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Navigating Stainless Material and Finishes for Hygienic Vessels

Stainless Finishes for Hygienic Vessels are measured by an RA (Roughness Average) meter.  Manufacturers of custom vessels for life science, health and pharmaceutical industries adhere to strict design parameters to maintain compliance in these industries. The RA is a standard for an average of peaks and valleys on the metal’s surface, measured in microinches.  Here is the evolution of stainless material coming to Apache with RA designations as it is transformed into custom sanitary design vessels:

RA > 100 Mill Finish  A Mill Finish has an unpolished, dull-gray, matte appearance. This material type is the basis for supply for all stainless-steel flat products as well as the basis for additional finishing operations.  It is hot or cold rolled with an RA (Roughness Average) of more than 100 microinches, depending on the gauge of the material. 

RA 15 – 40 2B Mill Finish  2B Mill finish is widely used in food, chemical and pharmaceutical equipment applications. It is corrosion resistant and has a typical RA range of 40 (7 gauge) to 15 (16 gauge) microinches.

RA 29 – 58 No. 3 and No. 4 Finish  Mechanical polishing achieves these finishes. The No. 3 Finish uses a 120-grit abrasive and has a semi-polished finish with an RA range of 36 – 58 microinches.  The No. 4 Finishes uses a 150-grit abrasive and has a polished, brushed surface.  The RA range is 29 – 40 microinches.

RA 18 – 31 No. 4A  Also identified as No. 4 Dairy Finish, this finishes is required to meet the basic FDA 3-A standards. It uses a 180 grit and has a RA range of 18 – 31 microinches.

< 32 RA Pickle Passivation   Pickle Passivation often follows other manufacturing processes including welding and grinding. Also called Pickling, it is the immersion of the metal in a pickling bath or coating the material with pick­ling solution, such as nitric-hydrofluoric acid. The process removes both metallic contamination and heat-treating scales. Pickle passivated stainless steel has a matte appearance. Apache’s tests have confirmed improvements up to 25% in RA read­ings on material that has been pickle passivated.

Lowest RA Electropolishing Electropolishing is an electro-chemical process that removes surface materi­al from stainless steel. The process includes an immersion of the stainless-steel component into a temperature-controlled bath of electrolyte that is charged with a DC power supply. Electrolytes used in electropolishing are concentrated sulfuric and phosphoric acid solutions. The finish has a mirror appearance. Apache’s before/after tests have shown improvements in RA smoothness up to 50%; results vary depending on stainless material.

In the highest level of sanitary design applications the vessel is pickled after manufacturing and polishing, then electropolished.


12 Engineering Steps to Ensure ASME Compliance for Custom Vessels

Custom vessel manufacturing to industries requiring compliance is what we do. There is a process for customer service and engineering that is required to get the custom vessel you require for your application. There are numerous specifications that will be required based on your process or level of compliance. Apache will work with you to explain and provide options in your vessel project. This collaborative effort will have to control cost and expedite timing for your custom vessel. 

Here are our 12 Project Engineering Steps to Ensure Vessel Compliance:

  1. Understand the intent of the vessel.  Apache has 45 years of experience manufacturing custom vessels.  We can lead important project planning discussion if we know the intent or type of process in which the vessel will be used.
  2. Ensure and Verify Design Conditions.  At this step, our project engineers look at the design conditions, process, temperatures, ASME and other compliance requirement and perform initial calculations.
  3. Determine Finish Requirements. Once design is verified and viable, the project is examined for mechanical and electropolishing requirements, as well as access needed for fixtures and how that has an impact on the fittings.
  4. Final Calculations.  In this step, the engineer provides final calculations to address issues, verify material thickness and fit of fittings.
  5. Completion of Compliant Design.  The ASME/PED/CRN compliant design is completed in 3D Solid Works.
  6. Order long lead time components.  The long lead time components such as the mixer, body flanges, heads are ordered. The supply chain is monitored carefully for timing, and any changes are communicated that may affect delivery.
  7. Component Manufacturer Collaboration.  Apache leverages long term relationships with component manufactures to customize specifications to meet the needs of the process.
  8. Custom Approval.  The customer receives approval drawings with 2D, 3D models.  There is often a series of collaborative meetings to finalize the design and approval.
  9. ASME (or other faction) Submission.  The final design is submitted for ASME or other compliance agency for approval.  Apache also leverages long-term relationships with regulatory agencies to help facilitate a smooth process.
  10. Detailed Drawings.  The engineering team completes the detailed drawings for the manufacturing process and fabrication can begin.
  11. Tests / Certifications.  ASME tests are scheduled and performed by our Quality Assurance team to comply with the certifications required for the vessel.
  12. Turn-over Packet (TOP).  The documentation packet can be completed after the vessel is manufactured and the TOP is developed and uploaded to our customer portal.

Apache’s engineering team articulates technical discussions and is open with timelines, cost and compliance-related issues. Our competence for a pharmaceutical or life science industry vessel is strongly supported in providing all compliance related deliverables.


How to Evaluate a Custom Pressure Vessel Manufacturing Partner

Accreditations 

Custom and pressure vessel manufacturers must have accreditation for ASME certification. Compliance with the National Board of Boiler and Pressure Vessel code is required. Pressure vessel manufacturers must also manufacture to ASME material specifications, certificates, and welding qualifications.

Other accreditations are also crucial in the pharmaceutical, life science, and health industries. Confirm all industry compliance standards, including:
•    ASME UM
•    ASME U
•    FDA
•    3-A
•    CRN
•    PED
•    BPE

Quality Assurance & Compliance

Verify that the manufacturer has a dedicated quality assurance team.  There are significant testing, certifications, and documentation requirements for all global accreditation programs. In-house inspection services are a benefit to ASME projects. Review services that should include:
•    Pneumatic testing
•    Hydrostatic testing
•    Liquid Penetrant (Dye Penetrant) testing
•    Saline testing and certificate
•    Riboflavin/CIP (clean-in-place) coverage test
•    Material Test Reports
•    Base metal thickness certificate
•    Material trace
•    Welder trace
•    Ferroxyl test and certificate
•    Positive material identification (PMI) and certificate
•    Ferrite levels and certificate
•    Radiography and analysis
•    UT weld testing and certificate
•    Turn Over Packet (TOP) as required


Experience

The pressure vessel manufacturer must have expertise in the type of vessel and industry experience for the use of the vessel. Critical staff, fabricators, and welders must be ASME certified. All welders must be approved for the weld procedures required to make custom pressure vessels.

Experience and reputation are also significant when developing relationships with inspectors, agencies, and governing officials to keep the compliance process moving forward smoothly.  

Service & Support

Above all, assess the service and support provided by the manufacturer. The vessel manufacturer should be able to articulate technical discussions and be open and honest with timelines, cost, and compliance-related issues. Consider other research and questions, such as:

•    Is the proposal easy to understand and compare solutions?
•    Do you have direct access to the engineer for questions?
•    Does the company provide timely and accurate documentation?
•    Does the company offer after-market parts and field service?

Download Small Vessel brochure
Download Large Tank brochure


Custom Vessels for Extreme Compliance Industries

The Small / Portable Vessel group produces specialized ASME vessels that customers need for their extremely regulated processes.  Apache manufactures custom mix tanks, storage tanks, jacketed vessels, heat exchange surfaces, extraction equipment.

The Apache Stainless Equipment Corporation employs experts and artisans in the fabrication of stainless equipment for a range of industries. Our expertise in stainless and high-alloy vessels is shown on Apache's tanks and vessels in the beverage, biotechnology, life science, pharmaceutical, and food processing industries.

Apache offers engineering and 3D modeling to the customer's design conditions and ASME requirements for each vessel project. We have a dedicated quality and compliance team that focuses on verification, testing, and compliance documentation.

In addition to ASME, Apache is also accredited in many other global standards. By setting parameters for quality and compliance, we offer greater value for our equipment products.

Download the custom story of Apache's Small Vessel Group.


Visit Apache at Interphex Booth 3942, Javits Center, NY

 

Apache's large tank and small vessel team will exhibit at Interphex 2017 - booth 3942.  Interphex is a large pharmaceutical and biotechnology trade show and conference event.  The Parenteral Drug Association (PDA) sponsors this long running expo.  The show focuses on technology, innovation and education to include all product development cycles. It is held in New York City with 10,000 professionals and 600 vendors in attendance.

 

Mike Peterson will be at the show representing the large tank group. Mike has served the pharmaceutical and bio-pharma industry form 20 years in technical sales and customer service of ASME vessels and tanks.

 

David Foulkes will also be at Apache's booth representing the small portable vessel group.  David has supported the sales of both standard and custom sanitary design vessels for 30 years.  The core of vessels manufactured in the small vessel group is for biotechnology and pharmaceutical applications.

 

From precise quality control to documentation requirements, Apache is committed to bio-pharma processors to help with their processing and manufacturing goals. We manufacture our own components including dimple sheet or half pipe exchange surfaces, man ways, flanged and dished heads, leaders, platforms, support structures and custom vessel internals.  Apache offers in-house polishing, passivation, electropolishing, riboflavin and saline testing.

 

WATCH A VIDEO on the Making of a Pharmaceutical Vessel

 


Visit Apache at ISPE Raleigh, SC

The ISPE South Carolina chapter is a non-profit society of technical professionals and engineers in the pharmaceutical and biotechnology industry.  This chapter is one of several chapters throughout the United States. 

 

The ISPE-CaSA 24th Annual Life Sciences Technology Conference is Tuesday, March 14th. It is a one day show with vendor exhibits, speakers, seminars, product demonstrations and networking.  Nick Buchda will representing Apache Stainless at Booth #322.  

 

Apache custom designs and fabricates regulatory compliant tanks and ASME vessels for the pharmaceutical, bio-technology, food and beverage and water filtration industries.  Apache manufactures vessels from a capacity of 1 gallon to 160,000 gallons.  

 

We manufacture many types of speciality sanitary design tanks, including: pressure vessels, dryers, evaporators, holding tanks and mixing vessels. We also manufacture our own components from heads and supports to vessel internals to give greater control over the production process.  

 

Apache has dedicated in-house vessel finishing capabilities including mechanical and robotic polishing, passivation and electropolishing.

 

Watch Pharmaceutical Industry Video >


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