Explosions and XP Design, Safe and Compliant with ATEX and ......MAPAQ Explosions and XP Design, Safe and Compliant with ATEX and NFPA Standards. PBE, Pharma Bio Expert Inc. PBE-Expert

MAPAQ

Explosions and XP Design, Safe and Compliant with

ATEX and NFPA Standards

PBE, Pharma Bio Expert IncPBE-Expert Inc – CANADA

Training Company Agreement CPMT #0059104

MAPAQ

Health Canada & MAPAQ expert, Training Company Agreement CPMT #0059104

PBE, Training Company Agreement CPMT #0059104

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Table of content – ATEX

MAPAQ


Agenda

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

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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.

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ARE YOU PROTECTED?

MAPAQ


ARE YOU PROTECTED?

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ARE YOU PROTECTED?

Dust Control

Ignition Control

Prevention

Protection

Compliance Strategy Components

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ARE YOU PROTECTED?

IGNITION SOURCEOXYGEN

COMBUSTIBLE

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(Sherbrooke-Canada) The explosion at Neptune Technologies caused FOUR deaths

The explosion of a pharmaceutical factory in the United States caused

TWO deaths

An explosion at a Chinese pharmaceutical factory caused FIVE DEATHS and eight wounded.

Explosion of a warehouse of a pharmaceutical factory in eastern China

ARE YOU PROTECTED?

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http://www.lapresse.ca/actualites/201211/08/01-4591827-incendie-dans-une-usine-a-sherbrooke-2-morts-et-19-blesses.php?utm_categorieinterne=trafficdrivers&utm_contenuinterne=cyberpresse_vous_suggere_4591782_article_POS7

http://affaires.lapresse.ca/bourse/201211/09/01-4591975-neptune-avait-recu-une-subvention-de-3-millions.php?utm_categorieinterne=trafficdrivers&utm_contenuinterne=cyberpresse_vous_suggere_4591782_article_POS8

MAPAQ


ÊTES VOUS PROTÉGÉ?

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ARE YOU PROTECTED?

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MAPAQ


ARE YOU PROTECTED?

Fire

Fuel

Spark Oxidizing O2

Mitigation by aqueous formulation

-ElectricalConductivity-RH%- Hunting Spark

Nitrogen N2

Inerting

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ARE YOU PROTECTED?

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Characterizationof ATEX risks

MAPAQ


Risk assessment according to ICH Q9

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Explosive Atmosphere ATEX/NFPA► STANDARDS

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Explosive Atmosphere ATEX

► Assessment of the explosive hazards of solvents, powders and gases.

Kst (bar m / s) Class< 200 1

200 - 300 2> 300 3

If Kst > 600 : Product isEXTREMELY EXPLOSIVE

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Assessment of ATEX risks

MAPAQ


Explosive Atmosphere

► Assessment of the explosive

hazards of solvents,

powders and gases.

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Atmosphère Explosive ATEX

► Évaluation des risques d’explosivité des solvants, des poudres et des gaz.

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MAPAQ


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HOW TO KNOW IF A PRODUCT IS ATEX CERTIFIED ?

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What is your ATEX class?

Methane

Ethylene

Gaz Groups (and subdivisions)

Acetylene

Hydrogen

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Technology for explosion prevention

MAPAQ


Risk analysis vs ATEXP5

P4

P3

P2

P1

IDENTIFICATION OF THE RISKS

ESTIMATING RISKRISK ASESSMENT

RISK MITIGATIONMAINTENANCE, CONTROL, SOPs & TRAINING

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MAPAQ


Classification of ATEX areas*

0/201 212 22

Area Gas

AreaDust

Area in which the explosive mixture is

present continuously, or for

a long period

Area in which an explosive mixture

can form occasionally

Area in which an explosive mixture is

rather rare or of short duration

*Area: surrounding all or part of an installation

Directive 94/9/CE /

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Implementation of safety measures in compliance with ATEX standards

MAPAQ




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Explosive Atmosphere ATEX► ATEX classification:

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MAPAQ

Health Canada & MAPAQ expert, Training Company Agreement CPMT #0059104► Compliance assessment procedures:

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MAPAQ


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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

[email protected]

Laval, Canada

PBE Expert Inc. Votrepartenaire en conformité

http://www.pbe-expert.com/

mailto:[email protected]

http://www.pbe-expert.com/

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Explosions and XP Design, Safe and Compliant with ATEX and ......MAPAQ Explosions and XP Design, Safe and Compliant with ATEX and NFPA Standards. PBE, Pharma Bio Expert Inc. PBE-Expert