Vaccines
mAbs
RNA/DNA-based products
Low leachable profile, twice less particles then in glass vial
Cytotoxics
Radiopharmaceuticals
Nanomedicines
Unbreakable container, always closed to avoid contamination
Cell therapy
Gene therapy
Other low T° storage products
Container Closure Integrity even in liquid nitrogen
The AT-Closed Vial® Technology is based on the concept of the ready-to-fill Closed Vial, whereby polymer vials are provided:
- clean (molded in ISO 5 clean room)
- closed (stopper in place and secured)
- sterilized (gamma-irradiated)
AT-Closed Vial® ensures better sterility assurance, lower particle presence and uncompromised container closure integrity, even during cryogenic storage.
The overall filling process of the ready-to-fill AT-Closed Vials® is made of very few steps:
- Filling of the vial with a needle puncturing the elastomeric stopper.
- Immediate laser re-sealing to restore the closure integrity of the filled vial.
- Capping with a tight snap-fit cap protecting the piercing area.
Materials selected for the product contact parts meet USP and EP requirements for pharmaceutical primary container:
- COC (Cyclo-Olefin Co-polymer) for vial body, known for shock-resistance, barrier properties and transparency
- TPE (Thermo Plastic Elastomer) for stopper, a proprietary material allowing specific processing
both having excellent leachable profile.
The fully automated vial manufacturing process ensures clean conditions: vial and stopper are molded in Grade A/ISO 5 and immediately assembled by robots, minimizing particle content compared to other types of primary containers. AT-Closed Vials® are then packed and sterilized by gamma irradiation, being supplied as Ready-to-Fill containers.
| AT-Closed Vial® | 1 ml | 2 ml | 6 ml | 10 ml | 20 ml | 50 ml |
|---|---|---|---|---|---|---|
| Specific solutions for UV-, O2-sensitive, lyophilized products can be offered. | ||||||
| Height (in mm, +1mm if capped) | 33.10 | 33.10 | 39.30 | 49.80 | 61.20 | 84.90 |
| External vial diameter (in mm) | 18.30 | 22.30 | 25.00 | 25.00 | 30.00 | 36.00 |
| Maximum volume filled (in ml) | 1.35 | 2.25 | 7.60 | 11.70 | 21.80 | 52.10 |
| Cryogenic storage | can be cryopreserved while keeping Container Closure Integrity | |||||
| Colored caps | are available in different colors for product differentiation | |||||
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