The R DPX is an inspection platform for 100% 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.
LFC method ®
The LFC method® provides a highly sensitive 100%leak test at high production speeds for liquid filled and lyophilized primary packaging containers.
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
■ LFC method® with high sensitivity
■ Non-destructive, deterministic test method preferred acc. USP1207
■ Test method according ASTM – F 2338
■ Design according GMP guidelines
■ Data Handling in compliance with 21 CFR part 11
■ Reliable product handling
■ Toolless format changeover