Pharmaceutical Blend Uniformity Systems
Custom Powder Systems, partnering with Bruker Optics, offers the first true “plug and play” Near-Infrared PAT System for blend uniformity analysis for IBC tumble blending.
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Custom Powder Systems, partnering with Bruker Optics, offers the first true “plug and play” Near-Infrared PAT System for blend uniformity analysis for IBC tumble blending. The LANCIR II System’s unique design consists of a self-contained; battery operated wireless NIR diode array spectrometer mounted on the blending container with a quick release clamp. The wireless signal can be received up to 1,000 feet away from a wireless PC running the System’s proprietary software.
The LANCIR II system revolutionizes blend processing, reduces costs and speeds production by:
- Reducing costly lab analysis.
- Eliminating thief sampling.
- Providing real-time uniformity results.
- Insuring consistent blend uniformity by adjusting blender parameters on-the-fly.
- Validating every batch to achieve Real Time Release.
The LANCIR is a 256 element diode array near infrared spectrometer that covers the wavelength range from 1100nm to 2200nm. This wavelength range is ideal for monitoring pharmaceutical formulations as it covers the combination band, first and second overtone spectral regions. These are the regions used to characterize most of the modern pharmaceutical products. The sensitivity of the LANCIR is excellent, with the ability to measure magnesium stearate and many API compounds to less than 0.3%. The reason for this is the very good signal to noise ratio and the excellent specificity. The OPUS software platform provides both qualitative and quantitative results in a validated environment. OPUS uses a combination of advanced chemometrics and statistics to provide real time outputs which can be transferred to the blend control system via traditional I/O or by industry standard OPC protocol. The CPS package not only includes hardware and software, but a complete documentation package, including IQ/OQ/PQ, application and engineering support.
Custom Powder Systems offers the LANCIR II system on all new blending systems and the retrofit kit for existing blenders installs in minutes.