Pharmaceutical companies are a large industry that manufacture so many things. They make mostly medicines, among many other things, and they can come in various forms. From tablets to capsules and syrups, these things require some sort of equipment to make. The machinery and apparatus used for this also have standards to follow for making sure that the quantities of substances are at a proper amount.
Having only a few manufacturers make it safer for consumers to know what to buy, since having too many options may raise the possibility of side effects. These medicines have a standard to follow, but the machines that make them do not. At the consumer perspective it may not make as much sense to address something as trivial as tablet punches and dies.
There is an issue regarding this in the industry though. There are calls to standardized the equipment used for compression. Notice that tablets come in different forms and sizes. Since it is a solid dosage in units, there has to be some form of filler to keep the actual medicine intact. Standardizing the machine that compresses these things have many benefits for those that produce it.
Specifications for these products vary from one standard to another. So far there are two widely used standards for tablet compressions. One is the European ISO and second is the TSM or the tablet Specification Manual, most commonly used in North America. These dies and punches may only have a a few differences but their individual effects vary and have a huge impact on the product.
These are the European ISO, used in Europe and mostly outside the US and the Tablet Specification Manual standards used by mostly North American Manufacturing. This is a big deal for manufacturers that have plants around the world. Not having a set of the same metrics to follow mean extra expenses. Resources are expended to qualify the product and equipment for it to be allowable in that certain location.
One, there would be no need to have varying metrics and qualification for any operational inspections on the machinery. This can be different from one standard to another since even the smallest difference can mean a lot of change, on a medicinal level. Any fixes and replacements on the machinery parts become easier because the Original Equipment Manufacturers do not need to make different punches and dies that would fit the many standards that are in the industry.
The differences are very small but these minor variations are what makes interchangeability impossible between machines. The punches and dies have to be compatible for them to work properly. This makes the whole tablet making process costly. Pharmaceutical companies would have to have a variety of machines just to follow the set qualifications depending on where they will be selling the product.
Standardization for this process has been discussed and conceptualized since the early 90s. While the goal of only having one set of qualifications for tablet production is still not available, the ISO or International Organization for Standardization has approved the European standard back in the mid 90s. Despite this achievement towards the goal, the TSM is still practiced.
There is a call for some standardization for something that is so seemingly minor as nominal punch length, rotation and so on. This allows for better problem solving and addressing issues from one expert to another since there would be no specialized knowledge needed to address the technical difficulty. More importantly the quality of the products made would be uniformed and anything that goes beyond this uniformity can be easily checked and inspected.
Having only a few manufacturers make it safer for consumers to know what to buy, since having too many options may raise the possibility of side effects. These medicines have a standard to follow, but the machines that make them do not. At the consumer perspective it may not make as much sense to address something as trivial as tablet punches and dies.
There is an issue regarding this in the industry though. There are calls to standardized the equipment used for compression. Notice that tablets come in different forms and sizes. Since it is a solid dosage in units, there has to be some form of filler to keep the actual medicine intact. Standardizing the machine that compresses these things have many benefits for those that produce it.
Specifications for these products vary from one standard to another. So far there are two widely used standards for tablet compressions. One is the European ISO and second is the TSM or the tablet Specification Manual, most commonly used in North America. These dies and punches may only have a a few differences but their individual effects vary and have a huge impact on the product.
These are the European ISO, used in Europe and mostly outside the US and the Tablet Specification Manual standards used by mostly North American Manufacturing. This is a big deal for manufacturers that have plants around the world. Not having a set of the same metrics to follow mean extra expenses. Resources are expended to qualify the product and equipment for it to be allowable in that certain location.
One, there would be no need to have varying metrics and qualification for any operational inspections on the machinery. This can be different from one standard to another since even the smallest difference can mean a lot of change, on a medicinal level. Any fixes and replacements on the machinery parts become easier because the Original Equipment Manufacturers do not need to make different punches and dies that would fit the many standards that are in the industry.
The differences are very small but these minor variations are what makes interchangeability impossible between machines. The punches and dies have to be compatible for them to work properly. This makes the whole tablet making process costly. Pharmaceutical companies would have to have a variety of machines just to follow the set qualifications depending on where they will be selling the product.
Standardization for this process has been discussed and conceptualized since the early 90s. While the goal of only having one set of qualifications for tablet production is still not available, the ISO or International Organization for Standardization has approved the European standard back in the mid 90s. Despite this achievement towards the goal, the TSM is still practiced.
There is a call for some standardization for something that is so seemingly minor as nominal punch length, rotation and so on. This allows for better problem solving and addressing issues from one expert to another since there would be no specialized knowledge needed to address the technical difficulty. More importantly the quality of the products made would be uniformed and anything that goes beyond this uniformity can be easily checked and inspected.
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