From clinical phase to industrialization: Gx RTF Vials – top quality depyrogenated sterile ready-to-fill vials for injectables.
Gerresheimer offers both its own packaging, as well as the familiar Ompi EZ-fill packaging design.
Gx RTF vials – ready for filling
The Gx RTF injection vials are made from type I borosilicate glass and meet all current requirements of the applicable ISO standards and pharmacopeias (USP and Ph. Eur.). They are manufactured in accordance with cGMP, washed in a cleanroom, packed in trays or in nests and tub and finally sterilized. Gerresheimer offers its own packaging as well as the well-known Ompi EZ-fill packaging design. This means the vials are ready for the next steps in the filling process without any further and/or additional handling. The benefits are obvious: sterile delivery, a simplified fill and finish process, the highest quality standards, flexibility thanks to various possible packaging options and a wide range of filling and sealing technologies. These all lead to a significant reduction on overall manufacturing costs across the product’s entire lifecycle and improve patient safety.
Top quality requirements
The Gx RTF injection vials meet all established requirements of the applicable ISO standards and pharmacopoeias (USP and Ph. Eur.). By using its own or the Ompi EZ-fill packaging formats, the risk of glass-to-glass contact, which could result in breakages, cosmetic defects, and particle contamination is reduced to an absolute minimum. Gx RTF products are offered in Gx Elite, Gx Armor and Gx Pharma Plus quality formats to help exceed any of our customers quality requirements.
Gerresheimer injection vials for international standards
Injection vials set the benchmark for primary packaging for parenteral drugs. Gerresheimer’s come in all sizes and comply with the relevant international standards and pharmacopeias. The company’s range includes solutions for bioengineered drugs and other specialty pharmaceuticals.
Flexibility through various packaging configurations and global operational footprint
This new product offering currently exists in 2R, 6R, and 10R formats in nest & tubs configurations as well as in formats ranging from 2ml to 30ml (clear and amber) in tray configuration. Further formats are currently under development and will follow rapidly. The new packaging solution allows vials to be used from the development phase of new medications into small or large-scale production.
Multiple manufacturing locations will enable Gerresheimer to adapt to individual and specific market requirements and to support total cost of ownership requirements from our customers all over the world.
Intelligent defect recognition with state-of-the-art HD cameras
All Gerresheimer’s tubular glass plants producing vials work with standardized monitoring, inspection, and packaging technologies, which essentially comprise the Gx G3 and Gx RHOC systems. The inspection systems are developed in house and form part of a close-knit testing system that ensures the highest precision and quality assurance in line with the latest standards. Complete with state-of-the-art HD cameras, the Gx G3 inspection system makes sure that cosmetic defects are identified reliably, for instance. The intelligent software detects and classifies the defects in a few fractions of a second, while the Gx RHOC system ensures dimensional quality with HD matrix cameras and a hyper centric ID camera.