Ready-To-Use Vials for Aseptic Pharmaceutical Processing

As a leading manufacturer of top-tier RTU glass vials for the pharmaceutical industry, Nipro offers precise solutions tailored to the unique needs of both standard and complex drug products. Whether for vaccines, biologics, or other sensitive medications, Nipro’s D2F™ glass vials (powered by Stevanato Group EZ-fill® technology) provide a reliable option for pharmaceutical companies.

Leveraging extensive expertise in glass manufacturing, Nipro produces vials that seamlessly integrate into the intricate workflows of pharmaceutical production. D2F™ glass vials promote smooth fill-finish operations, stable storage, and efficient administration.

Manufactured in state-of-the-art facilities, Nipro’s RTU vials adhere to strict quality systems, including ISO 15378 and ISO 9001 certification.

Our robust support infrastructure, which includes regulatory guidance, technical assistance, and laboratory facilities, ensures a prompt response to queries and fosters successful partnerships.

Specifications

Reduced Time-to-Market

For pharmaceutical companies deciding to switch to RTU vials there is no need to develop and validate washing and depyrogenation in house. D2F™ vials are readily available and can be used directly in the aseptic production area.
Moreover, production capacity can be scaled up from test samples to commercial production according to customer needs.
D2F™ nest and tub formats have been developed in collaboration with the main machine suppliers. Consequently, D2F™ vials can be processed on a broad range of fill-finish lines, supporting easy and fast integration.

D2F™ vials’ availability and compatibility shorten time to market

Improved Container Performance on Filling Lines

D2F™ tub and nest formats prevent glass-to-glass contact. This reduces the risk of breakages, and minimizes cosmetic quality issues and particle generation during transportation and handling operations. As a result, D2F™ vials will keep their original strength and mechanical durability and maintain their high cosmetic quality, resulting in fewer breakages and less down time in the fill-finish line as well as fewer rejections at final inspection.

Ultimately this contributes to more stable and cost-efficient fill-finish operations.

Outsourcing of Non-Core Activities Improves Total Cost of Ownership

By outsourcing non-core activities for sterile vials (washing, depyrogenation, sterilization) to Nipro, our business partner will save the time and cost involved in preparing RTU containers. Our customers will receive D2F™ vials washed, depyrogenated, and sterilized.

D2F™ vials arrive ready to be used directly in aseptic fill-finish operations.

Depending on your drug product requirements you can choose from three distinct quality levels. Each quality level offers specific benefits and lists a comprehensive scope of product and service attributes that forms the perfect base to fine-tune the quality precisely to your needs.

ENABLE | Standard-quality

ENHANCE | High-quality

ENGAGE | Custom-quality

ENABLE | Standard-quality

[Preset, standardized product specifications, standard AQLs, standard service level, standard support, standard data package]

Vials manufactured to ENABLE quality standards meet the quality and service criteria essential for standard drug products. Critical dimensional and cosmetic parameters undergo rigorous camera inspection in real-time, guaranteeing swift and reliable performance along the filling line. These vials adhere fully to established quality standards, including ISO 15378, Pharmacopoeias, the "Defect Evaluation List," and the PDA Lexicon. They represent the optimal solution for drug products produced in high volumes that demand fast time-to-market.

Fast and Reliable Filling-line Performance

Control of critical cosmetic parameters
Inspection of key dimensional aspects
100% in-line camera inspection
Statistical process control

Compliant with Prevailing Quality Standards

Cosmetic and dimensional AQLs according to main quality standards
ISO 15378 (incl. 9001) certified
Conforms to ISO 8362-1
Compliant with prevailing Pharmacopoeia (EP, USP, JP)
Production in controlled environments and packaging in ISO-class cleanrooms

ENHANCE | High-quality

[Preset, standardized product specifications, exceptional strict AQLs, advanced service level, comprehensive support, extended data package]

ENHANCE quality vials excel in both drug-container compatibility and filling line efficiency. Our exclusive VIALEX™ technology significantly enhances the durability of the inner vial surface. This innovation translates into tangible benefits such as reduced pH shifts, minimized risk of delamination, and optimized lyophilization fogging. Moreover, our extended data package streamlines the acceptance of incoming goods, ensuring a seamless process. Service is our cornerstone and our experienced, cross-functional support team stands ready to swiftly address any inquiries or challenges that may arise. For drug products demanding high-quality packaging solutions, ENHANCE quality emerges as the right choice.

Outstanding Drug-container Compatibility

VIALEX™ - Superior surface durability for a significant lower risk of drug-container interaction
Significantly lower risk of pH shift
Minimized risk of delamination
All points in, each vial 100% inspected (thermal scan)

Optimized Filling-line Performance

100% in-line camera inspection of an extensive range of dimensional and cosmetic attributes
Reduced glass-to-glass contact leads to increased mechanical durability
Outstanding cosmetic characteristics minimize the risk of false rejects at final inspection, leading to reduced drug loss

Meeting the Highest Regulatory and Quality Requirements

Very tight dimensional and cosmetic AQLs reflect exceptional container quality
Production in controlled environments & packaging in ISO-class cleanrooms
ISO 15378 (incl. 9001) certified systems
Conforms to ISO 8362-1
Compliant with prevailing Pharmacopoeia (EP, USP, JP)

ENGAGE | Custom-quality

Fully customize your product and service specifications to meet your unique, non-standard quality and design requirements. Customization is fully supported by an experienced and cross-functional team.

The inner glass surface of the vial undergoes Nipro's proprietary thermal surface treatment, known as VIALEX™, which involves no additional materials or alteration in glass chemistry and is subject to 100% in-line inspection. This treatment mitigates the effects of the converting process in two ways: by reducing sodium concentrations and by improving the inner glass surface.

VIALEX™ treated vials offer unparalleled benefits for challenging drug formulations, featuring exceptional inner surface durability. The enhanced durability leads to lower levels of extractables and leachables (E&L), minimizing the risk of pH shifts and delamination events. Additionally, VIALEX™ technology has a positive effect on the lyophilization process, resulting in less fogging. These benefits enhance the storage stability of drug products and contribute to a longer shelf-life.