PT  - JOURNAL ARTICLE
AU  - Rothhaar, Uwe
AU  - Klause, Michaele
AU  - Hladik, Bernhard
TI  - Comparative Delamination Study To Demonstrate The Impact Of Container Quality And Nature Of Buffer System
AID  - 10.5731/pdajpst.2016.006577
DP  - 2016 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - pdajpst.2016.006577
4099  - http://journal.pda.org/content/early/2016/06/18/pdajpst.2016.006577.short
4100  - http://journal.pda.org/content/early/2016/06/18/pdajpst.2016.006577.full
AB  - Delamination of flakes in glass containers used for primary drug packaging has become a serious quality concern over the last years. Because glass delamination typically occurs weeks/months after filling and there is a variety of container, processing, and drug formulation factors that contribute to glass delamination, it is recommended according to USP <1660> [1] to conduct suitable container / drug product compatibility tests. Such predictive studies should give results that allow a graduated assessment for increasing risk of delamination that can be used to early stages of this phenomenon and help to select appropriate container/formulation systems to proactively prevent delamination instead of just monitoring for the presence/absence of flakes. This work demonstrates the capability of a container compatibility testing approach by determining the impact of 3 different model buffer/solution systems (citrate, phosphate, and sodium bicarbonate) with the delamination behavior of two different types of 2 mL glass vials, standard quality and delamination controlled quality. Vials of each type were filled and stored up to 48 weeks at 40°C. Using a USP <1660> compatible package of different analytical methods clearly demonstrates the significant influence of both vial quality and chemistry of the filling on glass delamination propensity.