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無菌雷射密封瓶-德叡


AT-Closed Vial®




技術概念 / Concept

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).

應用領域 / Fields of use

Biological
Biological
-Vaccines
-mAbs
-RNA/DNA-based products
Low leachable profile, twice less particles then in glass vial.
Potent
Potent
-Radiopharmaceuticals
-mAbs
-Nanomedicines
Unbreakable container, always closed to avoid contamination.
Cryostored
Cryostored
-Cell therapy
-Gene therapy
-Other low T° storage products
Container Closure Integrity even in liquid nitrogen.

步驟說明 / Process

The overall filling process of the ready-to-fill AT-Closed Vials® is made of very few steps:

3 process steps: filling, laser re-sealing, capping

1.Filling of the vial with a needle puncturing the elastomeric stopper.
2.Immediate laser re-sealing to restore the closure integrity of the filled vial.
3.Capping with a tight snap-fit cap protecting the piercing area.

材質 / Materials

Materials selected for the product contact parts meet USP and EP requirements for pharmaceutical primary container

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.

規格 / Technical specifications

AT-Closed Vial bottom
AT-Closed Vial® 1 ml 2 ml 6 ml 10 ml 20 ml 50 ml
Height (in mm, +1 mm 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

Specific solutions for UV-, O2-sensitive, lyophilized products can be offered.

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