Explosions and XP Design, Safe and Compliant with ATEX and NFPA Standards
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1 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 #
2 Health Canada & expert, Training Company Agreement CPMT # PBE, Training Company Agreement CPMT # /05/2018
3 Table of content ATEX
4 Agenda Health Canada & expert, Training Company Agreement CPMT # 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
5 Health Canada & expert, Training Company Agreement CPMT # 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) 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
6 ARE YOU PROTECTED?
7 Health Canada & expert, Training Company Agreement CPMT # ARE YOU PROTECTED? 7 23/05/2018
8 Health Canada & expert, Training Company Agreement CPMT # ARE YOU PROTECTED? Compliance Strategy Components Dust Control Protection Prevention Ignition Control 8 23/05/2018
9 Health Canada & expert, Training Company Agreement CPMT # ARE YOU PROTECTED? OXYGEN IGNITION SOURCE COMBUSTIBLE 9 23/05/2018
10 Health Canada & expert, Training Company Agreement CPMT # 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
11 Health Canada & expert, Training Company Agreement CPMT # ÊTES VOUS PROTÉGÉ? 11 23/05/2018
12 Health Canada & expert, Training Company Agreement CPMT # ARE YOU PROTECTED? 12 23/05/2018
13 Health Canada & expert, Training Company Agreement CPMT # ARE YOU PROTECTED? Fuel Mitigation by aqueous formulation -Electrical Conductivity -RH% - Hunting Spark Fire Nitrogen N2 Inerting Spark Oxidizing O /05/2018
14 Health Canada & expert, Training Company Agreement CPMT # ARE YOU PROTECTED? 14 23/05/2018
15 Characterization of ATEX risks
16 Health Canada & expert, Training Company Agreement CPMT # Risk assessment according to ICH Q /05/2018
17 STANDARDS Health Canada & expert, Training Company Agreement CPMT # Explosive Atmosphere ATEX/NFPA 17 23/05/2018
18 Assessment of the explosive hazards of solvents, powders and gases. Health Canada & expert, Training Company Agreement CPMT # Explosive Atmosphere ATEX Kst (bar m / s) Class < > If Kst > 600 : Product is EXTREMELY EXPLOSIVE 18 23/05/2018
19 Assessment of ATEX risks
20 Health Canada & expert, Training Company Agreement CPMT # Explosive Atmosphere Assessment of the explosive hazards of solvents, powders and gases /05/2018
21 Assessment of the explosive hazards of solvents, powders and gases. Health Canada & expert, Training Company Agreement CPMT # Explosive Atmosphere ATEX 21 23/05/2018
22 Assessment of the explosive hazards of solvents, powders and gases. Health Canada & expert, Training Company Agreement CPMT # Explosive Atmosphere ATEX 22 23/05/2018
23 Évaluation des risques d explosivité des solvants, des poudres et des gaz. Health Canada & expert, Training Company Agreement CPMT # Atmosphère Explosive ATEX 23 23/05/2018
24 Health Canada & expert, Training Company Agreement CPMT # /05/2018
25 Health Canada & expert, Training Company Agreement CPMT # HOW TO KNOW IF A PRODUCT IS ATEX CERTIFIED? 25 23/05/2018
26 Health Canada & expert, Training Company Agreement CPMT # What is your ATEX class? Methane Gaz Groups (and subdivisions) Ethylene Acetylene Hydrogen 26 23/05/2018
27 Technology for explosion prevention
28 Health Canada & expert, Training Company Agreement CPMT # 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
29 Health Canada & expert, Training Company Agreement CPMT # 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/ Area Gas Area Dust 29 23/05/2018
30 Implementation of safety measures in compliance with ATEX standards
31 Assessment of the explosive hazards of solvents, powders and gases. Health Canada & expert, Training Company Agreement CPMT # Explosive Atmosphere ATEX 31 23/05/2018
32 ATEX classification: Health Canada & expert, Training Company Agreement CPMT # Explosive Atmosphere ATEX 32 23/05/2018
33 Health Canada & expert, Training Company Agreement CPMT # Compliance assessment procedures: 33 23/05/2018
34 Health Canada & expert, Training Company Agreement CPMT # /05/2018
35 Health Canada & expert, Training Company Agreement CPMT # /05/2018
36 PBE Expert Inc (Canada) (Morocco) (Algeria) (Tunisia) Laval, Canada PBE Expert Inc. Votre partenaire en conformité
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