Tema Sinergie

CRP6

CRP小瓶灌装和压接装置

CRP is a precise and compact system for dispensing and sealing vials of radiopharmaceuticals in sterile conditions. It allows safe and rapid radiopharmaceutical dispensing into vials minimizing the operator’s tasks.
It is suitable for any laminar flow hot hell with a dose calibrator pit and tele-pliers.

The main parts of the unit are:

  • Opening/Closing/Crimping unit with:
    • station for rubber cap removing/positioning;
    • station for aluminum ring removing/positioning;
    • station for aluminum ring crimping;
    • actuated arm for vial moving among the above stations.
  • A diluting/filling unit
  • A piercing unit
  • Additional stand-alone balance for faster activity concentration calculation (optional)

The system automatically performs the following functions:

  • It measures both total and specific activity delivered by the synthesis module
  • It dilutes the main vial to the required specific activity
  • It fills open or closed vials, controlling the volume, using a built-in high precision electronic scale
  • It plugs and crimps the filled vial (if open vials)
  • It is possible to carry out the bubble point test (instruments not included) without touching the contaminated filter

A computer and operating software, compliant with GAMP5 and CFR21 (Image 3), are supplied together with a touch screen monitor, an optional dose calibrator and a printer for lead container labels and reports.

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尺寸、重量和主要特点
外形尺寸:280 x 520 x 400 mm
重量:45 Kg
内置读码器(用于小瓶识别和跟踪)
总体活度浓度测量和自动稀释达到预定最终浓度
自动去盖,小瓶灌装和压接
 
设有一个剂量活度计
 
性能
容量精度:<1% 容量> 1ml
灌装时间:10ml小瓶/60秒

 

  • 符合GAMP5和美国联邦法典第21卷第11部分软件规范
  • 三个安全密码(可编程):用户密码、维护密码和 RSO 密码
  • 可定制的用户账户
  • 报告和统计数据:分装循环结束、警报和事件(审核跟踪)、操纵员干预
  • 自动保存在一个既不易于破解也不可更改的文件中(加密)
  • 自动定期备份
  • 可从U盘或从热实验室管理软件(如果连接)导入日或周工作计划(如,病人清单)
  •  可在线下载的数据库(Excel和加密文件)

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FLEX hot cell mounting the CRP vial dispenser