The dry granulation process is a process whereby granules are formed without the aid of any liquid solution, as the ingredient to be granulated is moisture- or heat-sensitive. To form these granules, it is important to use compacting and to densify the powder. A slugging tool or a roller compactor tablet press machine is used to conduct the dry granulation process.
Validation is establishing documented evidence which provides a high degree of assurances that a specific process or equipment will consistently produce a product or result meeting its predetermined specifications and quality attributes.This article focuses on the process of dry mixing of powders, as one of the steps in producing tablets.Validation can therefore be applied to the dry mixing process itself, as well as the overall manufacture of tablets.
There are two principal methods of coating tablet: sugar coating and film coating. Both have advantages and disadvantages, and the following table provides a comparison between the two methods. The choice of which method is appropriate depends to an extent on how the tablets have been produced, the composition of the tablet and the intended market.
Description: Double Impression includes punches that embed monograms or images on tablets.
Cause: During the impression stage, each tablet undergoes imprinting. In the said stage, engraving machines imprint on the tablet; with the double imprinting, the lower punch might be uncontrolled and drops freely the short distance causing a new imprint on the tablet producing the double imprint on the tablet.
Tablet machines, also called as compressing machines or tablet presses, are the equipment used to compress the powder into its tablet form forming uniform size, shape and weight.
Tablet packaging machines comes in different types and is categorized as follows
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Tablet Coating machines are equipment devices used to coat the tablet’s outer surface with a thin coating film.
Tablets are defined as solid form of drug dosages where each unit is made up of one or more medicaments. Administered orally, the tablets are made up of powdered drugs with excipients that are compressed into its solid form.
Tray dryers are devices used to dry wet products of chemicals, powders and crude drugs. The simplest way to explain a tray dryer is a cabinet that has a heater at the bottom or a laboratory oven. The oven has little to no value because control is non-existent for humidity and heat transferred.
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Most tray dryers used in the pharmaceutical industry comprise a heated cabinet in which a rack of trays is located. They are frequently used for the drying of granulated powder. Heat can be provided by burning a fuel, e.g. natural gas or, more usually, by one or more electric elements located within the cabinet, together with a blower to circulate the air.
At LFA over the last 7 years we have seen a glimpse into every type of use for a tablet press. Nowadays when someone asks us how to press glass, or metal, or even coffee granules we are no longer surprised. One that was new to us was the pigeon problem.
The process of sugar coating is rare in the pharmaceutical world recently. That said, knowing the problems that one can encounter would help in the event that sugar coating is needed and problems arise.
Granulation is the process whereby powder forms are bound together to form aggregates, which are called as granules. Granulation is important as it helps prevent the separation of the ingredients in the mixture as well as improves the flow of the properties of the mixture. It also changes the size of the particles resulting to improved compression and density of the powder mix.
Even the simplest form of pharmaceutical manufacturing process can involve a range of process steps before the product is packaged and shipped to the consumer.These may include:
Poor environmental control, particularly in terms of air humidity can directly affect the pharmaceutical production line in a number of ways. Levels of humidity below 45%RH will allow electrostatic charges to build up in machinery and materials.
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The following is a brief operating and cleaning guide that can be used for most tablet de-dusting machines. It covers pre-start up, operation and cleaning, and lists some precautions that can be taken to help avoid contamination issues.