New Pharmaceutical-Pump Designs Can Provide a Competitive Edge

Economic pressures are forcing pharmaceutical manufacturers to look for ways to become more competitive. Many companies realize that they must reduce operating costs but maintain or improve product quality. Recognizing their clients’ needs, many equipment vendors’ process engineers are writing specifications to ensure that the latest innovations will lower energy consumption, reduce product waste, and minimize maintenance requirements. These specifications also improve the materials of construction, documentation, and testing while ensuring the sterility that critical processes require.

Manufacturers of sanitary pumps for the pharmaceutical industry have recently developed options to help meet the industry’s needs, including the following examples:

• Single-seal piping arrangements for internal seals eliminate the need for double mechanical seals and product-flush piping arrangements. These arrangements save money because they do not use the product as the flushing medium. This configuration option also creates high pressure in the low-pressure seal area to keep hot product from “flashing” or pitting the seal faces, and increases the life of the seal.

• Seal-piping designs require lower flush flows than traditional pumps. For example, some models require the external seal to be flushed with flows of 2–3 gal/h (rather than flows of 10–20 gal/min) before draining.

• New pumps include front-loading seal configurations that can be serviced quickly. These pumps do not need to be pulled out of line for seal changes. This option reduces the downtime needed for maintenance.

• Liquid-ring pumps for clean-in-place (CIP) return applications (e.g., Fristam’s FZX unit) retain their prime, unlike standard centrifugal pumps, which sometimes become airbound. The liquid-ring pumps are more efficient and less wasteful for the complete evacuation of tanks and lines during CIP processes.

The drive assemblies that rotate the pumps can greatly influence pumps’ efficiency. The following units are designed for improved operation:

• Premium efficient motors require less energy, operate at lower temperatures, and have a longer life expectancy because of their insulation materials, which allow the motor to run cooler.

• Variable-frequency drives (VFDs) allow operators to fine-tune processes and reduce energy costs. A VFD that controls a pump motor usually operates at less than full speed, thus reducing energy consumption by as much as 50% compared with a motor that runs at constant speed for the same period.

Pump manufacturers also have begun to use special materials to manufacture components that contact the product. Materials intended to improve cleanliness and sterility include the following:

• Low ferrite 316L stainless steel or Hastelloy materials may reduce rouging buildup that occurs in water-for-injection stills upstream of the pump.

• Disposable pumps and complete disposable systems made of plastics eliminate the risk of cross-contamination, reduce the validation burden, lessen change over time between batches, and eliminate the need for cleaning cycles.

• United States Pharmacopeia Class VI elastomers are made of pharmaceutical-grade rubber compounds to ensure sterility.

Increasingly stringent documentation requirements for pumps’ materials of construction and for the traceability of the components have put pressure on the industry. In response, some manufacturers etch the metal manufacturer’s heat numbers onto all of their wetted metal components to facilitate traceability.

New regulations typically require testing such as ferrite testing, baseline vibration testing, X-ray material verification, certified-performance and net-positive-suction-head testing, certified finish mapping, drainability testing, hydrostatic testing, welder certification, and noise testing. The testing ensures that the pumps will meet the material and performance specifications.

Recognizing drugmakers’ need for cost-efficient production processes and their goal of creating high-quality products, pump manufacturers are continually pursuing innovation. Their engineers seek to provide highly efficient pumps that require minimal maintenance and afford maximal cleanliness. By combining their efforts, pumpmakers and pharmaceutical manufacturers can achieve their mutual goal of providing safe and effective drugs to patients around the world.

Sam Raimond is a customer service supervisor at Fristam Pumps, 2410 Parview Rd., Middleton, WI 53562, sraimond@fristampumps.com.