The plant is aware that after
modification or replacement of the equipment, certification is required.
4 Does not apply
5 The sieve and all mobile equipment is grounded.
6 Does not apply: MIE is 30 mJ
7 Does not apply: The diameters of the receiver and of the drum are smaller than the
critical diameter d = 0.612 x MIE 0.297 x M-0.435=5.9m !
8 Does not apply
9 Does not apply
10 Metal drum 50L with plastic bag permitted. Drum is grounded.
12 Does not apply
13 No non conductive liner in the sieve
14 Does not apply: MIE >3mJ
15 Does not apply: sieve run in batch mode
16 Does not apply: powder does not deflagrate
17 The protection concept for small equipment (bench scale equipment is applied) with a
clearly designated hazard zone (see scheme to item 3)
18 Protective measures as implemented in measure 17 are required for the combination of
MIE=30-100mJ and MIT=390°C.
Novartis Pharma AG
Tablet Mixture X-15

Test Report 206231-03-8213-01
BASIC TEST SET FOR POWDERS

Company: NOVARTIS Sample: Table Mixture X-15
Site: Basle ID No. 999999.99
Requester: B.Miller Batch: 15/2003
Decomposition gas: Flammable gas detected at: 160ºC

(10L gas / kg substance at 350ºC)
Combustibility Test: Combustibility Index at 20ºC: 2

Combustibility Index at 100ºC: 5
Falling Hammer Test: NEGATIVE, no detonation
Dust Explosion Test: POSITIVE

(mod. Hartmann Tube)
Ignition Temperature: 390ºC

(airborne dust, BAM)
Particle Size Median Value 55?

(Laser diffraction) Residue on sieve > 63? 32%
Decomposition Test
(Lütolf test, open tube), (dynamic, 1st exotherm at: 190ºC
2.5C/min) dTmax 29ºC at 210ºC
(Grewer test, air stream), (dynamic, 1st exotherm at: 180ºC

1C/min) dTmax 40ºC at 220ºC
(RADEX, open tube), 8h-long-term temp. (LZT): 160ºC

(isoperibiolic) autocatalytic decomposition: NO
OPTIONAL TESTS
Bulk Resistivity: 6.1x1011 +/- 0.6x1011 Ohm m
Minimum Ignition Energy: 30mJ < MIE < 100mJ

(MIKE-3)
Spontaneous Decomposition NEGATIVE, at 70ºC

(Deflagration) Class: ----
Self-Ignition Temperature 230°C

(5mm layer)
Novartis Pharma AG
Work Place Situation:

Novartis Pharma ATEX Guide Version November 03

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Novartis Pharma ATEX Guide Version November 03

Uploaded by

Copyright:

Available Formats

Novartis Pharma AG

Global Pharma HSE & BCP

Novartis Pharma ATEX Guide

A guide for the implementation of the

Novartis Pharma ATEX Guide, Version November 03.doc © SWISSI 2003

Pharma Global HSE & BCP

Novartis Pharma ATEX Guide, Version November 03.doc © SWISSI 2003

Are you concerned? ....................................................................................................................... 3

Annex 1 Explosive Atmospheres .............................................................................................. 5

Annex 2 Prevention of the formation of Explosive Atmospheres............................................ 7

Annex 3 Ex-Zones .................................................................................................................... 9

Annex 4 Ignition Sources........................................................................................................ 12

Annex 5 Mitigation of explosion effects ................................................................................ 15

Novartis Pharma ATEX Guide, Version November 03.doc © SWISSI 2003

Annex 6 Documentation (Explosion Protection Document) ................................................. 17

Annex 7 Safety Management.................................................................................................. 19

Annex 9 Examples .................................................................................................................. 22

Novartis Pharma ATEX Guide, Version November 03.doc © SWISSI 2003

Novartis Pharma ATEX Guide

Are you concerned?

How to implement the Directive?

see Annex 2 3 Eliminate explosive atmospheres as far as possible (e.g. by

YES Ignition Risk

see Annex 6 10 Compile the explosion protection document, describing the

11 Conduct an explosion protection audit in new plants to

see Annex 7 12 Ensure the permanent reliability of the explosion protection

References: see Annex 8

Annex 1 Explosive Atmospheres

1.1 Fuels and oxidizers

Fuels (examples) Oxidizers (examples)

1.2 Flammable Gases

1.3 Flammable Vapor

1.4 Combustible Powder

1.5 Hybrid Mixtures

1.6 Aerosols, Mist

Annex 2 Prevention of the formation of Explosive Atmospheres

2.1 Substitution of flammable or combustible substances

2.2 Closed Handling

liquids are transferred

3.1 Special considerations concerning Zones 0 and 20

3.2 Ex-Zones in inerted equipment

3.3 Factors influencing the extent of Ex-Zones outside equipment

Annex 4 Ignition Sources

occurs continuously or for long

only for a short period

A. occurs during normal operation

B. does not occur during normal operation but

C. does not occur during normal operation but

D. does not occur

The following types of ignition sources are considered systematically:

4.1 Open Flames

4.2 Electrical Sparks

4.3 Classified Equipment

Gas Group, reflects MSG

Temperature Class, indi-

Equipment category, see

cates maximum surface

4.4 Mechanical Sparks

3) determined with inductance

4.5 Hot Surfaces

• gases: - 0.8 times the auto-ignition temperature of the gas in °C

4.6 Static Electricity

4.7 Chemical Reactions