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.
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.
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.
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.
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.
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.
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
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
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?
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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
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