ISO 8536-7 Infusion Equipment for Medical Use - Part 7: Caps for Infusion Bottles Made of Aluminum-Plastic Combinations

Medical Tests

ISO 8536-7 Infusion Equipment for Medical Use - Part 7: Caps for Infusion Bottles Made of Aluminum-Plastic Combinations

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 8536-7 testing. ISO 8536-7 specifies closures made from aluminum-plastic combinations intended for use on infused glass bottles conforming to ISO 8536-1.

ISO 8536-7 Infusion Equipment for Medical Use - Part 7: Caps for Infusion Bottles Made of Aluminum-Plastic Combinations

The materials from which glass infusion bottles (including elastomeric closures) are made are the primary packaging materials suitable for storing infusion solutions until administration. However, in this part of ISO 8536, closures of aluminum-plastic combinations are not considered primary packaging materials in direct contact with the infusion solution.

The requirements for plastic components and the combination between the plastic component and the aluminum cap must comply with ISO 10985. Structural elements penetrating the inner cavity of the aluminum cover will not interfere with the sealing process. 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.

Infusion therapy is mainly used to treat serious or chronic diseases and infections that do not respond to oral antibiotics. There are many instances of disease conditions and infections that are consistently treated using infusion therapy. This includes different types of cancer, gastrointestinal tract infections, Crohn's disease, ulcerative colitis and inflammatory bowel disease.

EUROLAB assists manufacturers with ISO 8536-7 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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