ISO 9187-1:2010

Overview

ISO 9187-1:2010 - "Injection equipment for medical use - Part 1: Ampoules for injectables" specifies requirements for glass ampoules used as primary packaging for injectable pharmaceutical products. The standard covers three standardized ampoule forms (B, C and D), applicable nominal volumes (1–30 ml series), material selection, dimensional tolerances, performance tests and packaging/marking rules. ISO 9187-1:2010 applies to ampoules with or without a colour break‑ring (colour selection by agreement) and defines ampoules as intended for single use only.

Keywords: ISO 9187-1:2010, ampoules for injectables, glass ampoule standards, pharmaceutical packaging standards

Key Topics and Requirements

• Ampoule forms and dimensions: Detailed dimensional tables for forms B, C and D and nominal volumes (1, 2, 3, 5, 10, 20, 25, 30 ml) including body, constriction, stem, funnel and overall heights.
• Material: Colourless (cl) or amber (br) glass of hydrolytic resistance grain class HGA 1 (per ISO 720).
• Hydrolytic resistance: Internal surface must meet container class HC 1 and T HC 1 when tested per ISO 4802‑1 and ISO 4802‑2 to avoid drug–container interactions.
• Annealing quality: Maximum residual stress for uncoloured ampoules limited to optical retardation ≤ 50 nm/mm of glass thickness.
• Breaking force: Defined breaking force ranges and a tensile test procedure (example setup, test speed 10 mm/min, machine verification per ISO 7500‑1, measuring range ~200 N) to ensure predictable, clean stem separation.
• Sampling & testing: Sampling guidance (ISO 2859‑1 recommended, inspection level S‑4) and conditioning (20 °C ± 5 °C) before tests.
• Packaging & marking: Packaging unit dimensions, particle‑minimizing materials, and mandatory marking (manufacturer name/address and ISO designation).

Applications and Who Uses the Standard

• Ampoule manufacturers: design, production tolerances, material selection, QC testing and supplier documentation.
• Pharmaceutical companies: primary packaging selection for liquid injectables, stability and compatibility assessment.
• Regulatory and quality assurance: compliance checks, incoming inspection, lot acceptance and audit criteria.
• Laboratories and test houses: performing hydrolytic resistance, breaking force and annealing quality tests.
• Procurement and supply chain: specifying ampoule form, volume, glass colour and break‑ring options in contracts.

Keywords: pharmaceutical packaging, ampoule dimensions, hydrolytic resistance testing, breaking force testing

Related Standards

• ISO 720 - Glass: hydrolytic resistance classification
• ISO 4802‑1, ISO 4802‑2 - Hydrolytic resistance test methods for glass containers
• ISO 7500‑1 - Verification of tensile/compression testing machines
• ISO 2859‑1 - Sampling procedures for inspection by attributes
• ISO 1101 - Geometrical tolerancing (referenced for run‑out)

This concise guide helps manufacturers, QA/QC and pharmaceutical users understand the scope and practical requirements of ISO 9187-1:2010 for safe, compliant glass ampoules for injectables.