At this year's ACHEMA event, Natoli will be exhibiting its new NP-400 tablet press. With integrated NIR and PAT technology, the NP-400 (designed, engineered and manufactured in the United States) is an economical, heavy duty medium output press that was designed with many standout features.
It can produce up to 180,000 tablets per hour and utilises a 21 CFR part 11-compliant supervisory control and data acquisition system (SCADA) to continuously monitor the tablet pre-compression and main compression forces, and tablet ejection force. Automatic punch barrel oil lubrication comes as standard. Natoli is the first company to offer automatic punch head lubrication as a standard feature.
Non-proprietary off-the-shelf-controls offer a significant reduction in replacement part costs, availability and delivery times. Being both cGMP- and CE-compliant, the NP-400 can be supplied worldwide.
Just as Natoli Engineering partners with its customers to solve their most pervasive tableting challenges, they have partnered with leading instrument manufacturers to integrate Process Analytical Technology (PAT) and Near Infrared Spectroscopy (NIR) solutions into the new NP-400 tablet press.
Visiotec’s VisioNIR sensor has been installed to analyse tablet quality and improve tableting efficiency. The VisioNIR takes a measurement of the NIR spectrum of each tablet following compression and uses a multivariate calibration model to determine whether the tablet is within the specification range.
If the tablets are out of specification, the NIR controller communicates with the NP-400’s on-machine SCADA system and the tablets are directed to the reject chute of the tablet press for later evaluation.
This capability offers significant advantages to manufacturers. In addition to producing consistently high quality tablets, they can also improve efficiency and reduce costs by identifying non-conforming tablets during production.
Natoli will also demonstrate a tablet testing and analysis system using PAT technology. The Kraemer Tablet Testing System complements the SCADA monitoring and control systems and can be integrated with the VisioNIR tablet analysis scheme (also installed on the press).
The Kraemer Tablet Testing System can be used to test sample tablets at predetermined intervals so that the manufacturing batch can be characterised from the beginning to the end. The system tests the tablets for weight, thickness, diameter and hardness.
Each of these devices provides significant opportunities to improve tablet quality, but the combination of real-time tablet press monitoring systems with offline tablet testing data delivers a comprehensive assessment of tablet compression performance.
Additionally, the data package provided by the SCADA system could present significant improvements in real-time release testing protocol, offering Natoli’s customers the opportunity to realise significant cost savings through reduced laboratory testing and faster lot release.
Using the PAT-enabled NP-400 is a cost-effective solution that allows smaller scale pharmaceutical companies or contract manufacturers to implement and realise the economic value of this approach to modernisation. These solutions provide economical opportunities to companies looking to improve tablet quality and manufacturing efficiency.
Natoli invites you to visit Stand F15, Hall 3.1 to view this technology in action at ACHEMA (15-19 June, Frankfurt, Germany).
Featured companies
- Companies:
- Kraemer and Martin Pharma Handels GmbH
