Vial Options Expand

Makers of parenteral products gained a new vial option with this summer’s launch of Viridian Vials by Corning. The vials serve as a drop-in replacement on fill/finish lines and combine performance and improved safety with sustainability (1), often a challenging objective for pharmaceutical manufacturers since packaging for parenteral products is likely to be incinerated and landfilled (2).

The improved sustainability profile can be attributed to a 20% reduction in glass material versus conventional glass vials, with no impact on the quality or safety of the vial. This reduction in glass material lowers manufacturing and transportation-related emissions (carbon dioxide equivalents) by up to 30% and decreases the total amount of glass entering the waste stream and ending up in the landfill (1). In addition, vials are produced using 100% renewable electricity (2).

Under development for several years, the Viridian Vial features a nanometers-thick coating, which reduces the coefficient of friction on the outer surface of the vial. It also reduces glass particulates in the fill/finish process by up to 96% (3). The proprietary polymer coating, which was developed for the company’s Valor Glass vial, introduced in 2017, ensures a low coefficient of friction before, during, and after filling to protect the vial and its contents (2). Viridian Vial’s external coating is capable of withstanding temperatures up to 360 °C and can maintain the vial’s strength during transportation, fill/finish, and delivery, helping to minimize cracks, breaks, and cosmetic rejects while substantially reducing tipovers and improving filling-line efficiency by up to 50% (1, 3). This increase in efficiency also has the potential to lower total product costs (3).

Extensive testing of the coated vial has shown the coating is robust under typical fill/finish conditions including machine-to-vial and vial-to-vial contact as well as when experiencing temperature extremes from the heat of depyrogenation to the cold of cold storage and lyophilization (4). “The tests indicate the coating remains where it is supposed to be, on the outside of the vial,” says Ron Verkleeren, senior vice president and general manager, Corning Life Sciences.

Commercial applications await FDA approval, but Verkleeren expects the approval process to move smoothly because the vials are made of Type I glass, an industry standard, and regulatory approval has been given to drugs packaged in Corning’s Valor Glass vials and Velocity Vials, which use the same external coating as Viridian Vials. “All elements of the process have been approved in one form or another,” he notes. “As a result, the regulatory approval process should be exactly the same if a customer is using Viridian Vials or a conventional Type I vial.”

The first product to use the vial could be almost any drug that is compatible with Type I glass, from a pediatric vaccine to a generic small-molecule formula. However, Verkleeren thinks a small-molecule drug is the most likely product to be first on the market in the Viridian Vial. “The validation process tends to be more straightforward for small-molecule drugs,” he explains.

West Pharmaceutical Services serves as the exclusive distributor for Viridian Vials (1).

References

1. Corning. Corning’s New Viridian Vials Reduce Waste and Carbon Emissions in the Pharmaceutical Supply Chain. www.corning.com, July 13, 2023.

2. Forcinio, H. Phone interview with Ron Verkleeren, senior vice president and general manager, Corning Life Sciences. July 12, 2023.

3. Corning. Corning Viridian Vials. Brochure, 2023.

4. Corning. Corning Viridian Vials. www.corning.com, Sept. 6, 2023.