What is Container Closure Integrity?
Container Closure Integrity (CCI) is a critical component in the pharmaceutical, medical devices, and biotechnology industries. It is essential in maintaining product sterility, stability, and quality throughout its shelf life. The integrity of the container closure system safeguards your product from external contaminants, moisture, and oxygen, which could compromise its safety and efficacy. A robust CCI ensures product protection against potential leaks and breaches that can lead to significant recalls, as has been observed in numerous industry cases.
At Synergy Bioscience, we recognize the vital role of CCI in product safety and quality assurance, playing a pivotal role in minimizing product recall scenarios.
Investing in State-of-the-Art CCI Testing
To ensure your products are secure and reliable, we’ve invested in state-of-the-art instrumentation and cutting-edge technologies. Our advanced laboratory features a comprehensive array of testing equipment for delivering accurate and reliable CCI assessments.
We’ve equipped our lab with high-resolution imaging systems capable of detecting the smallest defects or leaks in container closures. These systems employ multiple techniques including vacuum decay, laser-based headspace analysis, and high voltage leak detection, ensuring thorough and efficient testing.
Comprehensive CCI Testing Methods
Our suite of testing methods and equipment includes:
- Headspace Gas Analysis:
- Our gas-sensitive detector measures specific gases within the container’s headspace to detect leaks or breaches.
- Vacuum Decay:
- A non-destructive method that monitors pressure changes to identify significant drops, indicating a leak in the container closure system.
- Microbial Challenge:
- This test ensures no microorganisms can compromise the product’s sterility by simulating real-world conditions.
- Laser-based Headspace Analysis:
- We use laser technology to detect leaks in the headspace of containers, identifying even minute defects without compromising product integrity.
- High Voltage Leak Detection:
- This method applies high voltage to the container closure system, monitoring the resulting electrical currents to detect leaks and flaws in the seal.
- Dye Ingress Testing Apparatus:
- We use equipment including dye solution applicators, inspection stations, and illumination sources for visual detection of leaks or breaches using colored dyes.
- Pressure Decay Testing System:
- Our system uses pressure sensors and monitoring equipment to measure pressure changes within a sealed container, enabling leak detection.
- Mass Spectrometer:
- Our analytical equipment measures the mass-to-charge ratio of ions from gas samples collected from the container closure system, allowing for detection and analysis of gas leaks.
- Microscopy Equipment:
- We employ optical microscopes and digital imaging systems for visual examination of containers, enabling detection of defects or breaches.
Unparalleled Expertise in CCI Testing
Our team of highly skilled scientists and technicians possess extensive expertise in container closure integrity testing. They are committed to delivering accurate results and providing valuable insights into your packaging systems, enabling informed decisions about product safety and quality.
Partner with Synergy Bioscience for CCI Testing
By partnering with Synergy Bioscience, you gain access to our cutting-edge instrumentation, state-of-the-art testing methods, and unparalleled expertise. Together, we will ensure the safety, stability, and efficacy of your pharmaceutical and biotechnology products, placing product integrity at the forefront.
Contact us now to schedule a consultation or to learn more about our container closure integrity testing services.
Together, let’s ensure the safety, stability, and efficacy of your pharmaceutical and biotechnology products.
Remember, at Synergy Bioscience, your success is our priority.
