Pumps and Systems, January 2007
Fluid handling requirements and methods in the biopharm industry are in transition. For example, the industry's primary technical trade group, the International Society of Pharmaceutical Engineering (www.ISPE.org), is readily debating and analyzing these changes at all levels.
Mr. Nat Ricciardi, president of Pfizer Global Manufacturing, gave the keynote speech at the 2006 ISPE annual meeting. His primary message was the need for further innovation, transition to continuous processes, and other changes to mitigate external pressures. For the purpose of evaluating the outlook for the pump industry, opportunities arise from this innovation and change. Major nascent trends resulting from this may be missed if only growth of traditional fluid handling applications is studied.
The guiding forces for change are financial, regulatory, and legal. Classical drug manufacturers must be innovative, as price pressures now influence the industry with the entry of the generic manufacturers and the growing trend of socialized medicine. Yet these companies have to maintain the highest safety standards and regulatory compliance of any industry. Among one of the most notable trends is the shift of certain processes from batch to continuous or a hybrid combination of both. Here is the greatest potential for upside growth for pumps.
An example of a well-established pump application with more predictable growth is water for injection (WFI) or highly purified water recirculation loops. These are best handled by high level sanitary centrifugal pumps. Growth in this area should parallel the general industry growth. These water circuits are commonly needed in most new facilities being built. The same can be expected from laboratory pumping solutions that are traditionally dominated by low capacity peristaltic hose and metering pumps.
IMS Health (www.imshealth.com), in their October 24, 2006 forecast release, states that the 2007 global pharmaceutical market (final drug sales) should grow 5 percent to 6 percent. Largest growth will be in the biotechnology sector with 13 percent to 14 percent growth. Mirroring this, growth in centrifugal pumps used for water loops will likely be at these levels worldwide. Some variance can be expected as a result of plant utilization and the delay between market sales and new facilities construction,
The most unexpected upside growth will come from positive displacement pump technologies, as these solutions are pivotal to the process concept changes occurring at this moment. In his keynote address, Nat Ricciardi also notes this specific detail, despite being at the presidential level of Pfizer. In this category are the larger peristaltic, diaphragm, lobe, and piston pumps. New ways of solving process issues are creating new demand, which will outpace the standard industry growth.
Double digit growth or more, as seen in 2006 by our own company, can be expected in 2007 and beyond for pumping solutions that address the following needs:
Shift from Batch to Continuous Processes
The biopharm industry is in the midst of this transition while most other chemical industries, such as the petrochemical industry, have already optimized continuous processes where possible. The fluid transfer solutions that best resolve the challenges of continuous processes in the biopharm industry will have significant growth.
Examples of growth applications now using new pump fluid handling solutions are: (1) replacing manual container transfers, (2) inert gas purges, (3) gravity transfers, (4) filter feeds, (5) centrifuge feeds, (6) centrifuge effluent discharges, (7) homogenizer stuffing (8) in-line dosing, (9) CIP circuit pumping and (10) filler feeds.
Secure High Containment Requirement
The industry processes demand full containment, both preventing external contaminants from entering the process environment and dangerous substances down to the molecular level, from leaving the process. This has been resolved already for valves, the fluid handling cousin of the pump. The diaphragm valve and pinch valves offer complete physical barrier to the outside environment. Pump-wise, the diaphragm pump and hose pump do the same.
Separation of Process and Mechanical Equipment
The best and most expensive HVAC environments for the process are found in the biopharm industry. It is closely rivaled by the semi-conductor industry. To keep costs in check and increase reliability, the amount of space serviced by the HVAC needs to be kept to a minimum. Equipment that could compromise this environment should be placed outside the high cost environment, where possible.
In the pump world, motors' gear reducers require space and pose a risk. One solution is placing motorized pumps through walls so the clean fluid end is in the clean process and the motor, gear reducer, and wiring is outside of the high HVAC environment.
Air-operated equipment offers a unique solution to this need as well. In the case of the pump, the bulk of the power generation component, the air compressor and accessories, is located in a less stringent environment. The quality of the air can be controlled going into the process environment and the air discharge can be plumbed outside of the environment. Compared to equipment mounted through a wall, this arrangement offers portability and flexibility that may be needed for the process.
Increased Use of Disposable Technologies
The hazardous nature of the product or process may mean that the cost to attempt to clean and reuse a pump and other equipment would be greater than replacing the equipment outright. The high cost is driven by safety issues and exposure during the cleaning work, effectiveness of the cleaning work, and the risks or consequences of inadequate cleaning. All of this must be thoroughly validated.
As with any equipment that will be used in a disposable manner, cost remains very important in its effect to the bottom line. PTFE or other plastic based pumps offer a distinct price advantage while meeting chemical compatibility and purity needs. Metal based pumps suffer from high material and fabrication costs, making them more practical when they can be certified to be highly cleanable and thus not disposable.
The above trends are recent, and solutions used in other industries more than a decade ago are likely not to be applicable without considerable innovation or adaptation for the biopharm industry needs. This means the modern pharmaceutical engineer must seek innovative technologies of the present to meet his needs. The outlook for the industry is still to be defined by those technologies to step up to the challenge. For those that succeed, growth can be expected to exceed the industry's projected 5 percent to 6 percent growth for 2007.