The ISO 9187-2 standard, developed by the International Standards Organization (ISO), describes the characteristics and test methods of single-point cut ampoules, which are injection equipment for medical use. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 9187-2 Injection equipment for medical use - Part 2: Single point cut (TNK) ampoules.
This standard describes the materials, dimensions and requirements for injectable single point ampoule forms (forms B, C and D). The ampoules defined in this standard are suitable packaging materials for the storage of pharmaceutical products until they are administered to the patient. Due to direct contact between the injectables and the container due to the long storage times, possible interactions should be avoided to ensure patient safety. For this, specific requirements and methods must be applied for proper selection of packaging materials, selection of the appropriate packaging design, and testing of individual container systems.
The standard that is referred to as normative in the implementation of the ISO 9187-2 standard and indispensable for its implementation is the following: TS EN ISO 9187-1 Injection equipment for medical use - Part 1: Ampoules for injectable drugs.
In single- point cut ampoules, a point on the neck marks the cut location to aid in breaking or opening the ampoule. If done correctly, this process is clean and free of glass fragments, and the liquid or solution inside the ampoule is safely preserved. Single-point cut ampoules are easy and safe to open, reducing the risk of shattering or sharp edges.
Our organization also provides testing services for single-point cut ampoules with ISO 9187-2 injection equipment for medical use within the scope of laboratory services.
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