German pharmaceutical glass specialist Schott has developed what the firm claims is the first large pharmaceutical vial to provide a reduced delamination propensity and decrease the risk of product recalls. In a customer project for a large US-based biotech company, Schott succeeded in applying its proven manufacturing process for delamination controlled vials to a customised 50ml vial.
In response to the pharmaceutical industry’s delamination concerns surrounding the storage of pharmaceutical products in glass vials, Schott has combined high-quality Fiolax glass tubing with an optimised hot forming process, as well as a quantitative chemical glass surface test routine, to develop Schott Vials DC. The DC manufacturing process ensures that the glass surface is more homogeneous and therefore less susceptible to delamination. Currently, the company’s portfolio includes ISO sizes from 2R to 10R. Through this project, Schott has also proven its capability to apply this knowledge to large and customised vials.
Schott says it is the first manufacturer capable of determining the risk of delamination based on threshold values. During the company’s patented Delamination Quicktest, a certain number of vials are randomly removed from every batch and subjected to stress for four hours inside an autoclave to identify the delamination critical zone. In a second step, the vials are filled with high purity water (WFI – Water for Injection) and sodium is extracted inside an autoclave. The volume of sodium extracted correlates with the probability that the vials will experience delamination at a later point in time.
'By monitoring these values and adhering to certain thresholds, Schott is able to control the risk of delamination,' says Dr Bernhard Hladik, Senior Product Manager at Schott Pharmaceutical Systems. 'We validated the new customised 50ml vials with the Schott Delamination Quicktest, which from our point of view is the most suitable method to minimise the manufacturing related risk for glass delamination.
'The first approach trying to quantify the delamination tendency was based on limiting the surface alkalinity of the respective container. However, Schott found that vials that scored well in the surface alkalinity test still showed a high tendency to delaminate if the Schott Delamination Quicktest was not passed. Therefore, the firm only uses the proven Delamination Quicktest to measure the risks of delamination.'
