生產線型全自動西林瓶微孔檢漏設備 真空衰減法檢漏機-Pharma
R DPX集成了壓力衰減法和真空衰減法符合ASTM測試方法和FDA標準,適用于密閉容器完整性在線檢漏。
型號:R DPX
R DPX集成了壓力衰減法、真空衰減法和LFC法符合FDA標準,適用于醫(yī)藥包裝檢測、密閉容器完整性檢漏,是一臺為空/滿的注射器、有液體/凍干的小瓶以及其他含有液體的包裝(無論柔軟還是堅硬的)提供高精度無損檢測的系統(tǒng)。PK-DPV具有高的靈敏度、可重復性和準確性。
優(yōu)點:
· 整機不銹鋼制造, IP65防護等級;設計,容易清洗;
· 一體式設計,測試腔體位于主機內部,根據(jù)不同的產品類型提供各種不同的測試腔體;產品類型涵蓋了絕大部分產品包裝:瓶裝、袋裝、盒裝、安瓿瓶、西林瓶、卡式瓶、預充針、BFS、FFS、水針、粉針等
· 通過不同的外部接口可對產品進行真空衰減測試以及壓力衰減測試;
· 測試腔體尺寸根據(jù)客戶產品尺寸定制,確保在最短時間內產生的靈敏度;
· 每個腔體內置5~15微米的標準泄露檢測閥,方便日常校驗及驗證服務
· 可選擇自動烘干系統(tǒng),對每個測試腔體進行自動烘干;
· 在檢測過程中,可按要求選擇開啟/關閉不同的測試腔體;
· 內置各類壓力傳感器,每個測試腔體獨立計算并管理壓差;支持開機與在線對檢測腔體進行自檢;
· 產品高速跟蹤與剔廢系統(tǒng);
· 觸摸式人機界面,操作簡單快捷:設置/選擇測試程序后設備自動運行;
· 交互式圖形設計,方便操作者實時查看各類測試數(shù)據(jù)
· 根據(jù)不同的操作者可設置不同的操作權限;
· 采用統(tǒng)計學方法,可以對同一批次的產品進行統(tǒng)計學分析(選項);
· 可提供中文操作界面(選項)
· 外部帶有以太網(wǎng)與USB接口,方便測試的結果數(shù)據(jù)導出,可與外部計算機上的質控軟件鏈接共享數(shù)據(jù)及測試結果,也可與外部的打印機連接打印測試報告
動控制。
R DPX
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 PK-DPV 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.
Various packaging and product types
The R DPX can process glass and plastic vials, ampoules and cartridges. Besides liquids it can test solid,
powder and lyophilized products.
GMP design
The R DPX is designed for the use in GMP environments following international guidelines.
Features
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
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