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    Welding Quality: in The Pharmaceutical-, Biotech-And Food Industry

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    Jiddu Nguyen
    Flemming Frengler, a senior quality specialist and mechanical engineer, gave a presentation on welding quality requirements in the pharmaceutical, biotech, and food industries. He discussed the importance of welding procedures, welder qualification, traceability, inspections, and documentation to ensure welds meet regulatory standards and guidelines. Frengler also covered practical handling of welds, including methods for qualifying welders, performing inspections, documenting defects, and approving process units through factory and site acceptance testing prior to handover.

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    Welding Quality: in The Pharmaceutical-, Biotech-And Food Industry

    Uploaded by

    Jiddu Nguyen
    85 views24 pages
    Flemming Frengler, a senior quality specialist and mechanical engineer, gave a presentation on welding quality requirements in the pharmaceutical, biotech, and food industries. He discussed the importance of welding procedures, welder qualification, traceability, inspections, and documentation to ensure welds meet regulatory standards and guidelines. Frengler also covered practical handling of welds, including methods for qualifying welders, performing inspections, documenting defects, and approving process units through factory and site acceptance testing prior to handover.

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    Flemming Frengler, a senior quality specialist and mechanical engineer, gave a presentation on welding quality requirements in the pharmaceutical, biotech, and food industries. He discussed the importance of welding procedures, welder qualification, traceability, inspections, and documentation to ensure welds meet regulatory standards and guidelines. Frengler also covered practical handling of welds, including methods for qualifying welders, performing inspections, documenting defects, and approving process units through factory and site acceptance testing prior to handover.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    85 views24 pages

    Welding Quality: in The Pharmaceutical-, Biotech-And Food Industry

    Uploaded by

    Jiddu Nguyen
    Flemming Frengler, a senior quality specialist and mechanical engineer, gave a presentation on welding quality requirements in the pharmaceutical, biotech, and food industries. He discussed the importance of welding procedures, welder qualification, traceability, inspections, and documentation to ensure welds meet regulatory standards and guidelines. Frengler also covered practical handling of welds, including methods for qualifying welders, performing inspections, documenting defects, and approving process units through factory and site acceptance testing prior to handover.

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    You are on page 1of 24

    2015.06.

    24 Svejsekonference

    Welding Quality
    in the pharmaceutical-,
    biotech- and food
    industry
    Welding’s in stainless
    steel pipes
    Flemming Frengler
    M.Sc. Mech. Eng.
    Senior Quality Specialist
    Agenda

    1. Introduction
    2. Background for a welding
    3. Welding Requirement’s in Pharmaceutical-, Biotech- and
    Food industry
    4. Practical handling and documentation

    2
    INTRODUCTION

    Flemming Frengler
    Senior Quality Specialist
    Mechanical Engineer, Fitter, B.Sc, M.Sc Eng.
    Altas Industries, 5 year
    NNE 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 Y
    Hvidovre (Copenhagen)
    Married
    3 children

    3
    BACKGROUND FOR A WELDING

    • 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).

    4
    BACKGROUND FOR A WELDING

    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

    5
    WELDING REQUIREMENT’S IN PHARM-, BIOTECH- AND FOOD INDUSTRY
    Welding requirement’s
     Regulatory Requirement’s Welded material
     Standards: EN, ISO, ASME-BPE, ASTM  Metals or
     Guidelines: Third part Company's (FORCE, AWS, ect.) and Company’s Thermoplastics
    Company’s: interpretation (fortolkning) and Handling of types
    the Guidelines and Rrequirement’s

    Untreated and treated weldings in contact with media


    Practical handling and
    Sanitary finish
    documentation
     Hygiene
     Welding method
     Smooth surfaces
     Welders qualification
     Effective cleanable
     Tracebility
     Minimises the risk of corrosion, microbial growth and other
     Inspections
    contamination of the product
     Documentation
     Tracebility and documentation

    6
    WELDING REQUIREMENT’S IN PHARM-, BIOTECH- AND FOOD INDUSTRY
    Installation Requirement’s Specification = IRS

    7
    WELDING REQUIREMENT’S IN PHARMA-, BIOTECH- AND FOOD INDUSTRY

    8
    Execution model in practice
    PRACTICAL HANDLING AND DOCUMENTATION
    REQUIREMENT’S

    9
    PRACTICAL HANDLING AND DOCUMENTATION
    WELDERS QUALIFICATION - HANDWELDING

    10
    PRACTICAL HANDLING AND DOCUMENTATION
    WELDERS QUALIFICATION – ORBITAL WELDING

    11
    PRACTICAL HANDLING AND DOCUMENTATION
    WPS – WELDING PROCEDURE SPECIFICATION

    12
    PRACTICAL HANDLING AND DOCUMENTATION
    WELDING TEST – NOT REQUIRED

    13
    PRACTICAL HANDLING AND DOCUMENTATION
    WELDING LOG

    14
    PRACTICAL HANDLING AND DOCUMENTATION
    WELDING INSPECTION - WELDING DEFECTS
    EN ISO 5817
    EN ISO 5817

    EN ISO 5817
    Quality limits in 3 levels
    Imperfections are given
    EN ISO 5817
    for the 3 Quality levels.
    Quality limits in 3 levels
    B = High
    C = Medium
    D = Low

    15
    PRACTICAL HANDLING AND DOCUMENTATION
    WELDING INSPECTION - WELDING COLOR, REPORT 1337-3

    Acceptance criteria:
    For Chloride containing
    aqueous media
    and surfaces exposed without post
    weld treatment:
    Heat tint levels A to C are
    acceptable
    D and above to be rejected.

    16
    PRACTICAL HANDLING AND DOCUMENTATION
    WELDING INSPECTION - WELDING COLOR, REPORT 94.30

    17
    PRACTICAL HANDLING AND DOCUMENTATION
    WELDING INSPECTION – WELDING COLOR, AWS 18.1

    18
    PRACTICAL HANDLING AND DOCUMENTATION
    WELDING INSPECTION – INSPECTION’S TOOLS

    19
    PRACTICAL HANDLING AND DOCUMENTATION
    WELDING INSPECTION – INDEPENDENT INSPECTION (THIRD PART)

    20
    PRACTICAL HANDLING AND DOCUMENTATION
    WELDING INSPECTION – INDEPENDENT INSPECTION
    EN ISO 9712 LEVEL 2 (EN473)

    21
    Practical
    handling and
    documentation

    FAT/SAT

    Verify all requirements and reporting

    FAT = Factory Acceptance Test (Off side test)


    SAT = Site Acceptance Test (On side test)
    22
    Practical
    handling and
    documentation

    Handover

    Before handover of process units, the process units


    operational satisfactory and meet all the installation,
    operational, performance requirement’s.
    23
    2015.06.24 AMU and

    Welding Quality
    in the pharmaceutical-,
    biotech- and food industry
    introduction for weldings
    in stainless steel pipe

    By Flemming Frengler
    M. SC. Mech. Eng
    Quality Specialist
    NNE Pharmaplan

    24

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