Explosions and XP Design, Safe and Compliant with ATEX and NFPA Standards PBE, Pharma Bio Expert Inc PBE-Expert Inc CANADA Training Company Agreement CPMT #0059104
Health Canada & expert, Training Company Agreement CPMT #0059104 PBE, Training Company Agreement CPMT #0059104 2 23/05/2018
Table of content ATEX
Agenda Health Canada & expert, Training Company Agreement CPMT #0059104 1. Framework & regulatory and security requirements 2. Fire triangle & Sources of explosions 3. Dress code & preventive measures, explosion protection equipment 4. Assessment of the explosive hazard of solvents, powders and gases and their classification 5. Room classification vs standard, applications & process requirements by integrating ATEX classes 6. Elements of room and HVAC design, including ATEX requirements 7. Types of segregation, flow, cleanliness and pressure cascades, including ATEX requirements 8. Architectural construction elements and finishes, including ATEX requirements 9. MAL vs S/D technologies: Pass-Through, SH, DH 10.Specific technologies: LAF & FFU 11.HVAC design and systems in compliance with ATEX and Zoning 12.Optimization of filtration cascades 13.Control requirements: ACTIVE vs PASSIVE for FDA vs Europe 4 23/05/2018
Health Canada & expert, Training Company Agreement CPMT #0059104 Agenda (Continuing) 14. Requirements for the quality for the humidification steam 15. Introduction of a new concept: PURS ==» FURS ==» VURS 16. Specification of Bioprocesses, of services and of «Typical» clean utilities and facilities 17.Purification processes: TFF Filtration 18. Energy and ACR optimization 19. Acceptable pressure cascades case study 20. Development of the room and COP specification matrix 21. Measure & control instruments, automate PLC, BMS, DCS, SCADA (GAMP)... 22. Define control requirements and list critical instruments 23. Critical instruments specification (design, operation, validation ranges) 24. Main characteristics of instruments for measuring level, pressure, temperature, hygrometry, flow, particle count, H2 peroxide, O2, 25. Summary specifications of the requirements of the CFR 21, part 11, EMA, annexe 11, GAMP 26. Elements of Commissioning/ Premises & HVAC validation. 5 23/05/2018
ARE YOU PROTECTED?
Health Canada & expert, Training Company Agreement CPMT #0059104 ARE YOU PROTECTED? 7 23/05/2018
Health Canada & expert, Training Company Agreement CPMT #0059104 ARE YOU PROTECTED? Compliance Strategy Components Dust Control Protection Prevention Ignition Control 8 23/05/2018
Health Canada & expert, Training Company Agreement CPMT #0059104 ARE YOU PROTECTED? OXYGEN IGNITION SOURCE COMBUSTIBLE 9 23/05/2018
Health Canada & expert, Training Company Agreement CPMT #0059104 ARE YOU PROTECTED? (Sherbrooke-Canada) The explosion at Neptune Technologies caused FOUR deaths The explosion of a pharmaceutical factory in the United States caused TWO deaths Explosion of a warehouse of a pharmaceutical factory in eastern China An explosion at a Chinese pharmaceutical factory caused FIVE DEATHS and eight 10 wounded. 23/05/2018
Health Canada & expert, Training Company Agreement CPMT #0059104 ÊTES VOUS PROTÉGÉ? 11 23/05/2018
Health Canada & expert, Training Company Agreement CPMT #0059104 ARE YOU PROTECTED? 12 23/05/2018
Health Canada & expert, Training Company Agreement CPMT #0059104 ARE YOU PROTECTED? Fuel Mitigation by aqueous formulation -Electrical Conductivity -RH% - Hunting Spark Fire Nitrogen N2 Inerting Spark Oxidizing O2 13 23/05/2018
Health Canada & expert, Training Company Agreement CPMT #0059104 ARE YOU PROTECTED? 14 23/05/2018
Characterization of ATEX risks
Health Canada & expert, Training Company Agreement CPMT #0059104 Risk assessment according to ICH Q9 16 23/05/2018
STANDARDS Health Canada & expert, Training Company Agreement CPMT #0059104 Explosive Atmosphere ATEX/NFPA 17 23/05/2018
Assessment of the explosive hazards of solvents, powders and gases. Health Canada & expert, Training Company Agreement CPMT #0059104 Explosive Atmosphere ATEX Kst (bar m / s) Class < 200 1 200-300 2 > 300 3 If Kst > 600 : Product is EXTREMELY EXPLOSIVE 18 23/05/2018
Assessment of ATEX risks
Health Canada & expert, Training Company Agreement CPMT #0059104 Explosive Atmosphere Assessment of the explosive hazards of solvents, powders and gases. 20 23/05/2018
Assessment of the explosive hazards of solvents, powders and gases. Health Canada & expert, Training Company Agreement CPMT #0059104 Explosive Atmosphere ATEX 21 23/05/2018
Assessment of the explosive hazards of solvents, powders and gases. Health Canada & expert, Training Company Agreement CPMT #0059104 Explosive Atmosphere ATEX 22 23/05/2018
Évaluation des risques d explosivité des solvants, des poudres et des gaz. Health Canada & expert, Training Company Agreement CPMT #0059104 Atmosphère Explosive ATEX 23 23/05/2018
Health Canada & expert, Training Company Agreement CPMT #0059104 24 23/05/2018
Health Canada & expert, Training Company Agreement CPMT #0059104 HOW TO KNOW IF A PRODUCT IS ATEX CERTIFIED? 25 23/05/2018
Health Canada & expert, Training Company Agreement CPMT #0059104 What is your ATEX class? Methane Gaz Groups (and subdivisions) Ethylene Acetylene Hydrogen 26 23/05/2018
Technology for explosion prevention
Health Canada & expert, Training Company Agreement CPMT #0059104 Risk analysis vs ATEX P5 P4 P3 P2 P1 IDENTIFICATION OF THE RISKS ESTIMATING RISK RISK ASESSMENT RISK MITIGATION MAINTENANCE, CONTROL, SOPs & TRAINING 28 23/05/2018
Health Canada & expert, Training Company Agreement CPMT #0059104 Directive 94/9/CE / Classification of ATEX areas* *Area: surrounding all or part of an installation Area in which an explosive mixture can form occasionally Area in which the explosive mixture is present continuously, or for a long period Area in which an explosive mixture is rather rare or of short duration 2 1 0/20 21 22 Area Gas Area Dust 29 23/05/2018
Implementation of safety measures in compliance with ATEX standards
Assessment of the explosive hazards of solvents, powders and gases. Health Canada & expert, Training Company Agreement CPMT #0059104 Explosive Atmosphere ATEX 31 23/05/2018
ATEX classification: Health Canada & expert, Training Company Agreement CPMT #0059104 Explosive Atmosphere ATEX 32 23/05/2018
Health Canada & expert, Training Company Agreement CPMT #0059104 Compliance assessment procedures: 33 23/05/2018
Health Canada & expert, Training Company Agreement CPMT #0059104 34 23/05/2018
Health Canada & expert, Training Company Agreement CPMT #0059104 35 23/05/2018
PBE Expert Inc (Canada) 1.514-616-2692 1.450-600-0790 (Morocco) 212-622-629-224 (Algeria) 213-540-961-234 (Tunisia) 216-96-751-330 www.pbe-expert.com pbe@pbe-expert.com Laval, Canada PBE Expert Inc. Votre partenaire en conformité