From clinical phase to industrialization: Gx RTF Vials – top quality depyrogenated sterile ready-to-fill vials for injectables

From clinical phase to industrialization: Gx RTF Vials – top quality depyrogenated sterile ready-to-fill vials for injectables
From clinical phase to industrialization: Gx RTF Vials – top quality depyrogenated sterile ready-to-fill vials for injectables

Düsseldorf/Paris, January 15, 2020. At booth B60/B64 at Pharmapack in Paris, Gerresheimer, a leading global manufacturer of primary packaging for the pharmaceutical industry is presenting its new Gx RTF vials product offering. 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 cGMPs, washed in a cleanroom, processed through a depyrogenation cycle, and then packed for sterilization. Gerresheimer offers its own final packaging solutions as well as the industry known Ompi EZ-fill packaging designs. This means the vials are ready for the next steps in the filling process without any further and/or additional handling by our customers. 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. Multiple RTF manufacturing locations will also enable Gerresheimer to adapt to individual and specific market requirements. These benefits all lead to a significant reduction in our customer’s total cost of ownership across the product’s lifecycle and provide improved patient safety.

Top quality requirements

The Gx RTF injection vial products meet all established requirements of the applicable ISO standards and pharmacopoeias (USP and Ph. Eur.). Gx RTF products are offered in Gx Elite, Gx Armor and Gx Pharma Plus quality formats to help meet or exceed any customer or industry quality requirements.  RTF packaging solutions offered with the Ompi EZ-fill packaging platforms further enhance the finished product quality performance by preventing glass-to-glass contact, which could result in glass breakage and the creation of cosmetic defects.

Gerresheimer injection vials for international standards

Injection vials set the benchmark for primary packaging for parenteral drugs. Gerresheimer RTF vials come in many sizes and exceed all international standards and pharmacopoeia requirements. The company’s application range includes custom solutions for high value products for combination healthcare devices, bioengineered and branded drugs, and other specialized Pharmaceutical applications.

Flexibility through various packaging configurations and global operational footprint

This new RTF vial product offerings have several different final packaging solutions.  These new packaging formats allow customers to use RTF vials to support their operation in all phases of drug and product development of new medications and into small or large-scale commercial production.

  • Ompi EZ-fill nest & tub packaging products that offer 2R, 6R, and 10R vial formats.
  • Specialized tray packaging formats that support all tubular glass products sized from 2ml to 30ml (clear and amber).
  • Additional packaging solutions are currently under development that will support moulded glass products sized from 5ml to 50ml (clear and amber).

Intelligent defect recognition with state-of-the-art HD cameras

All of the Gerresheimer tubular glass plants that produce RTF vials work with standardized monitoring, inspection, and packaging technologies, which consist of the Gx G3 and Gx RHOC systems. The inspection systems are developed by Gerresheimer Global Engineering and form a highly specialized vial testing platform that ensures the highest precision and quality assurance requirements for our customers glass packaging. Complete with an enhanced, integrated system of modern HD cameras, the Gx G3 inspection system makes sure that cosmetic defects are identified reliably to support the production and quality control processes. 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.

More information:

Gx RTF Vials

About Gerresheimer

Gerresheimer is a leading global partner to the pharma and healthcare industry. With specialty glass and plastic products, the Company contributes to health and well-being. Gerresheimer operates worldwide and its approximately 10,000 employees manufacture products in local markets, close to its customers. With plants in Europe, America and Asia, Gerresheimer generates revenues of around EUR 1.4 bn. The company’s comprehensive product portfolio includes pharmaceutical packaging and products for the safe, simple administration of medicines: insulin pens, inhalers, micro pumps, prefillable syringes, injection vials, ampoules, bottles and containers for liquid and solid medicines with closure and safety systems as well as packaging for the cosmetics industry.

Gx® and RTF® are registered trademarks of the Gerresheimer Group. Ompi EZ-fill® is a registered trademark of Ompi, a Stevanato Group brand.

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