High-quality Vials for Stable Storage of Drug Products
Nipro vials are made of high-quality glass tubing that meets the stringent standards of global pharmacopoeias (EP, USP, JP). Our vials feature a high chemical resistant to drug-container interactions and support stable storage of liquid and solid drug products.
Each vial is subject to careful cosmetic and dimensional inspections, using advanced in-line camera technology. Supported by rigorous statistical process control (SPC) and in-process controls (IPCs), our manufacturing processes adhere precisely to defined quality specifications. Forming and packaging processes take place in controlled environments or ISO class cleanrooms.
As a result, our vials offer exceptional dimensional and cosmetic quality, facilitating an efficient fill-finish process, and contributing to stable storage throughout the entire shelf-life of pharmaceutical products.
Specifications
Depending on your drug product requirements, you can choose from three distinct Quality Levels. Each Quality offers specific benefits and lists a comprehensive scope of product and service attributes, providing 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.
| Nominal Volume (ml) |
Outer Ø - Body |
Outer Ø - Neck |
Height (mm) |
Wall thickness (mm) |
|---|---|---|---|---|
| 2(R) | 16 | 13 | 35 | 1 |
| 4(R) | 16 | 13 | 45 | 1 |
| 6(R) | 22 | 20 | 40 | 1 |
| 8(R) | 22 | 20 | 45 | 1 |
| 10(R) | 24 | 20 | 45 | 1 |
| 15(R) | 24 | 20 | 60 | 1 |
| 20(R) | 30 | 20 | 55 | 1.2 |
| 25(R) | 30 | 20 | 65 | 1.2 |
| 30(R) | 30 | 20 | 75 | 1.2 |
| 50(R) | 40 | 20 | 73 | 1.5 |
| 75 | 40 | 20 | 100 | 1.5 |
| 75 | 47 | 20 | 75 | 1.7 |
| 75 | 47 | 28 | 75 | 1.5 |
| 75 | 47 | 32 | 75 | 1.95 |
| 100(R) | 47 | 20 | 95 | 1.7 |
| 100 | 47 | 28 | 95 | 1.5 |
| 100 | 47 | 20 | 95 | 1.95 |
| Type of Blowbacks |
Surface Treatments |
Printing |
|---|---|---|
| EU | VIALEX™ | Ceramic |
| US | Ammonium Sulfate | |
| Siliconization |
Frequently Asked Questions (FAQs)
What is a "crimp neck" glass vial?
A "crimp neck" glass vial refers to a type of glass vial that features a neck designed to be sealed with a crimp-on closure or cap. The neck of the vial typically has a specific shape or profile that allows for secure sealing with a crimping tool.
What is a "screw neck" glass vial?
A "screw neck" glass vial is a type of glass vial that features a threaded neck, allowing it to be securely closed and sealed with a screw-on closure or cap. The threaded design enables the closure to be easily twisted onto the vial neck, creating a tight seal that helps prevent leakage and contamination.
Need help?
Get in touch
For information regarding Nipro products, services, and resource material:
| Give us a call +32 15 263 500 |
E-mail us pharmapackaging@nipro-group.com |
| Submit a detailed inquiry: Contact per expertise |
View our manufacturing locations: Our global network |