Tablet tooling standard

Figure 17 Preferred tablet thickness for standard concave, round tablets based on production packaging tools.

A standard IPT Type B tooling was used with a f " round flat tool tip. Tablets were made one at a time, and the compression force as well as the upper punch displacement and lower punch displacement were recorded. Tablet weight, thickness, and breaking hardness were measured for each tablet. 

Regarding the importance of compression tooling to the performance of the tablet press and the quality of the tablets, it is of paramount importance that punches and dies are handled with care. The first criterion is the identification of the tooling that is, punches and dies should be identified according to the standard and be designated by upper punch without key, upper punch with key, lower punch with key, lower punch without key, or die, the reference of the standard (e.g., TSM, EU, JN, ISO), and the punch or die diameter. Punches and dies should also have a marking that includes at least the manufacturer s identification, the number of the punch in the series, and/or the identification number. Upon... 

The F-distribution has great utility in a statistical test referred to as analysis of variance (ANOVA). ANOVA is a powerful tool for testing the equivalence of means from samples obtained from normally distributed, or approximately normally distributed, populations. As an example, suppose that the following are the content uniformity values on 20 tablets from each of four different lots lot A mean = 99.5%, standard deviation = 2.6% lot B mean = 100.2%, standard deviation = 2.8% lot C mean = 90.5%, standard deviation = 2.1% and lot D mean = 100.3%, standard deviation = 2.7%. 

During tablet compression, the distance between the rollers remains constant unless a machine adjustment is made to change tablet hardness or thickness. Additionally, all tooling dimensions (tooling length and die cavity size) are constant within established standards. Under these conditions, for a specific material of uniform density, if the same volume of material is delivered to each die, the maximum measured compression force for each punch station is the same. If, on the other hand, different volumes of material are delivered to each die, the maximum measured compression force for each punch station is different. On this basis, adjustment of fill depth (fill volume) to maintain a constant compression force should result in a constant tablet weight. This concept is the general basis of all rotary tablet press force control systems. 

Standardization of tooling dimensions has been agreed to facilitate interchangeability between presses and to reduce the number of spare parts. In many cases, a certain press is available with different turrets in order to standardize tooling within a tablet manufacturing company irrespective of the make of tablet presses used... 

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