◆ Packaging container for marketed drug: glass bottle, rubber stopper, infusion bag, eye drop bottle, and aerosol spray bottle, etc.; 

◆ Production process components: silicone tube, filter, gasket, filling needles, etc.; 

◆ Clinical administration device: syringe, infusion set, spray valve, etc.; 

◆ Information collection and initial risk evaluation: carry out scientific risk assessment according to the information of drug packaging materials, packaging specifications, physical and chemical properties, route of administration, and maximum daily dosage provided by customers, and customize project-specific research protocol for customers;

◆ Extraction research covers all aspects of ionic strength, pH, polarity, etc., to obtain sufficient and complete extractable materials and help client screen excellent direct packaging materials;

◆ Combined with the actual production and development process of clients, simulation experiments under extreme conditions are designed to simulate the extractable situation of drugs and packaging systems under the worst conditions in actuality, so as to provide a scientific basis for the selection of migration research detection items and methods;

◆ Life cycle management for the testing method is carried out according to the Chinese Pharmacopoeia, USP, and other relevant regulations. The methodology validation items include but are not limited to specificity, accuracy, precision (repeatability, intermediate precision), detection limit, and quantitative limit; 

◆ Safety evaluation: refer to the toxicological data provided by TOXNET, FDA, ICH, EMA, etc., and calculate the analysis and evaluation threshold (AET) according to PDE and SCT, so as to evaluate the safety of extractable and extractable content results;

◆ Research evidence: YBB 00142002-2015 Drug Packaging Materials and Pharmaceutical Compatibility Test Guidelines, Technical Guidelines on Compatibility Research between Chemical Drug Injection and Plastic Packaging Material (Trial), Technical Guidelines on Compatibility Research between Chemical Drug Injection and Pharmaceutical Glass Packaging Container(Trial), Technical Guidelines on Compatibility Research between Chemical Drugs and Elastomeric Sealants (Draft for Comments), USP<1663>, USP<1665>, USP<665>, and ICH Guidelines, etc.