TC12: Pharma Packaging

TC12 has the main general objective to verify the “weaknesses” of glass containers for pharmaceutical products in front of the demands of new drugs and new drug delivery systems, and to identify the R&D needs in this field. The short term project is aimed to better understand the interaction of the glass surface with pharmaceutical products, including “delamination” phenomena, adsorption effects and the influence of big molecules. Longer term themes are related to the fragility of glass.
The first objective of TC12 is to find a experimental method for the evaluation of the propensity to delamination, which is reliable and accepted by most important actors in the field. The delamination problem is nowadays considered with great attention by both glass and pharma industries, and many activities have been started for a better comprehension of the mechanisms, the most important parameters involved (from composition to processing), the strategies to solve the problem.

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Activities and planned actions

ACTIVITIES IN 2016

At the end of 2015, during the meeting in Murano (October 2), the Technical Committee deeply discussed the results obtained by the several tests performed by almost all the members, arriving to the conclusion that further work was necessary. During the same meeting the Committee also arrived to the conclusion that there was not much interest to start a new activity on the problems related to the mechanical properties of pharma glass. All the members were invited to suggest topics of common interest for the TC.
A meeting was then organized in Venice on April 11, in coincidence with the PDA Europe’s Conference. Unfortunately only few members were present. 
At the meeting a long discussion was devoted to the need for further experiments to complete the work on the delamination propensity test. In particular it was decided that a correlation between the results of the “delamination propensity test” and the occurrence of delamination was needed before to publish the results of the round riobin tests.  
Infact, although the results obtained demonstrated good reproducibility, good capability to catch differences among different vials lots and good sensitivity 
(no delamination was produced in any of the tested vials), it is important to give evidences that the differences are related to a different propensity to delamination, 
whether or not this event will occur really in the future (being this event, in any case, unlikely).
After considering different possibilities it was finally decided to run repeated autoclave cycles till observing delamination, and compare the attacked vials by ICP analysis, methylene blue coloration and SEM observation of 
the inner attacked surface. 
GTS was available to perform these experiments and, after the meeting, also SSV accepted to participate. 
The deadline fixed for this activity was september 2016. 
After the meeting detailed instructions were sent to SSV and GTS. However, due to the amount of work necessary, both SSV and GTS had difficulties in allocating time and resources for this activity, that stopped. 
In December 2016 Daniele Zuccato of Stevanato Group and the Chair proposed to strongly simplify the experiments and to participate to the work. The new program was suggested to SSV and GTS, and both accepted to participate to this reviewed and simplified action.
 

PLANS FOR 2017

1. Two types of vials with different results at the delamination propensity test will be distributed among the labs which will perform the final tests (Stazione Sperimentale del Vetro, Glass Technology Services, Stevanato Group and University of Padova).

2. Experiments to correlate the occurrence of delamination with the results of the delamination propensity test.

3. Submission of a scientific paper on the experience of TC 12 on the PDA Journal of Pharmaceutical Science and Technology.

4. Presentation of the results at the first event of ICG after the conclusion of the work on delamination.

5. Planning a new activity.


 

Committee Members: back to top

Cerdan-Diaz, Juan
Choju, Ken
Espersen, Mads
Flynn, Carol
Gavioli, Lodovico
Guglielmi, Massimo Committee Position: Chair
Iacocca, Ronald Committee Position: Vice Chair
Meysner, Amy
Pfeifer, Joachim
Roehl, Holger
Rupertus, Volker (Prof)
Scarpa, Martina
Sun, Huimin
Zhang, Jingwei
Zuccato, Daniele Committee Position: Secretary

Committee Contact Details: back to top

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