Pumps in the Pharmaceutical Industry
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Modern pharmaceutical production has seen significant advancements in the equipment used, and today, pharmaceutical pumps play a crucial role in the industry. While there isn't a single type of pump used across all drug manufacturing processes, various pumps have been adapted from other industries to suit these needs. For instance, the peristaltic pump, originally designed as a well pump in the mid-1800s, underwent refinements in the 1930s to enable precise dosing of active ingredients and other pharmaceutical manufacturing processes.
By the mid-20th century, specialized types of pharmaceutical pumps became more common in drug manufacturing. Magnetic drive pumps, a type of centrifugal pump, were adopted due to their ability to prevent leaks and contamination, making them ideal for transferring corrosive and hazardous fluids. Positive displacement double diaphragm pumps are also widely used for dispensing and dosing tasks. These pumps are easy to clean and maintain, capable of handling highly abrasive and viscous liquids, including slurries.
Today's pharmaceutical pumps incorporate advanced computerized control systems and innovative features that enhance precision dosing while maintaining sanitation and preventing cross-contamination. Beyond drug manufacturing, these pumps are also utilized in biotechnology, biopharmaceutical sectors, and laboratory settings. The evolution of pharmaceutical pumps continues as manufacturers strive to improve processes by creating more reliable and efficient pumping systems.
Pharmaceutical pumps are essential for hygienically and safely managing the blending, dosing, handling, and transportation of raw materials, intermediate solutions, and final medications. Maintaining a sanitary manufacturing environment is critical, and strict hygiene standards apply to pharmaceutical pumps to ensure active ingredients retain their efficacy throughout the various stages of production.
### Types of Pharmaceutical Pumps
A variety of pharmaceutical pumps are employed in the production of modern medications. The choice of pump depends on the type of fluid being transported and the specific application. Within each category, there are further subtypes, as mentioned earlier.
#### Pharmaceutical Pump Types:
- **Peristaltic (Hose) Pumps:** Used in waste management systems, these robust pumps handle slurries, solids, and viscous fluids. Hose pumps are ideal for moving corrosive chemicals, residues, sludge, and wastewater over long distances.
- **Booster Pumps:** Essential for maintaining consistent pressure when moving fluids over greater distances, these pumps supply water, steam, and heat-transfer fluids to higher areas. They are commonly used in cleaning and sanitizing processes.
- **Centrifugal Pumps:** Among the most common types, centrifugal pumps transport large volumes of low-viscosity liquids during drug production. They are frequently used for solvents, raw ingredients, and finished products between containers.
- **Diaphragm Pumps:** Ideal for transporting abrasive, corrosive, and viscous fluids, these pumps can handle toxic and hazardous substances. Diaphragm pumps help prevent degradation and cross-contamination of pharmaceutical formulations.
- **Industrial Chemical Pumps:** Designed specifically to process and transport toxic chemicals, these pumps safely move reactive chemicals used in modern medications. They must meet strict safety requirements to handle hazardous materials.
- **Lift Pumps:** Used to push fluids from lower to higher points, lift pumps are vital for transporting large amounts of processing fluids, solvents, and water to higher floors within a pharmaceutical plant. They maintain the integrity of the liquid and minimize shear in pumped material.
- **Lobe Pumps:** Useful for creams, gels, ointments, syrups, and other viscous fluids, lobe pumps are ideal for shear-sensitive materials. They can handle solids and run dry, providing continuous flow for delicate medications.
- **Positive Displacement Pumps:** Allowing precise control over flow rates, these pumps are used for metering and dosing liquid ingredients and chemicals, including highly viscous ones. While accurate in dosing and other advantages, they are less efficient with higher operational costs due to lower flow rates.
- **Vacuum Pumps:** Efficient at creating suction to remove air and gases from centrifuges, condensers, containers, filtration systems, reactors, and transfer lines, vacuum pumps are used in distillation and drying processes. They are also employed in freeze-drying and solvent recovery, handling explosive, heat-sensitive, and toxic substances.
Regardless of the type used, these pharmaceutical pumps must comply with strict industry standards.
### Meeting Industry Standards for Pharmaceutical Pumps
In the U.S., the standards for pharmaceutical pumps primarily fall under the jurisdiction of the FDA, part of the U.S. 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. Given the similarities between food and drug processing, most pharmaceutical pumps resemble those used in the food processing sector.
When equipment used in the pharmaceutical industry is deemed FDA-compliant, it signifies that it can safely come into direct contact with pharmaceutical drugs and their constituent ingredients. The FDA ensures that this machinery, including pharmaceutical pumps, is made from materials of a certain standard and with specific properties that allow manufacturers to supply products with sufficient purity and safety for consumers. In addition to FDA guidance, drug manufacturers must adhere to international guidelines, laws, and regulations, including those concerning pharmaceutical pumps.
### Hygienic Design
Pharmaceutical pumps are manufactured according to designs that facilitate easier cleaning and maintenance, reducing costs by simplifying these processes, lowering water consumption, and decreasing maintenance time. This aligns with the "hygienic design" requirements for pumps in the drug manufacturing sector. Such designs also boost a drug manufacturer's operational efficiency, enhancing competitiveness and productivity. Components for pharmaceutical pumps not only need to be FDA-compliant but also adhere to good manufacturing practices for medicine production.
Key considerations for a hygienic design include:
- Construction materials should be antimicrobial
- Reduced maintenance needs
- Easy access for servicing
- Maximum cleanability
- Reproducibility of production
Hygienic design starts with plant designers, but manufacturers and suppliers of equipment and components must also contribute to continuously improving pump designs.
### Cleanability
Implementing hygienic design principles involves preventing contamination from the product and its ingredients. This requires examining the time involved, processing temperatures for sanitation, and the concentration of cleaning agents, all of which incur economic costs. Water consumption, downtime, energy, and cleaning agents contribute to the overall expense.
### Dead Spaces & Gaps
Factors affecting the cleanability of pharmaceutical pumps include the materials used and the design itself. Ideally, this means a pump design free of gaps and dead spaces around internal components. If eliminating dead spaces isn't feasible, they should be minimized to reduce their impact on cleaning. Gaps should also be designed to optimize accessibility for cleaning and servicing.
### Construction Materials
Pharmaceutical pumps are often made from cast stainless steel and polished to eliminate cracks, scratches, and other imperfections that could harbor microorganisms. This is particularly important for surfaces exposed to moisture during processing. Electropolishing is well-suited for pharmaceutical pumps, as it provides a durable finish that enhances corrosion resistance while reducing adhesion to the metal surface, facilitating cleaning. Low-carbon stainless steels like marine-grade 316L are commonly used, whether forged or rolled, as long as the surface remains nonporous.
### Seals
Ensuring mechanical seals remain sterile requires several considerations. These seals should be resistant to both cleaning agents and the product while being enclosed and flushed to provide cooling and lubrication during pumping. Operators should pay particular attention to the shaft seal, as it is the component most prone to failure in pharmaceutical pumps.
### Fluid Type
The type of fluid being transported is the most critical factor when selecting pharmaceutical pumps for an application. Sterilized or purified water is typically used in pharmaceutical processes, making centrifugal pumps preferable. 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 vs. Positive Displacement Pharmaceutical Pumps
Centrifugal pumps are more commonly used in pharmaceutical applications than those that rely on positive displacement. With a simpler design, centrifugal pumps are easier to maintain and tend to last longer. Their straightforward structure allows for easier adaptation to hygienic design, resulting in lower capital costs. However, using centrifugal pumps with viscous materials will quickly lead to failure.
Positive displacement pumps excel at handling thicker and more corrosive materials. As fluid solid content and viscosity increase, these pumps offer drug makers an advantage. Positive displacement pumps transport a fixed volume of liquid regardless of pressure, with throughput controlled by adjusting the motor's speed. These pumps handle delicate materials with greater precision.
### Energy Efficiency & Technology
Pharmaceutical pumps equipped with variable frequency drives (VFDs) offer benefits beyond energy savings, such as enhancing filtration processes. Along with pharmaceutical pumps, these systems must prevent inorganic and organic contaminants from interfering with active ingredients passing through valves, pumps, pipelines, and fittings. This forms the basis of hygienic design in pharmaceutical pumping systems. This includes designing pumps without dead spaces and avoiding gaps wherever possible. Electropolishing prevents cracks or scratches where bacterial colonies can form. These designs also consider seals and other connections to ensure they withstand constant sanitization in pharmaceutical manufacturing.
### Pharmaceutical Pumps from Hayes
Hayes Pump Inc. offers a wide range of high-quality pharmaceutical pumps that meet stringent standards regarding contaminants and efficiency for drug-making applications. Complying with ANSI (American National Standards Institute) and ASME (American Society of Mechanical Engineers) regarding safety and quality requirements, Hayes provides pharmaceutical pumps and systems that operate optimally and efficiently.
Some of the more popular pharmaceutical pumps offered by Hayes include:
- **Diaphragm Pumps:** Typically used for cell and protein transfer, chromatography, coating operations, and extruders.
- **Piston Pumps:** Known for accuracy and reliability, these pharmaceutical pumps are commonly used in various biopharmaceutical processes.
- **Rotary Pumps:** Often used for transporting highly viscous fluids while adhering to sanitation requirements during processing.
Hayes Pump can also provide customized pumping systems for specific pharmaceutical applications, including chemical feeding systems and processing skids. Hayes offers support such as installation, maintenance planning, training, and other aspects of pump operation. For more information about the pharmaceutical pumps we carry and our other products and services, contact the pump system experts at Hayes.