The Pi Mobile In-Process system is a state-of-the-art dynamic image analyzer incorporated into an Analysis Module controlled by a portable battery-operated control unit on a tether.

With new techniques coming into the market, industry has come to understand the value of Dynamic Image Analysis. Not only does Dynamic Image Analysis give high resolution traditional size information, it also gives extensive shape information. This added feature, along with images of all measured particles, allows end users to have high resolution process change information as well as the ability to differentiate different populations in a sample, such as what percentage of an Active Pharmaceutical Ingredient (API) vs what percentage of excipient is in a sample. Dynamic Image analysis has also been adapted to an on-line process tool and allows to see real-time process changes and track parameters over time such as size, aspect ratio, concentration, temperature changes and other measurements as they happen, using the Time Series Chart feature.

As a new generation of the traditional Particle Insight instrument, the new features are:

• Improved optics. All components related to image capture (camera and Lens) have been noticeably improved, including easier magnification configuration. Higher speed data transfer rate improves real-time analysis.

• Improved images. Higher resolution and image capture for better edge definition.

• Improved accuracy. Better accuracy and ability to differentiate minor differences in particle shape down to one micron.
• Improved resolution. High resolution digital camera with up to 5 MPs resolution and higher speed data transfer rate and capable of taking up to 127 frames per second rated, captures live images of thousands of particles.

• Improved fluidics. New fluidic design to improve sample suspension and organic solvent compatibility and reliability.

• Improved Sample Cell assembly. The Quartz sample cell has been implemented with quick connectors (body and insert) to facilitate easy removal for cleaning purposes or replacement.

• Improved thumbnail features. When viewing particle thumbnails, the left-mouse button will display all the shape measurement values for that selected thumbnail, the right-mouse button will allow the user to eliminate that specific particle from the database and statistics. Useful when, for example, a single air bubble is not wanted in the database.

• Improved correlation plot features. Correlation Plot now, able to view thumbnails directly from correlation plot area of interest.

• New perimeter measure. A second Circularity measure was developed called “Perimeter Circularity” to assist customers with existing FPIA systems who have data using this different Circularity measure.

• New 3 digits resolution. Circularity and ALL other fraction measures have data reported with 3-decimal place accuracy. A requirement for transition from FPIA data to Pi Sentinel PRO data.

• New flexible connectivity. This makes possible the connection of the system to a reactor or a standard manufacturing process via tethering connection.

• New instrument Certification program. A Qualification Program using NIST traceable samples is available to certify the system annually and contains all the data required and paperwork to be ready for FDA audits for compliance with 21CFR Part 11 as well as Data Integrity guidelines.

• New Data Integrity compliance. The Certification program complies to new Data Integrity FDA Guidance document.

• New computing platform. Included with every system is a Touchscreen All-in -One computer with wireless keyboard and mouse to allow the customer more interaction with the software features.

• Notification to initiate an additional process. As critical shape parameters are met, the Pi IPS can provide an alarm signal or notification to initiate a separate required process.

• The reactor operation is not interrupted. Keep in mind, being an on-line system, detachment of the Pi IPS module does not disrupt the process, unlike other probe-based methods. This means that the reactor and its contents will not be compromised by the measurement module.

• New software interface. . The software user interface has been changed to reduce the clutter of options presented to the user. The user still has all the options of the old Pi, they are just accessed differently.

• New Time series chart feature. . This feature allows the evaluation of behavior from particles suspended in a solution by plotting results of pre-selected measures and statistics from a collection of run files, over a period of time under the same conditions and settings. The charts created for each combination of parameters reflect the behavior of particles and can be used in different application and processes like dissolution and crystallization in pharmaceutical industries.