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
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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
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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).
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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
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WELDING REQUIREMENT’S IN PHARM-, BIOTECH- AND FOOD INDUSTRY
Welding requirement’s
 Regulatory Requirement’s
 Standards: EN, ISO, ASME-BPE, ASTM
 Guidelines: Third part Company's (FORCE, AWS, ect.) and Company’s
Company’s: interpretation (fortolkning) and Handling of
the Guidelines and Rrequirement’s
Practical handling and
documentation
 Welding method
 Welders qualification
 Tracebility
 Inspections
 Documentation
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Welded material
 Metals or
Thermoplastics
types
Untreated and treated weldings in contact with media
Sanitary finish
 Hygiene
 Smooth surfaces
 Effective cleanable
 Minimises the risk of corrosion, microbial growth and other
contamination of the product
 Tracebility and documentation
WELDING REQUIREMENT’S IN PHARM-, BIOTECH- AND FOOD INDUSTRY
Installation Requirement’s Specification = IRS
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WELDING REQUIREMENT’S IN PHARMA-, BIOTECH- AND FOOD INDUSTRY
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Execution model in practice
PRACTICAL HANDLING AND DOCUMENTATION
REQUIREMENT’S
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PRACTICAL HANDLING AND DOCUMENTATION
WELDERS QUALIFICATION - HANDWELDING
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PRACTICAL HANDLING AND DOCUMENTATION
WELDERS QUALIFICATION – ORBITAL WELDING
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PRACTICAL HANDLING AND DOCUMENTATION
WPS – WELDING PROCEDURE SPECIFICATION
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PRACTICAL HANDLING AND DOCUMENTATION
WELDING TEST – NOT REQUIRED
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PRACTICAL HANDLING AND DOCUMENTATION
WELDING LOG
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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
for the 3 Quality levels.
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EN ISO 5817
Quality limits in 3 levels
B = High
C = Medium
D = Low
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.
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PRACTICAL HANDLING AND DOCUMENTATION
WELDING INSPECTION - WELDING COLOR, REPORT 94.30
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PRACTICAL HANDLING AND DOCUMENTATION
WELDING INSPECTION – WELDING COLOR, AWS 18.1
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PRACTICAL HANDLING AND DOCUMENTATION
WELDING INSPECTION – INSPECTION’S TOOLS
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PRACTICAL HANDLING AND DOCUMENTATION
WELDING INSPECTION – INDEPENDENT INSPECTION (THIRD PART)
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PRACTICAL HANDLING AND DOCUMENTATION
WELDING INSPECTION – INDEPENDENT INSPECTION
EN ISO 9712 LEVEL 2 (EN473)
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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)
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Practical
handling and
documentation
Handover
Before handover of process units, the process units
operational satisfactory and meet all the installation,
operational, performance requirement’s.
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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
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