HarleNIRc is a Near InfraRed (NIR) spectroscopy solution developed by SEA Vision which uses a hyperspectral system with camera for an Active Principles inspection of solid dose products.
It is a PAT (Process Analytical Technology) tool able to identify different active principles, incorrect API dosages or uneven API distribution directly during the production process avoiding productS mix-ups.
In-line API and dosage control
Non-destructive analysis
Total quality of products ensured
Improved sampling procedures
Less products rejected, increased OEE
Even behind an apparently perfect product, great risks can be hidden. HarleNIRc is the revolutionary hyperspectral system for the in-line controls of pharmaceutical products that are only apparently identical to all the others (in terms of shape and colour), but actually with defects in terms of active ingredients chemical composition.
This NIR system is able to perform a qualitative and quantitative pharmaceutical chemical analysis, with the aim to control if they have the correct dosage and the correct API, preventing errors and possible mix-ups. In this sense, HarleNIRc brings the inspection to a higher level, guaranteeing the production total quality and the 100% safety of products.
The HMI display shows in real-time the results of every product checked and, while 100% of products units are inspected, the vision system manages the rejection of each non-compliant item.
HarleNIRc can be installed on every type of thermoforming and counting/filling machine currently present on the market, with no impacts on the production speed thanks to the high frame rate of the hyperspectral camera and the computational power of the system.
HarleNIRc inspects the entire production, and it is capable of detecting defects that would otherwise be invisible to a conventional vision system.
HarleNIRc can be combined with other SEA Vision solutions such as Harle2D|3D and Harleblister.
- Active ingredients
- Dosage
- Foreign objects
- Presence of fractures
- Missing coating
- Humidity content analysis
- Active ingredient distribution
- Active ingredients
- Dosage
- Foreign objects
- Presence of cracks
- Closing defects
- Empty cavity
HarleNIRc can control all solid oral products:
- White and coloured tablets
- Uncoated tablets and pills
- Capsules – monochromatic
- Capsules – bicolored
The usage of a linear hyperspectral camera allows to acquire the value of spectral bands for every single section of an image. By applying multivariate analysis algorithms the software represents the inspection results as false colour images, where each colour represents if a specific chemical information is correct or not, since every chemical substance has its own specific spectral reference.
In this way it’s then possible to evaluate even the minimal difference (less of milligrams) in every single product, granting control of the whole batch without the need of sampling for laboratory analysis.
The system is provided with latest generation industrial computers including multicore technology and multithreaded processors, in order to take full advantage in terms of elaboration speed and accuracy.
The hyperspectral cameras and light units components are specifically designed and assembled for an optimal inspection, and for perfect integration with the machines mechanical design. The hyperspectral vision system which includes halogen lighting, uses an active source of light in the infrared spectral band, ranging from 900 to 1700nm. Images acquisition speed is fast and accurate.
The touch-screen displays provided have an optimized graphic interface that increases usability and interaction.
The system is specifically designed for the pharmaceutical market, and it is compliant with the industry regulations, with user access regulated by FDA 21 CFR part 11 and annex 11.
All events are registered by the software in an audit trail file to keep track of all the security-relevant activities.
The continuous Software development follows Gamp 5, to always improve products quality and consistency.
Hyperspectral camera system on blister machine
Hyperspectral camera system on counting machine
SEA Vision’s expertise in integration is built on decades of experience working alongside machine manufacturers to satisfy the needs of pharmaceutical customers worldwide.
Such experience guarantees correct machine integration, accurate signal exchange management, and integrated automation and rejection logic.
HarleNIRc can be integrated on machines with different automation levels, from entirely automated or semi-automated to modules with a low automation level.
The graphical oscilloscope allows the observation of signal patterns and keeps them under control, facilitating the diagnostical operation.
The entire process is handled efficiently, from the control execution to the rejection of defective products.
HarleNIRc is natively integrated with Yudoo, the 4.0 pharmaceutical software suite for the full management of automation processes, digital quality, data analysis and for Track&Trace. A digital hub that is everywhere accessible through a secure-access web interface or dedicated devices.
A scalable and modular suite, including tools for automation (centralized management of production, workflows and timesheet), for the digital quality (creation of paperless systems, support systems for line clearance operations), for data analysis (analysis of production data, business intelligence dashboard, condition monitoring and predictive maintenance) and for Track and Trace (complete solutions for Level 3 and 4 of serialization, monitoring of serialization operations).
Yudoo offers multiple advantages such as the possibility to centralize production formats and data, avoiding duplicates and reducing work time. The suite can connect to existing company systems to retrieve updated data exactly from where they are.
SEA Vision provides an extensive product portfolio of natively integrated solutions. Vision, traceability and data management solutions for pharmaceutical packaging lines are developed with a common approach to obtain a seamless ecosystem.
