SIST EN ISO 9187-1:2011 PDF

Overview

EN ISO 9187-1:2010 - Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2010) is a CEN-endorsed international standard that specifies the materials, dimensions, capacities, performance and packaging requirements for glass ampoules used as primary containers for injectable pharmaceutical products. The standard covers three ampoule forms in current pharmaceutical use (forms B, C and D) and applies to ampoules with or without a colour break‑ring. Ampoules complying with this standard are intended for single use only.

Key topics and technical requirements

• Ampoule forms & sizes: Defines geometrical dimensions and nominal volumes for forms B, C and D (common nominal volumes include 1, 2, 3, 5, 10, 20, 25 and 30 ml).
• Glass material: Specifies the use of colourless (cl) or amber (br) glass of hydrolytic resistance grain class HGA 1 (ISO 720). Manufacturers must notify users of chemical composition changes in advance.
• Hydrolytic resistance: Internal surface resistance classified to container classes HCT 1 and HCF 1 when tested per ISO 4802‑1 and ISO 4802‑2.
• Annealing and stress: Ampoules must be annealed; uncoloured ampoules have limits on residual optical retardation to control stress.
• Breaking performance: Specifies a tensile breaking test (separation of stem from body) using a tensile testing machine per ISO 7500‑1 (test speed typically 10 mm/min, appropriate force range). All individual test results must meet the values in the standard’s breaking‑force table.
• Sampling & testing: Recommends sampling schemes per ISO 2859‑1 (e.g., inspection level S‑4) and stipulates conditioning and test reporting requirements.
• Packaging & marking: Defines a typical packaging unit internal footprint (384 × 143 mm) and requires marking of manufacturer name/address and full designation (form, nominal volume, glass colour, break‑ring where applicable).

Applications

• Ensures consistent primary packaging for parenteral pharmaceuticals to reduce risk of drug-container interactions and maintain patient safety.
• Used to design, manufacture and qualify production ampoules, internal QC tests, incoming inspection and supplier agreements.
• Supports regulatory submissions and quality-system controls for pharmaceutical containers and parenteral product fills.

Who uses this standard

• Pharmaceutical companies (packaging and regulatory teams)
• Glass ampoule manufacturers and converters
• Medical device and packaging engineers
• Quality control / analytical laboratories and validation teams
• Hospital procurement and sterile‑supply specialists

Related standards

• ISO 9187‑2 (One‑point‑cut (OPC) ampoules)
• ISO 720, ISO 4802‑1 / ISO 4802‑2 (hydrolytic resistance)
• ISO 7500‑1 (tensile testing machine verification)
• ISO 2859‑1 (sampling by attributes)
• ISO 1101 (geometrical tolerancing)

This standard is essential for anyone specifying, producing or qualifying glass ampoules for injectables, helping ensure dimensional consistency, material suitability and safe single‑use performance.