Learn More About Direct Compression
PAT Technology for Reproducibility
Since the use of PAT technology is another prerequisite for the reproducibility of a process, an inline NIR sensor is installed in the mixer to continually measure the homogeneity and composition of the powder mix. By virtue of the plant’s short start-up and shutdown times, the product is automatically removed from the process before it reaches the tablet press until the specified degree of homogeneity has been achieved.
Only then is the quality product led directly to the tablet press. This means that even segregation effects can be recognized in a timely manner, since homogeneity is monitored continuously during the process and any potential “out of spec” mixtures are removed. In most cases, however, provided the dosing and the rotational speed of the mixing process are accurate and constant, a homogenous mixture is guaranteed. Consequently, inline measurement is normally only used for quality assurance purposes.
If specially requested, inline measurement can be used as a critical process parameter to not only monitor the process but to also control it. However, the core of the Modcos concept is the process control system which amalgamates, monitors and controls all processes as a superordinate unit. Each raw material can be followed exactly as it passes through the system, due to the use of a retention time model.
Modcos also Available as an Upgrade
The entire process sequence is fully documented with all events. Glatt View Conti measures the mass flow and operating conditions, calculates the set points according to the PAT measurements and synchronizes all process units to allow their simultaneous operation. Constant manufacturing reports referencing the process times of the source and target lots are generated, meaning that the system fulfills the requirements for real time release.
Glatt also offers Modcos as an upgrade to existing tablet presses to serve as an introduction to continuous direct compression. In the event of such a request, Glatt’s experts will work out case studies with the customer and create the necessary specifications. Glatt also offers sealed systems for applications with highly potent active substances, for which Glatt can draw on long-term in-house experience of designing containment solutions up to OEB 5. Glatt’s new Innovation Center allows the testing of continuous direct compression, continuous wet granulation and batch processes with integrated PAT systems.