Watlow® Tech Tips on process control in tablet coating

The latest Tech Tips posting from internationally renowned industrial thermal and process control solutions specialist Watlow® highlights the role of effective overall process control in improving the quality and efficiency of tablet coating.

The article emphasizes the importance of ensuring end-to-end data integrity respecting ALCOA+ principles in both supporting higher quality and more consistent manufacturing, as well as in achieving full regulatory compliance.

Tablet coating fundamentals

The technical article provides an overview of the various process steps involved in tablet coating; applying a suspension or solution containing the components needed for the coating formation, on a moving bed of tablets, keeping a constant temperature in the bed.

One key element is maintaining a controlled atmosphere inside the perforated rotating drum where tablets are turned and sprayed. This also involves regulating the airflow through drum for temperature and volume to ensure optimal drying and extraction, while simultaneously maintaining slightly negative drum pressure to ensure an isolated process.

Quite apart from control of the mechanical process; also including drum rotation speed, pan pressure, and exhaust air temperature; there are also the aspects of batch control including, identification, recipe selection, loading and dispensing, and equipment cleaning.

ALCOA+ principles

These demands, plus regulatory requirements, mean that the overall tablet coating process control solution must incorporate a distributed control system with configuration lock, highly responsive and accurate sensor co-ordination, overall batch and recipe management, flexibility to extend from local HMIs to full SCADA solutions, high availability architecture, full data analysis capabilities with Historian function and end-to-end secure data management.

Data integrity needs to be anchored on the ALCOA principles that data should be Attributable, Legible, Contemporaneous, Original, and Accurate (as well as Complete, Consistent, Enduring, and Available to produce ALCOA+).

Pharma 4.0 ready QbD technology

Eurotherm (acquired by Watlow® in 2022) has been a pioneer in building in these principles to its control solutions and the article shows how these systems can be applied to tablet coating to create fully digitalized processes that are guided by quality by design (QbD) approaches to allow product quality to be continuously monitored and controlled from the outset. This approach involves identifying, controlling, and validating all process variables that could cause non-compliant results, including managing quality target product profile (QTPP), critical quality attributes (CQAs), and critical process parameters (CPPs).

Eurotherm control and data recording solutions are IoT ready, providing a data integrity layer within open IoT platform system architectures and aiding the digital transformation to Pharma 4.0 technology.

Resources

Click on Tablet Coating Solutions in the Life Sciences Industry  to read the full article.