Issue link: https://www.e-digitaleditions.com/i/1267517
40 July 2020 Tablets & Capsules Jennifer McGonigle, director of operations, SMI: Specifications and an instructional section discussing the use of single and multi-tip tooling for minitablet produc- tion would be very beneficial. Which existing specifications should be revised and how? Tousey: There are many, including clearances, head flats, and tolerances. Also, many new copies of tablet presses have come out with new and different punch and die configurations. The steering committee would need to determine whether these presses should be included. Martin: I would recommend the following revisions to existing specifications: • Update Figure 37 to include D3 steel; • Update Figure 40 (Quote/Order Form) to indicate a specific tool material (such as S7 or D2 steel) rather than "standard" or "premium;" • Change the surface finish tolerance from "±" to a maximum value, as tools should not be rejected due to a surface finish that is too good; • Correct the "BB" die O.D. dimension tolerance from +.0005"/-0 to +0/-.0005;" • Remove Note 3 regarding the Stokes GEM Supreme stem length—incorrect (B & D); • Correct Table 3 (Standard Clearances) 5/32" metric value from 3.3970 millimeters to 3.969 millimeters; and • Clarify 408 steel force rating (the text says 10 per- cent less than S7, while Figure 36 shows higher toughness than S7). Hoskin: There are now many more options in terms of punch head forms to increase desirable features such as dwell time without slowing down press speed or upsizing punches. Also, new innovations in tool steel, coatings, and treatments have been specifically tailored to provide wear and corrosion resistance or improve anti-stick properties. These developments have changed tablet manufacture significantly by addressing challenging formulations or production issues and have improved tableting efficiency. Other procedures that should be updated and added to include anti-stick guidance and tooling maintenance. Planned, professional tooling maintenance, management, and storage is fundamental to achieving optimal equip- ment efficiency and tablet output. Natoli: The standard TSM angled head configura- tion should be eliminated in lieu of the domed head for extended tooling life and smooth tablet press operation. Lapinsky: Tables 5-8, which cover interchangeable tooling for rotary tablet presses, should be updated to indi- cate the newer tablet presses in the market. There is a need to add tolerances to the seal groove formation. This would help establish a profile of size range to ensure that all tool manufacturers' European dust cup reliefs (seal grooves) meet the TSM specifications. Also, bisects should be cate- gorized as functional or non-functional, and more informa- tion from the FDA should be added to that section. industries, where tooling specifications are completely missing. Customers' requests need to be fulfilled not with TSM or EU punches but with product-specific tooling, such as IMA32. Frederick J. Murray, president, Korsch America: Most of the machines listed in the document are old and, in many cases, have been replaced with newer models that are not referenced. There are also a number of Euro- pean tool specifications, such as EU441 and FS12, which have no real equivalent in the TSM. In Europe, there is a different specification (DIN ISO 18084) to describe and define punch and die dimensions and tolerances and allow for exchangeability between presses from different suppliers. An effort should be made to bring all tool spec- ifications into a single document if at all possible, and in the longer term, a process to harmonize tooling specifica- tions should be considered. With regard to current TSM standards, the upper key position on the punch barrel should be fully defined for all tool configurations. This can be a critical consider- ation, and the arbitrary placement of the key position can cause interference with the oil seal and risk lubricant con- tamination on the die table. Martin: I would suggest adding BBS die specifications and updating the press tables as follows: • Indicate whether the press has punch seals; • Specify key location range per model (X-min. and Y-max. from Table 4 on page 40); • Specify upper punch penetration per model; and • Specify minimum lower punch pull-down value. Lapinsky: The common punch head configurations for type B and D punches should be reviewed for additions to the TSM domed head profile. There are one or two domed punch head profiles that are considered standard, but they have not been added to the TSM. These head profiles increase the punch head flat. A question should be asked if die segments need to be added to the standard TSM die line of (0.945", 1-3/16" & "D"). Also, information about automated polishing machines should be added. Natoli: New tooling standards may not be required, but the manual should identify and explain innovative and accepted tooling options, such as extended head flats, special lower tip reliefs, and multi-tip tooling, that do not conform to the published standards relative to tablet press operation and product quality. Hoskin: Tooling specification is very similar to a decade ago. However, as with all engineering refine- ment, incremental change is the driver. It is important to account for these incremental changes—for example, die segment technology and micro die tapers—in the manual. Multi-tip tooling has advanced rapidly. As mass-pro- duction of tablets grows, multi-tip tooling is helping to transform the way tablets are produced by increasing production without requiring investment in new machin- ery or operator hours. Information on multi-tip setup pro- cedures as well as general information on the setting of presses using this tooling is essential.