Vendors Making Improvements
Mani Krishnan, director for process systems at Millipore, agrees that customers do not require a hard sell to adopt disposables, adding that end-users are beginning to think of single-use equipment for critical as well as non-critical applications. “It’s not just for buffers any more. People have gone beyond that,” he reports.
Millipore’s acquisition of Newport Biosystems has given the company entry into markets that integrate process bags (Newport’s specialty) with connectors and filters. Millipore’s Lynx® ST (steam-to) and Lynx S2S (sterile-to-sterile) connectors are two enabling products that allow custom integration based on users’ specific applications, Krishnan adds.
While chromatography remains a difficult adaptation for disposables, Krishnan believes that a good case could be made, in many instances, for single-campaign utilization (vs. truly single-use or single-batch) for even the most expensive resins. A manufacturing campaign might entail five or six batches, for example. Krishnan mentions pre-packed chromatography columns as products that might tip the balance in favor of single-campaign use. Another such product is Millipore’s Prosep® Ultra Plus protein-A chromatography media, a resin with high binding capacity and high linear velocities—attributes that are desirable for high-productivity, small-footprint unit operations.
These products are just a start. Operating in disposable or single-campaign manner will require that vendors continue to innovate and that industry change its mindset regarding chromatography, Krishnan says.
For example, Millistak+® filters were first developed to be used in large stainless steel housings that required large CIP loops. Millipore launched the fully disposable Pod format containing the same filter media, which significantly minimizes the demands of the CIP loop.
Vendors also need to do a better job of making their single-use products more user-friendly, he says. “When customers take a disposable assembly out of the box it is a ‘spaghetti’ of piping and tubing. The more complex the process, the more complex the ‘spaghetti’.”
At a recent IBC conference, Millipore exhibited a Tangential Flow Filtration process skid that simplifies the task of unraveling and utilizing the bags, tubing, and connectors. The skid features supports and connectors of its own that enable the various components to be installed in the correct location making the numerous components more accessible and enabling easier use of single-use processing systems.