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Type I Glass for Pharmaceutical Containers: Technical ...
Type I Glass for Pharmaceutical Containers: Technical Requirements and regulatory updateDaniele Zuccato, Core Team Leader-Strictly ConfidentialTopicsGlass Containers for PharmaceuticalUseGlass Containers ProductionDelaminationRegulatoryUpdatesT his is the title of the Section of the current editionof the European Pharmacopoeia, EPF. Nicoletti -2014 Glass Containers for Pharmaceutical Use4-Strictly ConfidentialGlass Containers for Pharmaceutical UseGlassesAccordingto the EuropeanPharmacopoeia(EP)Titrationof the ExtractSolution obtainedfrom10 g glasspowderin 50 ml water at121 C for 30 GlassIdentificationItem( Glass GrainTest)NeutralGlassLimit Value 0,10mlHCl0,02 MPer gramof glassSoda Lime SilicaGlassLimit Value 0,85mlHCl0,02 MPer gramof glass5-Strictly ConfidentialTypeIHigh HRTypeIIHigh HRTypeIIIM oderateHRGlass Containers for Pharmaceutical UseGlass Containers According to the European Pharmacopoeia (EP)6-Strictly ConfidentialGlass Containers for Pharmaceutical UseGlass Containers.
“When glass containers for pharmaceutical use are manufactured under stressed conditions (e.g. temperature time profile) and/or are placed in contact with particularly aggressive pharmaceutical preparations, they may give rise to delamination, i.e. the separation of the inner glass surface into
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