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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 / FFr@nnepharmaplan.com

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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