Tablets & Capsules

TC0720

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Tablets & Capsules July 2020 39 tablet presses. The manual also provides information on troubleshooting, tablet designs to help strengthen tools and withstand formulation changes, logo design, and specific applications for coated and non-coated tablets. The standards also allow manufacturers to establish and track wear patterns and overcome them through tooling design, steel selection, or both. My TSM is always next to me, and I still have my first IPT manual from the 70s. Todd Martin, senior tooling engineer, Wilson Tool International and contributor to the TSM's 7th edition: The TSM is the essential bible for tablet tooling in North America. I reference my dog-eared copy every day in my work. The standards and reference information allow for efficient design and manufacture of tooling. Consistent standards help end users purchase tooling that works in their machines, and press manufacturers rely on TSM standards to provide machines that fit our market. Do you believe the TSM is due for an update? Natoli: I do believe the TSM is due for an update. Even more so, the next edition has an opportunity to be the go-to publication, with more useful information including a reference for all tool features, modifications, and exclusive tool configurations. Tousey: Yes, tablet presses have changed. The TSM is a good guide, but there is always room for improvement. I believe the TSM should be gone through from top to bottom and should include international standards as well and be considered a world book. Too many think it is just a North American book. Pistillo and Giatti: It would be interesting to have an update that integrated some new developments in the market from tooling suppliers as well as tablet press man- ufacturers. The reality of the market has changed a lot since 2006. Lapinsky: Yes, there have been advancements to rotary tablet presses, tablet tooling materials and coat- ings. These new specifications should be added. Hoskin: Tablet manufacturing has come a long way in the last 14 years and there have been many innovations in tablet compression tooling and its associated maintenance and management. These considerations make some of the guidance in the TSM's 7 th edition a little out of date. Additionally, perhaps now would be the ideal time to bring the TSM into a digital format to work alongside the more traditional workbench document. At I Holland, we have introduced online training and believe this is the way forward to help tablet manufacturers improve their knowledge and skills. Putting the TSM into a similar for- mat would allow those who follow the manual to access it with ease. Are any new tooling specifications needed? Pistillo and Giatti: Back in 2006, the steering com- mittee was focused on the pharmaceutical market. How- ever, there are new markets that need to be investi- gated. IMA is promoting tablet presses not only in pharma but in the chemical and other non-pharma industry and had them weigh in on aspects of the manual that might need to be updated in a future edition. What benefits does the TSM provide for manufacturers of tablet products and suppliers of tablet presses and tooling? Andrew Lapinsky, engineering and CNC program- ming manager, Elizabeth: The TSM is a great refer- ence for the many users of tablet tooling across diverse companies within the healthcare industry. The nuances related to compression tooling can be daunting, and the TSM establishes a common vocabulary and principles for both experienced and novice users alike. Employee mobility and turnover across the pharmaceutical industry creates a demand for ongoing tablet manufacturing train- ing. The TSM provides the foundation for establishing repeatable processes and cost-effective decision making within the industry. Dale Natoli, president, Natoli Engineering, chairman for the TSM's 3rd edition, and steering committee mem- ber for the TSM's 7th edition: In general, the standards provide efficiency related to manufacturing processes, quality assurance, standard operating procedures, com- munications, training, cleaning, and storage. Also, tooling standards reduce variables when transferring a product from one manufacturing site to other, international sites. Mark Rice, technical service manager, SMI: The TSM provides tablet manufacturers with a good resource for troubleshooting tablet press issues as well as aiding in tooling and custom parts design. Luke Hoskin, technical sales manager, North Amer- ica, I Holland: The TSM offers a clear and compre- hensive guide to tableting principles, which have been combined from a number of different influential industry sources. This ensures that the information is objective and specific to each subject area. The TSM allows solid dose manufacturers to follow a common operating standard, helping to ensure inter- changeability of tooling across the various tablet press types in use in North America. But the manual is not only useful for tablet press users in the Americas. Global users from time to time adopt a press made to TSM standards, so knowledge of the standard is helpful. The general information in the manual is also good to have available. Nicola Pistillo, product manager, and Federica Giatti, compression technologist, IMA Active: From a tablet press manufacturer's point of view, TSM tool- ing requires a different cam configuration and assembly specifications compared to EU tooling, so the manual is a must for companies that supply equipment to both the European and US markets. From a process point of view, there is no particular advantage to TSM tooling versus EU tooling. On the contrary, the existence of two standards covering the same tablet size represents an increased cost of ownership for pharmaceutical companies. Mike Tousey, president, Techceuticals: The TSM standards allow for tooling interchangeability between

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