Increasing demands for Container Closure Integrity Testing (CCIT) in the pharmaceutical industry are driven by recent FDA and international guidelines for sterile barrier. Whether you are testing sterile barrier, moisture barrier or general protection packaging we offer nondestructive and deterministic container closure integrity test equipment for:
As part of the Pfeiffer Vacuum cooperation (https://www.pfeiffer-vacuum.com/en/products/leak-detection/leak-testing-ccit-solutions-for-pharma/) 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.
Furthermore we also offer leading Micro-Flow leak and flow test equipment for Medical Devices such as catheters, drug delivery systems and similar devices.
For more information, please check our additional information on products and applications below.
Advanced Test Concepts (ATC) by Pfeiffer Vacuum
4037 Guion Lane
Indianapolis, IN 46268
Phone: (317) 328-8492
Key risks for drug contamination are by humidity, oxygen or microbiological ingress, which can impact the drug stability throughout the product life cycle.
This video shows ATC's patented Mass Extraction technology in a container closure integrtiy testing example of system verification and system testing.
The poster shall explain a Mass Extraction technology, especially suitable for Pharmaceutical Container Closure Integrity Testing (CCIT) applications and is acknowledged by an own ASTM standard.
An overview of integrity tests where a high sensitivity are required to prevent the risks of stability failure of highly moisture sensitive drugs or the risk of biological ingress of sterile parenteral drugs.
A major pharma company had a problem. Its manufacturing process engineers could not reliably verify that pouch packages were sealed properly. Product could potentially ship with questionable packaging.
Package integrity is defined as a package’s ability to prevent product loss, maintain product sterility, and in some cases, prevent oxygen ingress or maintain sub-atmosphere headspace pressures.
Since February 2017, ATC is a 100% subsidiary of Pfeiffer Vacuum, a global leader in vacuum and detection solutions. With this merger, Pfeiffer Vacuum can offer its customers a complete range of leak testing and leak detection solutions.
Mass extraction tests are nondestructive and offer higher measurement sensitivity. In addition, the instruments are efficient, offer short test times, and are more accurate than many of the other methods.
Pfeiffer Vacuum Technology AG acquired 100% of the shares of Advanced Test Concepts (ATC), Inc. an Indianapolis, Indiana USA corporation as of February 14, 2017.
CCIT system for flexible pouches using mass extraction technology.
Great confusion exists in the definition and application of leak tightness. That confusion is a result of improper leak-tightness design specifications.
A major pharmaceutical company in North America was using the dye ingress testing method, and found it was not only slow and operator dependent (not reliable), causing false accepts.
A major pharma company could not reliably verify that their pouch packages were sealed properly and the product could potentially ship with questionable packaging which failed stability testing.
As a means to ensuring the safety of sterile products, the FDA and the United States Pharmacopeia have provided strict guidelines for the testing of container closure systems.