Automated CCI Tester
Some packaging materials require 100% integrity testing according to Annex 1 of the EU GMP guidelines. In order to meet those requirements and to not reduce production outputs, high speed inspection systems are put into place. High speed machines reach up to 600 test samples per minute. The size of the machine is dependent upon the size of the test sample and the required leak sensitivity.
CCIT for IV bags
R FSB
Annex 1 of the EU GMP guidance requires a 100% CCIT of fusion sealed sterile pharmaceutical containers. This includes fusion sealed bags for injections. Our automated bag testing platform can test up to 150 bags per minute.
Robot handling system
Fully automatic handling system for large bags by means of multi axis robots.
Gentle force sensors
Gentle sequeezing of bags for leak detection in critical areas of bag by force sensors.
Fully integrated
Testing process and bag handling system is fully integrated.
Features
- High throughput (150/min)
- Multiple bag sizes (250ml, 500ml, 1000ml)
- Full integration in MES
- Applicable for non-conductive products
- Applicable for products after thermal sterilization
- Non-destructive test method
- Deterministic test method preferred acc. USP1207
- Reliable product handling
- Easy format changeover
Need more information about the possibilities of automated leak testing of infusion bags?
We would be happy to advice you personally.
