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Tag Archive: Pharmaceutical Condenser

  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. 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.