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FACILITIES AND
EQUIPMENT
Defects Produced
in Orbital Welding
for Pharmaceutical
Process Piping: Case
Study and Simulation
Jorge Domingo and Margarita Morquillas
Bonding or welding processes used in the construction of distribution Orbital welding is the controlled rotation of components within a fixed
systems for utilities are some of the most critical activities on projects with support, while an adjustable, nonconsumable tungsten electrode attached
high sanitary requirements in the life sciences and similar industries. to a guide moves (or “orbits”) the joint. The electrode, the arc, the area
surrounding the weld, and tube interior are protected by a shield of inert
Project implementation experience, both domestically and internationally, gas—usually argon—with a purity of 99.995/99.999% (Figure 2).
indicates that activities requiring high levels of quality monitoring are relat-
ed to the installation of critical fluids distribution systems, most specifically Although orbital welding is an automated process, weld quality depends
those constructed from stainless steel alloy tubes jointed by gas tungsten on a number of parameters, in addition to the operator’s training and skill.
arc welding (GTAW), also known as tungsten inert gas (TIG), using orbital Changes in any of these parameters can result in weld defects, which can
welding techniques. lead to nonconformities. As a result, each weld must be verified individually.
Difficulties are more likely to occur when working on-site, where the welding Nondestructive Weld Verification
conditions are not as favorable as those in specialized workshops, which pro- Nondestructive weld verification inspects the surface and subsurface of the
vide better opportunities for control. Another challenge is the need in many weld and surrounding base material to verify weld quality. Commonly used
cases to use resources that are unfamiliar, due to the project requirements of nondestructive verification methods include:
the, the client, or locally applicable regulations. It is also worth noting that lo-
cal welding companies contracted to perform work often don’t have enough ¡ X-ray
experience in large welding projects. This increases the risk of noncompliance ¡ Penetrant liquid
and may require additional resources for performance monitoring. ¡ Ultrasound
¡ Magnetic particle
This article evaluates the causes of defects in welds. The approach taken
was to simulate conditions that can affect the quality of welds by changing Within the world of critical facilities, however, visual verification by video
the parameters used to diagnose defects. Weld quality was verified endoscopy has wider acceptance. The main advantage of this method over
visually, since this is the most common method in pharmaceutical facilities, those listed above is that provides visual verification of the weld surface
as recommended in American Society of Mechanical Engineers Bioprocess
Equipment (ASME BPE) group regulations. Figure 1: Weld rejection due to scratches (a and b)
This article also presents a case study performed after extensive experience
in installation of international projects, during which various types of
nonconformities were identified in a variety of welds (Figure 1).
Orbital Welding
Over the years, the pharmaceutical industry has become increasingly
aware that the welding process used to join components of process piping
systems that will be in contact with the product must be controlled and
consistent to reduce the likelihood of defects in individual welds.
Figure 2: Tungsten and piece preparation (a) and weld head (b) Figure 3: Boroscope probe (a) boroscope machine (b)
Figure 5: Discoloration acceptance criteria for weld HAZs on electropolished 316L Weld Acceptance Criteria
tubing
Since one of the recommendations in this article is to
follow ASME BPE-2014, we have included references
to and extracts from the international standard. For
further details, please review MJ-8 pages from 122
to 139.
All parties involved should agree upon inspection procedures, methodology, Most welding companies have these (and other) parameters under con-
and logistics in advance. trol in workshops. Provided on-site welding is carried out in appropriately
controlled environments to correct procedures and uses required pa-
rameters, weld quality can be guaranteed outside the workshop. Due to
on-site constraints (time and resources), however, procedures Figure 6: Discoloration acceptance criteria for weld HAZs on mechanically
polished 316L tubing
can be compromised, increasing the risk of nonconformities.
It is therefore imperative that time and resources be invested
to assure appropriate conditions, and ensure the weld quality.
General conditions
The tests were conducted under the direction and advice of
specialists using the following equipment and parameters:
Welding conditions
¡ Welding procedure: TIG orbital fusion
¡ Orbital head model: 8-4000 (Arc Machines, Inc.)
¡ Orbital current source model: 207-A (Arc Machines, Inc.)
¡ Feed: Continuous
¡ Shield gas: Argon 100% [99.995%] (Arcal TIG/MIG) EN 439, I1.
¡ Support gas: Argon 100% [99.995%] (Arcal TIG/MIG)
EN 439, I1
¡ Component dimensions: 38.1 mm diameter, 1.65 mm
thickness
¡ Base material: 316L stainless steel, ASME BPE-2014
¡ Electrode: Tungsten, ø 1.6 mm esp., 20 sharp, 1.3 mm Source: Reprinted from ASME BPE-2014, by permission of The American Soceity of Mechanical Engineers.
distance All rights reserved. No further copies can be made without written permission.
Figure 7 (a and b): Weld coupon exterior and interior; welding Low-purity purge gas
with excessive purge gas
We maintain the purge gas, but to simulate an inert gas with 99.995%
purity we use an active gas to represent contaminants in the purge gas.
Argon (98%) + CO2 (2%); Arcal 12 (M12; EN 439)
We also obtain lack of fusion zones, and zones in which the external weld
bead is sunken. A composition change in the purge gas implies a change in
the welding parameters.
Figure 11: Weld coupon exterior (a) and interior (b) ¡ Purge gas flow: 20 L/h
¡ Preliminary purge gas flow: 5 L/min (preliminary purge time, min. 15 sec.)
¡ Shielding gas flow: 5 L/min
¡ Tungsten diameter: 1.6; sharp angle 20°
¡ Distance tungsten piece: 1.3 mm
Observations: Externally, the weld bead is sunken in the central part, but
this kind of failure appears by sectors and decreases the effective thickness
of the tube (Figure 13).
Figure 12: Weld coupon exterior (a) and interior (b) Installation component defects
Dimensional tolerance failure in components
Welding parameters are correct, but one component is mechanically
deformed and dished. This type of failure may occur when tubes and
accessories have been stored improperly.
Purge gas overpressure Figure 13: Weld coupon exterior (a) and interior (b)
We increase the shielding gas flow 20 L/min more than the correct gas flow.
Figure 15. Weld coupon exterior (a) and interior (b) Edge facing failure
Welding parameters equal to those of the reference sample P 34 E31. We
make a defective edge facing (small notch) in one zone of the tube.
¡ Purge gas flow: 20 L/min Figure 18: Weld coupon exterior (a), interior (b), and
preparation (c)
¡ Preliminary purge gas flow: 5 L/min (preliminary purge time, min. 15 sec.)
¡ Shielding gas flow: 5 L/min
¡ Tungsten diameter: 1.6; sharp angle 20°
¡ Distance tungsten piece: 1.3 mm
Figure 19: Weld coupon exterior (a) and interior (b) Figure 21: Weld coupon exterior (a) and interior (b)
Figure 20: Weld coupon exterior (a), interior (b), and Figure 22: Weld coupon exterior (a), interior (b), and
preparation (c) preparation (c)
Observations: Externally, we can see a mild oxidation, but no other imper- Observations: Externally, the weld bead is very irregular, breaking in, and
fection. Internally, the weld bead looks dirty, irregular, and in some zones very rusty. We can see the difference of diameter between both compo-
there is a lack of fusion; visually, however, the pores are indistinguishable nents. The joint is misaligned. Internally, the weld bead is very irregular
(Figure 19). and it is partially rusted. Color difference in base materials is due to the
difference between the two polished materials (Figure 21).
Metallic contaminants in the components
Welding parameters are correct, iron filings are placed inside. Weld preparation defects
Excessive track welding with penetration and
¡ Purge gas flow: 20 L/min without shielding gas
¡ Preliminary purge gas flow: 5 L/min (preliminary purge time, min. 15 sec.) Welding parameters are correct; we make several track welds between
¡ Shielding gas flow: 5 L/min both pieces and with 60A of intensity and without shielding gas.
¡ Tungsten diameter: 1.6; sharp angle 20°
¡ Distance tungsten piece: 1.3 mm ¡ Purge gas flow: 20 L/min
¡ Preliminary purge gas flow: 0 L/min (preliminary purge time, min. 15 sec.)
Observations: Internally, we can see metallic inclusions. Externally, the weld ¡ Shielding gas flow: 0 L/min
bead is sunken and rusty in some zones (Figure 20). ¡ Tungsten diameter: 1.6; sharp angle 20°
¡ Distance tungsten piece: 1.3 mm
Different base material components
Welding parameters are correct, but we used a piece made of 316L ASME Observations: Externally, we can observe that the track welding is too large
BPE stainless steel and another piece of the same material for alimentary in comparison to the rest of the weld bead. The track welding should be
industry. invisible, and should be covered with the welding bead. Also there are
blacking holes in the crater point. In the internal part of the weld coupon
and around the track welding, there is rust and it is completely black and
cracked: Figure 22.
Excessive track welding with penetration and with covered with the welding bead. Unlike the previous weld coupon, there are
shielding gas no rusted parts (Figure 23).
Welding parameters are correct; several track welds were made between
both pieces with 60A of intensity and with shielding gas. Alignment failure of the components in the track
welding
¡ Purge gas flow: 20 L/min Welding parameters are correct, several track welding was done between
¡ Preliminary purge gas flow: 5 L/min (preliminary purge time, min. 15 sec.) both pieces with a 30A of intensity.
¡ Shielding gas flow: 5 L/min
¡ Tungsten diameter: 1.6; sharp angle 20° ¡ Purge gas flow: 20 L/min
¡ Distance tungsten piece: 1.3 mm ¡ Preliminary purge gas flow: 5 L/min (preliminary purge time, min. 15 sec.)
¡ Shielding gas flow: 5 L/min
Observations: Externally, the track welding is too large in comparison to the ¡ Tungsten diameter: 1.6; sharp angle 20°
rest of the weld bead. Track welding should not be visible, and should be ¡ Distance tungsten piece: 1.3 mm
Figure 23: Weld coupon exterior (a), interior (b), and
preparation (c) Observations: Welding is not uniform. Penetration is excessive in some
zones and limited/insufficient in others. Excessive rust in one external zone
of the welding bead. There are “get downs” without even cause perfora-
tions (Figure 24).
Component misalignment
Welding parameters are correct. To simulate this failure, we leave one of the
orbital weld head jaws open (clamp inserts looseness).
Figure 27: Weld coupon exterior (a) and interior (b) ¡ Shielding gas flow: 5 L/min
¡ Tungsten diameter: 1.6; sharp angle 20°
¡ Distance tungsten piece: 1.3 mm
Figure 29: Weld coupon exterior (a), interior (b), and ¡ Purge gas flow: 20 L/min
preparation (c)
¡ Preliminary purge gas flow: 5 L/min (preliminary purge time, min. 15 sec.)
¡ Shielding gas flow: 5 L/min
¡ Tungsten diameter: 1.6; sharp angle 20º
¡ Distance tungsten piece: 1.3 mm
Observations: The weld bead is bulky in the overlap. In the overlap zone, we
see an excessively wide root (Figure 34).
Observations: The weld bead is slightly sunken and narrow. There is a lack
of penetration in several zones (Figure 35).
Observations: Visually the weld bead is very narrow. There is a lack of pen-
etration along the weld bead. One weld coupon not even get melt reaches
a part of the piece (Figure 33).
Figure 35: Weld coupon exterior (a) and interior (b) three weld coupons there is an overall lack of fusion in the entire internal
weld bead (Figure 36).
Figure 37: Weld coupon exterior (a), interior (b), and ¡ Purge gas flow: 20 L/min
preparation (c) ¡ Preliminary purge gas flow: 5 L/min (preliminary purge time, min. 15 sec.)
¡ Shielding gas flow: 5 L/min
¡ Tungsten diameter: 1.6; sharp angle 20º
¡ Distance tungsten piece: 3 mm
Observations: There is a lack of penetration and the root of the weld bead
is very narrow (Figure 38).
Figure 38: Weld coupon exterior (a), interior (b), and ¡ Purge gas flow: 20 L/min
preparation (c)
¡ Preliminary purge gas flow: 5 L/min (preliminary purge time, min. 15 sec.)
¡ Shielding gas flow: 5 L/min
¡ Tungsten diameter: 1.6; sharp angle 20º
¡ Distance tungsten piece: 1.3 mm
Figure 39: Weld coupon exterior (a) and interior (b) References
1. US Code of Federal Regulations. Title 21, Part 210. “Current Good Manufacturing Practice in
Manufacturing, Processing, Packing, or Holding of Drugs; General.” http://www.accessdata.
fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=210.
2. US Code of Federal Regulations. Title 21, Part 211. “Current Good Manufacturing Practice
for Finished Pharmaceuticals.” https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/
CFRSearch.cfm?CFRPart=211.
3. American Society of Mechanical Engineers. ASME Bioprocessing Equipment Standard: BPE-2014.
4. International Society for Pharmaceutical Engineering. Water and Steam Systems, 2nd ed.
ISPE Baseline® Guide, Volume 4. ISPE, December 2011.
5. 3A Sanitary Standards. “P3-A Pharmaceutical Standards.”
6. American Society of Mechanical Engineers. ASME B31.3-2002. “Process Piping.” Revision of
ASME B31.3-1999. 30 April 2002. http://www.iu.hio.no/~pererikt/Konstr/Konstr-design-II/
standarder/ASMEB31.3-1.pdf.
7. 2015 ASME Boiler and Pressure Vessel Code. Section IX: “Qualification Standard for Welding
and Brazing Procedures, Welders, Brazers, and Welding and Brazing Operators.” 07 July 2015
8. American Welding Society. D 18.1/D18.1M: 2.009. “Specification for Welding of Austenitic
Figure 40: Weld coupon exterior (a) and interior (b) Stainless Steel Tube and Pipe Systems in Sanitary (Hygienic) Applications.”
9. ———. AWS B2.1/B2.1M_BMG: 2009-ADD1. “Base Metal for Welding Procedure and
Performance Qualification.” March 2012. https://app.aws.org/technical/B2.1-B2.1M-BMG-
2009-ADD1.pdf.
10. ———. AWS B4.0:2007. “Standard Methods for Mechanical Testing of Welds.” 2007. http://
bjchaozhan.com/admin/uploadpic/201292386223002249.pdf.
11. ———. AWS D18.2: 2009. Guías Para la Decoloración de la Soldadura en Tubos de Aceros
austeníticos.
12. American Society for Nondestructive Testing. Recommended Practice No. SNT-TC-1A 2011.
“Personnel Qualification and Certification in Nondestructive Testing.”
13. British Standards Institution. BS EN 287-1:2004. Cualificación de Soldadores. Soldeo por
Fusión. Parte 1 Aceros.
14. Riesco, Gemán Hernández. Manual del Soldador. 16º edición. Cesol.
15. Gómez, Manuel Reina. Soldadura de los Aceros. 4ª edición.
16. Arc Machines, Inc. Seminario Soldadura Orbital.
17. Barbara K. Henon articles:
Henon, Barbara K, and Y.K. Tan. “Autogenous Orbital GTAW of Large, High-Purity Tubes.”
Conclusion The Fabricator, 15 July 2010. http://www.thefabricator.com/article/arcwelding/autogenous-
orbital-gtaw-of-large-high-purity-tubes.
In these studies, the GTAW/TIG orbital welding process is robust and reliable.
Henon, Barbara K. “Documenting Welds from an Orbital Welding Power Supply.”
In many cases, it was very laborious to reproduce weld failures, even when Practical Welding Today, 12 February 2004. http://www.thefabricator.com/article/
conditions and parameters were quite extreme. In some instances, it was tubepipefabrication/documenting-welds-from-an-orbital-welding-power-supply.
Henon, Barbara K. “Specifying the Sulfur Content of 316L Stainless Steel for Orbital
not possible to produce anticipated faults. Welding.” TPJ: The Tube & Pipe Journal, 27 March 2003. http://www.thefabricator.com/
article/tubepipefabrication/specifying-the-sulfur-content-of-316l-stainless-steel-for-orbital-
welding.
There are numerous factors that can affect weld quality, so systematic
quality control of the entire welding process—from preparing materials
and setting conditions to inspection of the welds obtained—is necessary. About the authors
In this regard, the importance of using visual systems like video endoscopy Jorge Domingo has a BSc in industrial engineering from Polytechnical University of Madrid
demonstrated that in certain cases welds that appeared to be correct (UPM) and a Masters in sales and marketing management from ESDEN Business School.
He has more than 10 years of experience in process, high purity water, CIP and biowaste
externally were found to be nonconforming after inspection. For this reason,
technologies, acting as engineer and product manager in the pharmaceutical industry
tests based on inspection by noninvasive methods that do not provide sector. Until August 2015, as a Technology Unit Manager at Telstar he was responsible
information on the inside finish should be considered as complementary, for pharmaceutical and biotechnology process and high purity water systems. Presently
he combines the role as an Engineer Expert in Pharmaceutical Water Systems with this
but not as a substitute for internal visual inspection.
position as the Asia Pacific Regional Office Manager at Telstar. He can be contacted by email
at jdomingo@telstar.com, and by post at Telstar, Av, Font i Sagué, 55 Terrassa Barcelona
These studies also demonstrate the importance of purging with an 08227, Spain.
appropriate gas under correct conditions. Variations in gas characteristics
Margarita Morquillas started her career as a draftsman designer and has developed
(quality, flow, and pressure) produce significant variations in weld quality. extensive experience in the design of pharmaceutical process installations. She has been
We therefore recommend that this is one of the first points checked early working in the biopharmaceutical industry for more than 19 years with more than 16 years
in the performance of welding works, welding documentation and welding inspection. She
in the process. ¢
is currently the TIG Welding Senior Expert, responsible for commissioning and start-up at
Telstar. She conducts welding inspections and performs commissioning plans for Telstar’s
Acknowledgements project facilities. She can be contacted by email at mmorquillas@telstar.com, and by post at:
Telstar, Av, Font i Sagué, 55 Terrassa Barcelona 08227, Spain.
The authors acknowledge and greatly appreciate the effort and dedication
of Oerlikon (Spain) in carrying out the tests and trials, without whom this
study would not have been possible.
Table B: Visual examination acceptance criteria for groove welds on tube-to-tube butt joints
Includes all products (e.g., tubes, fittings, castings, forgings, and bars) whose final dimensions meet Part DT requirements
Discontinuities Welds on product contact surfaces Welds on nonproduct contact surfaces
Cracks None None
Lack of fusion None None
Incomplete penetration None [see Fig. MJ-8.4-1, illustration (e)] None [see Fig. MJ-8.4-1, illustration (e)]
Porosity None open to the surface; otherwise, see note 1. None open to the surface; otherwise, see note 1.
Inclusions [metallic (e.g., tungsten) or nonmetallic] None open to the surface; otherwise, see note 1. See note 1
Undercut None See note 1
Concavity 10% TW max. [see Fig. MJ-8.4-1. Illustrations (c) and (d). 10% TW max. [see Fig. MJ-8.4-1, illustrations (c) and (d)] over
However, O.D. and I.D. concavity shall be such that the wall entire circumference with up to 15% of the nominal wall thick-
thickness is not reduced below the minimum thickness ness permitted over a maximum of 25% of the circumference
required in DT-3 [see note 2] [see note 2].
Convexity 10% TW max. [see Fig. MJ-8.4-1, illustration (f)] [See note 2] Maximum of 0.015 in. (0.38 mm) [see Fig. MJ-8.4-1, illustration
(f)] [See note 2].
Discoloration (heat-affected zone) Heat affected zone (HAZ) may be permitted to have light Discoloration level will be agreed upon between the owner/
straw to light blue color (see Figs. MJ-8.4-2 and MJ-8.4-3). user and contractor. Postweld conditioning may be allowed
Any discoloration present must be tightly adhering to the to meet discoloration requirements at the discretion of the
surface such that normal operations will not remove it. In owner/user. See note 3.
any case, the HAZ shall have no evidence of rust, free iron, or
sugaring. See note 3
Discoloration (weld bead) None allowed. For welds in nickel alloys, and for welds in Discoloration level will be agreed upon between the owner/
superaustenitic alloys made with nickel alloy inserts or filler user and contractor. Postweld conditioning may be allowed
metals, slag is permitted as long as it is silver to light gray in to meet discoloration requirements at the discretion of the
color and adherent to the surface. See note 3. owner/user. See note 3.
Reinforcement See Convexity See Convexity
Tack welds Must be fully consumed by final weld bead [see note 4] Same as product contact side.
Arc strikes None See note 5
Overlap None None
Weld bead width No limit provided that complete joint penetration is achieved. If process contact surface cannot be inspected (such as I.D. of
a tube beyond the reach of remote vision equipment), then
the nonproccess contact surface weld bead shall be straight
and uniform around the entire weld circumference [see Fig.
MJ-8.4-1, illustration (g)]. The minimum weld bead with
shall not be less than 50% of the maximum weld bead width
[see Fig. MJ-8.4-1, illustration (h)]. The maximum weld bead
meander shall be 25% of the weld bead width, measured as a
deviation from the weld centerline, as define in Fig. MJ-8.4-1,
illustration (i).
Minimum throat N/A N/A
Misalignment (mismatch) 15% TW max. [see Fig. MJ-8.4-1, illustration (b)], except Same as process contact surfaces
that 4 in. tube may have a maximum of 0.015 in. (0.38 mm)
misalignment on the O.D and 6 in. tube may have a maximum
of 0.030 in. (0.76 mm) misalignment on the O.D. Figure
MJ-8.4-1, illustration (b) does not apply to 4 in. and 6 in. tube
[see note 2].
General note: Includes all product forms (e.g.: tube, fittings, castings, forgings, and bar) whose final dimensions meet Part DT requirements.
NOTES
1. The limits of ASME B31.3 shall apply
2. TW is the nominal wall thickness of the thinner of the two members being joined. Weld metal must blend smoothly into base metal.
3. Welds on tubing that has been in service may require unique criteria.
4. Any weld that shows unconsumed tack welds on the nonproduct contact surface must be inspected on the product contact surface; otherwise they are rejected. If the weld cannot be
inspected on the product contact surface, rewelding per MJ-8.4.2 is not allowed. Rewelding per MJ-8.4.2 is allowed if the weld can be inspected on the product contact surface after rewelding.
5. Arc strikes on the nonproduct contact surface may be removed by mechanical polishing as long as the minimum design wall thickness is not compromised.
6. Note that misalignment is controlled on the O.D. and is based on allowable O.D. dimensions and tolerances of fittings and tubing. The owner/user is cautioned that this can result in
greater ID misalignment because this also takes into consideration that wall thickness dimensions and tolerances of fittings and tubing. However, there are no specified ID misalignment
acceptance criteria.
Source: Reprinted from ASME BPE-2014 (Table MJ-8.4-1), by permission of the American Society of Mechanical Engineers. All Rights Reserved. No further copies can be made without written
permission.