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Supervision of pharmaceutical packaging

May 06 , 2020

Packaging is a non-medicinal part of medicines. Direct contact with medicines will have an important impact on the quality and safety of medicines. Therefore, the supervision of pharmaceutical packaging must be synchronized with pharmaceutical quality management.


Supervision of pharmaceutical packaging

vitamin c tablets tubes with desiccant caps

Industry insiders pointed out that the production requirements of medical packaging are very strict. Taking plastic bottles as an example, China consumes more than 10 billion medical plastic bottles every year, but because of the strict requirements for medical plastic bottles, including light weight and high strength , It is not easy to break, good sealing performance, moisture-proof, and hygienic. It can be used directly for pharmaceutical packaging without washing and drying after one-time molding. At present, all domestic production equipment for pharmaceutical packaging bottles need to rely on imports.


Supervision of pharmaceutical packaging

child proof bottle

The direct contact between the medicinal bottle and the drug, and the long-term contact due to material stability and other reasons may cause problems such as reaction, seriously affecting the quality of the drug, and even causing pathogenic and fatal factors. Therefore, the relevant domestic authorities are also supervising this Keep increasing.

Earlier, the Food and Drug Administration has issued Notice No. 132, requiring that for injections sensitive to biological products, partial acids and bases and sensitive to ph, the 121 ℃ granule method water resistance should be selected as Class 1 and the inner surface water resistance should be Class HC1 Medical glass or other suitable packaging materials. There are more clear regulations on pharmaceutical packaging materials, which are considered by the industry as a signal for the relevant state departments to tighten industry standards.

Relevant experts believe that the domestic pharmaceutical field and related industries are in a critical period of transformation and upgrading. Continuously raising industry standards and continuously achieving international integration are development goals and basic requirements for further market expansion.

Domestic pharmaceutical packaging manufacturers can only guarantee the safety performance of products before the industry by continuously improving production standards and developing packaging requirements suitable for more varieties and dosage forms.


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