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

The first paper authored by all the members of the TC12 was published recently in the PDA Journal of Pharmaceutical Science and Technology. Please find it at this link. http://journal.pda.org/content/72/6/553.abstract

ACTIVITIES IN 2017

To conclude the activity on delamination it was important to give evidences that the differences observed in the round robin tests on different type of vials were 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 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. 
Three labs accepted to run the experiments, after a semplification of the procedures and the decision that only one lab had to examine the samples with SEM involved in this activity: GTS, SSV and Nuova Ompi. The last accepted to perform SEM evaluation.
Two types of vials with different results at the delamination propensity test were distributed among the labs, which performed the final tests. This activity lasted much more than planned, and the results of the autoclaving runs were available in february-march 2017. No lab was able to observe delamination after four runs, and they stopped the experiment. Nuova Ompi provided the results of SEM analysis in June 2016. They showed significant differences in terms of chemical corrosion on the inner bottom regions of the vials, where delamination is expected to occur, if any.

Based on these results a face-to-face meeting was organized in Padova on October 18, 2017, where the results were discussed and a draft of a paper to be submitted to a scientific journal was presented by the Chairman to all the present members.

There was also a discussion on the future activity of the TC. The members underlined the importance of the chemical behavior of pharma glasses, related both to the problem of delamination (or, in a more wide sense, corrosion) and the problem of extractables. It was generally accepted that the TC should go on in this direction, looking for an interaction with TC2 (Durability and Analysis). Concerning delamination it was suggested to complete the work looking indeed for conditions promoting the occurrence of observable flakes. Two proposals were suggested: a) using, for comparison, “positive” vials (known to be propense to delaminate) to be compared with commercial ones, and b) trying a different, more severe testing protocol. It was also discussed the importance of testing “good chemical properties” vials present on the market, which should be made available by the members of TC12. The final decision were postponed after a phone meeting befor the end of the year.

After the meeting some of the members sent their comments and suggestions on the paper draft, which will be used to prepare the final document that will be submitted to the PDA Journal of Pharmaceutical Science and Technology.

On October 17, the day before the TC12 meeting, the members participated to a one-day Workshop organized by the TC on the problems related to autoclaving, based on the experience gained during the roun robin tests. Experts on the topic were invited, and the discussion during and after the presentations was extremely useful. A final document will be prepared on the results of this Workshop.

A phone meeting was held on December 7, completely devoted to try to define the details of the future activity. Unfortunately, only 7 members could participate. The technical details of the different proposals were discussed, and it was decided that at least three producers should provide samples for the tests, and at least 80% of the labs should participate.

In order to start with the new activity, the last action of 2017 was to send to all members a questionnaire to fix technical details and  the strategy for testing in order to start soon at the beginning of 2018.

 

PLANS FOR 2018

1. Submission of a scientific paper on the experience of TC 12 on delamination.

2. Presentation of the results at the Annual Meeting in Yokohama in September 2018

3. Starting a new Round Robin activity, that will be defined in detail at the beginning of the year.

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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