ISO 8536-6 Infusion Equipment for Medical Use - Part 6: Test of Freeze Drying Caps for Infusion Bottles

Medical Tests

ISO 8536-6 Infusion Equipment for Medical Use - Part 6: Test of Freeze Drying Caps for Infusion Bottles

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 8536-6 testing. ISO 8536-6 specifies the shape, dimensions, material, performance requirements and labeling for the type of cap for infusion bottles as described in ISO 8536-1 used in conjunction with freeze drying (or lyophilization). Size requirements do not apply to barrier lined covers. The caps specified in this standard are for single use only.

ISO 8536-6 Infusion Equipment for Medical Use - Part 6: Test of Freeze Drying Caps for Infusion Bottles

After filling, freeze-drying caps are placed on the infusion bottles and sufficient openings are left for the sublimation process and vacuum. At the end of the drying process, they can be completely placed in the glass container by hydraulic or mechanical means in the vacuum chamber.

During transport, storage, washing and steam sterilization cycles, freeze-drying lids can absorb water that is difficult to remove in the next drying cycle. As a result, freeze-drying lids are often loaded with residual moisture. Depending on the mass of the freeze-dried product and its degree of sensitivity to water, residual moisture in the rubber material may degrade the freeze-dried preparation during storage.

These specific process requirements are addressed in this document by specifying the relevant requirements for freeze-drying closures, including a test method for determining residual moisture. Primary packaging components made from elastomeric materials are an integral part of medical products and therefore the applicable Good Manufacturing Practice (cGMP) principles apply to the manufacture of these components.

The maximum period of pharmaceutical use between the date of manufacture and the delivery date should be agreed between the manufacturer of the caps and the user. Caps must retain performance characteristics throughout the entire shelf life of the medicinal product tested by the user as part of the stability test.

Upon request, the rubber manufacturer will provide a recommendation on what time and temperature (duration/temperature profile) the user can reduce the residual moisture from the freeze-drying hoods to a predefined humidity level, as exposure to dry heat can be harmful.

EUROLAB assists manufacturers with ISO 8536-6 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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