Delamination propensity of pharmaceutical glass containers by accelerated testing with different extraction media
E Guadagnino, D Zuccato - PDA Journal of Pharmaceutical science …, 2012 - journal.pda.org
The delamination of pharmaceutical glass is a serious issue, as it can cause glass particles
to appear in vials, a problem that has forced a number of drug product recalls in recent …
to appear in vials, a problem that has forced a number of drug product recalls in recent …
Comparative delamination study to demonstrate the impact of container quality and nature of buffer system
U Rothhaar, M Klause, B Hladik - PDA Journal of Pharmaceutical …, 2016 - journal.pda.org
Delamination of flakes in glass containers used for primary drug packaging has become a
serious quality concern in recent years. Because glass delamination typically occurs …
serious quality concern in recent years. Because glass delamination typically occurs …
Evaluation of glass delamination risk in pharmaceutical 10 mL/10R vials
Glass delamination is characterized by the dissociation of glass flakes from the glass
surface. Since glass delamination is time dependent, 5 vial types were investigated to …
surface. Since glass delamination is time dependent, 5 vial types were investigated to …
Factors affecting the chemical durability of glass used in the pharmaceutical industry
RG Iacocca, N Toltl, M Allgeier, B Bustard, X Dong… - Aaps Pharmscitech, 2010 - Springer
Delamination, or the generation of glass flakes in vials used to contain parenteral drug
products, continues to be a persistent problem in the pharmaceutical industry. To …
products, continues to be a persistent problem in the pharmaceutical industry. To …
Glass delamination: a comparison of the inner surface performance of vials and pre-filled syringes
J Zhao, V Lavalley, P Mangiagalli, JM Wright… - Aaps Pharmscitech, 2014 - Springer
The occurrence of glass delamination is a serious concern for parenteral drug products.
Over the past several years, there has been a series of product recalls involving glass …
Over the past several years, there has been a series of product recalls involving glass …
Determining the delamination propensity of pharmaceutical glass vials using a direct stress method
C Sloey, C Gleason, J Phillips - PDA Journal of Pharmaceutical …, 2013 - journal.pda.org
An accelerated lamellae formation (ALF) methodology has been developed to determine the
delamination propensity and susceptibility of pharmaceutical glass vials. The ALF process …
delamination propensity and susceptibility of pharmaceutical glass vials. The ALF process …
A quick test to monitor the delamination propensity of glass containers
V Rupertus, B Hladik, U Rothhaar… - PDA Journal of …, 2014 - journal.pda.org
Glass delamination has developed as a quality problem for primary packaging containers
over the last years. Beside other factors the container production process can contribute to …
over the last years. Beside other factors the container production process can contribute to …
Corrosive attack of glass by a pharmaceutical compound
RG Iacocca, M Allgeier - Journal of materials science, 2007 - Springer
Glass delamination, or the generation of glass flakes, continues to be an unwanted
occurrence in the manufacture of parenteral (injectable) solutions and suspensions. In this …
occurrence in the manufacture of parenteral (injectable) solutions and suspensions. In this …
Impact of glass corrosion on drug substance stability
MA Watkins, RG Iacocca, TL Shelbourn, X Dong… - Journal of …, 2014 - Elsevier
The delamination of glass contact surfaces because of hydrolytic instability has been well
documented. However, the lack of glass surface integrity can also lead to other undesirable …
documented. However, the lack of glass surface integrity can also lead to other undesirable …
Glass vials for small volume parenterals: influence of drug and manufacturing processes on glass delamination
RD Ennis, R Pritchard, C Nakamura… - Pharmaceutical …, 2001 - Taylor & Francis
Purpose: Studies were initiated to examine the effect of formulation and process variables
on the delamination process and also the influence of the glass manufacturing process …
on the delamination process and also the influence of the glass manufacturing process …
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