EUROLAB laboratory provides testing and compliance services within the scope of ISO 11040-2 standard. Primary packaging components made from elastomeric materials are an integral part of medicinal products. Therefore, current Good Manufacturing Practice (cGMP) principles apply to the manufacture of these components.
This part of ISO 11040 specifies the shape, dimensions, material, performance requirements, and labeling of piston plugs for single-use dental local anesthetic cartridges only.
The water-filled cartridges are prepared using the piston plugs to be tested. A force is applied to the piston stopper in a certain time interval by means of a suitable device. Any observed leakage is recorded.
EUROLAB assists manufacturers with ISO 11040-2 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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EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
