Are there substantial reasons to prefer tubing glass vials over “Delta” moulded glass vials?
According to the results of a new experimental investigation launched by pharmaceutical glass packager Bormioli Pharma entrusted to external laboratories and validated by Massimo Guglielmi, Professor and Coordinator of the Technical Committee "Pharma Packaging" of the International Commission on Glass (ICG), the answer is no.
The aim of the investigation was to compare the properties and performance of vials obtained from tube processing from Delta processing, the result of Bormioli Pharma's advanced proprietary moulding technology.
The scientific work included numerous tests including dimensional, mechanical, thermal, aesthetic and chemical tests, carried out according to the indications of the European Pharmacopoeia and conducted at the Stazione Sperimentale del Vetro (SSV), and examined 10 ml and 30 ml vials, both produced by Bormioli Pharma.
The results show that both tubing and 'Delta' moulded glass vials have clear and identifiable benefits, and that for such reason there is no better choice in every condition.
On the one hand, tubing vials are generally considered better by pharmaceutical manufacturers due to their better dimensional consistency, reduced weight and excellent aesthetic appearance.
On the other hand, Delta moulded glass vials - the production of which has considerably improved over the past decade - have better mechanical strength, due to their thicker walls, and better chemical behaviour, especially in relation to extractables and delamination.
In the pressure range relevant for pharmaceutical freeze-drying, the differences between tubes and Delta vials are negligible.
Similarly, when considering thermal shock resistance, the two types of vials have, in fact, the same behaviour, at least up to 90°C.
“Although some differences remain between the vials produced by the two types of process, some favouring one, some favouring the other, in the case of the two types of Bormioli Pharma vials examined in this paper, it can undoubtedly be said that they are practically equivalent for their intended purposes," said Andrea Sentimenti, Marketing & Innovation Director of Bormioli Pharma.
"With this experimental investigation we want to begin to shed light on the properties of glass types and demonstrate how the choice between one product and another should not be guided by the type of glass itself, but rather by the specific requirements dictated by the pharmaceutical application and the type of production process."