PK-A Inline Ampoules and Cartridges CCI Tester

Pharmaceuticals

Non-Invasive, Non-Destructive, 100% in-line Integrity Inspection System at high production speed.

PLAY VIDEO

Ampoules

Cartridges

Tech specifications

Highlights

Autotest in real time
Easy to validate
CFR 21 part 11 compliance and 4.0 full integration
Quick format changeover
High installation flexibility
Automatic Drying System, no testing chamber contamination (Vacuum Decay Only)
Easy cleaning

Contact Us

Technical Features

Additional Benefits

Full batch control testing: fast, reliable and repeatable
Testing of all nominal production line speed
MES (Manufacturing Execution System connection) allows remote machine data exchange & download
Statistical Process Control reduces deviations for a better yield control
Real time display of testing cycle diagrams, statistical raw data
Easy, quick and safe remote access
AHE (Automatic Head Exclusion)

Technology

Container Closure Integrity Testing is a non-destructive measurement technology based on the following testing methods:
- Vacuum Decay Method
- Pressure Decay Method
Measurement system comprises applying a pressure differential into an airtight testing group enclosing the container.
The test objective is to detect container leakages by measuring the reached pressure level as well as the pressure change over test time.

Quality Assurance

Equipment test method refers to:
- Approved industry standard “ASTM F2338-09”: “Standard Test Method for Non-Destructive Detection of Leaks in Packages”
- United States Pharmacopoeia – USP General Chapter «1207» “Packaging Integrity Evaluation”
- EU Guidelines to GMP Medicinal Products for Human and Veterinary Use – Annex 1 “Manufacture of Sterile Medicinal Products”
- PDA Technical Report No. 27 “Pharmaceutical Package Integrity”
- FDA 21 CFR part 11 as well as EMA Annex 11

Download datasheet