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BS ISO 11040-4
BS ISO 11040-4
An international standard for injectable drug products—glass barrels for prefilled syringes (ISO 11040-4)—outlines requirements and testing methods for the use of glass barrels for prefilled syringes and for sterilized subassembled syringes ready for filling. The standard is part of the ISO 11040 series, which pertains to the prefilled syringe system, and this standard deals with the dimensional, material, and functional features of syringe barrels. Such components are vital in pharmaceutical packaging and drug delivery systems, where accuracy, cleanliness, and top quality are extremely vital. Manufactures can utilize ISO 11040-4 to create consistent quality criteria that apply to syringe components intended for use in healthcare applications.
Significance
Prefilled syringes are used for drug delivery because of the ease of use, dose accuracy, and minimization of contamination. A standard for verification of quality and compatibility of glass syringe barrels is given in ISO 11040-4. The standard defines issues like dimensions, material properties, performance criteria, and other attributes that will affect the safety and usability of the final product. Follow-up tests (according to ISO 11040-4) will help quality control programs, product development processes, and regulatory requirements. Presto Laboratories offers advanced testing solutions that assist manufacturers in evaluating critical syringe component characteristics with accuracy and consistency. Scope ISO 11040-4 is used for glass barrels for prefilled syringes and sterilized subassembled syringes delivered for filling with injectable preparations. The standard defines dimensions, material specifications, and test methods for determination of product quality and performance. It includes characteristics that are essential to proper assembly, filling, storage, and administration of pharmaceutical products. The standard is applicable to manufacturers, pharmaceutical companies, and testing laboratories participating in the production and verification of prefilled syringe systems intended for use in the medical and health care industries.