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ISO FDIS 11418-5

2014 Edition, August 26, 2014

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CONTAINERS AND ACCESSORIES FOR PHARMACEUTICAL PREPARATIONS - PART 5: DROPPER ASSEMBLIES



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Superseded By: ISO 11418-5

Additional Comments:
SEE ISO 11418-5
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Description / Abstract:

This part of ISO 11418 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.
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