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Category Archive: Sanitary Equipment

Tag Archive: Sanitary Equipment

  1. Heat Exchanger Helps Aloe Processor Improve Quality

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    In 2012, a producer of pure aloe for medicinal and nutritional products approached Enerquip with a unique cooling problem. In the tropical region where aloe is harvested, the ambient temperatures hover near 95° F (35°C) most of the time. This tropical climate was accelerating bacterial growth in the product, which was lowering its value and shelf life. Enerquip worked with the producer to develop a solution using a shell and tube heat exchanger.

    Ideal conditions for the product were discovered after performing some testing. The aloe producer found that if they could cool the product below 40°F (4.4°C) before packaging it, there was a significant improvement in quality.

    However, the customer’s lack of utilities at the packaging site led to complications in the cooling process. They had electricity, but the cooling water system already in place did not supply water that was cold enough to provide the low temperatures necessary to impede bacterial growth. Also, the staff using the equipment was not technically inclined, so any solution needed to be easy to control and understand. Because the aloe processor only packed the product several times per season, the equipment needed to be easy to clean, move and store during the off-season.

    After reviewing the process and existing equipment, the thermal team at Enerquip realized that a heat exchanger was required for the application. Heat exchangers are built for efficient heat transfer from one medium to another. There are multiple types of heat exchangers that offer the ability to either separate the media or, for them, to be in direct contact.

    Shell and tube heat exchangers consist of a series of tubes inside a larger pipe. The tubes contain the product, which is the fluid being heated or cooled. The second fluid – a heating or cooling medium – fills the larger pipe around the outside of the tubes, with the heat transferring between the product and the medium through the tube walls.

    During the heat exchanger sizing and selection process, several factors are taken into account:

    • The product specifics
    • Temperature (in/out)
    • Flow Rate (product quantity in/out)
    • Cooling medium
    • Temperature and size limitations

    The ability to easily clean the equipment played a major role in this application. Aloe is a very viscous product, and due to the frequency of use, it became evident that a shell-and-tube heat exchanger would best fit this application. The exchanger was designed in a straight-tube, multi-pass configuration, which allowed the product to travel back and forth through the exchanger several times before heading to the packaging line. The straight tube exchanger option with removable bonnets allowed for easier mechanical cleaning than other designs.

    Due to ground water availability and temperature at the plant location, a chiller was added to complete the process for this application. The air-cooled chiller was installed and utilized to provide enough cold glycol and water to cool the aloe product in a single pass through the exchanger. Once filled with glycol and water, the chiller only needed plant electricity to run. The chiller supplier installed simple pushbutton procedures that were easy for the plant staff to follow. Independent shut-off valves and removable hoses between the chiller and exchanger also allowed for easy tear down and cleaning following production.

    The end results of this process provided the aloe producer with an efficient system and cleaner, colder and more valuable aloe products.

    Click here to read more about the Aloe Vera processing.

  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. Exchanger System Helps Food Packager Put the Soup On

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    A mechanical contractor for a Chicago-based liquid-foods packager had an interesting and challenging cooling application. An important client planned to award the foods packager a large contract for packaging soup if they could satisfy one stipulation: The company had to guarantee that the product would be cooled from 198°F (92°C) to precisely 77°F (25°C) before packaging.

    In addition to the tight temperature requirements, process flexibility was required. The contract was for various types of soups, so the packager had to be able to cool products having different thermal properties. At the same time, the packager needed to be able to clean the system easily between batches to avoid any carry-over from different soup types. The cooling point had to be met precisely. If the soups were too warm when packaged, spoilage potentially could occur. If they were too cool during packaging, the containers could sweat, and the labels would not properly adhere to the packages.

    In addition, the packager had to accomplish this within a physical area with space limitations. The entire cooling system had to fit within a 14-by-6’ footprint and fit under a 12’ ceiling. Additionally, in order to minimize utility costs, the packager wanted to take advantage of ambient water from their cooling tower to perform the bulk of the cooling. A glycol/water mix through a chiller would be used for final cooling. Another factor considered in the design was the requirement for a sanitary food-grade system that met the 3-A sanitary standards for polished surface finishes and cleanability.

    Dual-Stage Heat Exchanger Design Selected

    After exploring the options, the food packager selected a designer of shell-and-tube heat exchanger systems. Often when designing shell-and-tube heat exchangers, multiple configurations can perform the duty requested. The best design is selected based on surface area, utility service provided, regulatory preferences and customer priorities. Working together in a collaborative process, the heat exchanger designer and food packager pursued the best option balancing all of the conditions.

    In order to provide a fairly simple solution, the first design presented was for a pair of 24” by 10’ long BEM-style straight tube exchangers in series. The soup product would flow through the tubes of the first exchanger while being cooled by cooling tower water in the shell. After the first exchanger, the soup would flow through the tubes of the second exchanger while being cooled by 45°F (7°C) glycol/water mix in the second shell. Both exchangers were inclined to allow the units to drain out when not in use between batches. The two heat exchangers were designed with davit swing-arm assemblies to help facilitate removal of the bonnets for periodic inspection and manual cleaning when needed.

    This dual exchanger approach, despite the advantage of simplicity, had several drawbacks. First, the cooling performed in the first exchanger was limited to the temperature that the cooling tower water was being heated to on the shell side. In other words, when the soup entering the exchanger at 198°F (92°C) met the cooling tower water entering the shell at 70°F (21°C), it heated up the cooling tower water to around 120°F (49°C). The soup could not be cooled below this level of 120°F (49°C), which is known as the temperature cross or temperature pinch. This would then put most of the burden on the glycol/water chiller to perform the bulk of the cooling, requiring a larger and more expensive chiller unit.

    The other issue that presented itself was the ability to completely clean the unit between batches of product. Although the exchanger could be cleaned by backflushing the tubes with water and cleaning solution, there was no way to accelerate the wash water to the preferred velocity (5 ft/sec) needed for adequate cleaning. This was limited by the size of the onsite cleaning clean-in-place (CIP) system (200 gal/min). With the sheer size of the exchangers and number of tubes, it would have taken a CIP system using 1,500 gal/min to reach the proper cleaning velocity. These factors led to a redesign to a more complex yet more effective solution.

    In order to allow for a smaller tube field that would provide the 5 ft/sec velocity for cleaning, the exchanger diameter was reduced from 24” to 6”. Because of the reduction in surface area per heat exchanger, it was necessary to add more exchangers to the set. The first, large unit being cooled by the cooling tower water was replaced by six smaller exchangers. For the final cooling utilizing the chiller, the larger exchanger was replaced by two of the smaller units.

    As the design simulations unfolded, other benefits started to show themselves. By restricting the flow of the product to a smaller number of tubes, the velocity of the product also increased. This improved the heat transfer when cooling the soup product. It also allowed the cooling tower water to be split into a fresh stream flowing into each of the six shells, avoiding the temperature cross experienced in the larger unit. During winter months, when their cooling water was colder than 70°F (21°C), it was possible to shut down the glycol/water chiller and perform all of the cooling with just cooling tower water, saving utility costs.

    The smaller diameter exchangers were easier to construct and polish to meet the 3-A sanitary requirements. They were efficient to clean using the onsite CIP system, and they were simpler to take apart to inspect due to the smaller, lighter bonnets on each exchanger.

    The eight exchangers were stacked on a custom rack with all of the interconnecting product jumpers, utility piping and the contractor’s manual valves. During design, it was decided to leave enough space to mount two more of the same size exchangers on the rack, allowing for future growth in batch size, or for tough-to-cool products requiring more surface area. The units were all pitched slightly to allow for full draining of the product and cleaning fluids from the tubes. Another advantage was that spare parts like gaskets and tri-clamps were less expensive and more readily available for the smaller exchangers than with the two original, large exchangers. An added bonus is that the parts are interchangeable between the eight exchangers in the set.

    The new system of stacked heat exchangers in series still fit within the packager’s space limitations, and it ended up costing about the same as the two larger custom units. This allowed the food package to stay within the budget and timeline for the project. The stacked set approach of smaller heat exchangers in series performed consistently. This allowed the packager to win the contract while enjoying the benefits of lower utility costs, increased regulatory compliance and automation of the maintenance process for the system.

  6. How Food Processing Brings Your Holiday Favorites to the Table

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    The holidays are packed with timeless traditions—family gatherings, festive decorations, and the foods we wait all year to enjoy. Think creamy eggnog, rich pumpkin pie, and tangy cranberry sauce. But long before these dishes hit your plate, they go through carefully controlled food processing steps to ensure they’re safe, shelf-stable, and delicious.

    Let’s take a behind-the-scenes look at how thermal processing plays a key role in preparing these seasonal staples.

    Eggnog: Pasteurization is Key

    Eggnog combines two ingredients known for being finicky in food safety: milk and eggs. Because both can carry harmful bacteria, pasteurization is a must.

    There are two common methods for pasteurizing eggnog:

    • Batch pasteurization: Heating the mixture to 155°F for 30 minutes.

    • High-temperature, short-time (HTST) pasteurization: Heating to 175°F for 25 seconds.

    Both methods help eliminate pathogens like Salmonella and E. coli, making that festive glass of eggnog safe to sip.

    Canned Pumpkin: More Than Just Pumpkin

    Spoiler alert: your pumpkin pie may not be 100% pumpkin. Canned “pumpkin” often includes a blend of pumpkin and sweet squash—perfectly legal and very tasty.

    What matters most is food safety. Pumpkin puree falls into a category known as low-acid canned foods (LACFs), which means its pH (typically 4.9–5.5) is high enough to allow for bacterial growth if not handled properly. That’s why these products must go through high-heat processing—often pressure-cooked inside the can—to eliminate spores like Clostridium botulinum, which can cause botulism.

    The production process also includes:

    • Washing and sanitizing

    • Removing stems, seeds, and pulp

    • Chopping, steaming, and mashing

    • Sterilizing and canning

    It’s a complex journey, but all those steps are essential for that smooth, pie-ready texture.

    Cranberry Sauce: Naturally Acidic, Still Needs Processing

    Cranberries are naturally high in acid (around 2.4 pH), which makes them a less likely host for some dangerous bacteria. Still, pathogens like Salmonella can thrive if products aren’t processed correctly.

    That’s why cranberry juice and sauce are typically pasteurized. It not only extends shelf life, but ensures these tangy treats are safe to eat. In some cases, unpasteurized juice must carry a warning label to alert consumers of potential risks.

    Why Equipment Matters

    No matter the product—milk, juice, or squash—quality food processing equipment is critical. Consistent temperature control, cleanability, and durability are all essential for safe, efficient pasteurization.

    Stainless steel is a top choice for food-grade equipment thanks to its:

    • Corrosion resistance

    • Smooth, easy-to-clean surface

    • Compatibility with CIP (clean-in-place) systems

    It’s the material of choice for many processors looking to meet strict hygiene and safety standards while maintaining efficiency and reliability.

    Looking Ahead

    Holiday dishes may be rooted in tradition, but the equipment behind them is anything but old-fashioned. As food safety regulations evolve and consumer expectations grow, so does the demand for high-performance, hygienic processing systems.

    At Enerquip, we design and fabricate stainless steel shell and tube heat exchangers trusted by food and beverage manufacturers across the country. Whether you’re processing dairy, juice, or purees, we’ll help you find a thermal solution that meets your standards—and keeps your customers safe.

    Planning a process upgrade? Contact us to talk about your next project.

     

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  7. Pharmaceutical Manufacturers Must Meet ASME-BPE Standards

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    Editor’s note: Content last updated 3/7/24

    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 highly cleanable surfaces with many requiring electropolished finishes. 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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