03-25-2019, Mainz, Germany / New York City, NY, U.S.
SCHOTT EVERIC™: Vials optimized for high potency drugs, even with low filling volumes
SCHOTT presents a new generation of ultra-pure pharmaceutical vials to meet the exacting drug stability needs of low-fill drugs. Designed as a modular concept, EVERIC™ provides pharmaceutical companies with a unique combination of attributes to package biologic drugs while supporting today’s quality requirements of fill and finish lines.
The newest pharmaceuticals have exacting packaging requirements to protect against interactions between drug and container. Especially the bottom-near heel region of standard vials often acquires an inhomogeneous chemical structure during the forming process and is prone to ion exchange, which might potentially harm the drug. At the same time, the heavy costs of developing and producing highly potent drugs such as biologics or vaccines put pressure on the pharmaceutical filling process to increase yields and reduce waste.
SCHOTT EVERIC™ is a new generation of ultra-pure pharmaceutical vials to meet the exacting drug stability needs of low-fill drugs. Picture: SCHOTT
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.
EVERIC™ pure is available now and will be supplied from SCHOTT’s production facilities in the U.S. (Lebanon, Pennsylvania) and Germany (Müllheim).
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.
Modular approach for optimized fill & finish
In the future, pharmaceutical companies will be able to add even more features to their EVERIC™ vials to improve the drug filling and transportation process:
EVERIC™ strong: SCHOTT used computer simulation to improve forming and geometry at the vial’s handling and contact points in the heel and shoulder area. As a result, the vials can better withstand side compression and axial load during filling and transportation, reducing the risk of glass breakage.
EVERIC™ smooth: The direct vial-to-vial contact on conventional bulk filling lines can create glass particles that may end up inside the container. To reduce the friction and allow the container to run smoothly through the production line, EVERIC™ vials can be delivered with a coating of the outer surface. The surface treatment is abrasion-free and fully transparent to ensure unimpeded visual inspection. It is limited to the most relevant areas of the vial body, i.e. the sidewall, and withstands washing and depyrogenation without degradation. Tests have shown an 80% improvement of the coefficient of friction (CoF) through the treatment.
These additional features will be available for sampling in the course of 2019.
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, pharma, electronics, optics, life sciences, automotive and aviation industries. SCHOTT strives to play an important part of everyone’s life and is committed to innovation and sustainable success. With more than 15,500 employees at production sites and sales offices in 34 countries, the group has a global presence. In the 2017/2018 fiscal year, SCHOTT generated sales of around $2.5 billion.
Gregory FCA on behalf of SCHOTT