TABLETING
The right tools
Here tableting tool specialist Natoli takes a deep dive into the role of tooling specifi cations in tablet manufacturing
The TSM Standard is in its 7th edition Q
uality tablet compression tooling is critical for tablet quality and the optimisation of the tableting process.
If substandard or tooling out of specifi cation is used you can expect issues such as poor tablet quality, low yields, slower press speed and excessive cam wear to name only a few. Troubleshooting quality and performance involves the interplay between process parameters, including formulation characteristics, press condition, setup, operation, tablet design and tooling. In many cases the value of
compression tooling is not respected for what it is. Tooling is responsible for the last step of the Oral Solid Dosage (OSD) process, a compressing formulation that has taken years to develop. The inception of a new product, as well as pre-formulation, research and development, product development, granulating and mixing, all the way to clinical trials and scale- up requires a monumental investment. Once all the boxes are ticked and the product is approved, it is fi nally on its way to production. In production, tablet tooling is the last step in this daunting process of compressing powder into a usable form. When an issue arises and hinders production,
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many tablet manufacturers reach out to the tooling supplier fi rst since tooling optimisation can be an easy fi x. Suggesting an alternate steel type, a specifi c tooling option, or even the addition of a punch coating is a common scenario. Broader support from high-
quality tooling suppliers includes assessments of process parameters. Examples include assessing the formula, excipient selection, powder processing, moisture, particle size, and segregation. Segregation is often caused by powder transfer systems within the process, especially the tablet press feeder as well as the improper selection of a fi ll cam which can over work the excessive powder as it is recirculated. Excessive powder reintroduced into the feeder can result in packing or overfi lling the feeder with powder, this will damage the feeder paddles and drive gears.
REFER TO SUPAC GUIDELINES SUPAC guidelines describe and off er deviation when issues arise without regulatory resubmittal. However, when the formula and critical process attributes have already been approved, overcoming challenges such as poor fl owability, sticking, and
capping may likely be compensated for with adjustments to the tooling specifi cations. To eff ectively mitigate tableting issues it is essential to have a good understanding of the compression cycle, tooling and tooling wear. Three key tooling specifi cations to
consider are the working length, cup depth, and land width. Variation in lower punch working length within a set directly aff ects tablet weight. Cup depth aff ects tool strength, friability, tablet density uniformity, and propensity for capping. Land is an incredibly important feature that impacts tool life and strength. The two most common tool
confi gurations are the ‘B’ and ‘D’ type tool. There are established and published standards related to the ‘B’ and ‘D’ type tools, and these are available in two formats, the American (TSM) and the European (EU). The TSM Standard (Tablet Specifi cation Manual) is published by the American Pharmacist Association and is in its 7th edition with the enhanced 8th edition under review and available in the fi rst quarter of 2025. The TSM Manual is the most complete and comprehensive manual related to tablet compression tools. The EU standard is published by the International Organisation for
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