Cup and Tablet - Depth and ConsistencyPrint
The cup depth is the space between the punch tip and the lowest possible measurable area of a cup cavity. In order to form proper inspection and wear limits of the tooling equipment, it is important that one should know about it, and how premature wear can affect the tablet.
Two guidelines that one can follow about tablet compression tooling have been published. Originally published in 1971, the first standard appears in the American Pharmacist Associations tablet Specification Manual – the TSM. The TSM defines the format of the tooling that is used in the Americas. The second one is the ISO 18084 International Tooling Standard, which defines the EU tooling format. In the TSM manual, the cup depth tolerance is set at +/- 0.003 inch. This tolerance is set for new tools and not
The cup depth is essential to the overall punch length and when the tolerance changes or deviates from the standard set the overall punch, length is affected. That said, the variation does not affect the “working length” which is the most important length tool of the tooling equipment. The tablet’s consistent weight, hardness and thickness show how well the punches remain within the tolerance level.
According to the TSM manual, the working length tolerance should be 0.002 inch TIR that is the allowable deviation that lower/upper punch can deviate in. That said, the TSM do not specify a tolerance for the overall punch length, which is the reference dimension. As such, one does not need to measure all of the three punches, as one of the dimension is the result of the other two. The overall length therefore is the combination of the cup depth and the working length.
The cup depth tolerance was developed for tooling vendors and not specifically for tablet manufacturers as it is used as a way to identify out of spec tooling equipment. Once the tools are used in production, it is important to consider an
Establishing A Limit
As new tools enter the production and now become
The set limit would also allow tablet manufacturers to maintain the tools and polish these without having to worry about affecting the tooling life or service. With the