HOME / PHARMACEUTICAL & SANITARY STAINLESS FABRICATION

Pharmaceutical & Sanitary Stainless Fabrication

Stainless process equipment, vessels and weld repair for pharmaceutical and process facilities, built and documented in our own shop in Bend, Oregon. This page is the paperwork rather than the pitch, because on a job like yours the paperwork is half the deliverable. Everything below is what actually leaves the shop with the work.

01

WHAT LEAVES WITH THE JOB

A signed certificate and a step by step record, plus the certificates behind every number on them. Your quality group should be able to check the work without calling us.

CERTIFICATE OF COMPLIANCE
Two pages. Page one is the job, the materials, the process, the qualification and the inspection. Page two is the record, with the weld parameters as run and every consumable used.
FILLER METAL CERTIFICATE
The manufacturer's certificate for the exact heat number that went into your weld, so the heat on the certificate and the heat on the rod agree.
WELDER QUALIFICATION REPORT
The third party test report behind the welder who did the work, by report number.
WELDING PROCEDURE
The standard welding procedure specification the work was performed to, with the demonstration record number. A copy on request.
PHOTOGRAPHS
As received, the excavation, and the finished work.
SERIALIZED CERTIFICATE NUMBER
Every certificate carries its own number and a job number, so it can be cited in your change control without ambiguity.

That is the package on non-code work. Code work carries more, because an Authorized Inspector is involved and code documentation is added, and it is quoted at a different rate.

02

HOW A JOB IS RECORDED

The record is filled in while the work happens, not written up afterwards. These are the steps on the repair record, and each one carries a result, an initial and a date.

01
RECEIVING INSPECTION
Photograph as received. Mark the defect ends. Record location, length, wall thickness and base metal identification.
02
CLEAN
Degrease the work zone with clean solvent and lint free wipes. No chlorinated cleaners.
03
EXCAVATE
Cut the defect out to sound metal with a stainless zip wheel. Taper the groove for access.
04
VERIFY REMOVAL
Visual examination of the excavation under magnification. Re-excavate until nothing remains.
05
PRE-WELD CHECK
Filler heat in hand and matching the certificate. Argon purge set where accessible. Groove clean and dry.
06
WELD
GTAW with ER316L. Amps, passes and interpass temperature recorded. Heat input kept low to limit sensitization.
07
BLEND
Blend flush with a 36 grit cloth disc, then nylon mesh coarse, medium and very fine, to the finish the job calls for.
08
FINAL INSPECTION
Final visual examination, photographs, and the certificate completed and signed.
03

WHAT GOES INTO THE WELD

Every one of these is a line on the certificate, and every one has a number behind it you can look up or ask us to send.

PROCESS
GTAW, manual, DCEN
WELDING PROCEDURE
AWS B2.1-8-024 standard welding procedure specification, demonstrated under ASME Section IX. Demonstration record QW-485 No. 202010919
WELDER QUALIFICATION
IMR Test Labs report No. 202100008
FILLER METAL
voestalpine Bohler Welding, Avesta ER316 and ER316L, to AWS A5.9 and ASME SFA-5.9. Manufacturer's certificate per AWS A5.01 on file, by heat number
SHIELDING GAS
Argon, 100 percent
BACKING GAS
Argon purge where the back of the joint is accessible, and recorded as not accessible where it is not
TUNGSTEN
3/32 in., 2 percent lanthanated or ceriated
INTERPASS TEMPERATURE
350 F (177 C) maximum
BASE METAL
304, 304L, 316 and 316L, recorded by type and by thickness at the work
SURFACE FINISH
Blended to the finish the job calls for and recorded on the certificate. Final Ra is measured by you, not by us
04

WHAT TOUCHES THE METAL

Contamination control is the question a pharmaceutical quality group asks and most shops cannot answer. Iron free abrasives only, tooling dedicated to stainless, no carbon steel contact. Every consumable goes on the record by manufacturer part number, so your team can look it up and check it against their own standard instead of taking our word for it.

ITEM
MANUFACTURER AND PART NO.
USED FOR
ER316 and ER316L filler rod, 0.045 in.
voestalpine Bohler Avesta, item 59480
Weld
Zip cut-off wheel, 4-1/2 x 0.045 x 7/8 in., type 27/42, A-60-SS-ZIP, Fe, S and Cl under 0.1 percent
Walter Zip Stainless 11-F 142
Excavation
Ceramic cloth disc, 3 in., 36 grit
McMaster-Carr 46395A76
Weld removal, rough blend
Nylon mesh disc, 3 in., coarse
McMaster-Carr 6531N152, 3M Cubitron
Blend
Nylon mesh disc, 3 in., medium
McMaster-Carr 6531N153, 3M Cubitron
Blend
Nylon mesh disc, 3 in., very fine
McMaster-Carr 6531N155, 3M Cubitron
Final blend
Backup pad, 3 in., medium, 1/4 in. shank
McMaster-Carr 4701A73
Disc holder
Passivating electrolyte
Walter SURFOX-T, 54A006
Electrochemical weld cleaning, where the job calls for it
Neutralizer
Walter SURFOX-N, 54A025
Neutralizing after the electrolyte, followed by a clean water rinse

Where a chemistry is used we send its safety data sheet, its technical data sheet and its NSF registration before it touches your equipment, and we ask your quality group to approve it first. SURFOX-T is NSF registered as an A3 acid cleaner, No. 142984. SURFOX-N is NSF registered as an A1 general cleaner, No. 142985. Walter publishes SURFOX-T as meeting ASTM A967 for passivation.

05

WHAT THE CERTIFICATE SAYS

CERTIFICATION, SECTION 6

N.B. Oler LLC certifies that the weld repair described above was performed with the materials, process and personnel listed, that the filler metal conforms to the specification and heat stated above per the manufacturer's certificate, and that the completed repair was inspected as recorded. This is a non-code repair to non-ASME-stamped equipment and is not an ASME or National Board (NBIC) stamped repair.

Signed, Nathaniel Oler, Owner, and dated

That last sentence is on the certificate deliberately. A certificate that overstates what it is gets a reviewer to throw out everything else on it. If your equipment carries an ASME nameplate, a weld repair on it has to be done by a shop holding a National Board R certificate, and that is not work we take on. We will tell you that before you ship anything.

06

WHAT WE WILL TELL YOU UP FRONT

We do not hold ASME BPE, 3-A, GMP or FDA certification, and we will not imply that we do. If your project requires one of those, say so at the inquiry stage and we will tell you honestly whether this is the right shop for it.

Work is performed to ASME standards. That is a statement about the procedure, the qualification and the records, not about a code stamp, and the certificate says so in its own words.

We specify a finish and we blend to it. We do not measure final Ra. If a number has to be verified, you verify it, and the certificate records that it was yours to verify.

We ask before we introduce a chemistry we did not quote. If a step gets added mid job you hear about it with the data sheets attached, and the change goes on the certificate once you sign off.

Inspection on this kind of work is visual. If your job needs liquid penetrant, radiography or a pressure test, say so at the quote stage so it can be built into the price and into the record.

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START A PHARMACEUTICAL PROJECT

This is the same qualifying form the Custom Fabrication page uses, so your inquiry lands in the same place and nothing is duplicated. Tell us what the equipment is, what it has to hold and what documentation your quality group needs, and you get a real answer instead of a back and forth. If you would rather talk it through, call 541-330-6409 during shop hours.

WHO YOU ARE
THE DUTY

This is what decides whether we can build it, what it costs, and whether it needs a code stamp. Estimates are fine. Not sure is fine.

Fields marked * are required. We ask for all of it because a real quote cannot be written without it, and because it tells us you are a customer rather than somebody selling us something.