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Comparing Base, Mid, and High-level Sanitary Finishes [Infographic]

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".


Anatomy of a Sanitary Design Vessel

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:

  • CIP (Clean in Place) Process and Components
  • Continuous, crack and crevice-free welds, ground flush and polished smooth to specific RA (Roughness Average) <32 RA
  • 304 or 316 stainless material, mechanically finished to <32 RA
  • Electropolished and Nitric passivated finishing
  • Electropolished sanitary fittings, including:
    • Tri-clamp ferrules
    • Tube connections
    • NA Connects
    • Flush mount outlet valves
    • Sight glasses
    • Orbitally welded j-tubes
    • Dip-tubes
    • Polished internal coils
    • Samples Ports
    • Spray devices
    • Control panels
    • External thermal jacketing

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.


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.


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, 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!


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