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 2018

As planned in 2017, the three main activities for 2018 were:

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 on delamination, to complete the study on this important problem.

 

1. The first paper authored by all the members of the TC12 was published recently in the PDA Journal of Pharmaceutical Science and Technology. It describes the results of the round robin activity of TC12 on the delamination propensity of glass vials was submitted. The paper was accepted in June 2018 and published online (doi:10.5731/pdajpst.2018.008599). Please find the abstract at the link: http://journal.pda.org/content/72/6/553.abstract

The process for the publication of the printed version was completed on November 9, with the acceptance of the corrected proofs. The paper was published on the November-December issue:

Juan Cerdan-Diaz, Ken Choju, Carol Rea Flynn, Ludovico Gavioli, Ron Iacocca, Amy Meysner, Joachim Pfeifer, Holger Roehl, Volker Rupertus, Martina Scarpa, Huimin Sun, Jingwei Zhang, Daniele Zuccato, andMassimo Guglielmi, Delamination Propensity of Glass Containers for Pharmaceutical Use: A Round Robin Activity Looking for a Predictive Test, J Pharm Sci Technol, November/December 2018 72:553-565.

It was agreed that the published results will be shared and discussed with the expert panel of the USP.

2. The results were also presented at the Annual Meeting in Yokohama in September 2018. Two presentations were given by the Chairman Massimo Guglielmi and the Secretary Daniele Zuccato, the first aimed to give an update on the problem of delamination in borosilicate glasses, the second describing the activity of TC12. The session was followed by several participants, and both presentations were much appreciated, activating an interesting discussion.

At the Annual Meeting TC12 was explicitly mentioned by the ICG Board as an example of a good Technical Committee.

3. Following the discussions of the members in 2017, a new testing activity on delamination started soon in 2018. Two steps were planned. The first step was aimed to test, using the TC12 protocol for predicting the delamination propensity, the best vials made available by the members of the TC, and to compare them with a set of “positive” vials. Nuova Ompi, Schott, Nipro, Corning and Bormioli Rocco provided 10 R vials considered of good quality with respect to delamination. Nipro provided also “positive” vials, i.e. made with 33 expansion borosilicate glass treated with ammonium sulfide in the inside. All the vials were shipped to the chair, who collected and labelled them. The chair shipped to eleven labs 60 vials from each producer. Nine labs completed the work within November, and the results were shortly discussed during a teleconference on November 19. A deeper discussion has been scheduled in January 2019 with a teleconference completely devoted to this task. The second step will start soon in 2019. It will be based on the use of a more aggressive testing protocol on the same type of vials used in step 1, with the minimum objective to provoke delamination at least in the “positive” ones, in order to support the results of the predicting test with the observation of the predicted phenomenon of delamination.

In July, from 3 to 6, TC12 was present at the Summer School of ICG in Montpellier. The chairman and the secretary participated to the school giving the following four lectures in the Pharma Glass session:

  • Introduction to glasses for pharma uses
  • Production Processes
  • Mechanical properties of glasses for pharma uses
  • Chemical Properties of glasses for pharma use

A further activity was started in 2018: the organization of an open session on Glasses for Pharma at the 25th International Congress on Glass (ICG2019) that will take place in Boston on June 2019. The session will be open to all topics of interest in the field of pharmaceutical applications of glass, and will end with a roundtable.

During 2018 there was an intense email activity for discussing all the aspects of the activity of the TC. The Chairman, the Vice-Chairman and the Secretary had a phone meeting on June 2018 to discuss which option to select for a more severe testing condition to induce delamination in vials. It was decided that the Amgen test is the best one to try, and to prepare a clear and operative protocol before starting the discussion with the other members of the TC. A teleconference with most of the members of the TC was held in November 2018., and a teleconference, with the participation of most of the members, was held in November.

 

PLANS FOR 2019

The activity in 2019 is planned as follows:

January: Proposal for an aggressive testing protocol.

January 21: teleconference to discuss the results of the new testing activity – step 1, and the final decision on the aggressive test.

February: start of lab activity - step 2.

April-May: teleconference to discuss the results of step 2.

June 9-14, 2019, 25th International Congress on Glass: TC12 Meeting, Open Session, etc.

In the second half of the year the TC will have to decide on the future activities.

 

Committee Members: back to top

Bessegato, Nicola
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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