Custom Sensors & Technology is the only company that supplies a GMP (GxP) compliant light-induced fluorescence (LIF) sensor to address a wide range of fluorescent process analytical problems – in particular tumble blending – within the pharmaceutical industry, in order to aid in delivering QbD or lean manufacturing via PAT. Current commercial ‘field’ LIF instruments are grossly insufficient to address such problems.
The LIF sensor is a small, lightweight, self-contained form factor that offers integration across various GMP and non-GMP manufacturing unit operations. The LIF sensor addresses a wide range of real-time intrinsic fluorescent monitoring problems. The following novelties were envisioned:
- 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 on-board 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
- 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 that is unrivaled by existing real-time LIF instruments
Benefits of LIF sensors
Customers are benefitting from using this technology in several ways. The technology has enabled real-time monitoring of fluorophore solutes via intrinsic fluorescent sensing in the solid state that has not been previously possible. This has afforded customers a pivotal ability to significantly increase manufacturing science process understanding now required by many regulatory bodies worldwide.
Historically, off-line techniques have been used to develop rudimentary manufacturing process understanding. This increase in knowledge will ultimately lead to improved product quality by reducing process upsets, lower annual product waste, improved root-cause analysis during manufacturing quality incidents often common within the pharmaceutical industry, improved process efficiency by reducing manufacturing processing time, and improved operator safety via an in-line approach as opposed to the classic, ergonomically challenging grab sampling and off-line analytical method approach.
Pharmaceutical blender installation with LIF sensors
The LIF sensor easily adapts to different types of pharmaceutical blenders (V-blender, bin blender, etc.) and the integral accelerometer technology can determine the X-Y axis rotation of a bin blender or the Y-Z axis rotation of a V-blender.
Each LIF sensor comes with a validation checkout package including the material traceability and finish certificate, a certificate of conformance and a test report. A certificate of conformance verifies that the sensor meets all specifications and testing requirements. A test report is furnished outlining all validation testing, including application-specific standards, if desired.
Applications for LIF sensors
LIF sensors can measure liquid, solid or gas phase intrinsic or native fluorophoric analytes. LIF sensors can be configured for in situ, at-line, on-line for process control or portable field monitoring applications. They can be applied to several real-time analytical problems, including security / surveillance, powder blending, cleaning validation, oil in water and organics in water.