EUROLAB laboratory provides testing and compliance services within the scope of EN ISO 8536-2 standard. EN ISO 8536‑2 specifies the shape, dimensions, material, performance requirements and labeling of closures for infusion bottles as specified in EN ISO 8536-1.
Dimensional requirements do not apply to barrier lined covers. The caps specified in EN ISO 8536‑2 are for single use only.
The purpose of this part of ISO 8536 is to specify the shape and dimensions and requirements for elastomeric closures designed for infusion bottles. To ensure the sealing of container closure systems, the dimensions of elastomeric closures must match the dimensions of the brew bottles and closures as specified in the relevant sections of ISO 8536.
Primary packaging components made from elastomeric materials are an integral part of medicinal products and therefore existing Good Manufacturing Practice (cGMP) principles apply to the manufacture of these components.
EUROLAB assists manufacturers with EN ISO 8536-2 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.
