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PSM in pharma industries- Hangzhou China 2008

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PSM in pharma industries- Hangzhou China 2008

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PSM in pharma industries- Hangzhou China 2008

  1. 1. www.issehs.com Process Safety Management in Pharmaceutical Industries Ms. Lili Deng, EHS Specialist (lili.deng@issehs.com), Maharshi Mehta, CSP, CIH (maharshi.mehta@issehs.com) International Safety Systems, Inc. www.issehs.com The 9th RDPAC EHS Working Group Meeting Hangzhou, China October 30, 2008
  2. 2. www.issehs.com Learning Objectives  In this session, participants will learn: – Process Safety Incidents in Pharmaceutical Industries – Control of Process Safety Risk Lessons Learned – Hazards: Flammability, Reactivity and Dust Explosion Hazards – Hazard Assessment Technique Review – Risk Prevention and Controls – Elements of Process Safety Management Program
  3. 3. www.issehs.com Process Safety Incidents  “Powerful explosion in pharma firm” News – Surrounding area up to 3 km affected – Reactor in which distillation was done exploded
  4. 4. www.issehs.com Another explosion incident.. KINSTON, North Carolina (CNN) -- A massive explosion and fire gutted pharmaceutical supply plant, killing at least three people and injuring more than two dozen others Volatile mix of air and suspended dust caused explosion The explosion was so powerful it blew doors open on houses more than a mile away
  5. 5. www.issehs.com More Incidents..  Suspended acetone bucket caught fire during filling  Explosion during vinyl acetate transfer (same operation conducted number of times without problems): External paints prevented grounding of the drum  Centrifuge caught fire as nitrogen purging was not enough
  6. 6. www.issehs.com Laboratory Accidents  Mixing of incompatible waste (nitric acid in ethanol rinsed bottle)  Methylene chloride mixed with oxidizer without knowing incompatibility – Hood and about 2000 sq feet of laboratory area caught fire – Broken glasses of bottles traveled 10 meters away and caused injuries
  7. 7. www.issehs.com Common causes of PSIs  Awareness and training  Systems not in place  Systems not implemented  Preventive maintenance was reactive maintenance
  8. 8. www.issehs.com What is PSM Managing process safety and organization to reduce fire, explosion and imminent health risk
  9. 9. www.issehs.com Why PSM?  Plant’s existence  Harm to people, process and environment  Process Interruptions  Regulatory and Corporate Requirements  Liability  Return on Investment – Recovery of resources  Pre-requisite to participate in Global Economy  Public Image
  10. 10. www.issehs.com Hazards Considered  Flammability  Reactivity  Dust Explosions  Imminent health risk from acutely harmful substances (will not be discussed due to time limitation)
  11. 11. www.issehs.com Fire Principle  A fire in pharmaceutical industry occur occur if ALL of the following are present – Fuel (e.g., methnaol) in sufficient concentration in air – Source of ignition – Oxygen  A chain reaction between oxygen and fuel with sufficient concentration of each is required for a fire to occur and continue  Removing one of the three elements will prevent fire
  12. 12. www.issehs.com Flammability Terms  Flash Point – Minimum temperature at which flammable chemical gives off sufficient vapor to initiate fire with ignition source – Lower the flash point, more flammable a chemical  Lower Explosive Limits (LEL) – Concentration of flammable vapor in %, below which fire does not occur  Upper Explosive Limits (UEL) – Concentration of flammable vapor in % , above which fire does not occur
  13. 13. www.issehs.com Flammability of Solvents Used in Pharmaceutical Industry Chemical FP 0 C LEL % UEL % Toluene 4 1.2 7.1 Methanol 11 6 36 Triethylamine -17 1.2 8 n-PA -37 2 10.4 Which chemical is more flammable?
  14. 14. www.issehs.com Fuels in Pharmaceutical Industries Solvents used in reactors and centrifuge (e.g., toluene and methanol ) Uncontrolled Inventory Flammable liquids in plastic containers
  15. 15. www.issehs.com Static Electricity Ignition Sources Electrical fittings and apparatus Open Flames Overheated Heated apparatus (vacuum pumps, hot plates, ovens), distillation units
  16. 16. www.issehs.com Ignition Sources  Electrical (23%), Smoking (18%)  Friction (10%), Hot Surfaces (7%),  Overheated Material (8%)  Cutting, Welding, Open Flames (4%)  Static Electricity (1%)
  17. 17. www.issehs.com Static Electricity  Flammable chemicals accumulate static charges readily as they have high insulating values  Flow of liquid through pipe, strainers, filters  Splashing of liquid jets  Ejection of droplets from nozzles  Stirring and Mixing  Solid handling-Sieving, pouring and grinding
  18. 18. www.issehs.com Activities with Static Electricity Potential ▪ Flammable liquid loading, unloading, transfer ▪ Flow of liquid through pipe, strainers, filters, stirring and mixing ▪ Solid handling-Sieving, pouring, grinding, micronizing, pneumatic conveying
  19. 19. www.issehs.com Potential Risk of Fire in Pharmaceutical Process  Tanker unloading and tank storage  Reactors – Charging of solids in reactor containing flammable liquid  Solid liquid separation – Centrifuge – Methanol or any other solvent – High static electricity during charging and spinning  Distillation – Cooling stops  Drying
  20. 20. www.issehs.com Reactive Chemicals  High reaction rate  Reaction rate increases with temperature.  If the reaction rate and resulting heat are not controlled , an explosion could occur  Heat initiated decomposition could result in explosion e.g., certain peroxides  Light could be initiator of an explosive reaction e.g., hydrogen and chlorine reacts explosively in the presence of light  Shock could initiate an explosion, e.g., acetylides, azides, organic nitrates, nitro compounds and peroxides  Picric acid becomes highly shock-sensitive when its normal water content is allowed to evaporate
  21. 21. www.issehs.com Incompatible Chemicals  React dangerously when mixed with certain other materials  Spontaneous ignition or fire could occur  Decomposition product may ignite or could be harmful to health  Examples – Organics and Oxidizers – Acids and Bases More on Incompatible chemicals: http://msds.chem.ox.ac.uk/incompatibles.html
  22. 22. www.issehs.com Chemical Structure with Explosive Tendencies  -ONO2 nitrate R-NO2 aliphatic nitro  -NH-NO2 Primary nitramine Ar-NO2 aromatic nitro  -N-NO2 Secondary nitramine -N3  -NO nitroso =N-X halamines  -N=N-diazo -C=C-acetylides  -N=N-S-N=N-diazosulfide  Organic salts of chlorates, perchlorates, picrates, nitrates, iodates.
  23. 23. www.issehs.com Dust Explosion Potential ▪ Presence of Comustible Dust ▪ Oxygen concentrations 3% and above ▪ Small particle size (< 100 microns more potential) ▪ Minimum Explosible Concentrations (MEC) ▪ MEC for most materials is 10 to 500 g/m3 ▪ 10 g/m3 dust concentration looks like dense fog with visibility of 1Meter. ▪ More moisture less dust explosion potential
  24. 24. www.issehs.com Activities with Dust Explosion potential  Fluidized Bed Dryers  Dust collectors  Solid charging in Reactors
  25. 25. www.issehs.com Why Hazard Identification “ For every dollar it costs to fix a problem in the early stage of design, it will cost $10 at flow sheet stage, $100 at the detail design stage, $1000 afte r the plant is build and $10,000 to cleanup the mess after an accident” KLETZ
  26. 26. www.issehs.com Hazard Identification  Can the process/activity pose a threat to health, safety, environment or property?  INPUT: Properties of materials, historical experience, knowledge of process parameters, management system, available safeguards, application of analytical methods  Output: List of potential problem materials, process conditions, and situations and understanding of what can go wrong.
  27. 27. www.issehs.com Process Hazard Analysis  Hazards of Process  Previous Incidents  Engineering and Administrative Controls  Consequence of Failure  Human Factors
  28. 28. www.issehs.com Process Hazard Information Hazards Technology Equipment Toxicity Block Flow Diagram Construction Materials PELs Chemistry Piping & Instrumention Physical Inventory Electrical Reactivity Operating Ranges Relief Vents Corrosivity Hazards of Deviations Design Codes Stability Material Balances Compatibility Safety Systems
  29. 29. www.issehs.com Elements of Process Safety Management and Hazard Analysis 1  Process Safety Information (Hazards, Technology, and Equipment)  Prioritize the Process Hazard Analyses (PHA)  Conduct PHA  Develop Operating Procedures (for each operating phase and for safety systems)  Certify Current Employees Sufficiently Trained
  30. 30. www.issehs.com Elements of Process Safety Management and Hazard Analysis 2  Procedures for Maintaining Mechanical Integrity  Document Process Equipment Inspections and Tests  Hot-work Permits  Management of Change Procedures  Incident Investigation  Emergency Action Plan  Process Safety Management Compliance Audits
  31. 31. www.issehs.com Hazard Analysis - System Safety  Depending on complexity of process, Hazard Analysis is conducted using one or more of the following methods: – Job Safety Analysis (JSA) – Preliminary Hazard Analysis (PHA) – What-if and What if -Check List – Hazard And Operability Analysis (HAZOP) – Failure Mode and Effect Analysis (FMEA) – Fault-Tree Analysis (FTA) – Management Oversight Risk Tree (MORT) – Human Reliability Analysis (HRA)
  32. 32. www.issehs.com Principles-Risk Prevention and Controls Elimination Substitution Process Changes Engineering Controls Administrative Controls Personal Protective Equipment Respiratory Protective Equipment
  33. 33. www.issehs.com Risk Controls: Examples Process change (seal-less pump) and engineering controls (Laboratory Fume Hood and Local Exhaust Ventilation (LEV) on sink
  34. 34. www.issehs.com Flammable Liquids-Controls  Keep flammable liquids in covered containers when not in use  Keep flammable concentrations below 25% of LEL when an ignition source is present  Use a calibrated detector to determine flammable vapor concentration  Provide grounding and bonding for static electricity controls  Use of non sparking tools/ intrinsically safe electrical apparatus and lighting  Provide a non-return valve in flammable gas supply line  Avoid using flexible hoses for transfer  Provide and maintain explosion proof lighting
  35. 35. www.issehs.com Solvent Storage Cabinets  Flammable liquid limited to 60 gallons in approved cabinet  Flammable chemical storage cabinet to have 1hour fire rating  Cabinets to be labeled "Flammable - Keep Fire (ignition sources) Away".  Vent through two ports on side with flame arrestor
  36. 36. www.issehs.com Flammable Chemical Storage Room  Allowable quantity 5 gal/sq feet of floor area when fire protection is not provided and room fire resistance is 2 hrs  Explosion proof electrical wiring  Liquid tight room  Ventilation to provide six air exchange rate per hour  Provide clear aisle of 3' wide  Stacking of containers one upon the other over 30 gallon prohibited
  37. 37. www.issehs.com Static Electricity Controls  Bonding and grounding  Metal to metal contact essential (painted surface)  Testing conductivity of wire and connections  Avoid free fall of liquid by bottom entry or extend fill pipe. Fill pipe to terminate within 6” from the bottom of vessel
  38. 38. www.issehs.com Grounding bonding-Poor and best practices
  39. 39. www.issehs.com Dust Explosion - Prevention and Controls  Inerting, Purging, to keep oxygen concentration below 3%  Suppression  Explosion Venting  Process Isolation  Pressure Vessel Design  Control of Ignition Sources
  40. 40. www.issehs.com Inerting ▪ An inert gas such as nitrogen is passed through to remove oxygen ▪ Keep oxygen concentration to below <3% to prevent a dust explosion or fire ▪ Ensure nitrogen is used and by mistake other gases such as oxygen is not used ▪ Determine volume and flow rate of nitrogen needed ▪ Ensure flow of nitrogen ▪ Provide low pressure alarm to warn about loss of inerting
  41. 41. www.issehs.com Tank Storage: Flammable Chemicals ▪ Do not overfill, level indicator ▪ Measure metal thickness ▪ Provide flame arrestor, breather valve with flame arrestor preferred ▪ Level indicator ▪ Provide dyke of 1.5 times tank volume ▪ Unloading/Loading rack to be located at least 25 feet away ▪ Steel support to be protected by 2 hour fire resistance covering on batch tanks with supports
  42. 42. www.issehs.com Unloading of Tank Cars/Trucks of flammable liquids  Metallic gauging rod prohibited when electrical power line is within 20’ of tank opening  Setting of brakes, “STOP....” signs 25’ in front  Bottom unloading is preferred  Continuous present of the operator throughout unloading  No smoking, grounding/bonding connection  Applying chocks on wheels
  43. 43. www.issehs.com Hot Work Permit ▪ Needed when welding, has cutting or any spark producing work is carried out ▪ Define responsibility ▪ Remove all flammables, purge, cover areas ▪ Close valve, block flow ▪ Provide fire extinguisher ▪ Test for presence of flammable vapors ▪ Randomly inspect ▪ Issue permit
  44. 44. www.issehs.com Hazard Information  Material Safety Data Sheets – Manufacturer has legal duty to provide in most countries – Available on Internet  International Chemical Safety Cards – International Labor Organization (ILO) publishes and contain hazard information with terms used globally  Labels – Hazard Material Information System (HMIS) label – National Fire Protection Association (NFPA) label – Symbols and Risk Phrases used in European Community  References – Useful publications and Internet Sites
  45. 45. www.issehs.com National Fire Protection Association Label  Used globally to indicate flammability, reactivity and health hazard  Applied on chemical containers, except those container used in analysis Container without a label or with defaced label must be safely discarded
  46. 46. www.issehs.com Hazard Information-Websites  Hazardous Substance Data Bank (HSDB) www.nlm.nih.gov  European Agency for Safety and Health – http://europe.osha.eu.int  Asia Pacific Health and Safety Network from ILO – http://www.ilo.org/public/english/region/asro/bangkok/asiaosh/  Canadian Center for Occupational Health and Safety – http://www.ccohs.ca/products/shop.html  National Occupational Health and Safety Commission, Australia – http://www.nohsc.gov.au/

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