Abstract：
:Pharmaceutical containers for parenterals have been predominantly manufactured using glass as a packaging material of choice, especially Type-I glass, since it has been regarded as a chemically inert and an effective container closure system (CCS). Nevertheless, there have been reports and recalls related to glass quality issues, such as breakage, flakes, and particles observed in marketed products. The novelty of this research is based on the knowledge gathered from our previously conducted risk assessments and establishing a comprehensive testing platform focused on risk factors for glass container failure modes and applicability to other types of pharmaceutical containers. The evaluation of container quality attributes was performed for three model glass vials using a mechanical and chemical durability testing platform: freeze-thaw, lyophilization, compression, scratch tests; visual inspection, pH, particle size analyses, extractable, leachable and imaging studies that were conducted under normal (4 and 25 °C), and stress condition (60 °C), respectively. The performance between the glass containers tested under certain stress conditions (failure modes) were variable and differentiated. The systematic platform testing approach shows the importance of lab-based risk evaluation in assessing common failure modes of pharmaceutical containers, since the quality attributes for injectable products are complex and can impact final product quality.
journal_name
Int J Pharmjournal_title
International journal of pharmaceuticsauthors
Srinivasan C,Ma Y,Liu Y,Wang Y,Hengst L,Liu X,Toth R,Rodriguez J,Mohammad A,Bandaranayake BMB,Simon D,Beekman C,Korang-Yeboah M,Sivan S,Lee SL,Cruz CNdoi
10.1016/j.ijpharm.2019.118510subject
Has Abstractpub_date
2019-09-10 00:00:00pages
118510eissn
0378-5173issn
1873-3476pii
S0378-5173(19)30552-6journal_volume
568pub_type
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