DANSK DS/ISO 11418-5 PDF

ISO 11418-5:2015 specifies the design, dimensions, material, and requirements of dropper assemblies consisting of a screw cap, dropper bulbs, and pipettes for the application and dosage of liquid pharmaceutical preparations. This part of ISO 11418 is applicable to dropper assemblies used in the medical field in order to deliver pharmaceutical preparations contained in screw neck bottles according to ISO 11418-1. Dropper assemblies are applicable to primary packs used in direct contact with the drug. NOTE The potency, purity, stability, and safety of a drug during its manufacture and storage can be strongly affected by the nature and performance of the primary pack.