R DPX
Product Descriptions
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.
Specifications and highlights
– 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
