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.
Activities and planned actions
Activities in 2019
The activities planned for 2019 were:
1. Completion of the testing activity on delamination.
2. Organization of an Open Session on Glasses for Pharma at the 25th International Congress on Glass.
3. Presentation of the results at the 25th International Congress on Glass.
4. Planning of future activities.
1. In 2018 a new testing activity on delamination was started with the aim to test, using the TC12 protocol for predicting the delamination propensity, the Low delamination propensity Vials available by the members of the TC, and to compare them with a set of “positive” vials (Vials with high delamination propensity). Nuova Ompi, Schott, Nipro, Corning and Bormioli Rocco provided 10 R vials with the desired low delamination propensity. Nipro provided also “positive” vials, i.e. made with 33 expansion borosilicate glass treated with ammonium sulfate. The results were mostly collected at the beginning of 2019 and were discussed in a teleconference in January. The preliminary conclusions were:
- There is clear evidence of the difference among actual “good” vials and “positive” vials.
- The percentage relative standard deviation (RSD%) is in general good. Considering the data for SiO2, 39 over 48 are below 15%, only 3 are over 20%.
- One lab reported, in general, more dispersed data.
- No delamination was observed, even in positive vials.
- The use of a more aggressive test is fundamental to draw conclusions on the correlation with delamination.
The discussion within the TC brought to the decision to initiate a further round robin activity testing the same type of vials used in the previous experiment, but using a different protocol with the minimum objective to provoke delamination at least in the “positive” vials.
It was decided to use the Accelerated Lamellae Formation protocol proposed by Sloey in 2013. It is based on a pre-treatment, to make the inner surface of vials more sensitive to the chemical attack, and the use of pH and temperature conditions able to induce delamination while avoiding the dissolution of flakes.
This activity involved 8 laboratories and was completed in November 2019. The results can be resumed as follows:
- Most labs could observe flakes only in “positive” vials.
- “Positive” vials reached very fast saturation (100% vials with lamellae) and maintained it till the end of the experiment (day 30).
- 2 labs observed lamellae also in “good” vials, but with a number of lamellae one to two orders of magnitude smaller than “positive” vials.
- The correlation between the TC12 protocol and delamination is demonstrated.
2. TC12 organized an Open Session on Glasses for Pharma at the 25th International Congress on Glass, in June in Boston. The organizers of the session were Daniele Zuccato, Holger Roehl and Massimo Guglielmi. The following six presentations were given:
N. Bessegato, Investigating the effects of the chemical composition on glass corrosion. A case study for Type I vials
E. Guadagnino, New challenges for Pharma glasses: Characterization updates, elemental impurities detection and data quality improvement (Invited)
M. Guglielmi, Delamination in pharmaceutical glasses: An update
M. Guglielmi (substituting D. Zuccato), TC12 “Pharma Packaging”: An update on the activities looking for a Delamination propensity predictive test
V. Rupertus, Dependency of Drug-Container-Interaction on filling volume
R. Schaut, Glass corrosion principles applied to pharmaceutical containers to predict extracted metal concentrations (Invited)
A Round Table followed, with a discussion on the most important and updated topics.
The Session was successful, with several active participants, many discussions and the generation of many interesting ideas.
3. The second presentation given by M. Guglielmi at the Open Session in Boston was devoted to explain the activity of TC12, and it was the first opportunity of divulgation of the preliminary results of the two round robins run in 2018 and 2019.
4. TC12 has now to plan the new activity steps. At the TC meeting held in Boston in June the discussion started and during the following months the opinions of the members were collected, but no decision has been taken yet. Several proposals are on the table, and will be afforded in detail in 2020, but modernization of compendial testing on Glass for Pharma and Extractables and Leacheables are the most shared themes.
PLANS FOR 2020
- Preparation of a paper to be submitted to a scientific journal, on the results obtained after the publication of the first paper on the propensity to delamination
- Submission of the first draft to the members and collection of opinions
February: Submission of the paper to the Journal of American Ceramic Society.
March 24: Meeting of the TC in Murano – Venice to decide the future activities.
May : Starting of a new experimental activity.
General plans for 2020 are:
1. Check the possibility to have common and synergic activities with TC02.
2. coordinate, if possible, the TC12 actions with the pharmacopoeias regulatory bodies (i.e. the United States Pharmacopeia, USP).
3. Trying to attract other members from the pharma world.
4. start new experimental activities on the topics of modernization of compendial testing on Glass for Pharma and / or Extractable and Leachables.
Guglielmi, Massimo Committee Position: Chair
Roehl, Holger Committee Position: Vice Chair
Rupertus, Volker (Prof)
Zuccato, Daniele Committee Position: Secretary
Committee Contact Details
TC12: Pharma Packaging