Bao Baoxie's recommendations on the safety of the raw materials for infusion plastic bottles

All relevant member units:
China Association of Drug Secrets [2009] No. 028 “Relevant Suggestions for Submitting Registration Data for Plastic Infusion Packaging Materials” After issuing relevant member units, plastic infusion packaging manufacturers have gradually carried out the safety evaluation of the raw materials for infusion packaging production. jobs. After soliciting comments from the review experts of relevant departments and drug packaging materials, the association again recommended that the enterprises that apply for registration and re-registration pay attention to the following matters when conducting safety experiments:
1. When the plastic infusion containers, interfaces, inner lids and other products are applied for registration and re-registration of drug packaging materials, the composition of the raw and auxiliary materials submitted shall include antioxidants, stabilizers, plasticizers, and lubricants in addition to the main components of the pellets. Agents, solvents, dyes, etc.
2. For all raw materials used and ingredients that may be introduced during the production process,
According to the requirements of the EU GUIDELINE ON PLASTIC IMMEDIATE PACKAGING MATERIALS (available on the association's website, both in English and in Chinese), safety assessment data are provided:
1. For the varieties (or ingredients) contained in the relevant pharmacopoeia at home and abroad, regular information, specification standards, and interaction studies with possible packages should be provided;
2. For species (or ingredients) not covered by national and international pharmacopoeias, except for general information and regulations
In addition to the interactions between the standards and possible packaging, additional studies on extraction studies and toxicology studies are required.
3. For the plastic packaging materials that have been registered and are in use, attention should be paid to their production and
Use process security. When re-registering, submit the safety conditions during the production and use, and submit research materials according to the first, second and third items of this notice.
IV. For infusion products that may be injected after other injections in clinical use, built
The infusion product manufacturer was asked to study the migration and adsorption between the infusion and the infusion.
At the same time, when registering and re-registering plastic packaging materials, interfaces, inner lids, and other packaging materials, it is recommended to submit the structural drawings and dimensions of registered products in various specifications in order to successfully complete the registration work.

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