GUIDANCE FOR IDENTIFYING AND MITIGATING DUST HAZARDS IN PHARMACEUTICAL

INDUSTRY
Authors: Steven I. Meszaros and Ron B. Sethi

INTRODUCTION

In pharmaceutical industry, all facilities that handle solid materials should conduct a dust hazard
analysis and prepare a risk assessment of the facility processes and equipment to ensure that specific
measures have been taken to mitigate fire and explosion hazards and safeguard the health and safety
of employees.

Dust explosion hazard exists when a combustible powder is present in a confined space. The presence
of following conditions creates the potential for a dust explosion.
Dust must be above the minimum explosive concentration of the compound (MEC)
It should be airborne
It should be in a confined space
There should be a source of fuel (such as O2 form air)
There should be source of ignition (such as electrical and electrostatic discharges, mechanical
energy, hot surfaces and flames, etc.)

OSHA'S NATIONAL EMPHASIS PROGRAM FOR DUST HAZARDS:

OSHA issued a new Directive No. CPL 03-00-006 on Oct. 18, 2007 for combustible dust explosion and
fire prevention. This directive contains policies and procedures for inspecting workplaces that create or
handle combustible dusts. In order to comply with this directive, each facility is required to make a
formal documented risk assessment of each applicable process step that involves the handling of
combustible dusts.

GUIDANCE:
Each facility should prepare an inventory of operations and processes that handle combustible dusts.
Each operation and process should have a formal documented risk assessment completed to evaluate the
adequacy of the layers of protection necessary. The facility risk assessment document should include the
following:
Explosion risks have been determined and assessed.
Adequate measures have been taken to mitigate the risk from explosive atmospheres.
Areas have been classified into zones for electrical hazard classification.
Workplace and work equipment, including warning devices, are designed, operated, and maintained
with due regard for safety.
Appropriate training has been provided, with respect to explosion protection, to those working in
places where explosive atmospheres may occur.
Work in hazardous places shall be carried out in accordance with written instructions issued by
Wyeth.
Procedures are in place to conduct risk assessment of the process when a Management of Change
(M.O.C) takes place.
The assessment must also document control measures that are used to address housekeeping in
both process and support utility areas
The risk assessment should clearly define layers of protection that are required for engineering,
administrative controls and operating procedures.
Existing Equipment and Processes: Each site with the help of a qualified person, should conduct a
formal risk assessment of existing equipment and processes to identify potential fire and explosion
 hazards from dust powders. This risk assessment should be documented. The document should
identify hazards, evaluate risks, and define safety measures. The risk assessment should clearly
define layers of protection that are required for engineering, administrative controls and operating
procedures. The assessment should also document control measures that are used to address
housekeeping in both process and support utility areas. The assessment should also include the
following:
Document the hazard properties of the powders being processed. If the required data is not
available, additional testing should be done to obtain this information.
Areas should be classified into zones for electrical classification in accordance with NFPA standard
499 and article 500 of National Electrical Code (NEC).
Determine the risk and explosion severity for each piece of equipment in the process.
Where risk is identified, prepare an action plan to mitigate the risk for each piece of equipment.
Ensure a safe working environment and appropriate surveillance during the presence of workers in
accordance with the risk assessment.
New Equipment and Processes: The person responsible for the project at the site (Project Manager,
Project Engineer, Process Engineer, etc.) should review the design of new equipment and process
to identify potential fire and explosion hazards from dust powders. A formal risk assessment of
each equipment should be done and should be documented. The document should identify
hazards, evaluate risks, and define safety measures. The risk assessment should clearly define
layers of protection that are required for engineering, administrative controls and operating
procedures. The assessment should also document control measures that are used to address
housekeeping in both process and support utility areas. The assessment should also include the
following:
Document the hazard properties of the powders to be processed in the new facility. If the required
data is not available, additional testing should be done to obtain this information.
Areas should be classified into zones and electrical classification in accordance with NFPA standard
499 and article 500 of National Electrical Code (NEC).
Determine the risk and explosion severity of each piece of equipment in the process.
Design of equipment and process should include actions required to mitigate the risk for each piece
of equipment.
Ensure a safe working environment and appropriate surveillance during the presence of workers in
accordance with the risk assessment.

CONSIDERATIONS FOR EVALUATING HAZARD PROPERTIES OF POWDERS:

Most of the powders handled in the pharmaceutical industry are likely to be combustible and
should be handled with basic safety controls to minimize the risk of an explosion or fire. The
basic safety controls consist of the following:
Evaluating the hazardous properties of the powder
Controlling dust generation and accumulation
Eliminating ignition sources
Ensuring adequate fire and explosion protection mitigation has been provided during handling and
for equipment. Protection may include, but is not limited to venting, suppression, isolation, etc.
Minimizing flame propagation and damage

TESTING FOR HAZARD PROPERTIES AND DETERMNING LEVEL OF RISK:

For initial screening, the following tests are recommended.
Minimum Ignition Energy (MIE)
Minimum Ignition Temperature (MIT)
Thermal Stability
Explosion Severity (Kst)
Note regarding minimum explosive concentration (MEC): Most of the active pharmaceutical
ingredients and excipients used in the pharmaceutical industry have minimum explosive
concentration (MEC) in the range of 25 to 60 grams/m3. Therefore, it is not necessary to
test the sample for this parameter. However, if the MEC is used as a process control, then
the test is necessary to establish safe parameters.
From the results of these tests, the risk can be classified for the following categories according to
the values listed in the following Table.
Low risk: not sensitive, non-flammable or not very violent. No action required.
Medium risk: may require actions on a case-by-case basis.
High risk: requires actions.

Parameter Low Risk Medium Risk High Risk

Minimum Ignition
>100mJ 25-100mJ <25mJ
Energy (MIE)
Minimum Ignition
Temp. (MIT), Dust >500°C 300-500°C <300°C
Cloud

Explosion Severity, Kst <50 bar-m/s 50-200 bar-m/s >200 bar-m/s

Thermal Stability No Exotherm Exotherm>200°C Exotherm<200° C

For powders having an MIE of less than 25 mJ, the following additional tests are recommended:
a. Volume Resistivity
b. Charge Relaxation Time
If N2 inerting is to be considered for any process step, testing to determine Limiting Oxygen
Concentration (LOC) should be performed. For products that are going to be processed in
tableting machines, Impact Sensitivity Test (Fall Hammer Test) shall be considered.
The exact material that is to be handled/milled/granulated/dried in the operation should be tested
to obtain accurate results. Particle size, moisture content, etc., can significantly affect the data of
the laboratory tests. If the material being handled is a mixture, the mixture should be tested.
Minimum Ignition Energy Test – Dust Cloud
The Minimum Ignition Energy (MIE) Test determines the lowest spark energy capable of
igniting a sample when dispersed in the form of a dust cloud. The test is used primarily to
assess the potential vulnerability of powders and dusts to electrostatic discharges, but is
also relevant to frictional sparks.
Minimum Ignition Temperature Test – Dust Cloud
The minimum ignition temperature (MIT) test determines the lowest surface temperature
capable of igniting a powder or dust dispersed in the form of a dust cloud. The MIT is an
important factor in evaluating the ignition sensitivity of powders and dusts and is relevant for
defining the maximum operating temperature for electrical and mechanical equipment used
in dusty environments.
Minimum Explosive Concentration Test
The Minimum Explosive Concentration (MEC) Test determines the smallest concentration of
material in air that can give rise to flame propagation upon ignition when in the form of a
dust cloud. The test involves dispersing powder or dust samples in a vessel and attempting
to ignite the resulting dust cloud with an energetic ignition source.
Limiting Oxygen Concentration (LOC) Test
The Limiting Oxygen Concentration (LOC) Test determines the minimum concentration of
oxygen (displaced by nitrogen) capable of supporting combustion. An atmosphere having
an oxygen concentration below the LOC is not capable of supporting combustion and thus
cannot support a dust explosion. The LOC test is used to study explosion prevention or
severity reduction involving the use of inert gases and to set oxygen concentration alarms or
interlocks in inerted plant and vessels.
Explosion Severity Test (Kst)
This test is performed using the 20-Liter Sphere apparatus. A powder or dust sample is
dispersed within the sphere, ignited by chemical igniters, and the pressure of the resulting
explosion is measured. The sample size is varied to determine the optimal dust cloud
concentration. The maximum pressure and rate of pressure rise are measured and used to
determine the Kst value of the material. These data can be used for designing dust
explosion protection measures.
Volume Resistivity – Powder
Volume Resistivity is a measure of the electrical resistance for a unit volume of material, and
is the primary criterion for classifying powders and dusts as low, moderately, or highly
insulating. Insulating materials have a propensity to generate and retain electrostatic charge
and can produce hazardous electrostatic discharges when exposed to grounded plant,
equipment, or personnel.
Charge Relaxation Time – Powder
The rate at which the charge on a material relaxes or decays provides an indication of its
relative insulating or conductive character and serves as a useful companion measurement
to volume resistivity. A powder or dust sample is placed in a test cell, and charging the
sample using a corona source, measures its charge relaxation rate.
Thermal Stability Test (Bulk Powder Screening Test)
The purpose of this test is to simulate conditions in hoppers, silos, drums or bags and at the
bottom of dryers where material can collect in bulk. If the heat developed by a reaction of a
substance with oxygen or by exothermic decomposition is not lost rapidly enough to the
surroundings, self-heating leading to self-ignition can occur.
Thermal Stability Test (Aerated Powder)
The purpose of this test is to simulate conditions in process equipment in which a hot air
stream passes through the material. If the heat developed by a reaction of a substance with
oxygen or by exothermic decomposition is not lost rapidly enough to the surroundings, self-
heating leading to self-ignition can occur.
Powder Chargeability
Chargeability testing is conducted to determine the charge per unit mass of the material that
can be developed on the powder material during a pneumatic conveying operation,
blending, spray painting, poring, etc.
Impact Sensitivity Test (BAM Fall Hammer Test)
This test is used to assess the sensitivity of the test material to drop-weight impact. This test
is performed using the BAM Fall Hammer apparatus developed by the German Federal
Institute for Testing Materials (BAM).
HOUSE-KEEPING:
Each facility should have written procedures to keep the equipment and area clean and free of
dust. Special attention should be paid to interstitial spaces where dust can settle and form layers
over period of time. Examples of these areas are: structural members, conduit and pipe racks,
cable trays, floors, above ceiling, on and around equipment (leaks around dust collectors and
ductwork).
In OSHA's directive, a layer of 1/32" thickness over a surface area of at least 5% of the floor area
is considered a potential hazard for fire/explosion. Accumulation on overhead beams, joists,
ducts, tops of equipment and other surfaces should be included when determining the dust
coverage area.

DETERMINING THE LAYERS OF PROTECTION REQUIRED:

Attached tables provide guidelines in the form of a matrix for protection of equipment for fire and
explosion hazards. The matrix system is divided into the following four critical areas:
Table A: Electrostatic Protection – All Equipment
Table B: Nitrogen Inerting Requirement for Aqueous Formulations, No Flammable Solvents.
Table C: Nitrogen Inerting Requirement for Formulations with Flammable Solvents.
Table D: Explosion Venting and Suppression System Requirements.
There are four primary options available for explosion protection:
Explosion venting with isolation
Suppression with isolation
Containment with 10-12 bar design
Nitrogen inerting
The four primary options for explosion protection should provide adequate explosion protection to meet the
requirements NFPA and FM guidelines. These layers of protection must be designed by experts and in
accordance to the code requirements. The selection of the correct layers of protection is driven by risks
and needs to be determined by the risk assessment. Competent individuals trained in making the correct
judgments on the risk factors need to be involved. The selection of a particular option will depend on the
risk factors. There are many considerations that need to be compiled when determining the risk factors
and completing a risk assessment. The tables below are not intended to cover every scenario that may
exist and users of the tables must be aware that scenarios out side the scope of the layers of protection
defined in these tables need to be considered in the risk assessment. The risk assessment should
consider the following, but not be limited to the following factors when determining the correct layer of
protection required:
Business interruption potential
Potential for employees injury
Potential for community impact
Capital cost
Maintenance cost
Environmental regulations for emissions release
Company policies and guidelines for product release
 DETERMINING THE LAYERS OF PROTECTION REQUIRED TABLES

TABLE - A: ELECTROSTATIC PROTECTION - ALL EQUIPMENT

MIE <10mJ MIE >10 & MIE >25 & MIE >100mJ
<25mJ <100 mJ
1 All equipment (fixed & portable) should be Yes Yes Yes Yes
grounded to a resistance of less than 10 ohms.
2 Plastic bags used for shipping and transfer of Yes Yes Not necessary Not
material should be anti-static with volume necessary
resistivity of less than 100 mega-ohms-meters
and should be grounded before material
transfer.
3 Operators involved in the transfer of materials Yes Yes Not necessary Not
should wear anti-static shoes or booties and necessary
anti-static gloves. The resistivity of ESD shoes
and anti-static gloves should be more than
50,000 ohms and less than 1 mega-ohm
(1x10^6 ohms) per NFPA-484. Specifications
for ESD shoes are also covered by ANSI
standard Z41-1991. See notes below.
4 Operators should stand on a grounded surface Yes Yes Not necessary Not
during the transfer of materials. This can be necessary
done by using a conductive floor with a
resistivity of more than 25,000 ohms but less
than 1 mega-ohms (1x10^6 ohms) as per
NFPA-484. Alternatively, if the floor is not
conductive, a grounded mat can be used. See
notes below.
5 Scoops used in the transfer of materials should Yes Yes Not necessary Not
be made of metal and must be grounded (no necessary
plastics). Materials should be charged at a
rate which is consistent with the capacity of
dust extraction system.
6 Flexible connections (hoses, socks, boots, etc.) Yes Yes Yes Not
should be made of conductive material with a necessary
resistivity of less than 100 mega-ohms (1x10^8
ohms), and should be grounded/bonded.
7 If any chutes are used, they should be Yes Yes Yes Yes
grounded. The length of chutes should not
exceed 3 meters (about 10 ft.). To minimize
dust cloud, chutes should be installed at an
angle to allow the material to slide rather than
free fall.

NOTES: a. For conductive flooring, the reason for specifying minimum resistance of 25,000 ohms is to provide
protection to personnel against electrical shocks.
b. The range for resistivity for conductive footwear (50,000 ohms to 1x10^6 ohms) provides grounding
of static discharge but reduces the potential risk of electrical shocks.
c. Measurement of resistivity of gloves should be done in conjunction with footwear.
d. Ground continuity should be checked periodically.
e. All equipment must be scrutinized and tested for isolated conductors. All such isolated conductors
must be eliminated, reliably bonded to the equipment, or separately grounded.
TABLE - B: NITROGEN INERTING REQUIREMENT FOR AQUEOUS FORMULATIONS (NO FLAMMABLE
SOLVENT PRESENT)

MIE <10mJ MIE >10 & MIE >25 & MIE

<25mJ <100 mJ >100mJ

1 Charging bins, totes, etc. Not Reqd. Not Reqd. Not Reqd. Not Reqd.

2 Vibratory Screeners Not Reqd. Not Reqd. Not Reqd. Not Reqd.

3 Low shear blenders (Ribbon, Tumble, Bin Blender, etc.) Not Reqd. Not Reqd. Not Reqd. Not Reqd.

4 High shear blenders/granulators (Diosna, ProcessAll, Collette type)

A. Stainless steel equipment in which the high speed
Not Reqd. Not Reqd. Not Reqd. Not Reqd.
choppers are fully immersed in the granulator
B. Stainless steel equipment in which the high speed
* * * Not Reqd.
choppers are not fully immersed in the granulator
5 Cone Mills (Quadro, Frewitt, etc.) Yes * * Not Reqd.

6 Oscillating Mills (Frewitt, Key International, etc.) * Not Reqd. Not Reqd. Not Reqd.

7 Hammer mills (Fitzmills type) Yes Yes * Not Reqd.

Not Reqd. Not Reqd. Not Reqd. Not Reqd.
8 Fluid Bed Dryers
(Note-1) (Note-1) (Note-1) (Note-1)
Not Reqd. Not Reqd. Not Reqd. Not Reqd.
9 Dust Collectors
(Note-1) (Note-1) (Note-1) (Note-1)
10 Tablet Machines, Coaters Not Reqd. Not Reqd. Not Reqd. Not Reqd.

* CONDUCT RISK ASSESSMENT WITH ASSISTANCE FROM EHS EXPERTS TO DETERMINE BEST
SOLUTION FOR THESE CASES

NOTE 1: Even though N2 inerting is not required for fluid bed dryers and dust collectors for aqueous
formulations, the equipment should be protected by explosion vent or suppression system or it should be a
10-12 bar containment design as per guidelines in Table “D”.
TABLE - C: N2 INERTING REQUIREMENT FOR FORMULATIONS CONTAINING FLAMMABLE SOLVENTS

MIE <10mJ MIE >10 & MIE >25 & MIE

<25mJ <100 mJ >100mJ

1 Charging bins, totes, etc. * * * *

2 Vibratory Screeners * * * *

3 Low shear blenders (Ribbon, Tumble, etc.) * * * *

4 High shear blenders/granulators:

A. Stainless steel equipment in which the high speed Yes Yes Yes Yes
choppers are fully immersed in the granulator

B. Stainless steel equipment in which the high speed Yes Yes Yes Yes
choppers are not fully immersed in the granulator

Yes Yes Yes Yes

5 Cone Mills (Quadro, Frewitt, etc.)

6 Oscillating Mills * * * *

Yes Yes Yes Yes

7 Hammer mills (Fitzmills type)
Yes Yes Yes Yes
8 Fluid Bed Dryers

9 Dust Collectors * * * *

10 Tablet Machines, Coaters * * * *

* CONDUCT RISK ASSESSMENT WITH ASSISTANCE FROM EHS EXPERTS TO DETERMINE BEST
SOLUTION FOR THESE CASES
TABLE - D: EXPLOSION VENTING, SUPPRESSION SYSTEM OR 10-12 BAR CONTAINMENT
REQUIREMENT
Explosion Severity, Kst (bars-meters/second) 1 to 100 101 to 200 201 to 300 > 300
Dust Hazard Classification ST-1 ST-1 ST-2 ST-3
Magnitude of Explosion Risk Low Medium High Very High
1 Charging bins, totes, etc. Not Reqd. Not Reqd. Not Reqd. Not Reqd.

2 Vibratory Screeners Not Reqd. Not Reqd. Not Reqd. Not Reqd.

3 Low shear blenders (Ribbon, Tumble, Bin Blender, Not Reqd. Not Reqd. if Not Reqd. if Not Reqd. if
V-Blender, etc.) vol. <8 ft3. If vol. <8 ft3. If vol. <8 ft3. If
vol. > 8 ft3, vol. > 8 ft3, vol. > 8 ft3,
conduct risk conduct risk conduct risk
assessment assessment assessment
4 High shear blenders/granulators (Diosna, Lodige, Not Reqd. Not Reqd. if Not Reqd. if Not Reqd. if
Processall, etc.) vol. <8 ft3. If vol. <8 ft3. If vol. <8 ft3. If
vol. > 8 ft3, vol. > 8 ft3, vol. > 8 ft3,
conduct risk conduct risk conduct risk
assessment assessment assessment
5 Cone Mills and Oscillating Mills Not Reqd. Not Reqd. Not Reqd. Not Reqd.
However, However, However, However,
follow N2 follow N2 follow N2 follow N2
inerting inerting inerting inerting
guidelines guidelines guidelines guidelines
6 Hammer mills (Fitzmills type) Not Reqd. Not Reqd. Not Reqd. Not Reqd.
However, However, However, However,
follow N2 follow N2 follow N2 follow N2
inerting inerting inerting inerting
guidelines guidelines guidelines guidelines
7 Fluid Bed Dryers (Note 2, Note 3) Not Reqd. Yes Yes Yes

8 Dust Collectors (Note 2, Note 4) Not Reqd. Conduct risk Yes Yes
assessment
9 Tableting Machines, Coaters Conduct risk Conduct risk Conduct risk Conduct risk
assessment assessment assessment assessment

NOTE 2: This table should be used in conjunction with the guidelines for N2 inerting for fluid bed dryers
and dust collectors in Tables B and C.

NOTE 3: Isolation for Fluid Bed Dryers: For non-solvent based formulations in fluid bed dryers, isolation
on the inlet air side is not necessary, because the fluidizing screen of the dryer acts as a mechanical barrier
to the propagation of deflagration. However, isolation on the outlet air side is required. For solvent based
formulations, isolation on both inlet and outlet sides are necessary.

NOTE 4: Isolation for Dust Collectors: For non-solvent based formulations, isolation valve or chemical
suppression is required on the inlet side of dust collectors that are protected with explosion venting or
suppression system. However, if flammable solvent is present with the dust, isolation on both inlet and
outlet sides are required.
REFERENCES:

Following references will provide valuable guidelines in prevention and mitigation of dust hazards.
NFPA-68 (current edition ’2007): Guide for Venting of Deflagrations
NFPA-69 (current edition ’2008): Standards for Explosion Prevention Systems
NFPA-70B (current edition ’2006): Recommended Practice on Electrical Equipment Maintenance
NFPA-77 (current edition ’2007): Recommended Practice on Static Electricity
NFPA-499 (current edition '2006): Recommended Practice for Classification of Combustible Dusts
NFPA-654 (current edition ’2006): Standards for the Prevention of Fire and Dust Explosions from
Manufacturing Combustible Particulate Solids
FM Global Property Loss Prevention Data Sheets, 7-73, Dust Collectors and Collection Systems
FM Global Property Loss Prevention Data Sheets, 7-76, Prevention and Mitigation of Combustible Dust
Explosions and Fire
ATEX-137 (for European Union).
American Society for Testing and Materials (ASTM) Standard E2019
British Standard 5958-991
European Standard 1241-2-1: 1994
European Standard: IEC 1241-2-3-1994
U.S. Bureau of Mines in ROI 5624, ASTM E-2021
The Institute of Chemical Engineers (UK), "Guide to Dust Explosion Prevention and Protection - Part 2"
(1988)
International Standards Organization (ISO) method 618411
ASTM E1515-93
American Society for Testing and Materials (ASTM) Method E 1226
German Society of Engineers (VDI) Method 3673
Authors:
Steven I. Meszaros is the Corporate Director of Environment, Health and Safety for Wyeth and the EHS Business Unit
Representative for Technical Operating & Product Supply, New Products and Process Development organization. He provides
oversight and standardization of the EHS services and support to Wyeth’s worldwide sites.
Steve was assigned to the TO&PS NP&PD organization in June 2007. Steve was assigned to the Global EHS group in 2001.
Prior to the assignment in the Global EHS group he was the Corporate Safety and Loss Prevention Manager for American Home
Products. Steve has worked for Wyeth since 1980. He has had many foreign assignments, in various roles in Manufacturing,
Engineering and EHS. His areas of expertise are Facility Management, Business Continuity, Process Safety, Environmental,
Safety, Hygiene and Loss Prevention.
He is a member of the Center for Chemical Process Safety (CCPS) Technical Steering Committee and is active with the AIChE
and NFPA. He has published numerous articles and texts on Process Safety. Recently he was the Committee Chair for the newly
published CCPS book “Inherently Safer Chemical Processes – A Life Cycle Approach, Second Edition”.

Ron B. Sethi is Staff Consultant for Wyeth. Ron has worked for American Cyanamid, BASF and Wyeth for 42 years. Ron is a
Process Safety Expert and focuses on providing technical process safety service in the areas of contract manufacturing, dust
explosion mitigation, reactive chemistry, flammable handling, and general facility and employee safety.