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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.


VIDEO: The Affect of Manufacturing Processes on Stainless Surface Smoothness

The particular RA (Roughness Average) value is a requirement for stainless vessel manufacturing for federal, state or local compliance agencies across many critical industries. It is a crucial standard in these industries to maintain a clean system. The instrument used in the measurement is called a profilometer, which provides an average in micro inches. The smaller the number, the smoother the stainless material. It is common for high compliance vessels to have single digit RA readings on product contact surfaces.

In the construction of pharmaceutical, life sciences, or medical-use vessels, meeting the RA requirement may include several steps, including material selection, grinding, polishing and chemical finishing. Manufacturing processes can affect the RA measurement on stainless material, including forming, stamping and welding. In the video, we walk out of the manufacturing plant with our quality controls manager to show measurements on material in vessels being manufactured in various stages of production. 

Pickle Passivation and Electropolishing chemical finishes have a high degree of improvement on RA smoothness compared to material before it is treated. Pickle passivation, also referred to as descaling, removes the scales and leaves a clean matte finish, free from contamination. Electropolishing is an electrochemical process that dissolves surface metal, removing all embedded contaminants and creates a smooth, mirror finish. 

ASTM International (American Standard for Testing and Materials) is one of several standards that Apache upholds. ASTM A967 is the standard specification for Chemical Passivation Treatment for Stainless Parts. ASTM B912 is the standard specification for electropolishing stainless steel alloys. The ASME-Bioprocessing Equipment (BPE) standard was created for the pharmaceutical and bioprocessing industry. The BPE surface finish standard classifies surface finishes and the acceptance criteria for compliance. 

In the business of compliance vessels, there are numerous standards that are required to deliver the necessary codes in any given project. Follow our videos, blogs and e-books developed specifically to help our processing customers understand the manufacturing and compliance process.


Video: 3 Levels of Sanitary Construction

Processors serving food or hygienic industries have varying degrees of compliance requirements for custom vessels solutions.  The designation of "sanitary" has a wide range of definitions depending on the customer, the industry or the standard.  

This video is a brief overview how Apache defines a base, mid, and high-level sanitary vessels.  

Apache Stainless Equipment Corporation is a manufacturer of stainless equipment for a range of hygienic industries, including, food, beverage, biotechnology, pharmaceutical, cannabinoid, and life sciences.

A dedicated quality control and compliance team directs all tests, certificates and documents for all sanitary, ASME, and global standards.


ASME Stainless Vessel Construction Parameters for Hygienic Vessels

 

ASME (American Society of Mechanical Engineers) is a leading developer of codes and standards in the mechanical engineering community. ASME code section VIII details mandatory rules regarding vessel design, including engineering, manufacturing, and testing of pressure vessels.   These standards enhance public safety and health as well as promote quality and innovation.  Here are the main parameters outlining ASME construction of pressure vessels with supporting ASME testing requirements.

Construction
Parameters such as wall thickness, material, and flange rating are determined by the application, including pressure, temperature, corrosion allowance, and fluid flow.  These conditions are calculated and reviewed/approved by the ASME inspector when required per code. Stainless, Hastelloy, AL6XN, duplex, and Inconel materials are ASME-approved materials for pressure vessel construction in the pharmaceutical, life sciences, and health-related industries, of which Apache is qualified to fabricate.

Welding

ASME standards also define the quality, type, and finishing of the welds. Head styles (ASME F&D, 80:10, 2:1 Elliptical), seams, nozzles, manways, and other components are designed per ASME Code. Applicable ASME Code welding procedures must be followed using certified ASME welders to maintain the structural integrity of an ASME pressure vessel. Welders must be certified to a qualified weld specification qualified per ASME code guidelines.

Safety Components
Gauges, valves, pressure outlets, and drainage are required safety components in ASME design pressure vessels. The proper selection of components and design is critically important to the safety and performance of the ASME vessel. The selection of safety components needs to be evaluated closely to define the required scope of supply.

Finishing
There is another ASME specification to ensure the quality and safety of parts used in pharmaceutical, bio-processing, and other industries requiring a hygienic vessel, called ASMP-BPE. BPE (Bio Processing Equipment Standard) specifies the surface finishes RA (roughness average) requirements and pickle passivation and electropolishing requirements.

Tests & Certification
There are significant testing, certifications, and documentation requirements for ASME compliance and satisfying the numerous customer requirements. Many require ASME inspection as well as a TOP (turnover packet).  Some ASME testing and certification requirements include pneumatic, hydrostatic, liquid penetrant, saline, riboflavin, CIP coverage, material, base metal thickness, material trace, welder trace, Ferroxyl, PMI (Positive Material Identification) radiography, and UT.

Apache has been ASME certified for over 40 years. In addition to ASME, Apache is accredited in many other global standards. By setting parameters for quality and compliance, we offer greater value for our custom stainless ASME tanks and vessels.


5 Key Questions When Searching for New Cannabis Processing and Extraction Vessels

As the Cannabis Processing industry continues to evolve, increasing regulations are following. With continuous new products and additive combinations entering the market, the sale and distribution of the products will have more regulations. The processing and production of CBD and cannabidiol components are already seeing increasing standards. 

When searching for a new Cannabis Processing or Extraction vessel equipment supplier, ask these five questions: 

  1. Does the vessel supplier have experience with the types of processing equipment you require to produce your product? The vessel manufacturer should have experience with CBD and Cannabis processing vessels, extraction tanks, mixing tanks and separating vessels. For complex applications or scale solutions, you may need to consult a process engineering firm to solve your CBD process challenges.
  2. If you aren’t sure about the type of equipment you need, do you have access to collaborate with the vessel manufacturer’s application and engineering team to discuss your challenges? There continues to be numerous start-ups for new types of CBD products, and that equipment can come at a high cost. There may be value in a collaborative meeting with application specialists to vet your project and costs and learn more about equipment offerings. 
  3. What types of processes and components does the vessel manufacturer offer for the hygienic design? The FDA and other regulatory agencies will set the standard for sanitation and hygienic design in the CBD / Cannabis processing industry. Your vessel manufacturer must have offerings and experience with COP (clean out-of-place) sanitation and CIP (clean-in-place) sanitation components. They must also meet RA (roughness average) requirements and offer mechanical and chemical finishing services to meet the hygienic requirements set by regulatory agencies. 
  4. Does the vessel manufacture hold ASME certification? Most local and state laws require vessels designed at 15 PSI and higher to be ASME certified. Moreover, ASME requirements are also in material specifications, construction, and welding qualifications. Determine all industry compliance accreditations, including FDA, 3-A, CRN, PED and BPE. 
  5. Does the vessel manufacturer provide the testing and documentation services you need for your Cannabis or CBD processing vessel? There are significant testing, certifications, and documents requirements for all US and global accreditation programs. An experienced quality assurance department will provide trained and certified personnel; and assure the proper procedures and documentation to support your vessel. 

Apache Stainless is a manufacturer of sanitary, highly engineered, ASME pressure vessels for a multitude of industries, including cannabis processing, pharmaceutical, health and biopharma. We have served the Cannabis and CBD processing industry several years with processing tanks, hydrocarbon extraction tanks, mixing tanks and separating vessels. We also design and manufacture vessels with Canadian Registration Numbers (CRN) for all Canadian provinces. We have all Stainless ASME certified manufacturing facility with custom capabilities including heat exchange surfaces, agitation, CIP (clean-in-place) componentry and controls. Apache has an in-house quality and compliance team to provide all testing and documentation requirements.

Visit Small Vessels for more information.


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


How to Troubleshoot a Pressure Tank

There are several reasons why a vessel may need service, however, two main causes why a vessel may need service are either accident or performance related.

In the case of an accident, such as a tool falling into the tank and causing damage; surface scratches and dents can typically be repaired on-site, provided they do not go beyond minimum requirements, with mechanical polishing or hand/wand electropolishing. 

Reduced agitator performance or failure is often due to worn parts, improper assembly or a bent or broken shaft.  Agitator repairs may be addressed with the agitator manufacturer or the vessel manufacturer, depending on the situation, down-time, and severity of the failure.

When troubleshooting a drop in pressure in a tank or vessel, a typical cause is often related to seals. One sign of seal failure is product coming out of the seal.  To help reduce the frequency of an unexpected seal leak occurring, it is recommended to use a good seal maintenance program to solve a lot of pressure / performance issues, such as:
•    Seal replacement has been neglected
•    Flat spots on seals are a sign for replacement
•    Improper or incorrect seals for the outlet
•    Nicks, scratches or mishandling of seals

A best practice is to avoid product waste and critical down-time is to inventory seals for all outlets and manage seals in a preventative maintenance program.

It is important to note that any weld repairs to the ASME pressures zones on tanks, require an R-Stamp.  The R-Stamp is a certification required by the National Board of Boiler and Pressure Vessels for repair of an ASME tank or vessel.

Depending on the size of the vessel and type of repair, Apache’s service techs may be able to make repairs on site or in some cases, tanks are shipped back to the factory. Apache can provide services including:
•    Field service and troubleshooting to all types of stainless and high alloy tanks
•    ASME / National Board R-Stamp repair and modifications
•    Surface finish repairs
•    Non-code repairs and modifications including piping and heat transfer jackets
•    Seal and agitation repairs and modifications
•    Accessory repairs
•    Head and tank shell repairs
•    Leak detection
•    Audit and service contract available

Visit Small Vessels

Visit Large Tanks


General Use VS Custom Vessel: When It's Time to Consider a Custom ASME Pressure Vessel

Emerging life sciences, and health and wellness product manufacturers must carefully plan budget and start-up costs to launch their products. Many of these entrepreneurs begin production with a general use vessel.

A stainless general use vessel has a lower entry price. Depending on the process and the demand for the product, general-use vessels may serve a small manufacturer very well for many years. Dispensing and storage vessels, vacuum and low-pressure vessels are common examples of general use applications.

However, when demand outpaces production, the manufacturer may require a vessel that is customized for the processing needs. Here is a case story of a manufacturer that switched from a general use to a custom ASME pressure vessel:

BEFORE: A fast-growing botanical extraction processor was unable to produce the quantity of product needed to fulfill demand. Their process involved an imported general use vessel that was placed in a rudimentary ice bath for temperature control. This process resulted in waste of non-consistent product and constant staffing and manual intervention to monitor and adjust.

AFTER: Apache's small vessel team provided an ASME processing vessel that completely replaced their batch process. The new vessel was designed with a thermal heat jacket that heated and cooled the product to the exact temperature required for the extraction process. The ASME vessel was jacketed with tri-clamp ferrules and included a site glass and high-pressure sanitary fittings. The vessel has a pickle passivated finish that provides ease of sanitation between batches.

While the price point for a custom manufactured vessel was higher than a general use tank, the ability to quadruple production off-set the cost of the vessel and resulted in a quick return on investment. Apache's custom vessel runs continuously day and night; it eliminated product waste and removed employee monitoring and intervention.

Visit standard vessels or visit custom ASME vessels, for more information!


What is the Significance of Domestic and Foreign Stainless Steel for Original Commercial Equipment?

The steel material used in manufacturing commercial original equipment must fit the performance, pricing, delivery time, and quality requirements for the end-user. Industrial equipment suppliers, like Apache, must leverage relationships with mills and partnering suppliers to manage the constantly changing market. Part of the purchasing program for the stainless material program at Apache, focuses on partnering with quality domestic and foreign suppliers. 

Stainless sheet and plate are produced in the United States, which is the majority of Apache’s base material for tanks, vessels and food processing equipment. Also, most Hastelloy and other high-alloy performance metal materials are made in the US. Pipes and fittings on the other hand are primarily from foreign suppliers since domestically there is not enough availability for demand. 

Depending on the political climate, import tariffs affect the cost and availability of steel material from China and other countries. Some industries require products from foreign markets that may be a specific sheet, size, and material type, but those industries will pay a premium for it and may be subjected to extended delivery times. 

One of the benefits to being a significant user of stainless steel is the relationships with stainless producers and distributors. Apache’s steel venders allocate an allotment of material to Apache, which affords relatively short transactions for supply. When we have a line on repetitive need, we initiate inventory strategies to keep our supply as fluid as possible. Many other components and materials are affected by timing and supply; Apache understands lead times and availability and also leverages relationships to manage delivery to provide the best timing possible. 

Our suppliers understand our needs and hold a higher level of steel quality. The relationship and partnership with our steel vendors has strengthened our expectations, with some partnerships lasting up to 45 years when Apache was founded. 

Apache uses more than 2000 tons of stainless and high alloy per year. We are in the business of heavy gauge commercial manufacturing of custom equipment for high-compliance industries. Our ability to manage domestic and foreign material as well as price, timing and quality of all material and components is resolved for serving over 100 industries represented by our industrial and commercial processing customers.


What is the Difference Between an ASME U and a UM Stamp?

There are many industry specific certifications in vessel manufacturing that regulate the construction of a vessel. However, for many types of pressure vessels, ASME certification is required and may be in addition to other industry requirements due to the vessel's geometry and pressure designation. Any tank that meets the requirements of ASME Code Section VIII can be certified. This certification is frequently referred to as "stamped" because the code symbol is most commonly applied using a stamp process. Here are the main differences between ASME U and ASME UM symbols and certification.

ASME Certification with U Symbol

  • Any vessel meeting the requirement of ASME Section VIII can be marked with the U Symbol.
  • Most local and state laws require vessel designs 15 PSI and higher to be ASME Code Certified.
  • Qualified manufacturers receive a triennial joint review (audit) by their authorized inspection agency, and the National Board of Boiler and Pressure Vessel inspectors.
  • U vessels require an Authorized Inspector (3rd party ASME inspector) to review with approved calculations.
  • U vessels require an ASME pressure test with the Authorized Inspector residing over the test.
 

ASME UM Symbol

  • UM vessels are smaller in volume (less than 5 cubic feet)
  • UM qualified manufacturers receive an annual ASME review by their authorized inspection agency and are also subject to the same triennial joint review (audit) as mentioned above.
  • UM vessels have size specifications, including:
    •   5 cubic feet of volume or small with pressures not exceeding 250 PSI
    •   3 cubic feet of volume or smaller with pressures not exceeding 350 PSI
    •   1.5 cubic feet of volume or smaller with pressures not exceeding 600 PSI
  • UM Vessels are inspected and tested by a manufacturer's own certified individuals.
 

Note that there may be exceptions to the ASME Certification requirements, depending on your state and local municipality.

Apache manufactures tanks and vessels for compliance and regulated industries, including pharmaceutical, food and beverage, petrochemical, biofuels, chemical and life science. We hold these certifications: ASME U Certificate, ASME UM Certificate, National Board of Boiler & Pressure Inspectors R Certificate, and National Board of Boiler & Pressure Vessel Authorization to Register Certificate.

Questions? Please call and ask for a Sales / ASME Specialist at 920-356-9900.

 


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