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.
Tableting has been a method widely used by many drug companies and even confectionery companies. It took quite a while to standardize this process but by mid 2000 There was an ISO certificate issued to the usage of tablet punches and dies for pharmaceuticals. The Eurostandard and others became widespread methods with standardized procedures. These have benefits that can vary from a proper production flow to cutting manufacturing costs.
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.
Having a global standard for these tablet presses means that the punches and dies may be interchangeable. This saves so many things for the manufacturing companies. One it makes production of the machine parts faster, thus making manufacturing of these tablets in different sites faster, since there are no special specifications of varying standards to follow.
The time allocated in making the tablets is reduced. As a result manufacturers have a faster time of delivering products to clients. With the basic nature of all standards, the procedures of making these products are still efficient without compromising quality.
Since this is a standardized way of tooling, getting the technology, operation and maintenance become easier. The set of instructions that need to be followed for these procedures become an industry standard that tableting professionals will be familiar with across different companies. Inspection and validation for this will also have specific standard, internationally.
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 .
There are still differences per machine depending on the manufacturers. While these may seem like very small variations, they still have an impact in the final product. The varying shapes of different tablet presses, between the Eurostandard and TSM make their interchangeability a restriction. By maintaining an protocol, there becomes a compatibility of all tablet presses and this eventually reduces costs for manufacturers.
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.
Tableting has been a method widely used by many drug companies and even confectionery companies. It took quite a while to standardize this process but by mid 2000 There was an ISO certificate issued to the usage of tablet punches and dies for pharmaceuticals. The Eurostandard and others became widespread methods with standardized procedures. These have benefits that can vary from a proper production flow to cutting manufacturing costs.
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.
Having a global standard for these tablet presses means that the punches and dies may be interchangeable. This saves so many things for the manufacturing companies. One it makes production of the machine parts faster, thus making manufacturing of these tablets in different sites faster, since there are no special specifications of varying standards to follow.
The time allocated in making the tablets is reduced. As a result manufacturers have a faster time of delivering products to clients. With the basic nature of all standards, the procedures of making these products are still efficient without compromising quality.
Since this is a standardized way of tooling, getting the technology, operation and maintenance become easier. The set of instructions that need to be followed for these procedures become an industry standard that tableting professionals will be familiar with across different companies. Inspection and validation for this will also have specific standard, internationally.
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 .
There are still differences per machine depending on the manufacturers. While these may seem like very small variations, they still have an impact in the final product. The varying shapes of different tablet presses, between the Eurostandard and TSM make their interchangeability a restriction. By maintaining an protocol, there becomes a compatibility of all tablet presses and this eventually reduces costs for manufacturers.
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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