You are on page 1of 10

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

A formal risk assessment of each equipment should be done and should be documented. 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. additional testing should be done to obtain this information.) should review the design of new equipment and process to identify potential fire and explosion hazards from dust powders. evaluate risks. suppression. New Equipment and Processes: The person responsible for the project at the site (Project Manager. Protection may include. Minimizing flame propagation and damage TESTING FOR HAZARD PROPERTIES AND DETERMNING LEVEL OF RISK: For initial screening. Areas should be classified into zones for electrical classification in accordance with NFPA standard 499 and article 500 of National Electrical Code (NEC). The risk assessment should clearly define layers of protection that are required for engineering. but is not limited to venting. 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. etc. The document should identify hazards. 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. If the required data is not available. The assessment should also document control measures that are used to address housekeeping in both process and support utility areas. The document should identify hazards. Ensure a safe working environment and appropriate surveillance during the presence of workers in accordance with the risk assessment. Process Engineer. etc. Areas should be classified into zones and electrical classification in accordance with NFPA standard 499 and article 500 of National Electrical Code (NEC). The risk assessment should clearly define layers of protection that are required for engineering. Project Engineer. Where risk is identified. The assessment should also include the following: Document the hazard properties of the powders being processed. and define safety measures.hazards from dust powders. Determine the risk and explosion severity of each piece of equipment in the process. isolation. Ensure a safe working environment and appropriate surveillance during the presence of workers in accordance with the risk assessment. the following tests are recommended. administrative controls and operating procedures. prepare an action plan to mitigate the risk for each piece of equipment. Design of equipment and process should include actions required to mitigate the risk for each piece of equipment. additional testing should be done to obtain this information. administrative controls and operating procedures. . This risk assessment should be documented. The assessment should also document control measures that are used to address housekeeping in both process and support utility areas. and define safety measures. evaluate risks. Determine the risk and explosion severity for each piece of equipment in the process.

The exact material that is to be handled/milled/granulated/dried in the operation should be tested to obtain accurate results. it is not necessary to test the sample for this parameter. if the MEC is used as a process control. etc. Low risk: not sensitive. Kst Thermal Stability Low Risk >100mJ >500°C <50 bar-m/s No Exotherm Medium Risk 25-100mJ 300-500°C 50-200 bar-m/s Exotherm>200°C High Risk <25mJ <300°C >200 bar-m/s Exotherm<200° C For powders having an MIE of less than 25 mJ. the risk can be classified for the following categories according to the values listed in the following Table. Impact Sensitivity Test (Fall Hammer Test) shall be considered. (MIT). Parameter Minimum Ignition Energy (MIE) Minimum Ignition Temp. Medium risk: may require actions on a case-by-case basis. Particle size. the mixture should be tested. From the results of these tests. testing to determine Limiting Oxygen Concentration (LOC) should be performed. non-flammable or not very violent. 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 following additional tests are recommended: a.. . No action required. Volume Resistivity b. moisture content. can significantly affect the data of the laboratory tests. Charge Relaxation Time If N2 inerting is to be considered for any process step. If the material being handled is a mixture. 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. Dust Cloud Explosion Severity. High risk: requires actions. However. For products that are going to be processed in tableting machines. but is also relevant to frictional sparks.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. 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. Therefore. The test is used primarily to assess the potential vulnerability of powders and dusts to electrostatic discharges. then the test is necessary to establish safe parameters.

or personnel. A powder or dust sample is dispersed within the sphere. Impact Sensitivity Test (BAM Fall Hammer Test) This test is used to assess the sensitivity of the test material to drop-weight impact. self-heating leading to self-ignition can occur. Insulating materials have a propensity to generate and retain electrostatic charge and can produce hazardous electrostatic discharges when exposed to grounded plant. blending. spray painting. ignited by chemical igniters. 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. . An atmosphere having an oxygen concentration below the LOC is not capable of supporting combustion and thus cannot support a dust explosion. The sample size is varied to determine the optimal dust cloud concentration. This test is performed using the BAM Fall Hammer apparatus developed by the German Federal Institute for Testing Materials (BAM). moderately.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. drums or bags and at the bottom of dryers where material can collect in bulk. etc. or highly insulating. measures its charge relaxation rate. 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. equipment. silos. These data can be used for designing dust explosion protection measures. poring. A powder or dust sample is placed in a test cell. and is the primary criterion for classifying powders and dusts as low. If the heat developed by a reaction of a substance with oxygen or by exothermic decomposition is not lost rapidly enough to the surroundings. The test involves dispersing powder or dust samples in a vessel and attempting to ignite the resulting dust cloud with an energetic ignition source. If the heat developed by a reaction of a substance with oxygen or by exothermic decomposition is not lost rapidly enough to the surroundings. Volume Resistivity – Powder Volume Resistivity is a measure of the electrical resistance for a unit volume of material. Explosion Severity Test (Kst) This test is performed using the 20-Liter Sphere apparatus. Thermal Stability Test (Bulk Powder Screening Test) The purpose of this test is to simulate conditions in hoppers. 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. 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. and the pressure of the resulting explosion is measured. selfheating leading to self-ignition can occur. Limiting Oxygen Concentration (LOC) Test The Limiting Oxygen Concentration (LOC) Test determines the minimum concentration of oxygen (displaced by nitrogen) capable of supporting combustion. and charging the sample using a corona source. The maximum pressure and rate of pressure rise are measured and used to determine the Kst value of the material.

These layers of protection must be designed by experts and in accordance to the code requirements. Accumulation on overhead beams. 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. Special attention should be paid to interstitial spaces where dust can settle and form layers over period of time. In OSHA's directive. conduit and pipe racks. The risk assessment should consider the following. Examples of these areas are: structural members. No Flammable Solvents. joists. 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 . Table D: Explosion Venting and Suppression System Requirements. Competent individuals trained in making the correct judgments on the risk factors need to be involved. cable trays. 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. Table C: Nitrogen Inerting Requirement for Formulations with Flammable Solvents. 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. ducts. above ceiling. The selection of the correct layers of protection is driven by risks and needs to be determined by the risk assessment. There are many considerations that need to be compiled when determining the risk factors and completing a risk assessment. 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.HOUSE-KEEPING: Each facility should have written procedures to keep the equipment and area clean and free of dust. on and around equipment (leaks around dust collectors and ductwork). The selection of a particular option will depend on the risk factors. tops of equipment and other surfaces should be included when determining the dust coverage area. floors. 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.

chutes should be installed at an angle to allow the material to slide rather than free fall. For conductive flooring. All such isolated conductors must be eliminated.000 ohms to 1x10^6 ohms) provides grounding of static discharge but reduces the potential risk of electrical shocks. reliably bonded to the equipment. Plastic bags used for shipping and transfer of material should be anti-static with volume resistivity of less than 100 mega-ohms-meters and should be grounded before material transfer. the reason for specifying minimum resistance of 25. The length of chutes should not exceed 3 meters (about 10 ft. or separately grounded. socks. boots. etc. Operators should stand on a grounded surface during the transfer of materials. d. The resistivity of ESD shoes and anti-static gloves should be more than 50.) should be made of conductive material with a resistivity of less than 100 mega-ohms (1x10^8 ohms). If any chutes are used. a grounded mat can be used.000 ohms is to provide protection to personnel against electrical shocks. To minimize dust cloud. Specifications for ESD shoes are also covered by ANSI standard Z41-1991. Alternatively. Yes Yes MIE >10 & <25mJ Yes Yes MIE >25 & <100 mJ Yes Not necessary MIE >100mJ Yes Not necessary 3 Yes Yes Not necessary Not necessary 4 Yes Yes Not necessary Not necessary 5 Yes Yes Not necessary Not necessary 6 Yes Yes Yes Not necessary 7 Yes Yes Yes Yes NOTES: a. Ground continuity should be checked periodically.A: ELECTROSTATIC PROTECTION .).ALL EQUIPMENT MIE <10mJ 1 2 All equipment (fixed & portable) should be grounded to a resistance of less than 10 ohms.000 ohms but less than 1 mega-ohms (1x10^6 ohms) as per NFPA-484. This can be done by using a conductive floor with a resistivity of more than 25. if the floor is not conductive. and should be grounded/bonded. Flexible connections (hoses. See notes below.DETERMINING THE LAYERS OF PROTECTION REQUIRED TABLES TABLE . All equipment must be scrutinized and tested for isolated conductors. . The range for resistivity for conductive footwear (50. Materials should be charged at a rate which is consistent with the capacity of dust extraction system. Operators involved in the transfer of materials should wear anti-static shoes or booties and anti-static gloves. Measurement of resistivity of gloves should be done in conjunction with footwear. c. e.000 ohms and less than 1 mega-ohm (1x10^6 ohms) per NFPA-484. Scoops used in the transfer of materials should be made of metal and must be grounded (no plastics). they should be grounded. b. See notes below.

Not Reqd.) 7 Hammer mills (Fitzmills type) 8 Fluid Bed Dryers 9 Dust Collectors 10 Tablet Machines. Not Reqd. Not Reqd. etc. * Not Reqd. Not Reqd. 4 High shear blenders/granulators (Diosna. Coaters Not Reqd. Stainless steel equipment in which the high speed choppers are fully immersed in the granulator B. Not Reqd. * * Not Reqd. Not Reqd. 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” .) 6 Oscillating Mills (Frewitt. Not Reqd. Not Reqd. Not Reqd. Not Reqd. (Note-1) (Note-1) Not Reqd. . Not Reqd. Not Reqd. Not Reqd.) Not Reqd.TABLE . Not Reqd. Not Reqd. Not Reqd. Not Reqd. Tumble. Collette type) A. Frewitt. (Note-1) (Note-1) Not Reqd. * Yes * Yes Not Reqd. Key International. etc. totes. Bin Blender. MIE >10 & MIE >25 & <25mJ <100 mJ Not Reqd. ProcessAll. etc.B: NITROGEN INERTING REQUIREMENT FOR AQUEOUS FORMULATIONS (NO FLAMMABLE SOLVENT PRESENT) MIE <10mJ 1 Charging bins. 2 Vibratory Screeners 3 Low shear blenders (Ribbon. etc. (Note-1) 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. Not Reqd. MIE >100mJ Not Reqd. (Note-1) Not Reqd. (Note-1) Not Reqd. (Note-1) Not Reqd. Not Reqd. Stainless steel equipment in which the high speed choppers are not fully immersed in the granulator 5 Cone Mills (Quadro. Yes Not Reqd.

etc. Coaters Yes Yes Yes Yes * Yes Yes * * * Yes Yes * * * Yes Yes * * * Yes Yes * * * CONDUCT RISK ASSESSMENT WITH ASSISTANCE FROM EHS EXPERTS TO DETERMINE BEST SOLUTION FOR THESE CASES . Frewitt. Stainless steel equipment in which the high speed choppers are fully immersed in the granulator B.) 6 Oscillating Mills 7 Hammer mills (Fitzmills type) 8 Fluid Bed Dryers 9 Dust Collectors 10 Tablet Machines.C: N2 INERTING REQUIREMENT FOR FORMULATIONS CONTAINING FLAMMABLE SOLVENTS MIE <10mJ MIE >10 & MIE >25 & MIE <25mJ <100 mJ >100mJ 1 Charging bins. Tumble. 2 Vibratory Screeners 3 Low shear blenders (Ribbon.TABLE . etc.) 4 High shear blenders/granulators: A. Stainless steel equipment in which the high speed choppers are not fully immersed in the granulator Yes Yes Yes Yes * * * * * * * * * * * * Yes Yes Yes Yes 5 Cone Mills (Quadro. totes. etc.

Not Reqd. follow N2 inerting guidelines Yes ST-2 High Not Reqd. However.) Not Reqd. if vol. Not Reqd. Not Reqd. ST-1 Medium Not Reqd. if vol. follow N2 inerting guidelines Not Reqd. Note 3) Dust Collectors (Note 2. Bin Blender.) ST-1 Low Not Reqd. if vol. However. totes. If vol. For solvent based formulations. . <8 ft3. isolation valve or chemical suppression is required on the inlet side of dust collectors that are protected with explosion venting or suppression system. follow N2 inerting guidelines Yes 4 High shear blenders/granulators (Diosna. conduct risk assessment Not Reqd. if vol. 6 Hammer mills (Fitzmills type) 7 8 9 Fluid Bed Dryers (Note 2. Coaters Conduct risk Yes Yes assessment 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. isolation on the outlet air side is required. V-Blender. follow N2 inerting guidelines Not Reqd. Vibratory Screeners Low shear blenders (Ribbon. isolation on both inlet and outlet sides are necessary. 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. Not Reqd. However. > 8 ft3.D: EXPLOSION VENTING. conduct risk assessment Not Reqd. If vol. If vol. > 8 ft3.TABLE . NOTE 4: Isolation for Dust Collectors: For non-solvent based formulations. 5 Cone Mills and Oscillating Mills Not Reqd. Not Reqd. However. <8 ft3. follow N2 inerting guidelines Yes > 300 ST-3 Very High Not Reqd. However. However. conduct risk assessment Not Reqd. However. Note 4) Tableting Machines. isolation on both inlet and outlet sides are required. Not Reqd. Tumble. follow N2 inerting guidelines Not Reqd. follow N2 inerting guidelines Not Reqd. <8 ft3. Lodige. Not Reqd. > 8 ft3. Processall. conduct risk assessment Not Reqd. Kst (bars-meters/second) 1 to 100 101 to 200 201 to 300 Dust Hazard Classification Magnitude of Explosion Risk 1 2 3 Charging bins. follow N2 inerting guidelines Not Reqd. etc. If vol. <8 ft3. > 8 ft3. etc. conduct risk assessment Not Reqd. If vol. However. conduct risk assessment Not Reqd. <8 ft3. <8 ft3. if flammable solvent is present with the dust. Not Reqd. > 8 ft3. > 8 ft3. SUPPRESSION SYSTEM OR 10-12 BAR CONTAINMENT REQUIREMENT Explosion Severity. if vol. Not Reqd. because the fluidizing screen of the dryer acts as a mechanical barrier to the propagation of deflagration. However. If vol. However. etc. if vol.

S. Safety. Steve has worked for Wyeth since 1980. Steve was assigned to the TO&PS NP&PD organization in June 2007. flammable handling. reactive chemistry. 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. Process Safety. Ron has worked for American Cyanamid.REFERENCES: Following references will provide valuable guidelines in prevention and mitigation of dust hazards. Recently he was the Committee Chair for the newly published CCPS book “Inherently Safer Chemical Processes – A Life Cycle Approach. He has published numerous articles and texts on Process Safety. 7-73. "Guide to Dust Explosion Prevention and Protection . His areas of expertise are Facility Management.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. ASTM E-2021 The Institute of Chemical Engineers (UK). and general facility and employee safety. He has had many foreign assignments. Meszaros is the Corporate Director of Environment. 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 Elec tricity 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. . New Products and Process Development organization. Hygiene and Loss Prevention. 7-76. Sethi is Staff Consultant for Wyeth. Prior to the assignment in the Global EHS group he was the Corporate Safety and Loss Prevention Manager for American Home Products. He is a member of the Center for Chemical Process Safety (CCPS) Technical Steering Committee and is active with the AIChE and NFPA. Steve was assigned to the Global EHS group in 2001. Second Edition”. He provides oversight and standardization of the EHS services and support to Wyeth’s worldwide sites. dust explosion mitigation. Ron is a Process Safety Expert and focuses on providing technical process safety service in the areas of contract manufacturing. Engineering and EHS. BASF and Wyeth for 42 years. Dust Collectors and Collection Systems FM Global Property Loss Prevention Data Sheets. Health and Safety for Wyeth and the EHS Business Unit Representative for Technical Operating & Product Supply. Prevention and Mitigation of Combustible Dust Explosions and Fire ATEX-137 (for European Union). Bureau of Mines in ROI 5624. Business Continuity. in various roles in Manufacturing. Environmental. Ron B.