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Category Archive: Pharmaceutical

Tag Archive: Pharmaceutical

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

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    Condensers are key components for pharmaceutical production. Increased regulations and oversight of pharmaceutical manufacturers over the past few decades have created a need for specifically designed for their intended purpose.

    Shell and tube heat exchangers used for pharmaceutical condensers should be easily cleaned, compatible with the appropriate heat transfer fluids, resistant to contamination and corrosion and reliable. Here’s what you need to know about choosing a heat exchanger that works for your pharmaceutical operation:

    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. By being able to completely empty the equipment of all fluids (either by free-draining or with air-assist), the cleaning process is more effective, and the next batch won’t be affected by traces of previous product.

    2. Silicone Heat Transfer Fluid Compatible

    Your equipment needs to be compatible with the substances that will pass through it – both on the tubeside and the shellside. 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.

    Silicone is becoming a more popular heat transfer fluid for a number of reasons. It is known for their thermal stability, an important quality of heat transfer fluid. Silicone fluids are ideal for temperatures above 350 degrees Fahrenheit, according to an article from The Dow Chemical Company originally published in Process Heating Magazine. While silicone is effective at high temperatures, it also has good pumpability at low temperatures, making it a versatile heat transfer fluid.

    They also are long-lasting and aren’t likely to cause chemical abrasion, even when exposed to high temperatures. For these reasons, more than 375,000 tons are expected to be generated by 2024, according to a press release from Global Market Insights.

    Silicone has a low risk of flammability, making it an attractive fluid for many manufacturers, Chemical Processing pointed out.

    3. Leak-Free

    No 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, reach out to the knowledgeable heat exchanger experts at Enerquip.

  2. Sani-Matic Testimonial of Enerquip Heat Exchangers

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    Sani-Matic shares why having a quality partnership with Enerquip means so much for their business. “We consider Enerquip a leader in their product range.” – Aaron Zell, President & CEO of Sani-Matic. “We can count on Enerquip – they do what they say they’re going to do. All foundations are built on trust and we have that firmly in place with Enerquip.”

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  3. Preventing Cross Contamination in Your shell and tube heat exchangers

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    Cross contamination is a shared concern at all stages of the food industry. Chefs need to make sure their fresh veggies are kept away from their raw meat; storage facilities strive to keep common allergenic foods like nuts separate from other ingredients; and food production plants must ensure products sent through their process equipment isn’t affected by harmful bacteria, chemicals or other items.

    Shell and tube heat exchangers are popular in food production plants as a method to pasteurize fruit, vegetable or dairy products, or to achieve a desirable consistency, as in honey or maple syrup production. Cross contamination is also a risk factor in industries like pharmaceuticals and personal care.

    It’s important that these important pieces of equipment don’t contribute to any form of cross contamination. If this were to occur, it could reduce plant efficiency, lead to a ruined batch of product or necessitate a recall. There are many different ways to reduce the chances of cross contamination in your food or pharmaceutical production facility. Here are a few:

    Work with quality equipment fabricators

    The materials used in the construction of your shell and tube heat exchangers play an important role in the quality, sanitation, cleaning requirements and lifespan of your equipment. Many food industry companies turn to stainless steel for its fouling resistance.

    Choosing a stainless steel shell and tube heat exchanger is therefore a good step toward preventing cross contamination in your facility. However, you can take this one step further by finding out what sort of environment in which your shell and tube heat exchanger is fabricated.

    Cross contamination isn’t just limited to food items; you can also cross-contaminate metals. As such, it’s worthwhile to find out if your stainless steel shell and tube heat exchanger is being made in a facility that also utilizes carbon steel. If it is, there’s always a chance that this metal, which is more prone to fouling, can contaminate your equipment.

    At Enerquip, we value the integrity of stainless steel, which is why we don’t work with carbon steel. When you receive one of our heat exchangers, you can feel confident that it hasn’t been affected by this metal.

    Strategically choose your tubes

    When cross contamination does occur in a shell and tube heat exchanger, it may be caused by the shell-side fluid mixing with the tube-side fluid. To prevent this from happening, added barriers or an adjusted tube design can help.

    Enerquip’s high purity shell and tube heat exchangers are fitted with double tubesheets, which reduces the risk of cross contamination of this type. These custom and standard pharma-grade exchangers are particularly useful for pharmaceutical, nutraceutical, animal health and personal care industries.

    Double tube sheet configurations typically have a form of leak detection installed in the exchanger. If a leak were to occur in these models, the fluid should drain away from the exchanger and into a safety container rather than mixing with the other fluid, and alerts the operator that there is an issue to repair.

    Understand pressure differentials

    The engineers who create shell and tube heat exchangers must understand many complex formulas to know how the equipment will behave once it’s put to use. The pressure differential, or the difference between the pressures inside the exchanger, is an important one that relates to the likelihood of cross contamination. Typically, the pressure on the shellside would be less than inside the tubes. That way, if a leak springs, the product will flow into the heat transfer medium, rather than the medium mixing into the product and entering the tubes. This helps to keep the negative effects of a cross contamination incident as low as possible.

    Regular inspections and cleaning

    If there’s a chance of cross contamination in your equipment, it’s best to know sooner than later. Periodic visual inspections is the first step in identifying weak points and emerging problems that could lead to contamination, Business Standard pointed out. In your inspections, you might see early signs of leaks in your tubesheet or gaskets. If you catch this early, you may be able to replace or repair the damage before it leads to mixing fluids.

    You may also see early signs of fouling. If fouling is allowed to continue for too long, it can lead to spoiled product. If you do, you’ll want to clean the exchanger and determine whether you can make any changes to your process to prevent fouling. This might mean exploring new options for heat transfer fluids, cleaning more frequently or changing your sanitation methods.

    Whether you’ve experienced cross contamination at your facility or simply want to ensure you’re doing everything you can to prevent it, strategically choosing your shell and tube heat exchanger and making sure it’s kept in good condition can go a long way to help your efforts. To learn about Enerquip’s stainless steel shell and tube heat exchangers, reach out to our knowledgeable engineers.

  4. Pharmaceutical manufacturers must meet ASME-BPE standards

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    Pharma Every step in pharmaceutical production must be sanitary.

    In any industry, it’s always 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 3A 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

    “With ASME-BPE, pharmaceutical manufacturers are better able to communicate their needs to equipment fabricators.”

    Where the food and beverage, and dairy, 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 3A 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.

    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 3A standards and applied them to their pharmaceutical operations, Pharmaceutical Manufacturing explained.

    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. ASME explained that this standard covers such important aspects as:

    • Materials.
    • Design.
    • Fabrication.
    • Inspections.
    • Testing.
    • Certification.

    The standard was first published in 1997and updated in 2002, 2005, 2009 and 2016, according to Pharmaceutical Technology. 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, Pharmaceutical Manufacturing explained.

    Understanding your operation’s needs

    It’s very likely that your operation has multiple systems and units for creating different products. Each one may have it’s own unique requirements and characteristics.

    ASME-BPE is split into 10 parts, according to ASEPCO. They are:

    • General requirements, which reviews all other standards and laws manufacturers must comply with when using pressurized equipment.
    • Systems design, which speaks to bioburden control and cleanability across all process systems, components and utilities.
    • Dimensions and tolerances for process components, which addresses topics like wall thickness, hygienic clamp unions, pressure ratings and more.
    • Material joining, which speaks specifically to joining metallic materials at various points throughout the system, including acceptable discoloration at welded portions.
    • Product contact surface finishes, which includes specifications regarding electropolishing and passivation.
    • Sealing components, which addresses valves, seals and fittings. Both static seals, like o rings and hygienic unions, and dynamic seals, like dual mechanical seals and diaphragm valves, are highlighted in this section.
    • Polymeric and nonmetallic materials, which goes into detail on compatibility and leachables.
    • Metallic materials, which details various alloys, reviews different material types and covers very specific details like sulfur content requirements and ferrite levels in certain materials, like 316 stainless steel.
    • Process instrumentation, which reviews instrumentation like temperature controls, flowmeters, pressure instruments and more. It also speaks directly to bioburden controls and cleanability.
    • Certification, which outlines how a company can obtain its ASME-BPE certification, as well as which requirements could change. Tubing and fitting manufacturers primarily earn this distinction. Additionally, it’s important to note that, just because a piece of equipment was built according to ASME-BPE standards, doesn’t mean the fabricator has been certified by ASME. By working with professionals who have earned a certification through ASME, buyers have an added level of assurance that the product is top-notch.

      • Different parts of your operation will relate more closely to certain sections of the standards than others. For example, your high-sensitivity processes, those that require the strictest adherence to the standards and are often the ones that come in direct contact with the product itself, should be highly cleanable and able to be electropolished. Materials selection should be carefully thought-out, not only for interior surfaces, but exterior as well.

      Low-sensitivity processes, on the other hand, won’t come in contact with the product but rather support those systems that do. They, therefore, must also be carefully fabricated to ensure a sanitary environment, but don’t need to be as high-grade as the processes that directly touch the final product, such as tank jacket systems.

      Preferred equipment suppliers like Enerquip, LLC 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, or you would like to discover where you can improve your sanitary processes to meet ASME-BPE standards,reach out to the expert engineersat Enerquip

  5. Closed-loop process cooling can help reduce water, energy use in pharmaceutical manufacturing

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    There is no denying the importance of the pharmaceutical industry. The products and innovations that come from it keep people healthy and can save lives. Despite the good that comes out of the pharmaceutical industry, there are some key problems the industry causes. Water and energy consumption are two things that industries of all kinds are working hard to decrease. Pharmaceuticals are not an exception.

    According to the World Health Organization, the most widely used product in pharmaceutical manufacturing is water. It is used as a starting material, as an added substance in products, and in the processing of the products.

    Water problems

    Being such a crucial ingredient and factor in the means of processing products, it’s hard to get away from using so much water. However, Pharmaceutical Manufacturing pointed out that many companies have been focused on conserving water to achieve two goals: improve the sustainability of their operations and cut operational expenses.

    The publication explained that one of the biggest culprits of high water usage is cooling towers. These provide an important step in the production of a wide range of products, including:

    • Forming tablets
    • Cooling creams and ointments
    • Sterilizing liquids
    • Batch processing

    Unfortunately, these important towers typically use between 1 and 1.5 million gallons of water every year. That water is used for its intended purpose once, then discarded and, many times leaves the plant contaminated.

    Not only do cooling towers use an exorbitant amount of water, but they are also heavy users of energy. Fans and pumps that are continuously running require high amounts of energy. Plus, contamination in forms of algae, solid deposits, microbiological growth, airborne diseases, scaling and more all require chemical treatment. This not only uses even more energy, but also further contaminates the water that is dispelled from the plant.

    Shell and tube heat exchangers provide a solution

    Given these issues, many pharmaceutical manufacturers have recognized the need to replace these important but costly cooling towers. A popular alternative is a closed-loop process cooling system.

    According to Medical Design Technology, many manufacturers in other parts of the world have already begun to recognize the wide range of benefits offered by closed-loop process cooling systems, including:

    • Decreased water and energy use
    • Lowered operational costs
    • Better control over cooling temperatures
    • Greater profitability

    These systems work using heat exchangers and an adiabatic chamber to cool process water, which is then available year-round at the correct temperature. Inside the chamber, a cooling mist is sprayed into the air when the temperature begins to creep up. The mist evaporates immediately so that it does not negatively affect the cooling process. The cooled water is circulated through the process machines.

    Water savings can reach up to 98 percent

    This technology reduces water consumption simply because it reuses water rather than getting rid of it and starting fresh with a new batch of water. Water savings can reach up to 98 percent using this method as opposed to the traditional cooling towers.

    Pharmaceutical Manufacturing pointed out that the system also reduces other contamination problems associated with cooling towers. The water that is recycled meets the sanitary requirements that manufacturers must adhere to. Plus, since the water won’t be contaminated, problems like airborne diseases such as Legionella are reduced.

    Energy consumption is also reduced using these systems. Pharmaceutical Manufacturing reported that in some climates, the plant can even turn off the chillers during colder months, reducing energy use even further.

    In today’s ever-developing world, it’s crucial that pharmaceutical manufacturers are operating at their best, and are doing so safely. However, for these companies to continue to become more profitable, it’s important that they find ways to cut costs and reduce energy and water use. To learn about how shell and tube heat exchangers can help improve your operation, talk to the experts at Enerquip.

    Want more about Pharmaceutical-grade shell and tube heat exchangers? Read on.

    Pharmaceutical heat exchangers – high purity design and fabrication

    Five important qualities to look for in Pharmaceutical process equipment

    Pharmaceutical manufacturers must meet ASME-BPE standards

    Important and applications of a double tubesheet design

    Understanding finish requirements for shell and tube heat exchangers

     

  6. Enerquip Pharma Exchangers meet cGMP’s

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    With the growing trend in the pharmaceutical industry to outsource production to contract manufacturers and international facilities, Enerquip knows it is more important than ever to ensure that process equipment used in production is up to FDA Standards. We have proactively improved our design and fabrication to ensure we incorporate best practices and full cGMP compliance into our exchangers.

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    ENERQUIP PHARMA EXCHANGERS MEET CGMP’S

  7. Specialty pharmaceuticals increase the market

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    The pharmaceutical industry reached some new heights in 2014, according to the 2015 CMR Pharmaceutical R&D Factbook from Thomson Reuters. Global sales reached $1 trillion, and they are expected to continue to rise.

    Sales growth increased more than 3 percent, a sign of good health in the industry. Plus, Thomson Reuters predicts that, by 2018, sales will reach $1.3 trillion.

    “Many new molecular entities that launched in 2014 were for specialty pharmaceuticals.”

    Also in 2014, the largest number of new molecular entities in 17 years came on the market, with 46 launches. Many of these launches were geared toward cancer treatment. More than two-thirds of NME launches were for specialty drugs meant to treat diseases like cancer and eye disorders. One-third of all launches were for rare indicators, such as cancer. Plus, 11 NME launches were geared toward oncology and seven received an orphan drug status. According to the U.S. Food & Drug Administration, this means they will be used for the treatment of diseases that fewer than 200,000 people in the U.S. have, or for those diseases where the cost of developing a treatment is not expected to be recovered.

    Specialty drugs improve market

    Drug, Chemical & Associated Technologies Association explained specialty products had a large part in market growth over the past few years, and will continue to do so in the years to come.

    One of the biggest specialty sales of 2014 was Gilead Sciences’ Sovaldi, or sofosbuvir, which is used to treat hepatitis C virus. HCV treatments were some of the new NMEs that were launched that year. According to DCAT Connect, Sovaldi sold $10.28 billion worldwide in 2014 alone.

    Specialty products aren’t just having a positive effect on pharmaceutical sales in the U.S. DCAT Connect explained these are also boosting the market in pharmerging countries, or those developing nations that are quickly beginning to use more pharmaceuticals.

    Stay up to date

    As more specialty pharmaceuticals are developed, and as more nations begin using these and pharmaceuticals in general, it is important that all companies maintain high quality standards. This is the best way to ensure products are safe and effective.

    “All equipment should be maintained and calibrated properly.”

    The FDA recommends that all equipment be maintained and calibrated properly, and regularly checked. The administration warns that some equipment should be replaced or upgraded if they no longer meet today’s standards. Anyone who operates equipment, such as shell and tube heat exchangers, needs to be properly trained. This includes the proper way to clean and inspect the equipment. Some equipment, such as shell and tube heat exchangers, can be difficult to clean without a CIP system, but it is crucial that it is done regularly and effectively to prevent contaminated products.