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One of the main obstacle to safe delivery of some biotech injectables in borosilicate containers can be glass delamination. The composition of the raw glass material, the conversion process of the glass tubing into containers and the drug formulation interaction are recognized as the main root causes of delamination. To control this phenomenon, the converting process can be optimized by an appropriate choice of key parameters like glass composition, flame temperature, exposure time, machine speed and annealing profile. Although the borosilicate glass is widely recognized as the most recommended glass to be used for parenteral preparations, it can be possibly subject to phase separation, which in turn may induce delamination. To combat this, new glass formulations which are deemed as delamination-free are currently under investigation. Up to now, the delamination propensity of pharmaceutical containers has been predicted on the basis of tests carried out on the container itself, but it would be advisable to develop a method that can predict it before its conversion into a finished product.
The focus of the SGLab Department (Stevanato Group) was then polarised on the raw glass material, either in form of tubing pieces or in form of stripes of the cane that have been thermally treated and tested by a conventional delamination test. Further research was carried out on glass sheets obtained from experimental melting at lab scale of potentially delamination-free glass compositions. Results for extracted silica were used to establish a correlation between the raw glass probes and the corresponding final product. Relevant information on the delamination propensity of glass can be achieved even if the final container or the mother glass cane are not directly available.
The SEM images illustrate the surface state of the raw glass material (left) and the corresponding container obtained from (right), after appropriate thermal treatment and extraction with an aggressive solution used to accelerate the delamination phenomenon. The two images are close comparable.
A complete scientific paper to be published in a specialized Journal is under preparation.
SGLab is an advanced analytical laboratory grown under the R&D department of Stevanato Group. The SGLab mission is to be a provider of new-added value analytical services to guarantee the integrity of parenteral drugs and to support the realization of strategic R&D projects. SG Lab is now serving the pharma industry to ensure the integrity of container closure systems and consecutively the drug delivering.
SG Lab analytical activity is mainly focused on primary packaging chemistry, surfaces characterization and CCS physical and mechanical performance. Among the analytical services, SG Lab is offering tailored testing protocols and consultancy services to allow customer to take decision and find the target.