300 tablet press

To describe the procedure for validation of the tablet press to ensure that it meets installation, operational, and performance qualification requirements 

It is the responsibility of the production manager, validation manager, and technical services manager to follow the procedure. The quality assurance manager is responsible for SOP compliance. 

2 Adjustment of compression forces of the precompression and main compression stations 

Use adequate pressure meter to adjust the compression forces. 

Determine the rotation speed of the product feeding unit at the variable adjustments per manufacturer specihcation. 

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Direct Compression. This process is relatively simple and time saving. AH the ingredients are blended and then compressed into the final tablet. This is an excellent method, but encumbered by a number of problems. Not all substances can be compressed directly, necessitating a granulation step. Likewise, the flow properties of many blends of fine, particle-sized powders are not such as to ensure even filling of the die cavities of tablet presses. In addition, air entrapment can occur. 

Tablet Press. The main components of a tablet compression machine (press) are the dies, which hold a measured volume of material to be compressed (granulation), the upper punches which exert pressure on the down stroke, and the lower punches which move upward after compaction to eject the tablets from the dies. Mechanical components deflver the necessary pressure. The granulation is fed from a hopper with a feed-frame on rotary-type presses and a feeding shoe on single-punch presses. A smooth and even flow ensures good weight and compression uniformity. Using the proper formulation, demixing in the hopper is minimized.

Tableting, pressing, mol ding, and extrusion operations are commonly used to produce agglomerates of well-defined shape, dimensions, and uniformity in which the properties of each item are important and output is measured in pieces per hour (see Ceramics, ceramics processing Pharmaceuticals Metallurgy, powderp tallurgy Plastics processing).

Tablet press Molding press Pellet mill 10 Up to 1 ton/hr flow and mechanical properties plastic preforms, metal parts, ceramics, clays, minerals, animal feeds...

Roll presses can produce large quantities of materials at low cost, but the product is fess uniform than that from molding or tableting presses. The introduction of the proper quantity of material into each of the rapidly rotating pockets in the rolls is the most difficult problem in the briquetting operation. Various types of feeders have helped to overcome much of this difficulty. 

Tabletten-form, /. tablet form, -maschine, /. tablet press.

The number of samples to be processed for every batch produced six samples of 13 tablets each are taken at prescribed times after starting the tablet press (10 tablets are ground and well mixed (= compound sample), two average aliquots are taken, and each is extracted) the additional three tablets are used for content uniformity testing this gives a total of 6 (2 -t- 3) = 30 determinations that have to be performed. 

Strategy Since the tablet press is still in operation, an experiment is devised... 

The stamp associated with the extreme hardness values (number 7, Fig. 4.12, left use STAMP.dat with program MULTI) is the next suspect It is identified and inspected on disassembly of the tablet press Due to mechanical wear, the movement of the stamp assembly is such that an above-average amount of granulate drops into cavity number 7, and is thus compressed to the limiting hardness supported by the granulate. The hardness for stamps 4, 8, and 11 tends to be low, and high for 12, but the data is insufficient to come to definite conclusions for these tools. The tablets from these stamps contaminated what would otherwise been a fairly acceptable product. Because... 

Conclusion The problem areas are tentatively identified the formulations department is asked to improve the flow properties of the granulate and thus decrease the weight dispersion. The maintenance department will now have to find a proposal for countering the excessive wear on one stamp. Note On more modem, heavily instmmented and feed-back controlled tablet presses, the described deviations would have become more readily apparent, and mechanical damage could have been avoided. 

Pharmaceutical compressed tablets are prepared by placing an appropriate powder mix, or granulation, in a metal die on a tablet press. At the base of the die is a lower punch, and above the die is an upper punch. When the upper punch is forced down on the powder mix (single station press) or when the upper and lower... 

An absorbent may also be necessary when the formulation contains a hygroscopic ingredient, especially when absorption of moisture produces a cohesive powder that will not feed properly to the tablet press. In such instances, silicon dioxide has been found to be of particular value. 

All tableting presses employ the same basic principle—they compress the granular or powdered mixture of ingredients in a die between two punches with the die and its associated punches being called a station of tooling. Tablet machines can be divided into two distinct categories ... 

Figures 15 and 16 provide a summary of the compression cycles for rotary and single-punch tablet presses. The formation of the tablet compact in these two types of presses mainly differs in the compaction mechanism itself, as well as the much greater speeds achieved with rotary type presses. The single punch basically uses a hammering type of motion (i.e., the upper punch moves down while the lower punch remains stationary), while rotary presses make use of an accordion-type compression (i.e., both punches move toward each other). The former find their primary use as an R D tool, whereas the latter, having higher outputs, are used in most production operations.

Table 17 Comparative Specifications of Some High-Output Tablet Presses... 

Measurement of the punch and die forces plus the relative displacement of the punches can provide raw data which, when suitably processed and interpreted, facilitate the evaluation of many tableting parameters. Many of the workers first involved in instrumenting tablet presses concentrated on deriving relationships between the applied force (FA) and the porosity (E) of the consolidating mass. 

Fig. 20 Automated high-output rotary tablet press. (Courtesy of Fette America.)...

Tablets were a viable dosage form well before William Brockendon s patent for a tablet machine in 1843. His invention only made them easier to produce. As tablet presses and production-monitoring systems developed,...

A major development in pharmaceutical technology has been the application of instrumentation techniques to tablet presses. The ability to monitor the forces that develop during the compaction, ejection, and detachment of tablets has brought about new insights into the physics of compaction, facilitated formulation development, and provided a means for the in-process control of tablet weight in manufacturing [62,63], In... 

JB Schwartz. The instrumented tablet press uses in research and production. Pharm Tech 5(9) 102-132, 1981. 

The manufacture of this system utilizes essentially the same process as the one inherent in the manufacture of OROS. The complicating factors are that a bilayer tablet press is required and the tablet must be oriented during the laser drilling operation to ensure that the drug-containing layer is directed toward the laser beam. 

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