The prefilled syringe system used in the production pro […]
The prefilled syringe system used in the production process of chemical injections may come into contact with liquids and interact, leading to the production and accumulation of related extracts. The extract persists in the liquid and is eventually transferred to the final product, which may affect the key quality attributes of the drug.
Principles for selecting the prefilled syringe component system for chemical injections:
Material characterization is the prerequisite for the selection and use of the prefilled syringe assembly system. Plastic materials should generally meet the relevant requirements for identification, biological reactivity, physical and chemical properties, additives, and extractable elements (if necessary).
Component system manufacturers should fully check the quality of selected materials, avoid the use of toxic and harmful additives, and control risks from the source.
When selecting a prefilled syringe component system, the preparation applicant/drug manufacturer should strengthen the audit of the manufacturer, conduct a comprehensive assessment of the quality of the component system and the manufacturer’s quality assurance system, and pay attention to the material regulatory compliance statement and special concern substances The statement or promise (such as the type of additive, the compliance with the dosage limit, etc.), the inspection report or the quality compliance statement.