Welding Qualityin the pharmaceutical-, biotech- and food industryWelding’s in stainless steel pipes
Flemming FrenglerM.Sc. Mech. Eng.Senior Quality Specialist
2015.06.24 Svejsekonference
Agenda
1. Introduction
2. Background for a welding
3. Welding Requirement’s in Pharmaceutical-, Biotech- and Food industry
4. Practical handling and documentation
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INTRODUCTION
Flemming FrenglerSenior Quality SpecialistMechanical Engineer, Fitter, B.Sc, M.Sc Eng.
Altas Industries, 5 yearNNE Pharmaplan, 18 year (5 Y Clean Utility, 3 Y Mechanical and last 10 Y as project QA) +45 30 79 72 15 / [email protected]
49 YHvidovre (Copenhagen)Married3 children
• Welding is a process in which two materials are joined together by melting the metals or thermoplastics.
• When welding may include a third material, filler material, which together with the two pipes materials form an “new” alloy (legering) in the weld joint (samling).
BACKGROUND FOR A WELDING
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Type of materials:• Steel (st. 37)• Stainless steel (AISI 316L or W. 1.4404)• Aluminum• Plast (thermoplastics)• ect.
Different welding process:• TIG (Tungsten Inert Gas) = No. 141• Plasma arc welding = No. 15• MAG welding = No. 135
BACKGROUND FOR A WELDING
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Welded material Metals or Thermoplastics types
Practical handling and documentationWelding methodWelders qualificationTracebilityInspectionsDocumentation
Untreated and treated weldings in contact with mediaSanitary finishHygieneSmooth surfacesEffective cleanableMinimises the risk of corrosion, microbial growth and other
contamination of the productTracebility and documentation
Welding requirement’sRegulatory Requirement’s Standards: EN, ISO, ASME-BPE, ASTMGuidelines: Third part Company's (FORCE, AWS, ect.) and Company’sCompany’s: interpretation (fortolkning) and Handling of the Guidelines and Rrequirement’s
WELDING REQUIREMENT’S IN PHARM-, BIOTECH- AND FOOD INDUSTRY
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WELDING REQUIREMENT’S IN PHARM-, BIOTECH- AND FOOD INDUSTRY
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Installation Requirement’s Specification = IRS
Execution model in practice
WELDING REQUIREMENT’S IN PHARMA-, BIOTECH- AND FOOD INDUSTRY
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PRACTICAL HANDLING AND DOCUMENTATIONREQUIREMENT’S
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PRACTICAL HANDLING AND DOCUMENTATIONWELDERS QUALIFICATION - HANDWELDING
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PRACTICAL HANDLING AND DOCUMENTATIONWELDERS QUALIFICATION – ORBITAL WELDING
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PRACTICAL HANDLING AND DOCUMENTATIONWPS – WELDING PROCEDURE SPECIFICATION
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PRACTICAL HANDLING AND DOCUMENTATIONWELDING TEST – NOT REQUIRED
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PRACTICAL HANDLING AND DOCUMENTATIONWELDING LOG
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PRACTICAL HANDLING AND DOCUMENTATIONWELDING INSPECTION - WELDING DEFECTS
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EN ISO 5817Quality limits in 3 levelsB = HighC = MediumD = Low
EN ISO 5817EN ISO 5817
EN ISO 5817Quality limits in 3 levelsImperfections are given for the 3 Quality levels.
Acceptance criteria:For Chloride containing aqueous media
and surfaces exposed without post weld treatment:
Heat tint levels A to C are acceptableD and above to be rejected.
PRACTICAL HANDLING AND DOCUMENTATIONWELDING INSPECTION - WELDING COLOR, REPORT 1337-3
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PRACTICAL HANDLING AND DOCUMENTATIONWELDING INSPECTION - WELDING COLOR, REPORT 94.30
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PRACTICAL HANDLING AND DOCUMENTATIONWELDING INSPECTION – WELDING COLOR, AWS 18.1
PRACTICAL HANDLING AND DOCUMENTATIONWELDING INSPECTION – INSPECTION’S TOOLS
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PRACTICAL HANDLING AND DOCUMENTATIONWELDING INSPECTION – INDEPENDENT INSPECTION (THIRD PART)
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PRACTICAL HANDLING AND DOCUMENTATIONWELDING INSPECTION – INDEPENDENT INSPECTIONEN ISO 9712 LEVEL 2 (EN473)
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FAT/SAT
Practical handling and documentation
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Verify all requirements and reporting
FAT = Factory Acceptance Test (Off side test)SAT = Site Acceptance Test (On side test)
Handover
Practical handling and documentation
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Before handover of process units, the process units operational satisfactory and meet all the installation, operational, performance requirement’s.
Welding Qualityin the pharmaceutical-, biotech- and food industryintroduction for weldings in stainless steel pipe
By Flemming Frengler M. SC. Mech. Eng Quality Specialist NNE Pharmaplan
2015.06.24 AMU and
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