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Container Closure Integrity
Capabilities and Expertise
West's analytical services offers the full battery of techniques and capabilities as described in USP chapter <1207>, including:
- Tracer Gas Detection, vacuum mode (helium mass spectrometry)
- High Voltage Leak Detection
- Frequency Modulation Spectroscopy (oxygen headspace)
- Tracer Liquid (dye ingress)
In addition to the technology above, West offers a wide variety of storage capabilities to fit a variety of needs for products and packages. We are able to perform CCI analysis at the below temperature conditions in real time, providing an accurate CCI assessment:
- Ambient
- Refrigerated
- Frozen
- -20 C
- -80 C
- -120 C
- Liquid Nitrogen
As packaging systems become more complex and research continues to develop new biologics, the ability to store container systems in a comparable way to their lifecycle storage is of the utmost importance.
Case Studies
New and Novel Technology
- Multi temperature condition capabilities, with real time CCIT analysis
- Equipment and technology to fit the need of every situation based on configuration and lifecycle stage
- Coming soon: HVLD for multiple vial/syringe configurations
- Coming soon: Vacuum decay for multiple vial/syringe configurations
- We are continuing to equip ourselves with a wide variety of test chambers and fixtures in order to provide customers with quick turnaround times and enhance cost efficiency
- Coming soon: Mass extraction/mass flow
Downloadable Resources
Related Products
Featured Blogs
April 27, 2021
Container Closure Integrity Testing (CCIT) - What Does It Mean?
For vial containment and pre-filled syringe systems, it is essential to maintain drug sterility over shelf life. Ordinarily, such maintenance comprises prevention of ingress of oxygen, water, and microbes. To demonstrate this, it is essential to perform "container closure integrity testing” (CCIT), or leak testing.
June 07, 2021
Robust CCI Performance Evaluation Through a New Integrated Approach
Container closure integrity (CCI) has been a fundamental core requirement of containment and delivery solutions in the West product portfolio. Container closure systems (CCSs) must maintain both the sterility and stability of pharmaceutical products; very importantly they must be free of microbial contamination. Microbial ingress into a CCS will jeopardize product sterility.
June 15, 2021
West China Receives Recognition from CNPPA for Pandemic Efforts and Thought Leadership
We are delighted to share that West China has recently received two acknowledgements from China National Pharmaceutical Packaging Association (CNPPA), an industrial authority in China, for West’s continuous efforts in supporting the healthcare industry during the pandemic and insightful sharing on scientific thought leadership.
April 27, 2021
Container Closure Integrity Testing (CCIT) - What Does It Mean?
For vial containment and pre-filled syringe systems, it is essential to maintain drug sterility over shelf life. Ordinarily, such maintenance comprises prevention of ingress of oxygen, water, and microbes. To demonstrate this, it is essential to perform "container closure integrity testing” (CCIT), or leak testing.
June 07, 2021
Robust CCI Performance Evaluation Through a New Integrated Approach
Container closure integrity (CCI) has been a fundamental core requirement of containment and delivery solutions in the West product portfolio. Container closure systems (CCSs) must maintain both the sterility and stability of pharmaceutical products; very importantly they must be free of microbial contamination. Microbial ingress into a CCS will jeopardize product sterility.
June 15, 2021
West China Receives Recognition from CNPPA for Pandemic Efforts and Thought Leadership
We are delighted to share that West China has recently received two acknowledgements from China National Pharmaceutical Packaging Association (CNPPA), an industrial authority in China, for West’s continuous efforts in supporting the healthcare industry during the pandemic and insightful sharing on scientific thought leadership.
West Services and Solutions LLC is a wholly-owned subsidiary of West Pharmaceutical Services Inc.
