The ISO 9187-1 standard, developed by the International Standards Organization (ISO), describes the characteristics and test methods of ampoules, which are injection equipment for medical use and used for injectable drugs. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 9187-1 Injection equipment for medical use - Part 1: Ampoules for injectable drugs.
This standard describes the material size, capacity, performance and packaging requirements of three glass ampoules used for injectable pharmaceutical products. In this standard, the three forms of glass ampoules are defined as forms B, C and D. This standard applies to bulbs with and without color breaker rings. The supply of bulbs with a colored rupture ring and the choice of color of the rupture ring depends on agreement between the manufacturer and the user. The bulbs conforming to this standard are single-use bulbs only.
The ampoules defined in the standard are suitable packaging materials for storing pharmaceutical products until they are administered to the patient. Due to the long storage periods between the injectable substances and the container, and the resulting direct contact, it is necessary to avoid potential interactions to guarantee patient safety. This requires the appropriate selection of packaging materials, the choice of suitable packaging design, and the application of specific requirements and methods for testing individual container systems.
In the past, four standard bulb shapes (forms A, B, C, and D) were commonly used. However, form A is no longer used in the pharmaceutical industry and is not included in the standard. In order to avoid any confusion between manufacturers and users, it has been decided to protect forms B, C and D.
Our organization also provides testing services for ampoules with ISO 9187-1 injection equipment for medical use and used for injectable drugs, within the scope of laboratory services.
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