Pharmaceutical and speciality glass manufacturer Schott has invested in the expansion of its delamination controlled vials manufacturing facility in the USA.
The rise in biotech drug formulations has triggered an increasing demand for primary packaging with superior surfaces and high cosmetic quality”, said Christopher Cassidy VP Sales & Marketing, North America, Schott Pharmaceutical Packaging.
To cater this need, the international technology group will be expanding its Schott Vials DC (Delamination Controlled) manufacturing capability in the beginning of the first quarter of 2018 to also supply customers from its Lebanon, PA facility.
Over the past few years, delamination has led to recalls of numerous injectable drugs. Schott said its Vials DC reduce the risk of glass delamination and brings it under control.
It developed a hot forming technology to prevent delamination. The hot forming technology creates a chemically homogeneous inner surface for the vial, improving its chemical stability.
Each batch of vials undergoes a clear control strategy based on the company’s Quicktest, which uses a predefined quantitative limit value to verify that the delamination risk has been reduced and is under control.
Optimised manufacturing is also the key to preventing chips and cracks in the glass surface and improving overall cosmetic quality. This facilitates automated machine inspection during filling operations and makes the vials less susceptible to breakage.
”Glass has a remarkably high internal strength”, said Cassidy. “Its weak points are small cracks on the surface or edges. Micro-defects caused during production or handling spread inward as mechanical stress increases.
"This can lead to fractures. An intact surface will already make a glass vial twice as resistant to breakage without any additional treatment.”