◆ Packaging containers for marketed drugs: glass bottles, rubber stoppers, infusion bags, eye drop bottles, aerosol bottles, etc;

◆ Production process components: silicone tubes, filters, washers, packaging needles, etc

◆ Clinical drug delivery device: syringe, infusion set, spray valve, etc

◆ Information collection and preliminary risk assessment: Conduct a scientific risk assessment based on the drug packaging material information, packaging specifications, physicochemical properties, administration routes, and daily to maximum dosage provided by the customer, and customize project specific research plans for the customer.

◆ Comprehensive extraction research covering ion strength, pH, polarity, and other aspects to obtain sufficient and complete extractable materials, helping customers screen for the best direct packaging materials.

Based on the actual production and development process of the customer, design simulation experiments under extreme conditions to simulate the extractability of actual drugs and packaging systems under extreme conditions, and provide scientific basis for the selection of migration research detection projects and methods.

According to relevant regulations such as the Chinese Pharmacopoeia and USP, the lifecycle management of testing methods is carried out. Methodological validation items include but are not limited to specificity, accuracy, precision (repeatability, intermediate precision), detection limit, and quantification limit.

◆ Safety assessment: Referring to toxicological data provided by companies such as TOXNET, FDA, ICH, EMA, etc., the analytical evaluation threshold (AET) is calculated based on PDE and SCT to evaluate the safety of extractable and extractable content results.

Research basis: YBB 00142002-2015 Guidelines for Compatibility Testing of Drug Packaging Materials and Drugs, Technical Guidelines for Compatibility Research of Chemical Drug Injections and Plastic Packaging Materials (Trial), Technical Guidelines for Compatibility Research of Chemical Drug Injections and Pharmaceutical Glass Packaging Containers (Trial), Technical Guidelines for Compatibility Research of Chemical Drugs and Elastomeric Seals (Draft for Comments), USP<1663>, USP<1665>, USP<665>, ICH guidelines, etc.