He cites GE's collaboration with ILC Dover, Frederica, Del., which has developed a novel mixing technology based on an internal perforated septum moving through the bulk fluid. This creates fluid jets capable of mixing solutions with viscosities up to 100,000 cP. Single-use units are in the offing. "This type of technology may find a home in the fine chemical and pharmaceutical industries in the near future," he adds.
Meanwhile, business developments are stirring up the disposables sector. Merck, Darmstadt, Germany, in late February announced its acquisition of Millipore, Billerica, Mass., for $7.2 billion.
Like GE, Millipore has a strong focus on the single-use market and its Mobius family of mixing systems delivers advanced technology for mixing pharmaceutical ingredients from intermediate to final drug products and for preparation of process solutions such as buffers and media.
Described by the company as the only single-use mixers that are part of an integrated solution, Mobius MIX100, MIX200 and MIX500 systems include, respectively, a 100-l, 200-l or 500-l container with a magnetically driven impeller and an electronic drive unit (Figure 2). A variety of filter, connector and tubing options enable tailoring to a specific application and environment, including sterile interfaces, from fermentation to final fill. The single-use mixing systems also are available with stainless-steel carriers with and without external-heat exchange jackets.
Disposables aren't the answer for all mixing chores requiring sterility, however. Some services call for capabilities that only can be provided by heavier-duty equipment. Innovations are emerging here, too. Indeed, future success in pharmaceutical processing depends on adopting such new technology, believes Peter Matthews, technical manager of Silverson Machines, Chesham, U.K. and East Longmeadow, Mass. He cites his firm's UHLS ultrahygienic in-line mixers and Flashblend mixing system as examples.
One veterinary vaccine maker links two vessels side-by-side with a UHLS in-line mixer, which is used to pass product back and forth to achieve the required level of mixing. "Remember that for some customers it is essential to know exactly how much shear a product has been subject to -- something which can be very costly in terms of time and equipment to establish," he notes.
Another long-term challenge is preventing loss of a powder's sterility when it's being added to a mixing vessel. With the Flashblend mixing system, the company has focused on eradicating dead areas, crevices and any other hindrance that might lead to contamination. "We've gone down to the nth degree on this one -- with the result that there is no horizontal pipework anywhere on the units."
A recent application at a U.S. pharmaceutical company that manufactures a product containing a particularly toxic ingredient underscores the system's value, he says. "While degowning, operators were still at risk of coming into contact with the toxic powder. The solution here was to put the powder into a containment unit -- a bag -- which is then introduced into the Flashblend via a total containment valve. So the operator is completely divorced from the ingredient and the product. More and more [companies] are now actively looking for solutions like this, both to apply health and safety regulations and to handle raw materials and products more effectively."