Overview
SIST EN ISO 9187-2:2011 is an international standard specifying the requirements for one-point-cut (OPC) ampoules used in medical injection equipment. Developed by ISO/TC 76 and adopted by CEN, this standard focuses on the materials, dimensions, and performance criteria for OPC ampoules-specifically forms B, C, and D-designed for injectables. These ampoules are intended for single use only, ensuring safety and sterility for pharmaceutical applications. The standard aligns with ISO 9187-1:2010, which covers ampoules for injectables in general.
Key Topics
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Scope and Purpose
Defines the specifications for OPC ampoules that provide a safe, reliable packaging solution for injectable medicines. These ampoules facilitate the sterile storage and administration of pharmaceuticals.
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Materials
Ampoules must be manufactured from materials complying with ISO 9187-1:2010, ensuring chemical compatibility and hydrolytic resistance to prevent interactions between the container and the drug product.
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Dimensions and Designation
Dimensions are standardized, with detailed specifications for the nominal volume, wall thickness, diameter of the breaking point, and overall height of the ampoules. Clear designation format includes ampoule form, volume, and glass color for easy identification (e.g., Ampoule ISO 9187-2 – OPC – B – 10 – cl).
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Breaking Force & Point Stability
The breaking force required to open the OPC ampoule is clearly defined, ensuring controlled opening with minimal risk of injury or contamination. The one-point cut includes a color pigment marking positioned centrally with a permissible deviation, guaranteeing consistent breakage performance. The breaking point must withstand sterilization and cleaning procedures as well as exposure to drying ovens.
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Packaging and Marking
Packaging and marking requirements align with ISO 9187-1 to ensure safe transportation, traceability, and compliance with medical regulations.
Applications
SIST EN ISO 9187-2:2011 OPC ampoules are widely used in pharmaceutical and healthcare settings for:
- Single-use injectable drug storage - Ampoules provide an airtight, sterile barrier to protect injectables until use.
- Hospital and clinical environments - Facilitate the safe and easy administration of critical medicines with hygienic opening features.
- Pharmaceutical manufacturing - Standardized ampoules support mass production and quality control procedures.
- Research and clinical trials - Ensure consistent sample containment with known physical and chemical properties.
The standardized dimensions and performance requirements help manufacturers produce compliant ampoules and enable healthcare professionals to handle the equipment confidently, improving patient safety and regulatory adherence.
Related Standards
- EN ISO 9187-1:2010 – Injection equipment for medical use – Part 1: Ampoules for injectables, addresses general requirements for ampoules.
- ISO 6710 – Glass containers for pharmaceutical use – provides complementary specifications for container glass.
- ISO 13485 – Medical devices – Quality management systems – Requirements for regulatory purposes, applicable to manufacturers of injection equipment.
Compliance with SIST EN ISO 9187-2:2011 ensures compatibility and interoperability with broader medical device standards, fostering quality assurance and confidence in injectable drug delivery systems.
Keywords: OPC ampoules, one-point-cut ampoules, injection equipment, medical ampoules standard, single-use ampoules, ISO 9187-2, pharmaceutical packaging, injectable drugs, ampoule breaking force, medical device standards, sterile drug packaging.
