EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of EN ISO 11040-5 testing. This part of EN ISO 11040 specifies the shape, dimensions, material, performance requirements and labeling of piston plugs for glass drums (single chamber design) for injection preparations according to EN ISO 11040-4.
Piston stoppers specified in this part of EN ISO 11040 are for single use only. This part of EN ISO 11040 does not apply to barrier lined piston plugs.
The strength, purity, stability and safety of a medicinal product during manufacture and storage can be significantly affected by the structure and performance of the primary packaging.
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.
Piston stoppers must be made of elastomeric formulation originally tested and approved by the end user. The manufacturer of the piston stop must ensure that each delivery complies with the type specimen and conforms to the previously agreed functional and summary requirements.
The maximum time between the date of manufacture of the piston stoppers and their pharmaceutical use should be agreed between the manufacturer and the user. Piston stoppers must retain their performance characteristics throughout the entire shelf life of the medicinal product tested by the user as part of the stability test.
EUROLAB assists manufacturers with EN ISO 11040-5 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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