Designing & Implementing Single-Use Solutions in Biopharmaceuticals

Three unique examples of single-use solutions that saved time and money and enabled growth.

By Rob Jewett, President, Terracon Corporation

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As companies in the biopharmaceutical industry increasingly look to single-use technology to cut costs and increase manufacturing efficiencies, they seek proven ideas and solutions that meet their unique needs. Often product engineers and their teams are faced with options that compromise their specific requirements. For the three single-use stories included in this article, the engineering teams achieved custom, reliable solutions designed to their specifications.

Every application is unique, of course, but the three cases described here demonstrate that product and engineering teams design and implement the best solutions, avoiding surprises, delays, functional compromises, and cost overruns when they engage early with a partner who specializes in custom solutions using innovation, creativity, strong engineering capabilities, and extensive experience.

An off-the-shelf solution was not an option for any of the following single-use applications. Their teams sought practical, reliable solutions that they could count on—to scale up to commercial production, to replace stainless steel tanks that were failing, and to launch a full product line of single-use mixers filling a market void. In all cases, Terracon Corporation was the partner to design and engineer the custom solutions that enabled each company to achieve its goals. Terracon, which is largely known for its high-quality, non-metallic tanks and vessels, offers single-use solutions as a natural extension of its capabilities to design tanks and mixing solutions, and incorporate the aseptic fittings and accessories required for complete, reliable, and pragmatic solutions.

With Limited Budget, Start-up Biotech Company Implements Scalable Single-Use System
When biopharmaceutical manufacturers implement single-use (or disposable) technologies, they gain a number of advantages that are not possible when stainless steel components are used. One of the key ones, of course, is cost-savings.

Companies can now build far less expensive production facilities using single-use systems than was previously possible using expensive stainless steel components. This is particularly advantageous for small labs or companies that have completed the research and development stage of product development and want to begin commercial production. They can now launch products and compete in the marketplace without the capital investment that was once required for entry into the industry.

Recently, a Massachusetts-based biotech research and development firm was preparing to bring a new product to market. The company needed to build an affordable production operation that would enable it to start off producing small quantities of its product and then scale as demand increased.

The company integrated Terracon Corporation into the design process to develop the cost-effective production environment to meet both its short- and long-term needs. From the early design phase, the Terracon team assisted by providing insight and ideas to finalize the design, and develop and implement the total solution.

As is the case with most biopharmaceutical operations, it was critical that the production facility provide aseptic conditions both for the mixing process, as well as transitions in order to adhere to current good manufacturing practice (cGMP) regulations. Knowing this was a critical requirement, the biopharma company completed a cost-benefit analysis to evaluate pursuing a single-use solution versus establishing a production environment that would include cleaning and validating the equipment. Confirming single use was the desired alternative as it would be more economical and faster, the teams moved forward on designing the various components for the production environment.

The production facility includes a single-use mixing system comprised of a dozen 20L custom-configured plastic tanks, disposable mixing bags, enclosed agitation, and aseptic withdrawal lines—all of which work to maintain manufacturing purity. During the prototyping phase, Terracon designed multiple versions of the mixing tanks to help finalize the design. Rapid revisions were possible by working with poly materials as the Terracon team could easily incorporate changes during the design cycles.

The final production system includes mixing tanks using low-sheer mixers and re-usable covers that provide the necessary sanitary transition protecting the tank's contents from any contamination risks. Dip tubes were added to the covers, as well, enabling the company to draw samples at critical intervals. Each tank also includes a non-shedding seal around a rotating disposable shaft to prevent contaminants from entering the vessels.

In the end, single-use technology decreased the initial investment required to build the facility, while increasing the flexibility of the overall manufacturing environment. The company can now easily and cost-effectively scale-up operations when demand for its product increases by simply incorporating bigger plastic tanks—up to 200L— and adding larger mixing impellers. The agitation system and other components of the plant will remain unchanged.

With Terracon’s help, this start-up company was able to quickly go from manual bench-top processing to small-scale automated mixing in single-use vessels for initial commercialization—no small feat.

‘Uh Oh’ Moment Leads Company to Disposable Mixing Tanks
When the health care division of a multi-national organization that manufactures clinical diagnostic equipment went into production with a fleet of 600L stainless steel process tanks for one of its pharmaceutical products, the company quickly realized that a material was creating batch to batch contamination. When the company installed stainless steel vessels, it had intended to reuse them, but discovered that the cleaning process was ineffective, which rendered the vessels unusable for repeated manufacturing.

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