Standards for Sanitary & High-Purity Processing Equipment

The 3-A Sanitary Standard requires food grade surfaces to have a 32Ra finish or better. Pharmaceutical standards may require an even better finish.


Understanding Sanitary Standards

It is important to understand the standards and code requirements that apply to processing equipment. And as industries grow and evolve, more regulation is sure to follow. It’s wise to get ahead of the curve, by designing in features that are preferred by the FDA and other state and federal agencies upfront. Consumers are becoming better educated and will research how your product is made and what safety standards you have in place to protect your products and their health. Other parties involved in the processing, packaging and distribution of your product will expect similar safeguards to be in place.

Let’s shed some light on the standards and codes that should be taken into consideration when designing and fabricating equipment for sanitary processes. Although our primary focus is on shell and tube heat exchangers, many of the same standards and codes apply to pressure vessels, pumps, valves and other components.

cGMP’s

One common term you may encounter is cGMP’s, which stands for current good manufacturing processes. This alone is vague and can mean almost anything. If an equipment manufacturer says they build equipment to cGMP’s – it is wise to dig deeper because this doesn’t necessarily mean it meets the industry standards for quality and safety. Let me give you an example of a tangible cGMP to help differentiate – the TEMA standards.

TEMA Standards

The TEMA standards are a definitive set of cGMP’s developed by the Tubular Exchanger Manufacturers Association, for the design and fabrication of shell and tube heat exchangers. This guideline standardizes the terminology and the best practices involved in building these exchangers. It is a detailed set of instructions governing material thicknesses, weld quality, hardware sizes and types, baffle spacing, and many other details related to the thermal design and construction. This helps to set a level playing field for companies like Enerquip who design and build shell and tube exchangers. If you purchase exchangers from a supplier following the TEMA standards, then you know that best practices (cGMP’s) are being followed.

Sanitary Standards

Since sanitary standards are critical to product quality and safety, it is important to determine the sanitary level needed, and then to insist on consistency and adherence to the standard that you select for your equipment.

One key facet of sanitary design is the material of construction selected. Universally in sanitary industries like food, beverage, dairy, personal care, cannabis, and pharmaceutical, stainless steel is the material of choice for process equipment. Stainless steel is abundant, cleans and disinfects easily, resists corrosion, is aesthetically appealing, and meets the known sanitary standards. Other materials like copper, carbon steel or aluminum may corrode and allow leaching of contaminants into your product, especially under extreme temperature and pressure conditions.

So, what are your options for sanitary standards for equipment? Isn’t bright and shiny good enough?

3-A Sanitary Standard

Developed back in the 1920’s and updated many times over the years, 3-A Sanitary Standards was developed by an independent, not-for-profit corporation dedicated to advancing hygienic equipment design for the food, beverage, and pharmaceutical industries.

Design details for equipment are defined by steering committees made up of representatives of three stakeholder groups with a common commitment to promoting food safety and the public health — regulatory sanitarians, equipment fabricators and processors.

This standard includes details on:

  • surface finish requirements
  • weld quality
  • approved types of gaskets and O-rings
  • connection styles
  • materials of construction
  • and more

Specific examples of guidelines applicable to food, dairy, and CBD oil processing include:

  • product contact surface finishes of 32Ra (food grade) or better
  • sanitary tri-clamp fittings with FDA approved EPDM or PTFE O-rings
  • the use of stainless-steel product contact materials

Fabricators can claim to be 3-A compliant but must pass an audit by 3-A inspectors to carry the 3-A symbol of quality. Working with equipment suppliers like Enerquip who carry this 3-A symbol is another safeguard that your equipment will stand up to the most rigorous third-party inspections.

ASME-BPE Pharmaceutical Standard

If you want to take your equipment design to the next level, or your pharma clients demand it, you will want to comply with the ASME-BPE standard.

This Standard provides the requirements applicable to the design of equipment used in the bioprocessing, pharmaceutical and personal-care products industries, as well as other applications with relatively high levels of hygienic requirements. It covers materials, design, fabrication, inspections, testing and certification. It is the leading standard on how to design and build equipment and systems used in the production of biopharmaceuticals. It incorporates current best-practices for enhancing product purity and safety.

Companies that rigorously apply ASME-BPE often can achieve production efficiencies, lower development and manufacturing costs, and increased quality and safety, while complying with regulations.

Specific examples of guidelines applicable to the pharmaceutical and cannabis process include:

  • product contact surface finishes of 20-25Ra max (pharma grade) or better
  • exchangers with a double tubesheet design for leak detection and cross-contamination prevention
  • seamless tubes and piping
  • pitching equipment to promote draining of product and cleaning fluids
  • Class VI O-rings and gaskets

Suppliers like Enerquip who follow the ASME-BPE Standards are true industry leaders who make compliance and quality a high priority.

Now that you have a couple of sanitary standards to review in more detail, and decide upon for your equipment, how should you address the safety aspects of equipment design?

ASME Boiler & Pressure Vessel Code

Since it is common practice in cannabis and hemp processing for oil extraction to use ethanol, propane, butane and other volatile chemicals, the safety of your people, your facility, and the environment are critical. When you add the element of extreme temperatures and pressures to the process, the risks multiply quickly.

The ASME Boiler & Pressure Vessel Code is an American Society of Mechanical Engineers standard that regulates the design and construction of boilers and pressure vessels. Evaporators, columns, kettles, heat exchangers, and condensers are all examples of pressure vessels that should be designed and Code-stamped to ASME Section VIII, Div 1. This ensures that the equipment is designed to operate at the most extreme conditions you may subject it to and is built and hydro-tested at 1.3X the design conditions as a safety factor.

ASME ensures that the materials, weld procedures and inspection processes are all Code compliant, and that only certified welders build the equipment. This entire process is overseen by a 3rd party inspector from Hartford or another authorized inspection agency. When the vessel is Code-stamped, it is given a unique National Board Number and U-1 report that stays with the equipment for its lifetime. This gives full traceability to the materials, procedures, certified welder and testing done on the equipment.

CRN Certification

For equipment being built for Canada, pressure vessels require a CRN (Canadian Registration Number). This is commonly needed in addition to the ASME National Board Number. The vessel designs are reviewed by a professional engineer and regulatory official from the Province that the equipment will be used in, and then certified prior to fabrication taking place.

This process can typically add 2 – 8 weeks to the design process, but once a design is approved, it can be used to build identical vessels for up to 10 years.

Applying the Appropriate Standards

Now that you have a better understanding of what standards apply to the equipment used in sanitary applications, you’ll need to apply the appropriate standards to your process equipment. In many cases, multiple standards and codes will apply. Don’t worry – if your supplier is reputable, they will understand and expect this in your specifications.

Enerquip builds heat exchangers and pressure vessels for many OEM’s in this industry, and most of them are built to TEMA C or TEMA B, as well as the 3-A Sanitary Standards and to the ASME Boiler & Pressure Code, Section VIII, Div. 1. Some clients request an upgrade from the 3-A Sanitary Standards to the ASME-BPE standard.

Not sure what you need for your specific application? Let’s talk. We’ll review your process needs to ensure your product quality and reputation are secure.

Learn more about the high-purity industries we serve including Food, Cannabis, Personal Care, and Pharmaceuticals.

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