Automated CCI Tester
CCIT for small volume parenterals
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.
R DPX
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.
Test method variety
The test procedures can be configured to various product and package configurations.
Reliable product handling
The robust handling systems of the R DPX guarantees gentle product transfers minimizing the risk of production stops or the cause of defects.
Toolless format changeover
The change in between different formats can be done quickly as no tools are required to do so.
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
