Pharmaceutical manufacturing is a complex process. There are different forms medicine can come in. From capsules, syrups to tablets. In each type of form there is a way they are specifically produced. This includes the equipment and technology that is used to manufacture these products.
If you are not keen into detail, there seems to be very little difference among tablets. These variations have a huge impact in its production and standardization. While there is still no one common practice for tableting, there was an ISO certification issued that added to one of the many standards used for this process. This Eurostandard of using tablet punches and dies has been getting traction since its certification on 2005.
The methods for tableting is a grueling process. With more advanced technology, there rises the need to automate the procedures. But its automation still calls for having a regulatory standard, we are dealing with pharmaceuticals, after all. There is a dilemma in the structural variation with the machine parts that does the tablet presses.
With the presence of a global standard, it becomes easier to have the same procedures, with similar machines in multiple manufacturing locations. Automation for these methods make production faster. Using the same technical regulations eliminates the need to shift from one standard to another. This sort of makes both the parts of the machine and the procedures portable and easier to duplicate from one site to another.
The time spent on making the tablets are also cut. This makes it easier for suppliers to adhere to the high demand of the medicines. The machines are programmed and designed to remain accurate without compromising speed and efficiency. The delivery of the merchandise become faster, as a result.
The procurement, operation and maintenance for the tablet pressers would come easier. Having only one type of punches and dies to produce means lesser time for learning the technicalities of other machine orientations. More companies will adapt to the standard. Since more people share the same knowledge for one globalized process of making tablets, compliance to inspections and reviews become easier to pass.
The technical aspects and information exchanged among the professionals who use this regulated method are also uniformed. If any problem arises, there will be many people available to help solve it. This is the side effect of having common tooling methods, the abundance of knowledge regarding the process. The main issue are the little mechanical details on the punches and dies depending on which tooling is used. These differences can be the thin line between a higher yield of successful results and a lot of mistakes. Standardization finds a way to circumvent these issues .
The little differences on the parts makes them not interchangeable with other tablet pressers. This means that a presser that uses Eurostandards in their punches and dies, cannot be used in a machine that operates with Tablet Specification Manual Standards, TSM. Standardization eliminates the need for such nit picky details and deal with the compatibility issue. This reduces the costs of procuring the little parts that make up for different standards, thus resulting to lesser manufacturing costs.
There are new and upcoming innovations in pharmaceuticals that a standardization of these methods may prove useful and necessary eventually. The benefits for a uniform process and regulation for making tablets are a given. While there is interest in this subject in the concerned industries, there is still a substantial amount of time for this concept to catch on as actual practice.
If you are not keen into detail, there seems to be very little difference among tablets. These variations have a huge impact in its production and standardization. While there is still no one common practice for tableting, there was an ISO certification issued that added to one of the many standards used for this process. This Eurostandard of using tablet punches and dies has been getting traction since its certification on 2005.
The methods for tableting is a grueling process. With more advanced technology, there rises the need to automate the procedures. But its automation still calls for having a regulatory standard, we are dealing with pharmaceuticals, after all. There is a dilemma in the structural variation with the machine parts that does the tablet presses.
With the presence of a global standard, it becomes easier to have the same procedures, with similar machines in multiple manufacturing locations. Automation for these methods make production faster. Using the same technical regulations eliminates the need to shift from one standard to another. This sort of makes both the parts of the machine and the procedures portable and easier to duplicate from one site to another.
The time spent on making the tablets are also cut. This makes it easier for suppliers to adhere to the high demand of the medicines. The machines are programmed and designed to remain accurate without compromising speed and efficiency. The delivery of the merchandise become faster, as a result.
The procurement, operation and maintenance for the tablet pressers would come easier. Having only one type of punches and dies to produce means lesser time for learning the technicalities of other machine orientations. More companies will adapt to the standard. Since more people share the same knowledge for one globalized process of making tablets, compliance to inspections and reviews become easier to pass.
The technical aspects and information exchanged among the professionals who use this regulated method are also uniformed. If any problem arises, there will be many people available to help solve it. This is the side effect of having common tooling methods, the abundance of knowledge regarding the process. The main issue are the little mechanical details on the punches and dies depending on which tooling is used. These differences can be the thin line between a higher yield of successful results and a lot of mistakes. Standardization finds a way to circumvent these issues .
The little differences on the parts makes them not interchangeable with other tablet pressers. This means that a presser that uses Eurostandards in their punches and dies, cannot be used in a machine that operates with Tablet Specification Manual Standards, TSM. Standardization eliminates the need for such nit picky details and deal with the compatibility issue. This reduces the costs of procuring the little parts that make up for different standards, thus resulting to lesser manufacturing costs.
There are new and upcoming innovations in pharmaceuticals that a standardization of these methods may prove useful and necessary eventually. The benefits for a uniform process and regulation for making tablets are a given. While there is interest in this subject in the concerned industries, there is still a substantial amount of time for this concept to catch on as actual practice.
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