EVERIC™ optimized Vials

SCHOTT EVERIC® pure is the ideal vial for all types of medicinal products. Proven drug stability especially for sensitive drugs and drugs with low filling volume. SCHOTT EVERIC® vials ensure drug stability by using FIOLAX® CHR (Controlled Hydrolytic Resistance) glass tubing, which has a higher chemical stability than standard borosilicate glass without changing the composition.

SCHOTT EVERIC® vials are manufactured on a special delamination controlled production line using SCHOTT's patented technology that provides tighter control during the process. This creates a homogeneous wall, even in the heel zone (the area near the bottom of a vial). For validation and product release, SCHOTT has also developed and patented the Quicktest, which quantifies the risk of washout / delamination of each production batch.

 

SCHOTT EVERIC® vials are also available in sterile and ready-to-use RTU versions. Please contact us.

 

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

SCHOTT EVERIC ™ pure was developed for sensitive drugs and medicines with low filling volumes. The new vials ensure the stability of the drug by using an improved borosilicate glass tube: Thanks to more stringent process control, FIOLAX® CHR (controlled hydrolysis resistance) provides higher chemical stability while the original glass composition remains unchanged. In addition, the vials are processed through the company's approved DC forming (delamination controlled) process, which ensures the chemical stability and homogeneous surface of the glass tubes during processing. Thanks to the existing regulatory validation, pharmaceutical companies can replace conventional tubular Type I glass vials with EVERIC ™ pure for already marketed drugs without the need for costly re-registration.

SCHOTT used a computer simulation to improve the shaping and geometry at the vial's handling and contact points in the heel and shoulder area. As a result, the vials can better withstand lateral compression and axial loading during filling and transport, reducing the risk of glass breakage.

Direct vial-to-vial contact on conventional filling lines can create glass particles that can enter the container. To reduce friction and ensure smooth running of the container on the production line, EVERIC ™ vials can be supplied with a coating on the outer surface. The surface treatment is non-abrasive and completely transparent to ensure unobstructed visual inspection. It is limited to the most relevant areas of the vial body, i.e. the sidewall, and resists washing and depyrogenation without degradation. Tests have shown an 80% improvement in coefficient of friction (CoF) with the treatment. These additional features will be available for sampling during 2019.

 

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