ISO 11418-1 2nd Edition, February 1, 2005
Containers and accessories for pharmaceutical preparations Part 1: Drop-dispensing glass bottles
Additional Comments: ENGLISH *SEE ALSO ISO FDIS 11418-1
Published By:International Organization for Standardization (ISO)
This document specifies the design, dimensions, material and requirements of drop-dispensing glass bottles. Drop-dispensing glass bottles are applicable to primary packs used in direct contact with a drug.
This document is applicable to drop-dispensing glass bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use.
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.