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Pre-filled syringes: trends and tips from the experts
WebThis part of ISO 11040 is applicable to aseptically filled or terminally sterilized finished prefilled syringes (intended for single use only) based on ISO 11040-4 or ISO 11040-6, together with ISO 11040-5, for parenteral injection preparations with focus on quality, functional performance and safety requirements, as well as relevant test methods. WebPre-filled syringes TM Regulatory Reference: 110408 System characterization Barrel (ISO 11040-4 or 11040-6 shall apply) Plunger stoppers (ISO 110405 shall apply; talks about laminated plungers in view of plunger - seeting) Additional components (plunger rod, finger flange extension, hypodermic needle, filter tubing etc) Pre-filled syringes TM WebEnoxaparin (Clexane) pre-filled syringes (various strengths) • A shortage of the ERIS automatic safety system will impact the availability of several Clexane pre-filled syringes until November 2024 (list below): o 4,000IU (40mg/0.4ml) o 6,000IU (60mg/0.6ml) o 8,000IU (80mg/0.8ml) o 10,000IU (100mg/1ml) crypto money today