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6 Pharmaceutical Technology ® Trends in Manufacturing eBook May 2023 PharmTech.com Solid doSage which at I Holland is categorized as PharmaGrade range of materials," he says. The materials for these tools need to be suitable not only for efficient production and commercial viability to the end user, but they also need to withstand the high forces commonly used in tablet production and provide long-lasting use, Dumelow adds. "Tablet tooling is far from disposable," he stresses. "These tools are certainly, in my eyes, some of the most important things a tablet manufacturer can purchase." Even with the most expensive tablet press on the market, Dumelow points out that without the punches and dies, nothing can be made. So, it is a good idea to have tools that can be used across a range of products, he confirms. Importance of maintenance As these tools are an integral part of tablet compression processes, their maintenance should be of paramount importance too. If these tools are not maintained correctly, they can become unusable, which impacts production output and can lead to added expenditure being incurred for repairs or replacements, Dumelow emphasizes. "Tablet tooling is often used at high speeds on expensive tablet presses, and tooling that is not in good order can slow down the operation or ultimately cause damage to the press, leading to expensive re- pairs," he states. An obvious issue arising from poor tablet tooling maintenance is that of sticking, Dumelow continues. If the tools are not kept to a high standard and sticking occurs, then there could be a major loss in production time and expensive loss in product, he notes. "Also, over polishing of tooling can lead to higher ejection forces, tablet capping among others," Dumelow says. During production, issues, such as sticking, can be picked up quite quickly Dumelow confirms, but if there are 500,000 plus white tablets being produced in an hour, then issues may not be caught straightaway. So, if the potential issue is not caught straightaway, there is the possibility for a manufacturer to make a lot of out of specification tablets very quickly, he warns. "Punches and dies are manufactured from hardened steel, but are also very fragile," Dumelow specifies. "Damage to these tools can take the form of corrosion, cracks, chips, and ultimately material failure. If the tools are chipped, end users' tablet products can have many defects that mirror the damage on the punches." Planning and preparation To ensure tools are optimally maintained and ready for use when needed, it is recommended that manu- facturers plan a good maintenance regime, such as the I Holland 7 Step process (2), Dumelow asserts. "Waiting to inspect the tools just prior to use is going to lead to delays in production at the last minute," he says. "So, the steps comprise cleaning effectively, and then assessing and repairing those tools if needed, measuring them to ensure continued accuracy, polish- ing them to ensure contact surfaces are kept optimal, and lubricating them to protect the tools in storage, which should also keep the tools secure," Dumelow continues. The last aspect, security, is important as only authorized personnel should be able to access the tools, he notes. "Strangely enough," Dumelow adds, "tooling is at its safest when it is installed correctly in the tablet press. Tooling tends to be most at risk when it is outside of the press, or storage, and is being handled by users in general. As noted earlier, tooling is very fragile and is designed to be used in the processing line, so over-han- dling of the tools could easily lead to damage." Furthermore, damage to the tools can occur when installation in the press is done incorrectly, Dumelow warns. If the tools are fitted incorrectly, it is possible to cause friction, which causes heat and can lead to early failure, he explains. "If the tools are fitted incorrectly, it is possible to cause physical damage not just to the tools, but to the tablet press itself," Dumelow states. Training is recommended "The first thing to stress with any organization is that they need to get their personnel to appreciate the value that tablet tooling delivers," Dumelow says. Then, once there is an understanding about the value, it is possi- ble to move onto understanding the fragility of the tools, he states. I Holland offers internal and external training, in- cluding via online platforms, to help other companies learn about tablet tooling maintenance and various pro- duction issues that can be experienced, Dumelow con- tinues. Essentially, it is not possible to have too much training, particularly for tablet tool maintenance, he specifies, as without the tools even the most expensive tablet press in the world is useless. "Although tablet tooling does have a finite life, with good training and good understanding of the tool- ing it is possible to maximize their life span, hav- ing made as many tablets as possible and, giving the maximum production output based on their expendi- ture," he concludes. References 1. Fact.MR. Oral Solid Dosage Pharmaceutical Market Analysis by Dosage Form (Tablets, Capsules, Powders and Granules, Gummies, Lozenges and Pastilles) by Drug Release Mechanism (Immediate, Delayed and Controlled Release) by Distribution Channel and Region—Global Market Insights 2022 to 2032. Market Report, July 2022. 2. I Holland. PharmaCare 7 Step Process: Protect Your Investment. Tablettingscience.com, accessed May 8, 2023. ■