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).

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