Custom Sensors & Technology Applies the LIF Sensor to Cleaning Validation Applications

Custom Sensors & Technology has recently developed a novel LED light-induced fluorescence sensor, the LIF sensor, in collaboration with GlaxoSmithKline for blend uniformity and end-point detection during the blending of powders. After further application studies were performed and market interest evaluated Custom Sensors & Technology started applying the LIF sensor to cleaning validation applications.

Mike Ponstingl, president of Custom Sensors & Technology, commented on the industry’s need for advancement in cleaning validation and use of PAT: “The cost of validating clean surfaces has escalated over the last ten years. The current swab testing can take anywhere from three to five days if done in-house and up to two to three weeks if contracted by an outside lab. It is our goal to shorten this time so our customers can make production decisions within one to three hours. Providing a portable at-line fluorometer which can monitor directly on solid surfaces or the swabs themselves for contamination will not only shorten the time for a production decision to be made, but will also increase plant throughput.”

Features of the LIF sensor include dynamic control to provide tailored analytical versatility via UV-Vis LED array technologies; integrated excitation referencing on each diode; small, lightweight and self-contained form factor ‘sensor’ device; versatile onboard hot swappable communication options and powering options, both AC and battery; optical configurations suitable for solid state detection (e.g. powders) with alternative schemes for liquids and gases; various smart sensing and diagnostics features for real-time detection assurance; open communication standard for efficient automation controls integration via OPC; solid state device for optimal robustness; and an onboard accelerometer for mobile applications such as pharmaceutical final drug product tumble blending. These comprehensive sensor novelties afford reliable monitoring for robust process control.

The LIF sensor was featured at the 2010 IFPAC show as well as 2010 INTERPHEX NY and received much attention from potential customers. As a valuable new process analytical technology (PAT) the LIF sensor enables manufacturers to build quality into the process, utilizing QbD to the fullest extent. Along with quality comes a decrease in product waste, reduced labor, and less equipment needed, making the LIF an economically attractive solution for all fluorescence applications.

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