品牌
其他厂商性质
上海所在地
型号:R DPX
R DPX集成了压力衰减法、真空衰减法和LFC法*符合FDA标准,适用于医药包装检测、密闭容器完整性检漏,是一台为空/满的注射器、有液体/冻干的小瓶以及其他含有液体的包装(无论柔软还是坚硬的)提供高精度无损检测的系统。R DPX具有高的灵敏度、可重复性和准确性。
优点:
· 整机不锈钢制造, IP65防护等级;*设计,容易清洗;
· 一体式设计,测试腔体位于主机内部,根据不同的产品类型提供各种不同的测试腔体;产品类型涵盖了绝大部分产品包装:瓶装、袋装、盒装、安瓿瓶、西林瓶、卡式瓶、预充针、BFS、FFS、水针、粉针等
· 通过不同的外部接口可对产品进行真空衰减测试以及压力衰减测试;
· 测试腔体尺寸*根据客户产品尺寸定制,确保在最短时间内产生的灵敏度;
· 每个腔体内置5~15微米的标准泄露检测阀,方便日常校验及验证服务
· 可选择自动烘干系统,对每个测试腔体进行自动烘干;
· 在检测过程中,可按要求选择开启/关闭不同的测试腔体;
· 内置各类压力传感器,每个测试腔体独立计算并管理压差;支持开机与在线对检测腔体进行自检;
· 产品高速跟踪与剔废系统;
· 触摸式人机界面,操作简单快捷:设置/选择测试程序后设备自动运行;
· 交互式图形设计,方便操作者实时查看各类测试数据
· 根据不同的操作者可设置不同的操作权限;
· 采用统计学方法,可以对同一批次的产品进行统计学分析(选项);
· 可提供中文操作界面(选项)
· 外部带有以太网与USB接口,方便测试的结果数据导出,可与外部计算机上的质控软件链接共享数据及测试结果,也可与外部的打印机连接打印测试报告
动控制。
The R DPX is an inspection platform for 99% leak testing of multiple types of primary
packaging containers in production environments. Being able to process both liquid,
powder and lyophilized products, the R DPX provides the versatile use in multi-product production lines.
The R DPX is an automated CCI tester for pharmaceutical primary packaging containers. It uses the latest
generation of vacuum and pressure decay testing procedures allowing a highly sensitive and robust
measurement in high-speed production facilities.
The LFC method® provides a highly sensitive 99%leak test at high production speeds for liquid filled and
lyophilized primary packaging containers.
The R DPX can process glass and plastic vials, ampoules and cartridges. Besides liquids it can test solid,
powder and lyophilized products.
The R DPX is designed for the use in GMP environments following international guidelines.
Up to 600/min
Format range from 1ml up to 250ml
Testing of entire container at once
Applicable for vials and ampoules
Applicable for glass and plastic containers
Applicable for liquid, lyophilized and solid products
Applicable for non-conductive products or low filling levels
LFC method ® with high sensitivity
Non-destructive, deterministic test method preferred acc. USP1207
Test method according ASTM – F 2339
Design according GMP guidelines
Data Handling in compliance with 21 CFR part 11
Reliable product handling
Toolless format changeover