10-14-2015, Lebanon, PA
CPhI: SCHOTT Expands Delamination Control with New Large-format 50 ml Vial DC
First large vial that keeps delamination under control paves the way for pharma manufacturers warding off the risk of product recalls
SCHOTT has developed the first large pharmaceutical vial that provides a reduced delamination propensity and decreases the risk of product recalls significantly. In a customer project for a US-based biotech company SCHOTT succeeded in applying its proven manufacturing process for delamination controlled vials to a customized 50 milliliter vial.
SCHOTT Vials DC have a very homogeneous glass surface and are therefore less susceptible to delamination.
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 optimized hot forming process, as well as a quantitative chemical glass surface test routine, to develop SCHOTT Vials DC. The DC manufacturing process ensures 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 customer project, SCHOTT has proven its capability to apply this knowledge to large and customized vials as well.
Validation through SCHOTT Delamination Quicktest, not through Alkalinity
SCHOTT 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 customized 50 ml vials with the SCHOTT Delamination Quicktest, which from our point of view is the most suitable method to minimize 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, SCHOTT only uses the proven SCHOTT Delamination Quicktest to measure the risks of delamination.
SCHOTT is a leading international technology group in the areas of specialty glass and glass-ceramics. The company has more than 130 years of outstanding development, materials, and technology expertise and offers a broad portfolio of high-quality products and intelligent solutions. SCHOTT is an innovative enabler for many industries, including the home appliance, pharmaceutical, electronics, optics, automotive, and aviation industries. SCHOTT strives to play an important part of everyone’s life and is committed to innovation and sustainable success. The group maintains a global presence with production sites and sales offices in 35 countries. With its workforce of approximately 15,400 employees, sales of $2.55 billion were generated in fiscal year 2013/2014. us.schott.com
Gregory FCA on behalf of SCHOTT
SCHOTT North America, Inc.
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