EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of EN ISO 11040-3 testing. EN ISO 11040-3 specifies the shape, dimensions, material, performance requirements and labeling of seals for disposable dental local anesthetic cartridges only.
Primary packaging components made of elastomeric materials are an integral part of medical products. Therefore, the principles of current good manufacturing practice (cGMP) apply to the manufacture of these components.
Discs must be made of an originally tested and end-user approved elastomeric formulation. The manufacturer of the discs must ensure that each delivery conforms to the type specimen and conforms to the previously agreed functional and mandatory requirements.
The maximum time between the date of manufacture of the seals and their pharmaceutical use should be agreed between the manufacturer and the user. Seals must maintain performance characteristics throughout the entire shelf life of the medicinal product tested by the user as part of the stability test.
Water-filled cartridges are prepared using the seals to be tested. By means of a suitable device, a force is applied to the gasket at a certain time interval. Any observed leakage is recorded.
The elastomeric material must withstand two sterilization cycles under normal use conditions while autoclaving at (121 ± 2)°C in saturated steam for 30 minutes. If other sterilization methods are used, e.g. irradiation, suitability of the material will be evaluated.
EUROLAB assists manufacturers with EN ISO 11040-3 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
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