Figure 2. All fluid contact parts of the Centrasette production-scale tangential-flow filtration system consist of pre-assembled,
single-use plastic.
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Equipment suppliers are making it even easier to incorporate more complicated single-use systems by integrating them with
critical unit operations. Modular TFF skids assembled with disposable filters, bags, tubing assembly and aseptic connection
devices provide the latest example of these customizable solutions (Figure 2).
ASEPTIC CONNECTORS
Smaller components such as aseptic connection devices reduce the steps required to make connections between sterile equipment
and disposable systems. These connections will impact the speed and safety of the whole process as the number and complexity
of disposable systems increase.
Figure 3. The new Kleenpak HT connector withstands elevated sterilization temperatures.
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Traditional methods include quick connectors and tubing welders that mandate the use of a welding device. Despite the name
"quick connector," it can take over 20 minutes to make a connection. The operations must be performed under a laminar flow
hood, which generally requires 15 to 20 minutes to set up, or in a laminar flow environment, which may or may not be readily
accessible, depending upon the layout of the facility. Laminar flow hoods are also costly, require maintenance, and take up
precious space.
Table 1. Comparison of Time Taken to Make a Connection with Kleenpak Connector, a Tubing Welder, and a Quick Connector.
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The Kleenpak HT is an aseptic assembly that allows connections to be made anywhere in the facility in seconds, because it
does not require the use of a laminar flow environment, or any other capital equipment (Figure 3). These connectors can be
supplied pre-sterilized by gamma irradiation or they can be autoclaved up to 130°C. We ran some timing estimates for connection
methods. The results are in Table 1.
DISPOSABLE PROCESSING ADVANTAGES
Eliminating cleaning and cleaning validation is the most widely recognized benefit of disposable processing. Additionally,
disposable technologies offer benefits that help drug companies streamline operations and shorten processing times. While
there is a baseline of benefits that all disposable technologies offer, carefully consider equipment selections based on scalability,
throughput and product performance, sterilization options, and availability of customized solutions and services. However,
the degree to which drug companies benefit from this processing paradigm will depend on the number and sophistication of the
disposable systems they implement.
Ian Sellick is director of marketing , Pall Life Sciences, Pall Corporation, 2200 Northern Boulevard, East Hills, NY 11548, 516.484.5400, fax 516.801.9548. ian_sellick@pall.com
Holly Haughney, Ph.D., is vice president of BioPharmaceuticals marketing with Pall Corporation 516.484.5400, fax 516.801.9548, holly_haughney@pall.com
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