Delamination of Type 1 pharmaceutical vials has resulted in an increasing number of recalls over the past several years. The factors leading to surface attack due to the interaction between the drug product and glass surface of filled vials are well documented and include elevated pH (greater than pH8), storage temperature (room temperature as opposed to cold storage), and use of vials constructed of glass tubing (as compared to molded vials). Other factors influencing the chemical resistance and durability are provided in UPS <1660>. This webinar will describe the process we have developed to examine glass delamination of pharmaceutical vials.
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