The processing equipment used for modern drug production has evolved, and modern pharmaceutical pumps are now integral to the industry. Yet pumps are used today for a range of applications during drug production, so there isn’t just one type of pump used to manufacture pharmaceuticals. Pumps from other industries were modified in the early 20th century, such as the peristaltic pump, a positive displacement pump first used as a well pump in the mid-1800s. Peristaltic pharmaceutical pumps were later refined in the 1930s to enable their use for precision dosing of active ingredients and other pharmaceutical manufacturing processes.
The mid-20th century saw the drug manufacturing industry adopt specialized types of pharmaceutical pumps. A type of centrifugal pump, the design of the magnetic drive pump helps prevent leaking and resulting contamination, so it was used to transfer corrosive and hazardous fluids. Pharmaceutical pumps that work on positive displacement double diaphragm pumps can also be used for dispensing and dosing. Easy to clean and maintain, these pumps can also handle highly abrasive and viscous liquids, including slurries.
Current pharmaceutical pumps use computerized control systems and innovations that assist with precision dosing while also helping maintain sanitation and prevent cross-contamination. Though pharmaceutical pumps are used widely in the drug manufacturing industry, they’re also used for similar purposes in the biotechnological and biopharmaceutical sectors and laboratory settings. The development of pharmaceutical pumps continues to advance as drug makers seek to improve processes by making pumping systems more dependable and efficient.
Pharmaceutical pumps are used to hygienically and safely control the blending, dosing, handling, and transport of raw ingredients, transitional solutions, and finished medications. Because of the need to maintain a sanitary manufacturing environment, there are strict hygiene standards for pharmaceutical pumps. These are necessary to ensure active ingredients won’t lose efficacy as they move through the assorted processes within a pharmaceutical manufacturing plant.
Various types of pharmaceutical pumps are used in the processing of modern medications. Selecting the best pump depends on the fluid transported type and the exact application. Because of their many different uses in the drug manufacturing sector, there are also subcategories of these pharmaceutical pumps within each of these classifications, as noted previously.
Pumps used in the pharmaceutical sector include:
Whatever the type used for an application, these pharmaceutical pumps must also meet strict industry standards.
The standards for pharmaceutical pumps in the United States largely fall under the purview of the US Food and Drug Administration (FDA), which is part of the US Department of Health. The FDA regulates beverages, cosmetics, food and food ingredients, medical devices, pharmaceutical drugs, and biological products like blood and materials used in gene therapy and vaccines. Because of the similarities between the processing of foods and drugs, most pharmaceutical pumps have similarities to those used in the food processing sector.
When equipment used for the pharmaceutical sector is deemed FDA-compliant, it means that it can safely come into direct contact with pharmaceutical drugs and their constituent ingredients. The FDA ensures this machinery – including pharmaceutical pumps – is made from material of a certain standard and with specific properties that enable manufacturers to supply products with sufficient purity and safety for consumers. In addition to guidance from the FDA, drug manufacturers must follow international guidelines, laws, and regulations, including those for pharmaceutical pumps.
Pharmaceutical pumps are made to conform to designs that ensure accessibility to make cleaning and maintenance simpler. This also leads to lower costs, as cleaning is less complicated, leading to lower water consumption and decreased time spent maintaining the pumping system. This gels with the “hygienic design” requirements for pumps used in the drug manufacturing sector. These designs also augment a drug producer’s operating expenses, increasing competitiveness and productivity. Components for pharmaceutical pumps don’t just have to be FDA-compliant, but they should also conform to good manufacturing practices for the production of medicine.
Core prerequisites for a hygienic design should consider:
Hygienic design begins with plant designers, though manufacturers and suppliers of equipment and components should also be involved in these processes to constantly improve the design of pharmaceutical pumps.
Implementing hygienic design principles centers around avoiding contamination from the product and its constituent ingredients. This should be approached by looking at the time involved, processing temperatures at which sanitation occurs, and concentration of cleaning agents. All these elements come with an economic cost. Along with water consumption, the expense of downtime, energy, and cleaning agents add to the overall expense.
Aspects regarding the cleanability of pharmaceutical pumps involve the material from which they’re made, and the design also matters. Ideally, this means a pump design absent gaps and dead spaces around the internal components. When eliminating dead spaces isn’t possible, they should be reduced to minimize their effects so as not to complicate cleaning. Gaps should also be carefully designed to optimize accessibility for cleaning and servicing.
Pharmaceutical pumps are often made from cast stainless steel and polished to rid the surface of cracks, scratches, and other imperfections that can provide microorganisms with a habitat to thrive. This is particularly true for surfaces that get wet during processing. Electropolishing suits pharmaceutical pumps well, as it’s a durable finish that enhances corrosion resistance while providing low adhesive properties to the metal surface that expedites cleaning. Low-carbon stainless steels like the marine-grade 316L are often used for pharmaceutical pumps, while these can be either forged or rolled as long as the surface is nonporous.
There are a few requirements for ensuring mechanical seals remain sterile. These seals should be sufficiently resistant to both cleaning agents and the product while enclosed and flushed to provide both cooling and lubrication while pumping fluids. Pump operators should especially take note of the shaft seal, as it’s the component most likely to cause failure in pharmaceutical pumps.
The type of fluid being transported is the most relevant factor when choosing pharmaceutical pumps for an application. Typically, sterilized or purified water is used in pharmaceutical processes, so centrifugal pumps work better. Positive displacement pumps are used for more viscous or corrosive fluids, such as alcoholic solutions, blood plasma, infusion solutions, nutrient solutions, ointments, or vaccines.
Centrifugal pumps are used more often for pharmaceutical pumps than those that transport fluids via positive displacement. With a more uncomplicated design, centrifugal pumps tend to be simpler to maintain and thus tend to last longer. As they’re less complex, their structure can be more easily adapted to hygienic design, leading to lower capital costs. However, using centrifugal pumps with viscous materials will rapidly cause them to fail.
Positive displacement pumps are better at handling thicker and more corrosive materials. As fluids increase in solid content and viscosity, these pharmaceutical pumps offer drug makers an advantage. Positive displacement pumps transport a set amount of liquid regardless of the pressure involved. All that’s needed to control throughput is upping the motor’s speed. Positive displacement pumps also handle more delicate materials while offering greater precision.
Pharmaceutical pumps that feature variable frequency drives (VFDs) offer advantages beyond saving energy, such as their role in augmenting filtration processes. Along with pharmaceutical pumps, these systems must prevent inorganic and organic contaminants from counteracting active ingredients passing through valves, pumps, pipelines, and fittings. This is the basis for hygienic design in pharmaceutical pumping systems. This includes designing pumps without dead spaces and avoiding gaps whenever possible. It includes electropolishing to prevent cracks or scratches where bacterial colonies can develop. These designs also must look at seals and other connections to ensure they can withstand the constant sanitization in pharmaceutical manufacturing.
Hayes Pump Inc. carries a range of top-quality pharmaceutical pumps to meet stringent standards regarding contaminants and efficiency for drug-making applications. Conforming to ANSI (American National Standards Institute) and ASME (American Society of Mechanical Engineers) regarding safety and quality requirements, Hayes provides pharmaceutical pumps and systems that perform optimally and efficiently.
Among the more popular pharmaceutical pumps Hayes carries include:
Hayes Pump can also provide various engineered pumping systems for specific pharmaceutical applications, including chemical feeding systems and processing skids to enable custom packaging. Hayes also offers support that includes installation, planning maintenance, training, and other aspects of pump operation. To learn more about the pharmaceutical pumps we carry and our other products and services, contact the pump system experts at Hayes.