Pharmaceutical Container Closure Integrity System – Sterility Property Physical Testing
There is an increasing demand for CCIT (Container Closure Integrity Testing), in the pharmaceutical industry that are driven by strict FDA guidelines requiring a sterile barrier. Whether you are testing sterile barrier, a moisture barrier or general protection packaging we can offer nondestructive container closure integrity test equipment.
- Parenteral Vials
- Pre-filled Syringes
- Capsules
- Cartridges
- Auto injection
- Filled flexible bags (IV bags, blood bags)
- Empty flexible bags
- Single use flexible bag systems for pharmaceutical process-incoming inspection and point of use leak testing
- Shipping containers
As part of the Pfeiffer Vacuum cooperation we are offering a variety of different CCIT solutions with different test technologies. These include helium leak detection (e.g. ASM2000) as well as our unique USP 1207 recognized Mass Extraction (e.g. ME2) and optical emission spectroscopy (e.g. AMI1000) technologies. With this broad solution portfolio we are able to support you with the various challenges that come along with CCIT for all different kinds of packaging's like vials, IV bags, syringes, pouches, blisters and more including method validation, process validation and IQ/OQ of our equipment at your facility.
We thereby have 2 major CCIT laboratories offering feasibility studies and application support in Annecy, France and Indianapolis, USA plus a network of more than 20 sales and service locations all over the globe.