DESIGN TO COMPLIANCE
Designing custom vessels to compliance, such as ASME or CRN, is a highly engineered approach. Certainly, manufacturers of the custom vessel must have required accreditation, but the engineering expertise goes beyond certification. The pressure vessel manufacturer must have experience and a reputation with inspectors, agencies, and governing officials to manage the compliance process smoothly and efficiently.
The process is complex, and we must educate customers about the important steps, all of which affect the project's outcome. The process includes consultation, project engineering, manufacturing, and compliance.
When discussing the intent of the vessel with the Customer or Engineering Firm, the sales team works to learn more about the industry and process that the vessel will serve. This will often help us make recommendations on design attributes that the customer may not know this early in the design and vessel selection process. This is especially important in the absence of a formal specification package.
A scope alignment meeting occurs to discuss the proposal and services. This meeting may include revisions, due dates, milestones, review of pricing, terms, and conditions, and certification timelines and deliverables.
After Apache receives the PO (purchase order), we assign the project to the engineer, and the kick-off meetings begin. Sales works closely with the project engineer to relay information back to the customer.
Engineering will perform final calculations, complete the design, consult with component manufacturers, and review designs with the customer. Construction, pressure, fixtures, and components must comply with ASME or CRN code.
Once the customer approves the design, Apache submits the compliant design to ASME, CRN or other faction approval and begins managing that process.
The project engineer creates detailed drawings for the manufacturing process. Staff, fabricators, and welders are ASME certified. All welders are approved for the weld procedures required to make custom vessels.
Project engineers work closely with manufacturing and quality assurance technicians to conduct the testing required for compliance. 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 provides in-house inspection services, which benefit customers with ASME projects. The documents are provided in the TOP (turnover packet) by Apache's Quality Assurance team.
Apache has been ASME certified for over 40 years. In addition to ASME, Apache is accredited in many other global standards, including CRN.
In addition to the "12 Steps to Compliance" video highlighted in this blog, learn more by downloading our e-book, "Road Map: Design to ASME Submission."
Many of Apache's customers, come to us with a full specification outline to custom manufacture their tank or vessel. For pharmaceutical, life sciences and health industries, Apache often works with integrators who add their process technology to sanitary equipment supplied by Apache. We also provide vessel solutions to end-users who have process technology support or experience, and need a vessel manufacturer to help them meet their quality and compliance standards.
In this e-book "Road Map: Design to ASME Submission", we offer project planning recommendations for vessels that require ASME or other compliance. It is especially helpful for engineers or purchasers new to the role of procurement of sanitary custom vessels and tanks. This detailed "road map" provides planning insight and knowledge to acquire custom-designed and manufactured ASME vessels with an understanding of compliance engineering.
It is very important to partner with a vessel manufacturer with expertise in the type of vessel and industry for the use of the vessel. In ASME applications, it is vital that critical staff, fabricators and welders be ASME certified. Experience as well as reputation are significant when working with inspectors, agencies and governing officials to keep the compliance process moving forward.
ASME is a leading developer of codes and standards in the mechanical engineering community. Apache has been ASME certified for over 40 years.
Read the e-book, and learn more about compliance, engineering and project management to meet goals and procure quality vessels that not only meet compliance standards, but project goals too.
Versatility of Dimple Jacket Heat Transfer Thermal Processing
Apache’s engineers and fabrication experts are entrusted by many national and international processors to provide complex vessels with a host of compliant driven specifications and required quality protocols. With nearly 45 years of experience providing custom vessels, Apache has significant experience in thermal heat exchange surfaces.
Heat exchange surfaces can be designed for heating or cooling. Jacketed vessels are used in many industries and can be used to remove the elevated heat of reaction (heat reactor vessel) or reduce the viscosity of high viscous fluids.
Depending on the application, dimple jackets offer versatility in heating or cooling for almost any shape or size of vessel.
Dimple jackets are constructed with a thin gauge stainless steel layer that is plug welded to the vessel shell in a pattern. The punched and spot-welded areas are called dimples, which create turbulence of the heating or cooling fluid flowing through the jacket. The dimple jacket design allows for thinner vessel shell walls compared to a convention jacket due to the strength of the dimple pattern design.
Dimple Jackets are manufactured in several different pressures and patterns. Apache provides both 12 ga. and 14 ga. material. Each pattern is validated and proof tested per ASME regulations.
Apache has proofed and certified designs up to 1 ¾” at 200psig at 300o F but can go to higher temperatures depending on the application.
Applications and Features
Apache specializes in manufacturing custom vessels for high compliance industries including pharmaceutical and bio-pharma. We manufacture specialty sanitary design tanks, including pressure vessels, processing tanks and mixing vessels. 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.
Learn more about Heat Transfer.
Categorizing levels of sanitary design is helpful to professionals new to compliance regulated industries requiring custom vessels because it bridges communications regarding standards and design requirements.
In hygienic applications, stainless equipment requires a sanitary finish which generally refers to a smooth, scratch-free, non-corrosive finish. The fineness of the finish, which determines its performance, is measured in RA (roughness average). The infographic illustrates the RA of different types of mill, mechanical, and chemical finishes. The smaller the RA reading in microinches (height in millionths of an inch), the smoother the finish.
When collaborating to qualify a project, we define a Base Level Finish as a 2B/Mill, 304 or 316 stainless materials that is pickle passivated. The welds are continuous and crack and crevice-free. This type of finish is paired with a Base Level Sanitary Design and is cleaned manually. Apache’s standard portable vessel line are an example of the base sanitary design and finish level.
A Mid-Level Finish is also composed of 304 or 316 stainless material and involves a secondary process of mechanical polishing greater than 32RA, with final finishing to include pickle or nitric passivation. The welds are continuous, crack and crevice-free, and are also ground flush and polished smooth to a specific RA. Sanitary fittings, mechanical polishing, additional passivation processes and a cleanable design with removable components are categorized as Mid-Level Sanitary Design features.
Providing the smoothest RA readings is an electropolished finish after a series of processes, including mechanical finishing to less than 32 RA, passivation, and nitric passivation, which are common for High-Level Finishes. The base material is 304/316 stainless. The welds are continuous, crack and crevice-free, ground flush and polished smooth to a specific RA designation less than 32RA. The sanitary fittings are also electropolished. Vessels with this level of specifications are typically cleaned automatically.
The specifications, construction and finishing of a vessel is often driven by standards and compliance requirements. All three categories, qualify for ASME UM, ASME U, FDA, 3-A, CRN, PED, BPE.
There are other factors that fall in these base, mid and high-level sanitary design categories, including construction features, processing applications and time to delivery. Download our e-book “Guide to Sanitary Design for Custom Vessels in Hygienic Industries".
When evaluating a custom vessel manufacturing partner for a new project, consider the manufacturing capabilities and experience that support the vessel’s application and sanitary requirements.
All custom design stainless vessels for the food, life sciences, pharmaceutical and health industries require sanitary construction. It is the application and automation that drives the level of sanitary componentry.
In reviewing each new custom vessel project, Apache identifies the sanitary requirements to categorize the vessel into a base, mid- or high-level design. Apache offers a standard line of vessels that qualify for various regulatory compliance agencies. However, these designs are considered a base level sanitary design, especially because the cleaning of the equipment is manual. Apache identifies a mid-level sanitary design vessel as having COP (Clean Out of Place) components.
In the video, a custom vessel is animated to walk through characteristics and examples in the highest and most automated level of sanitary design custom vessels.
High-Level Sanitary Design Characteristics Include:
Processes and application in high-level sanitary design vessels include heating and cooling vessels, mixing and processing tanks, WFI tanks, filtering and R & D lab equipment.
Certification requirements is an important part of the sanitary design criteria. Sanitary design standards include:
3A – A regulation of the design for processing equipment in the food and drug industries. A 3A certificate is proof of FDA compliance.
ASME U and ASME UM - A regulation of the design of boilers and pressure vessels, including traceability of materials, procedures, testing and documentation.
BPE – A standard within ASME that drives equipment design for the bio-processing, pharmaceutical and other hygienic required industries.
In qualifying design, safety, automation other application details, Apache will facilitate the required compliance for the vessel and provide well communicated delivery, cost and approvals required for a successful project.
Vacuum or Pressure closures for small/portable ASME vessels
Many processors come to Apache for a vessel solution in the incubation stage of their business. In some cases, they are looking for help to choose the right kind of vessel that will suit their needs and fit their budget. While Apache provides custom ASME vessels for a range of industries, we also offer a line of standard vessels that often solve what these manufacturers need for their process.
The use of the vessel will determine whether it is a pressurized solution, non—pressurized or vacuum vessel solution.
Vessels that require a minimum of 50 PSI, utilize a pressure closure. Numerous applications, including heating or cooling process, containment, and pressurized dispensing often utilize pressures at or above 50 psi.
It is important to note the safety and ASME requirements for pressure vessels, an ASME UM-mark is required for:
For vacuum requirements or non-vacuum applications, such as a storage vessel or collecting vessel, a vacuum closure may suit the application.
In the video, Nick Buchda, Apache’s Small Vessel Representative, demonstrates vacuum and pressure closures on our standard line of vessels.
Apache has produced stainless vessels with ASME certification for over 45 years, with other accreditations for pharmaceutical, life science and health industries including ASME UM, ASME U, FDA, 3-A, CRN, PED and BPE.
Whether the vessel needs fit a standard vessel, modifications to a standard vessel or a custom solution, Apache has the experience to fulfill a range of critical, sanitary-design vessel solutions.
ASME is a leading developer of codes and standards in the mechanical engineering community. These standards enhance public safety and health as well as promote innovation.
The ASME (American Society of Mechanical Engineers) mark is a single certification marketing to signify the international mark of safety and quality. Recognized worldwide, manufacturers that provide ASME have a rigorous quality program, and a third-party review to authorize the use of the mark.
The U mark certifies that the pressured tanks or vessel conforms to the latest edition of the ASME code and that the pressure vessel has been designed and manufactured in accordance with ASME. All aspects are approved by a Third party ASME Authorized Inspector (AAI). U stamps require an ASME inspector to witness the ASME hydro test.
Companies with a U mark undergo a review with the National Board every three years.
The UM mark certified that the pressure vessel or tank conforms to the latest edition of the ASME code and that the pressure vessel has been designed and manufactured in accordance with ASME. The UM vessel’s designation is related to the size of the tank/vessel.
While the American Society of Mechanical Engineers writes the rules for the new construction of pressure vessels and tank, the National Board of Boiler and Pressure Vessel Inspectors write the inspection code for new and repaired vessels.
The National Board of Boiler and Pressure Vessel Inspectors require a Certificate of Authorization and R stamp for the repair or alteration of boilers, pressure vessels and other pressure retaining equipment.
Apache has been ASME certified for over 45 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.
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:
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.
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.
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.
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