Single-use or disposable equipment first appeared in small laboratory-scale applications decades ago. Improvements in materials and processing know-how since then have led to a steady progression up the process stream and to increasing reliance on such units by manufacturers in sectors such as pharmaceuticals.
Thats not surprising because disposables offer several important advantages. Single-use units boast lower capital outlay, better return on investment, plus reduced expenditure on clean-in-place (CIP) procedures, autoclaving and validation, say their proponents. Such units avoid delays due to fabrication and commissioning common with some types of conventional equipment thus enabling faster batch or product changeover times and lower contamination rates. By avoiding the need for CIP, disposables reduce utility costs, generate less waste and require use and storage of fewer hazardous fluids. Overall, disposables can serve as a key tool in speeding a products time to market, backers stress.
Small wonder then that the Bio-Process Systems Alliance, founded just last year under the auspices of the Society of the Plastics Industry, Washington, D.C., has grown to more than 40 members. One of its aims is to increase the worldwide market for single-use components and systems. And, judging by all the action technical and commercial now underway, thatll be a cinch.
Joe Dallapiazza, global director single use systems for Pall Corp., East Hills, N.Y., undoubtedly speaks for many when he voices confidence about business growth. For instance, he points to an increasing role at contract manufacturing organizations and vaccine producers for whom productivity and quality are key drivers.
I think the market will keep growing. Their scale is getting bigger, so the demand is for bigger bags, bigger tubes and bigger connectors. At the same time, however, batch sizes are getting smaller because there are fewer blockbusters in the pipeline and [the] drugs industry is getting much more personalized. So contract manufacturers might be doing 20 or more different product lines each week and its a huge advantage not to have to clean from batch to batch.
Speedier turnarounds made possible by avoiding CIP procedures, etc., also certainly appeal to many pharmaceutical manufacturers such as Eli Lilly & Co., Indianapolis. This is a big issue for us, explains senior research scientist Mark Bailey. Today, with disposables, we can change the equipment set for making a batch of one material to making a batch of a completely different material in a matter of hours. Years ago, it could have taken days to turn the equipment around between batches.
The increasing progress of disposables certainly is evident in mixing and materials handling. For instance, Millipore Corp., Billerica, Mass., has just added a new disposable mixer to a range of bioprocess hardware that already includes filters, container valves, connectors and other mixers. Its modular Mobius MIX200 disposable mixing system is designed for biopharmaceutical manufacturers, especially those involved in pharmaceutical ingredient mixing and cell culture media preparation (Figure 1).
Its the first product to combine Millipores capabilities with the biopharmaceutical expertise of two recent acquisitions. NovAseptic, Gothenburg, Sweden, which was acquired in August 2005, provides a range of aseptic products, including high-performance mixers. Newport Biosystems, Anderson, Calif., which became part of Millipore in April last year, specializes in disposable process containers.
With our expanded footprint, we can help our customers reduce their risk, increase their speed and gain an edge in the marketplace, says Jean-Paul Mangeolle, president of Millipores Bioprocess Division.
Processing speed also is at the heart of the latest offering the PureFeed AP-300 auger feeder from Schenck AccuRate, Whitewater, Wis. To maximize material handling versatility, the feeder features a flexible hopper and programmable, external dual-arm agitation system. It also pioneers the use of flexible EPA-accepted ethylene propylene diene monomer (EPDM) feed-hoppers that are both disposable and recyclable. The result is simpler, shorter cleaning cycles with virtually no chance of cross-contamination when moving from one material to another, says the company.
PureFeed comes in both volumetric and gravimetric configurations for pharmaceutical, nutraceutical and cosmetic applications that involve feed rates from 500 g/hr up to 150 kg/hr. Such applications, the company says, include jet milling, continuous blending, medical-grade plastics compounding, packaging, coating and ingredient weighing.
Many companies also market disposable mixers. For example, LevTech Inc., Lexington, Ky., offers a range of units including the WandMixer, which comes in a 550-L benchtop model and a 50200-L mobile model, and the Magnetic Mixer with a 503,000-L capacity.
HyNetics, Logan, Utah, a 50/50 joint venture of Alfa Laval Biokinetics and the Fisher Scientific company HyClone, offers a family of mixing systems ranging from 20 L up to 10,000 L. The modular skid-based hardware allows the integration of completely disposable mixing systems. In other words, all product-contact surfaces are single-use, permitting their disposal after each batch and their replacement with a new system.
Of course mixers and other single-use equipment need to be connected with each other and with the rest of the process. Ensuring the sterility of this step was once a major headache for disposables suppliers. Now, however, such integration is routine thanks to developments in connection hardware. Take, for example, the latest additions to the Steam-Thru series from Colder, St. Paul, Minn. An innovative design allows quick and easy sterile connection between biopharmaceutical processing equipment and disposable bag and tube assemblies. Media can be safely transferred without the cleaning and validation concerns associated with reusable components (Figure 2).