Low leachable profile, twice less particles then in glass vial
Unbreakable container, always closed to avoid contamination
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|