Closed Vial<sup>®</sup> 無菌雷射密封瓶  |產程相關|無菌充填|Crystal® 機械手臂充填系統

Closed Vial® 無菌雷射密封瓶


The the ready-to-fill AT-Closed Vial® Technology is an aseptic fill & finish solution aiming to minimize the contamination risks while simplifying the process.




AT-Closed Vial® 無菌雷射密封瓶
應用領域 / Fields of use
Biological

Vaccines
mAbs
RNA/DNA-based products

Low leachable profile, twice less particles then in glass vial

Potent

Cytotoxics
Radiopharmaceuticals
Nanomedicines

Unbreakable container, always closed to avoid contamination

Cryostored

Cell therapy
Gene therapy
Other low T° storage products

Container Closure Integrity even in liquid nitrogen

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:

  • 潔淨性 (於ISO 5 清淨室內製模)
  • 密閉性 (膠塞已固定於瓶子上)
  • 無菌性 (加馬射線滅菌)
 
"Item-level isolator"

AT-Closed Vial® ensures better sterility assurance, lower particle presence and uncompromised container closure integrity, even during cryogenic storage.

材質 / Process

ready-to-fill AT-Closed Vials®

AT-Closed Vial® Technology與產品接觸材質符合USP及EP對於藥品 容器之要求:

  1. 瓶身COC (Cyclo-Olefin Co-polymer)
  2. 膠塞TPE (Thermo Plas�c Elastomer)
材質 / Materialst

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

  • 瓶身:COC (Cyclo-Olefin Co-polymer) for vial body, known for shock-resistance, barrier properties and transparency
  • 膠塞:TPE (Thermo Plastic Elastomer) for stopper, a proprietary material allowing specific processing

 

ready-to-fill AT-Closed Vials®
規格 / Specification
 
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.

高度 (mm, 若加蓋+1mm)

33.10 33.10 39.30 49.80 61.20 84.90
外部直徑 (mm) 18.30 22.30 25.00 25.00 30.00 36.00
最大充填體積 (ml) 1.35 2.25 7.60 11.70 21.80 52.10

低溫儲存

可, 瓶子都可低溫儲存並保持密閉性。

光敏性

可,瓶子可選用褐色瓶身以避光。

低氧性

可, 瓶子在充填及運送過程中可保持低氧狀態。

瓶蓋顏色

瓶蓋具有多顏色可選擇,便於區別

 


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Closed Vial® 無菌雷射密封瓶

The the ready-to-fill AT-Closed Vial® Technology is an aseptic fill & finish solution aiming to minimize the contamination risks while simplifying the process.