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Category Archive: Regulatory Standards

Tag Archive: Regulatory Standards

  1. Standards for Sanitary & High-Purity Processing Equipment

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    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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  2. Pasteurization of Raw Milk to Prevent Contamination

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    Raw milk, or milk that has not gone through a pasteurization process, is sometimes touted for its supposed health benefits. Claims of greater nutrition through raw milk may be contributing to its rising popularity.

    As more consumers seek out raw milk, the number of dairies providing this beverage is increasing as the number of states that outlaw its sale decrease, according to Food Safety News. At the same time, instances of foodborne illness linked to raw milk consumption are going up.

    Real Risks of Consuming Raw Milk

    From 2007 through 2012, 26 states reported 81 outbreaks linked to raw milk, according to the U.S. Centers for Disease Control and Prevention.

    People who consume raw milk or cheese products are more than 800 times more likely to experience a foodborne illness and more than 45 times more likely to be hospitalized for one compared to people who opt for pasteurized products.

    Pasteurization of Raw Milk Makes it Safe for Consumers

    Foodborne illness can be extremely harmful or even deadly. They can be prevented when food products are treated correctly before distribution to consumers. For dairy, that process is pasteurization, which involves heating the milk to a temperature that kills off the Salmonella bacteria and other illness-causing organisms.

    Pasteurization of raw milk maintains the nutritional value of the milk, the CDC explained. Some enzymes and vitamins are reduced during the pasteurization process, but these often aren’t critical to human health or can be obtained elsewhere, such as vitamin C.

    Contamination can happen at any stage of milk production, even if farmers maintain clean operations and make an effort to test their milk supply for bacteria. Foodborne illness-causing bacteria can enter milk supply in many ways, including: udder infection, insects or rodents near the cows; cross-contamination caused by farm employees, such as that due to dirty clothing or equipment; or animal feces near the milk. Even in operations where farmers strive to prevent contamination, bacterial infection is always a possibility until after the pasteurization phase.

    Incorporating Pasteurization into your Dairy Operation

    An important step in incorporating a pasteurization process into your dairy operation is identifying the right equipment.

    Shell and tube heat exchangers are a popular addition to any pasteurization process, because they provide a high heat transfer rate and are relatively easy to clean. Many fabricators choose stainless steel for the material of construction because it’s not prone to fouling and isn’t difficult to clean, making it an excellent choice to process products meant for human consumption.

    It’s important that pasteurization equipment is designed with the end use in mind. 3-A Sanitary Standards, Inc. is usually considered the industry standard regarding hygienic standards for equipment design and use. Though 3-A has been expanded to provide direction for choosing hygienic equipment for the food, beverage and pharmaceutical industries, it began as a dairy standards organization in the 1920s.

    Enerquip’s Heat Exchanger Solutions

    When it’s time to add or replace your shell and tube heat exchanger for dairy pasteurization at your facility, reach out to Enerquip. Our sanitary heat exchangers can be fabricated with 100 percent 304 stainless steel and manufactured according to 3-A standard 12-07 to ensure your process is safe and compliant with applicable regulations.

    We have several off-the-shelf heat exchanger models in stock or ready to ship. Need a custom sanitary exchanger, our team of heat exchange experts can design a solution specifically for your operation.

    Request a quote today.

  3. Tips for preventing food recalls from your production facility

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    As a food production company, it’s your responsibility to ensure the products you ship from your facility are in good condition and safe for consumers.

    A few aspects of this are ensuring your process is designed to prevent and detect potential contamination, and that your equipment is adequate for the job and thoroughly cleaned.

    Prevent Food Recalls: Why is it Important?

    Mistakes can happen. Food products are recalled on a regular basis. Often, recalls have to do with undeclared allergens. Other times, contamination can lead to a dangerous situation that prompts a recall. Some of the most common foodborne illness-causing organisms include:

    • E. coli.
    • Listeria monocytogenes.
    • Salmonella.

    These organisms can cause severe illness or even death, and may be found in food or dairy products that aren’t properly prepared. An estimated 1 in 6 Americans contract a foodborne illness annually, according to the U.S. Food and Drug Administration.

    It’s always important for companies to actively work to prevent food recalls, reduce the risk of food contamination, and report dangerous products as soon as they’re discovered.

    Food recalls are not only dangerous to consumers, but can also cost a business time, money and reputation. The average cost of a single product recall is $10 million, according to a study from The Grocery Manufacturers Association, Food Marketing Institute, Deloitte and GS1 US. That’s before lost sales and brand damage are taken into account.

    Prevent Food Recalls through Process Review

    If your process doesn’t support sanitary food production, you’ll always be at risk of a contamination. Since the FDA Food Safety Modernization Act came into effect, all companies who work with food products have completed a thorough process and equipment review and made any necessary changes where the operation put product at risk of contamination.

    Reviewing your process shouldn’t be a one-time task. It’s important to periodically review your systems and identify potential areas to improve. Vulnerability assessments can show you areas where your operations are most at risk.

    Regular inspections should be carried out, even during busy periods. During fast-paced production times, inspections may consist of simple visual reviews, which is fine in the short term. However, it’s important to follow these less detailed inspections with a more in-depth analysis later on.

    Investing in Sanitary Equipment

    The equipment you use plays a key role in product safety. There are two major factors that contribute to sanitary equipment: the features of the equipment itself (including materials and construction), and the continued maintenance and cleaning of them.

    Some basic sanitary equipment design principles include having smooth surfaces and rounded edges so product doesn’t get stuck in sharp corners, Food Quality and Safety noted. Equipment that’s easy to clean is also important.

    Stainless steel shell and tube heat exchangers meet these requirements. Here are a few options to consider:

    • Straight tube designs have virtually no corners where product can get trapped and foul, and they’re simple to clean.
    • U-tube models are a little bit trickier, but the rounded bend can be cleaned with the right process and equipment. Stainless steel in particular is a sanitary material because it’s resistant to contamination and fouling and is easy to clean.
    • Cleaning in Place is a technique that allows for thorough cleaning without disassembling equipment or wasted water. CIP systems use shell and tube heat exchangers to run water, steam and/or cleaning chemicals through the equipment, recycling the liquid when it’s complete. CIP is both an effective and environmentally friendly way to keep equipment clean.

    Choosing a Sanitary Shell and Tube Heat Exchanger

    Just like it’s important to note the quality of standards of your food vendors, it’s equally critical to work with an equipment supplier that can be trusted to provide high-quality sanitary equipment. Your process is only as safe as your equipment allows.

    Cross-contamination is a common concern in food processing facilities, but it’s also possible for your equipment to be affected by cross-contamination if it comes into contact with materials that aren’t meant to be food grade, such as carbon steel. Enerquip takes cross-contamination concerns seriously, which is why their engineers don’t work with carbon steel. Additionally, your equipment can be constructed according to 3-A requirements and other sanitary regulations.

    Enerquip’s heat exchanger surfaces that will come in contact with products have surface finishes of 32Ra, though they can provide higher polished or electro-polished surfaces for hygienic applications.

    To learn more about Enerquip’s custom shell and tube heat exchanger design process, reach out to our helpful heat exchange experts. We’ll talk through your process and determine your unique needs to provide you the best unit for your company, to help you prevent food recalls and product contamination.

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  4. Five Important Qualities to Look for in Pharmaceutical Process Equipment

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    In recent decades, there has been a notable surge in regulations and oversight pertaining to pharmaceutical manufacturers. This heightened scrutiny has resulted in stricter design specifications for process equipment. Notably, pharma-grade shell and tube heat exchangers must adhere to stringent criteria. These criteria include ease of cleaning, compatibility with appropriate heat transfer fluids, resistance to contamination and corrosion, and overall reliability. Let’s delve further into why these factors are crucial.

    Five Necessary Features of Pharma-Grade Shell and Tube Heat Exchangers

    1. Easily Cleaned

    Pharmaceutical products must be as pure as possible, and one step in achieving maximum purity is using clean equipment. Residue remaining from the previous batch or product type can taint the next round of product.

    Any amount of product left behind that could feasibly be removed through normal cleaning methods should not be present in equipment before production begins, according to the U.S. Food & Drug Administration’s Current Good Manufacturing Practices.

    Instruments that test for cleanliness today are highly accurate, able to detect even tiny amounts of residue. As such, it’s not always feasible to clean equipment to the point where absolutely no amount of previous product is detected. However, it’s always best to clean as thoroughly as possible.

    Choosing equipment that’s easily cleaned is a good step toward ensuring product batches are as pure as possible. Certain configurations of shell and tube heat exchangers are more easily cleaned than others. For example, straight tube exchangers are often easier to clean than U-tube style exchangers because there are no bends to maneuver around.

    Drainability can affect how easy it is to clean a shell and tube heat exchanger. If it’s hard to get the last ounces of liquid out of an exchanger, it’s harder to rid the equipment of all traces of the fluids. Exchangers that are designed to promote drainability, such as those offered by Enerquip, are best for this purpose.

    2.Compatible Heat Transfer Fluid

    Your equipment needs to be compatible with the substances that will pass through it – both on the tube side and the shell side. The heat transfer fluid used plays a large role in how effective the heating or cooling process is, as well as how well the equipment will hold up in time.

    Fluids that aren’t effective for heat transfer will require a longer process time and more energy to run. Additionally, fluids that can be corrosive can cause equipment to wear out faster. Some fluids are flammable, creating potential risks in the work environment if products or equipment are mishandled.

    3. Leak-Free

    Enerquip Double Tubesheet DesignNo manufacturer or equipment operator wants to have leaks. But for pharmaceutical processing equipment, leaks are particularly troublesome. Leaks create the possibility of product contamination, as well as corrosion or other chemical reactions that may occur when process and utility fluids mix.

    One way to reduce the risk of leaks is with a fully welded tubesheet. Another method to minimize the risk of leaks – or at least the negative impacts of them – is to design an external leak path to prevent any possible leakage from interacting with the fluid on the opposite side of the exchanger.

    Shell and tube heat exchangers constructed with double tube sheets are designed to drain any leakage away from the exchanger to minimize the chances of cross-contamination. At the same time, the operator is alerted to the problem so he or she can address it promptly.

    4. Resistant to Contamination and Corrosion

    Equipment used to create any product should not pose any risk of contamination. However, avoiding contamination means different things for different industries, processes and products.

    To minimize the risk of contamination as much as possible, equipment used for pharmaceutical production should be pharma-grade. Enerquip’s high purity exchangers are ideal for this industry. Our knowledgeable heat exchanger experts have ample experience fabricating shell and tube heat exchangers for pharmaceutical purposes, and are even used by companies like Bristol-Myers Squibb, Pfizer and Unilever.

    Corrosion-resistant materials also help to lower the risk of product contamination. Corrosion can be caused by chemical or physical processes, and the residue that emerges through this process can be reactive or can put the purity of the product at risk. Stainless steel and stainless-steel alloys are highly resistant to corrosion, making them smart choices for pharmaceutical construction.

    5. Highly Dependable

    All manufacturers, regardless of industry, strive to reduce or eliminate downtime. Every minute of downtime has a real impact on the company’s bottom line.

    Choosing reliable equipment is one of the most effective ways to reduce downtime. The less frequently equipment requires maintenance or spare parts, the more often it’s contributing to your facility’s production.

    Enerquip prides itself on fabricating equipment that is long-lasting and can be counted on. To learn more about choosing the right pharmaceutical process equipment for your facility, contact us today.

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    Editor’s note: This content was originally published in 2018 but was updated in 2024.

  5. Food Processing and Holiday Favorites

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    Do you know how food processing comes into play with your holiday favorites? The holiday season is marked by traditions, like family gatherings, gift-giving and, of course, seasonal foods people look forward to all year round. Treats like pumpkin pie, eggnog and cranberry sauce bring back memories of holiday feasts and large gatherings for many people. But do you know what it takes to place these traditional dishes on your table?

    Food processing and holiday favorites… here’s how these favorite wintertime dishes are processed:

    Eggnog

    Milk products sold in the U.S. must be pasteurized before being packaged and stocked on store shelves. Pasteurization is the process of heating the product to a temperature and for a length of time known to kill harmful organisms like E. coli, salmonella or Coxiella burnetii, which can cause Q fever in humans, according to Milk Facts.

    Eggnog is made by combining eggs with milk or cream. Both the eggs and the milk have the potential to contain dangerous bacteria. To offset the risk, the mixture needs to be heated to either 155 degrees Fahrenheit for 30 minutes for large-batch vat processing, or 175 degrees Fahrenheit for 25 seconds for continuous high-temperature, short-time processing. Eggnog must be pasteurized to ensure it’s free of harmful bacteria.

    Canned pumpkin

    Did you know your pumpkin pie might be more like squash pie? According to the Food & Drug Administration, it’s perfectly acceptable for Cucurbita pepo as well as varieties of Cucurbita maxima to bemixed together in the can of delicious creamy pumpkin puree you poured into your pie shell this winter. The former is commonly called a field pumpkin and isn’t as bright as the jack-o’-lantern you carved for Halloween, while the latter is firm-shelled, golden-fleshed, sweet squash.

    Regardless of what’s technically in the can, there are two truths almost everyone can agree on: pumpkin pie is delicious, and it’s important that the ingredients are prepared safely to prevent foodborne illnesses. An important aspect in implementing controls in processing to prevent bacterial growth is knowing the product’s pH. Different pH levels contribute to varying levels of bacterial growth; lower acidity, found in Low-Acid Canned Foods, generally means the product isn’t required to go through a hazard analysisor be subject to risk-based preventative controls, according to the FDA. Foods that have a final acidity of more than 4.6are considered LACF; since pumpkin averages a pH of 4.9-5.5, it’s considered a LACF.

    A critical distinction between LACFs and high-acidity foods is thepotential for Clostridium botulinum the bacterium that can cause botulism to grow, according to William McGlynn, a food scientist at Oklahoma State University’s Robert M. Kerr Food & Agricultural Products Center. pH levels of less than 4.6 don’t allow for this dangerous spore to grow, which means that LACF’s must undergo intensive heat treatments to kill any spores. Pressure cooking inside the can is one effective way to rid the puree from harmful bacteria.

    As Forbes contributor Nadia Arumugam explained, the journey from field to can is a long onethat involves heavy-duty machinery to wash, sanitize, remove the stem, seeds and pulp, chop, steam, condense and finally mash the squash. Each of these steps is critical in creating that consistent texture you imagine when you think of pumpkin pie.

    Cranberry sauce

    While pumpkin has a low acidity, cranberries fall on the higher end of the scale, with cranberry sauce having an average pH of 2.4 and cranberry juice a pH of 2.3-2.5, according to the Robert M. Kerr Food & Agricultural Products Center. While this may mean Clostridium botulinum has a very low chance of surviving in these environments, other toxins like salmonella can thrive in this level of acidity, and pasteurization is necessary to make sure they’re safe to consume.

    According to the FDA, fruit juices need to either be pasteurized or labeled with a warning messagestating that the product has not gone through a pasteurization processand could be a health risk to consumers, particularly those who have weak immune systems. As is dairy processing, heat pasteurization is a common practice among juices and fruit juice products.

    High-quality equipment matters

    When pasteurizing milk, fruit or vegetable products, it’s not just factors like temperature and process duration that makes a difference, but also the equipment in use. Some materials are naturally less prone to contamination than others.

    Stainless steel is one material that is well-suited for food processing because of its resistance to fouling, corrosion and pitting. Alloys that contain copper, which naturally has antimicrobial properties, can also be good choices for food processing equipment, according to Antimicrobial Copper. As such, stainless steel and copper alloys are commonly used in food processing operations.

    If your food processing plant is in need of new stainless steel shell and tube heat exchangers for your pasteurization process, reach out to the expertsat Enerquip.

  6. Investing in a CIP system: Here’s what you need to know

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    There are some basic priorities every food, beverage, and pharmaceutical manufacturer shares: Make a quality product, minimize downtime and maintain sanitary conditions in the facility.

    Careful planning, strategy and expertise are necessary to accomplish these tasks. They also require an effective cleaning strategy that reaches all the little crevices throughout the food manufacturing process and properly sanitizes all surfaces.

    One much-favored equipment cleaning strategy throughout the food, beverage, and pharmaceutical industries is the clean-in-place method. CIP systems are very effective in keeping equipment free of fouling and are regarded highly by the 3-A Sanitary Standard.

    Components of a CIP system

    There are many different configurations and styles for CIP systems, though there are some features the majority of them have in common. These may include:

    • Pumps to add the chemical sanitizers.
    • Pumps and valves to bring in the supply of water.
    • A supply-side heat exchanger.
    • A method of recording data (temperature, start/end times, amount of water and sanitizer used). The method can either be electronic or manual.

    All CIP systems have a system of one or more tanks: Some have one tank, which allows for a combined rinse and wash cycle. Others have two tanks to separate the rinse and wash processes. Some CIP systems add a third tank to be used for a recovery process, and others have a fourth tank for alkaline, acid or sanitizer storage.

    Some CIP systems are one-pass systems that require careful chemical dosing; others are multi-pass systems which necessitate an additional tank to hold alkaline, acid or sanitizer – often the reason a fourth tank is included in the CIP system.

    Manufacturers designing CIP systems also have a variety of options for how to distribute the water and cleaners throughout the equipment. They can use spray balls, which are more tailored to processes that don’t require very high water pressure. For those that do need highly pressurized water, rotary spray heads are used more often.

    In either case, it’s essential that the entire surface area is reached by the spray method to ensure a total and complete clean. A missed spot resulting from poor design or insufficient components may harbor contaminants and become a serious problem in the long term.

    Flow in a CIP system

    It’s important to consider what flow rate is really needed when designing a CIP system. One might immediately think the higher the flow rate the lower the risk for inadequately clean equipment. However, erring on the side of higher pressure can also mean higher energy, water and cleaning costs. It’s best to have it just high enough of a flow to be effective, but not overdo it.

    If a problem with a CIP system emerges, managers may assume the solution is to increase the flow. However, there are alternative solutions that can improve cleaning processes without a major impact on costs.

    The most challenging parts of equipment to clean are dead-ends, crevices and corners, such as the bends in a u-tube shell and tube heat exchanger. In these instances, increased flow is often ineffective, as well as costly. Some different approaches to cleaning challenging parts of the equipment include:

    • Pulsating and varying the direction of the flow.
    • Ice-pigging, or pushing an ice slushy through the piping from the CIP.
    • Effervescence in the water, which creates localized wall-shear stresses.
    • Jet cleaning, or directing a high force to a specific area.

    Additionally, draining the processing line before engaging the CIP system may also help. This way, when the CIP is turned on and the water fills the lines, it’ll create a moment of harder force than if the water was already in the line.

    Documentation of CIP systems

    It’s a legal requirement that food manufacturers document their cleaning process, Commercial Food Processing pointed out. Luckily, many CIP systems have automated documentation capabilities. However, just because it happens automatically doesn’t mean it shouldn’t be regularly and frequently monitored, or that manufacturers shouldn’t make adjustments or additions to the documentation process.

    Event archiving is also a necessary aspect of having and properly maintaining a CIP system. Event archives include cycle start and end times, wash times and quantities of materials used in the cleaning. In the past, this was done by hand, though manual recording is no longer industry standard, nor does it meet regulatory compliance. Software innovations have been brought to market to address this need as well.

    In addition to the typical information recorded by event archivers of the past, software-based event recorders also include data like whether a process was interrupted (and why); whether an operator took additional steps before, during or after the cleaning process; whether a step was repeated or skipped; and whether the operator paused or aborted the cycle before it was completed. The software can compile all the relevant data into reports that can be printed, as well as import it to databases so it can be accessed more conveniently and compared to past reports.

    Most importantly, using software-based historians and event recorders makes regulatory compliance easier for manufacturers, and can more accurately identify emerging or existing problems in the CIP system.

    If you’re in the market to upgrade your CIP system, consider how a stainless steel shell and tube heat exchanger can help. The knowledgeable engineers at Enerquip know the importance of fabricating exchangers that meet stringent regulations such as 3-A and ASME-BPE. Contact us today or request a quote.

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  7. New FSMA Guidelines for cGMP’s

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    According to the Centers for Disease Control and Prevention (CDC), about 48 million people in the U.S. (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases. This is a significant public health burden that is largely preventable.

    In 2015, the FDA Food Safety Modernization Act (FSMA) was enacted to help prevent foodborne illness rather than simply responding to it. FDA has seven major rules in regards to FSMA for both human and animal food. The FSMA rules are designed to make clear specific actions to prevent contamination.

    CGMPs for animal food

    CGMPs for animal food production cover elements like personnel, sanitation, work environment, water quality, equipment and more. Jenny Murphy, a consumer safety officer at FDA’s Center for Veterinary Medicine, explained that CGMPs are typically actions manufacturers should already be making throughout the normal course of their business.

    “I would say the CGMPs establish a base to make sure you don’t contaminate the animal food and the preventive controls take it a step further by making you really concentrate on things that, if they’re found in animal food, could be a public health concern,” Murphy said, according to the Food & Drug Administration.

    For example, according to CGMPs, equipment used for food manufacture should be:

    • Adequately cleanable.
    • Made from nontoxic materials.
    • Properly maintained.
    • Protected against contamination.

    Preventative controls for animal food

    While CGMPs cover the basics of maintaining a sanitary work environment and can be applied to any facility, preventative controls are more individualized to unique plants and are designed to address more specific situations.

    “Preventative controls are more individualized to unique plants.”

    “Once you have CGMPs in place, you can see where you need extra layers of protection,” Murphy explained. “Preventive controls require a food safety plan that includes an analysis of potential biological, chemical or physical hazards and the steps needed to reduce or minimize that risk.”

    Joann Givens, the director of FDA’s Food and Feed Program in the Office of Regulatory Affairs and a co-chair of the FSMA Operations Team Steering Committee, explained that it’s OK – even advisable – to have some redundant processes in place. This way, when one procedure falls short, another can pick up the slack. It ensures all your bases are covered.

    Givens explained that preventative controls are important because, if a violation does occur, some of the first questions a facility manager might be asked include:

    • Could you have predicted this issue?
    • What did you do to prevent it?
    • Once it became a problem, what did you do?
    • Did you educate your employees about the issue or how to address it?

    Every animal food manufacturing plant will have different risks, and therefore each may have different preventative control requirements. Facilities should have preventative controls in place for:

    • Processes, like heating or refrigerating.
    • Sanitation, like the minimization of pathogens or biological hazards.
    • Supply chain.
    • Recalls, when they’re needed.
    • Any other aspects of the facility where a preventative control might make sense, such as hygiene training or reviews of CGMPs.

    Making sure your equipment is compliant

    Your process equipment is a large investment, which means you’ll want to make sure it’s compliant from the get-go.

    Stainless steel shell and tube heat exchangers are a common component to animal food manufacturing facilities because they meet many CGMP expectations. For example, stainless steel is a highly sanitary surface, which meets the requirement that materials that come in contact with the product should be nontoxic.

    Certain configurations also allow for easy cleaning. Tube bundles on u-tube exchangers are often easier to remove, giving easy access to the crevices of the exchanger when cleaning. On the other hand, straight-tube designs don’t have difficult curves to work around when cleaning.

    It’s also important to think about the wear and tear equipment sustains over time. Shell and tube heat exchanger processes that involve high-pressure differentials can create more stress on the tubes and tubesheet, making a leak or other form of damage more likely. When a tube springs a leak, the batch of product inside the equipment could become contaminated. This is especially true if the feedwater used is of lower quality than required for animal food production. The U.S. Food & Drug Administration pointed out that this is often the case, which means facility managers must always be aware of the state of their equipment.

    The first step in preventing leaks in exchangers – and thus fulfilling CGMPs relating to avoiding contamination – is to regularly inspect the equipment and identify when a problem emerges. Seeing the signs of wear and potential leakage should be enough to pursue repair or replacement of the weathered part or the piece of machinery as a whole.

    Understanding the many requirements included in the FSMA isn’t always easy, but it’s important that animal food manufacturers determine where their current weaknesses are and address them sooner rather than later. Murphy explained that the FDA won’t begin conducting inspections to make sure everything is up to code until 2018, but that doesn’t mean there’s time to waste.

    For animal food companies looking to upgrade their equipment in compliance with current CGMPs, the engineers at Enerquip can help.

  8. Pharmaceutical Manufacturers Must Meet ASME-BPE Standards

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    In any industry, it’s important to have standards that lay out what consumers expect of the products created by manufacturers and define the processes by which these products can be created. Without standards, consumers may mistakenly purchase a subpar product that does not meet their expectations, leaves them frustrated and damages the manufacturer’s reputation.

    In certain industries, compliance with these standards is absolutely critical. In any market where end users are coming in direct contact with a product or ingesting it – like the food and beverage, dairy or pharmaceutical industries – manufacturers must take every step possible to ensure the final product meets consumer expectations and is safe to consume.

    To ensure that all products are high-quality, there are countless standards that govern many different industries. For example, fabricators of equipment for the dairy industry adhere to 3-A Sanitary Standards, created in the 1920s to ensure that all machinery that came in contact with milk and milk-based products created a sanitary environment.

    Pressing need for pharmaceutical standards

    Where the food, beverage, and dairy industries have excelled in having extensive rules and regulations regarding the environments in which products could be made, the pharmaceutical industry fell short. For many years, there was no 3-A equivalent for biopharma manufacturers that explained what sorts of materials could be used to make equipment or how that equipment needed to be treated or maintained.

    Enerquip Electropolish Finish

    Manufacturers filled the void in their own ways. Some created their own in-house standards to ensure their products would always be consistent. Many turned to the dairy industry’s 3-A standards and applied them to their pharmaceutical operations.

    Though sufficient to keep products sanitary, safe and consistent, the lack of a uniform standard weighed on the industry. After numerous requests, the American Society of Mechanical Engineers collaborated to come up with the ASME-BPE (Bioprocessing equipment) standard.

    The standard was first published in 1997 and updated several times since. With it, pharmaceutical manufacturers are better able to communicate their needs to equipment fabricators, collaborate with other companies and stay in line with the U.S. Food and Drug Administration’s policies and current good manufacturing practices.

    ASME-BPE related to heat exchangers

    The ASME-BPE standard covers a wide range of topics, but here are ten important parts related to shell and tube heat exchangers:

    1. Material selection: Heat exchangers should be constructed of materials that are compatible with the process fluid and cleaning solutions, and which meet the purity and quality requirements of the biopharmaceutical industry.
    2. Surface finish: The interior surfaces of heat exchangers should have a smooth, uniform finish that is resistant to corrosion and microbial growth.
    3. Welding and joining: The welding and joining techniques used in the construction of heat exchangers should meet the requirements of the ASME-BPE standard, including orbital welding, electropolishing, and passivation.
    4. Design and construction: Heat exchangers should be designed and constructed in accordance with the requirements of the ASME-BPE standard, including dimensional tolerances, material specifications, and surface finish requirements.
    5. Testing and inspection: Heat exchangers should undergo rigorous testing and inspection to ensure that they meet the quality and performance standards required by the biopharmaceutical industry.
    6. Cleanability: Heat exchangers should be designed and constructed to facilitate thorough cleaning and sterilization, with no dead spots or areas that are difficult to access.
    7. Surface finish measurement: The surface finish of heat exchangers should be measured using appropriate techniques, such as profilometry, to ensure that it meets the required standards.
    8. Gasket and seal materials: The gaskets and seals used in heat exchangers should be constructed of materials that are compatible with the process fluid and cleaning solutions, and which meet the purity and quality requirements of the biopharmaceutical industry.
    9. Pressure testing: Heat exchangers should undergo pressure testing to ensure that they can withstand the operating pressures and temperatures required by the biopharmaceutical process.
    10. Documentation: All aspects of the design, construction, and testing of heat exchangers should be fully documented, with detailed records of materials, processes, and inspections maintained for regulatory compliance and quality assurance purposes.

    Understanding your operation’s needs

    Your operation likely comprises multiple systems and units to produce various products, each with its own unique requirements and features.

    Certain sections of the standards will relate more closely to specific parts of your operation. For instance, your high-sensitivity processes require the strictest adherence to the standards since they come into direct contact with the product. Such processes need to be highly cleanable and able to be electropolished. It is important to choose appropriate materials for not only the interior surfaces but also exterior surfaces.

    In contrast, low-sensitivity processes do not come in contact with the product. Rather, they support the systems that do. Therefore, it is important to carefully fabricate low-sensitivity processes to ensure a sanitary environment. However, these processes do not need to be as high-grade as the ones that directly touch the final product, such as tank jacket systems.

    A seat at the ASME-BPE table

    Preferred equipment suppliers like Enerquip proactively participate in the ASME-BPE committee meetings to help shape the standards that apply to shell and tube heat exchangers. If your pharmaceutical manufacturing operations require new or upgraded shell and tube heat exchangers, we invite you to connect today.

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    Editor’s note: This content was originally published in 2017 but was updated in 2024.

  9. Shell and tube heat exchanger standards: Part 2

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    No matter what industry you operate in, standards matter. They are the measuring stick against which companies and consumers can measure products and choose which ones best suit their needs. They are a way of demonstrating precision and care in the manufacturing of each model of a product.

    There are some industries in which meeting standards is crucial to ensuring product safety and quality. The food, beverage and dairy industries must meet guidelines set by the Food and Drug Administration to ensure products are safe for human consumption. The pharmaceutical industry must also meet these requirements so that each medicine is not only safe, but effective.

    What these industries have in common is more than consumer-facing products and FDA regulations; they also rely on shell and tube heat exchangers to help make their products as safe, effective and consistent as possible. In order for these industries to produce food, beverages and medicines that are of high quality, they must use equipment that meets specific guidelines as well.

    There are a wide range of standards a shell and tube heat exchanger can adhere to. Knowing what they mean and which ones apply to your industry and area of operation are important for successfully moving forward.

    ANSI

    The American National Standards Institute has been coordinating the voluntary standardization system in the U.S. private sector for nearly a century. Groups called standards developing organizations work together to develop and improve upon standards.

    ANSI publishes Standards Actions every week, which include calls for comments on standards proposals. In it, suggestions are made along with what machinery the standard changes would apply to. As of last year, more than 240 SDOs were accredited by ANSI, and more than 1,100 American National Standards were in place.

    3-A Sanitary Standards Inc.

    Standards for equipment design used in the dairy industry first came about in the 1920s. There were three interest groups, or associations, that worked to develop the standards: equipment fabricators, regulatory sanitarians and processors. To highlight the three associations’ collaboration, the standards became known as 3-A.

    3-A Sanitary Standards were created and are maintained to ensure that all equipment used in the food, dairy and pharmaceutical industry is kept clean so that all products coming from them are safe for consumption. According to 3-A, the ideal equipment can be mechanically cleaned through a clean-in-place or CIP system, or can be easily taken apart for thorough manual cleaning.

    API 660

    The oil and gas industry is another area in which standards are crucial. Petroleum is used in nearly every aspect of today’s world. It fuels vehicles and heats buildings, but it is also used in textiles, health and beauty essentials, cleaning products and many more applications.

    In the oil and gas industry, there are several standards companies must adhere to. Often, it is the end user or consultant who creates demand for refineries to follow these standards. The American Petroleum Institute designed standards called API Standard 660.

    A newsletter from the CoDesign Engineering Skills Academy noted that these standards were drafted based on industry experience and practical considerations. They provide specifications for the design of a shell and tube heat exchanger for use in the petroleum industry, such as how thick the tubes can be, the type of exchangers allowed in refineries and how thick the tubesheet joints can be.

    As demonstrated in the newsletter’s chart, API 660 has some similar standards as TEMA, though not always. For instance, under API 660, TEMA type P and W exchangers, which have outside packed floating heads and a floating tubesheet that is externally sealed, respectively, are not allowed to be used in a refinery. However, under TEMA’s standards, these can be used in certain situations.

    It’s important to note the differences in standards when working in an industry where meeting regulations can help define the quality of a product. Knowing your customer base and what they value is also critical, as this will help manufacturers determine which equipment and which standards are right for them.

    If you are looking for a shell and tube heat exchanger for your operations, talk to the experts at Enerquip. Their in-house engineering team will understand your needs and be able to determine which standards your equipment needs to meet.