Prefilled syringes — Part 3: Seals for dental local anaesthetic cartridges
Prefilled syringes — Part 3: Seals for dental local anaesthetic cartridges
This document specifies the shape, dimensions, material, performance requirements and labelling of seals for dental local anaesthetic cartridges intended for single use only. NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be significantly affected by the nature and performance of the primary packaging.
ISO 11040-3:2025 - Prefilled syringes: Seals for dental local anaesthetic cartridges specifies the shape, dimensions, materials, performance requirements and labelling of single‑use seals (aluminium cap + elastomeric liner) used on dental local anaesthetic cartridges. The standard emphasizes the role of primary packaging in maintaining the potency, purity, stability and safety of medicinal products and aligns component production with good manufacturing practice (cGMP) principles.
Стандарты, упомянутые в описании
This standard is intended for:
Keywords: ISO 11040-3, prefilled syringes, seals for dental local anaesthetic cartridges, dental cartridges, liner, aluminium cap, leakage test, elastomeric parts, sterilization, cGMP.