You know, in the pharmaceutical industry, the pharmaceutical packaging is an important item. It affects pharmaceutical storage, transport and storage. So do you know pharmaceutical packaging standards and what factors influence the pharmaceutical packaging criteria? These questions of you will be fully opened up by us through the following article. Take a few minutes to consult and you will find yourself the correct answer!
Let's first learn about the pharmaceutical packaging industry. As we all know that the pharmaceutical packaging will be the essential and important factor to create the quality of the drug. Therefore, the production of quality packaging will bring useful effects in the storage and preservation of pharmaceuticals.
Because pharmaceutical packaging is the ingredient that has direct influence and contact with drugs, especially for grade 1 packaging. It preserves the drug from the time it is manufactured to the time it is used. The packaging will therefore affect the purity of the drug. If the packaging is not pure or mixed with foreign impurities, it is even more dangerous.
First: If the drug is classified according to the degree of exposure to the drug, it will be divided into
Packaging level 1: This is the type of packaging in which it will directly accompany the drug. These include tear blisters, buttons, blisters or pharmaceutical bottles.
- Packaging level 2: This is the type of packaging located on the outside of the grade 1 packaging that it will not contact with the drug directly. It could be the shutter or the paper box.
Second: If classifying pharmaceutical packaging based on chemical nature
Packaging of all kinds such as rubber buttons, knobs, glass. And these are all injectable products and come in glass bottle combinations. But due to safety requirements for users, rubber stopper packaging is often a special choice of care and safety.
There are also a number of other packaging such as aluminum packaging, plastic packaging or PVC packaging ...
Third: If classifying pharmaceutical packaging by industry
Packaging for the pharmaceutical industry such as complex blisters, blister packs, neutral glass, hard capsules or dosing gas cylinders.
- Packaging multidisciplinary such as carton boxes, glass bottles ...
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Because the pharmaceutical packaging will be in contact with the drug, if there is no specific standard, there will be an interaction between the package and the active ingredient in the drug. Specifically, it can cause:
- Release of chemical components of the package with the drug.
- Blowing dust from packaging.
- Causing the absorption or adsorption of the drug's internal ingredients and creating chemical reactions between the drug inside and the outside packaging material.
- Will cause changes when in contact with drugs ...
The management and inspection of pharmaceutical packaging should be done carefully. Ensure there is no leakage, not causing diffusion or osmosis. At the same time the packaging should also be responsive to the mechanical impact associated with the transport. On the other hand, it is also necessary to ensure that pharmaceutical products are not affected by light, moisture, and avoid breaking ...
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The factory manufacturing pharmaceutical packaging products must have a manufacturing process in accordance with the GMP process, including:
- Must build a system for quality control.
- Need to develop a process to train personnel.
- Construction of factory systems.
- Fully equipped with equipment inside the factory.
- There is training program on hygiene as well as sanitary conditions.
- There must be strict test regulations on input materials.
- There should be a fully documented production procedure for product identification.
- It is necessary to check product quality after forming.
- It is necessary to have a record keeping process.
Also, be sure to handle complaints and product recalls and deal with returned product.
There are also notes regarding food packaging standards as follows:
- Workers in the working process are required to wear medical masks, protective shoes and clothes for production, need to be changed and washed properly regularly.
- For the factory area for sterile or non-sterile packaging, there should be specific regulations. The warehouse system also needs to ensure clean, correct temperature as required by the Ministry of Health.
- The automatic machine system will work on behalf of humans to produce sterile plastic bottle packaging ...
So in the content of the article above, we hope to have partly helped you understand more about pharmaceutical packaging standards. Welcome to see more of our other articles you will be updated with many other important articles related.
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