Lenox Laser is committed to ensuring the integrity of container closure systems in pharmaceutical and critical packaging. As part of this commitment, we adhere to the latest Container and Closure System Integrity Testing (CCIT) guidelines.
These guidelines, established by the FDA, recommend methods other than sterility testing to confirm container and closure system integrity. They apply to sterile biological products, human and animal drugs, and medical devices. Here are the key points:
Purpose and Scope:
- The guidance provides recommendations for manufacturers.
- It emphasizes using alternative methods to sterility testing for confirming container and closure system integrity.
- These methods are essential components of stability protocols for sterile products.
Why CCIT Matters?
- Federal Standards: Compliance with federal standards is crucial to prevent widespread damage to products and ensure public safety.
- Reliable Testing: Companies need reliable methods to identify defects that compromise product integrity.
- Calibration Assurance: Ensuring that machines detecting imperfections are correctly calibrated is vital.
What’s Lenox Laser’s Role?
- Leak Detection Reliability: We contribute to the reliability of leak detection processes.
- Calibrated Leaks: By intentionally introducing calibrated leaks using our products, pharmaceutical companies can monitor and verify that their systems meet quality standards.
- Precision and Accuracy: Our proprietary laser drilling and flow calibration processes allow us to create orifices on a micron and sub-micron scale in various packaging materials.
- Custom Solutions: We tailor our processes to accommodate specific requirements.
For inquiries about our capabilities or to request a custom CCIT job quote, feel free to reach out. Unsure about the orifice size you need? Check out our custom orifice calculator on our website.