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.
This is not entirely a bad thing because this makes inspection and qualification of the products easier. This increases the safety of what products they release out into the public. Although the product can easily be standardized, the industry is not able to say the same about their equipment. Apparently, tablet punches and dies also need to have a standard, and not similar ones is used around the world.
It becomes a different story for the manufacturers. The standardization of these parts and equipment in machinery can save so much in overhead expenses. Tablets, specifically, come in different forms and sizes. Its dosage can differ without changing its physical form, but the question remains to be why they all look different. Standardization is meant to address these differences to solve manufacturing difficulties.
Before the automation and assembly line production of tablets was a more manual method involving presses. Tablets are not only for medicine, they can be for anything that can have a powdered form. They have been used for candy and other substances. While there is no one standard that is being followed globally, there are still two metrics most popularly followed by manufacturers.
One of its biggest benefits is for the OEMs or the Original Equipment Manufacturers. The checking up and qualification process for the machinery becomes easier across the industry since there would be a common blueprint for what to follow and what to look for. Not only will the parts be standardized, but consequently also the validation and inspection metrics.
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.
Procurement and maintenance of machinery and part become cheaper for both the pharmaceutical manufacturer and the OEM. This is the benefit of cross compatibility of between equipment parts. The same machinery can now be used in one plant and transported to another without compromising the qualification of the product in the market.
The concept of tablet compression machinery having one standard has been around since the 90s. There was little interest about the matter due to businesses and the nature of competition, but since the middle of the decade, the Euro ISO has been established and started to become widely used outside the US.
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.
This is not entirely a bad thing because this makes inspection and qualification of the products easier. This increases the safety of what products they release out into the public. Although the product can easily be standardized, the industry is not able to say the same about their equipment. Apparently, tablet punches and dies also need to have a standard, and not similar ones is used around the world.
It becomes a different story for the manufacturers. The standardization of these parts and equipment in machinery can save so much in overhead expenses. Tablets, specifically, come in different forms and sizes. Its dosage can differ without changing its physical form, but the question remains to be why they all look different. Standardization is meant to address these differences to solve manufacturing difficulties.
Before the automation and assembly line production of tablets was a more manual method involving presses. Tablets are not only for medicine, they can be for anything that can have a powdered form. They have been used for candy and other substances. While there is no one standard that is being followed globally, there are still two metrics most popularly followed by manufacturers.
One of its biggest benefits is for the OEMs or the Original Equipment Manufacturers. The checking up and qualification process for the machinery becomes easier across the industry since there would be a common blueprint for what to follow and what to look for. Not only will the parts be standardized, but consequently also the validation and inspection metrics.
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.
Procurement and maintenance of machinery and part become cheaper for both the pharmaceutical manufacturer and the OEM. This is the benefit of cross compatibility of between equipment parts. The same machinery can now be used in one plant and transported to another without compromising the qualification of the product in the market.
The concept of tablet compression machinery having one standard has been around since the 90s. There was little interest about the matter due to businesses and the nature of competition, but since the middle of the decade, the Euro ISO has been established and started to become widely used outside the US.
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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