SCHOTT EVERIC® Pure Vials

To meet these demands, SCHOTT has developed EVERIC® pure for sensitive drugs and drugs with low filling volumes. The new vials ensure drug stability by using an improved Borosilicate glass tubing: Thanks to tighter process control FIOLAX^® CHR (controlled hydrolytic resistance) comes with higher chemical stability while leaving the original glass composition unchanged. In addition, the vials are converted by the company’s approved DC forming process (delamination controlled), which carries the chemical stability and homogeneous surface of the glass tubing through the converting process. Thanks to existing regulatory validation, pharma companies can replace conventional tubular type-I glass vials for already marketed drugs with EVERIC® pure without costly re-registration.

Reduced delamination risk for low-fill applications

More than two thirds of all drugs in pipeline are biologics, and a large number will be filled in dosages under 1 ml (milliliter). In such low-fill scenarios, the high ratio of wetted container surface to drug volume leads to a proportional increase in exposure to leachables. Thanks to their better chemical resistance, EVERIC® pure vials show a very low concentration of leached ‘glass’ elements even for low fill applications – major advantage over aluminosilicate vials. As a result, the new vials provide a tool for pharma companies to keep delamination under full control.

SCHOTT EVERIC® is a modular system featuring solutions to common challenges faced by the pharmaceutical and biotech industries. Find out more about the rest of the EVERIC® range.