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.
Consultation
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.
Project Engineering
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.
Manufacturing
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.
Compliance
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."
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.
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
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.
Apache is a custom manufacturer of tanks and vessels. Due to our customized offering, we want to provide the exact vessel you need; and that might lead to many questions and back and forth responses. If you don't have a specification list, here are 5 recommendations for you to determine when ordering a tank.
1. Determine pressures and temperatures. The design criteria, pressures and temperature requirements will impact material grades, thicknesses, compatibility of fittings and components, and elastomer selection. The following items may help to determine pressures and temperatures.
2. Determine type of certification required. It is advantageous to identify the types of certification and documentation (turn-over packets) that will be required for planning purposes. The following are common requested certificates.
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.
In the video, this 150 liter mixing Pharmaceutical Vessel has a bottom mag mixer that comes with a stainless steel control panel, touch screen with speed control.
There are numerous sanitary ports for add-ins, CIP spray ball, and sight glass with LED light. The interior surface materials and welds are all ground and polished with an electropolished finish.
The sidewall and bottom head are dimple jacketed with Thermalox coating, insulation and shroud for heat transfer operations. The side wall has sampling ports with optional sparger tubes to assist the agitation process.
The tank features a 24" hinged man way top with tool-less knobs and is easily portable.
Upcoming Pharmaceutical Shows:
ISPE, Raleigh, SC (March 14 Convention Center) - Booth 322 - Meet Nick Buchda and Ryan Metzdorf. Interphex, NY (March 21-23 Javits Center) - Booth 3942 - Meet David Foulkes and Mike Peterson.
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.
Enter your email address to subscribe to this blog and receive notifications of new posts by email.