Automated Container Closure Integrity Testing (CCIT) is a process used to evaluate the integrity of containers for parenteral products, such as vials or pre-filled syringes, to ensure that they are free of defects or leaks. The goal of CCI testing is to ensure that the contents of the container remain sterile and protected from contamination.
There are several advantages to using automated CCI testing, including:
- Speed and Efficiency: Automated CCI testing is much faster and more efficient than manual operator testing, which can save time and resources for manufacturers.
- Accuracy: Automated CCI testing is less prone to human error, which can result in more accurate results and increased confidence in the integrity of the container.
- Reproducibility: Automated CCI testing is designed to be repeatable, allowing manufacturers to consistently and accurately monitor the integrity of containers.
Parenteral Products and its Advantages
Parenteral products are medical products that are administered directly into a patient's bloodstream, bypassing the digestive system. This means that the product is delivered into the body through a route other than the orally, such as intravenously, intramuscularly, subcutaneously, or through other routes. Examples of parenteral products include injectable drugs, intravenous solutions, intravenous nutrition products, blood transfusions, and others. These products are subject to strict quality control and regulatory standards to ensure their safety, efficacy, and sterility, and to maintain the integrity of their packaging to prevent contamination. The specific form of the parenteral product (e.g. solution, suspension, etc.) depends on the product and patient needs.
Advantages of Parenteral Products
Here are some advantages of parenteral products:
- Rapid onset of action: Parenteral products are delivered directly into the bloodstream, which allows for a faster onset of action compared to oral administration. This can be especially important in emergency or critical care situations.
- Measures and verifies container closure system integrity
- More effective for some conditions: Some drugs and therapies are more effective when delivered parenterally because they are absorbed more quickly or may not be well absorbed orally.
- Alternative for patients unable to take oral medications: Parenteral products provide an alternative for patients who are unable to take oral medications, such as patients with gastrointestinal issues or patients who are unconscious.
CCI Testing of Parenteral Products
CCI Testing is performed on parenteral products using a variety of methods, including vacuum decay leak testing, high-voltage leak detection, and others. The specific method used will depend on the type of product, the packaging material, and the desired level of sensitivity. The goal of CCI testing is to provide confidence in the integrity of the packaging and prevent any incidents of contamination or product failure.
The VeriPac LPX Series is a range of completely automated package quality inspection systems for container closure integrity inline testing. The VeriPac LPX has a dynamic robotic design that is customized to your production needs. To fulfil the demands of a production line, the LPX Series offers modular, scalable solutions. This adaptable platform offers a range of package forms that may be reliably automated. Flexible packaging, rigid containers, and parenteral pharmaceuticals are only a few examples of the applications for LPX automation.
The packages will be picked up and placed by a quick robotic gripper arm into the VeriPac LPX test chambers, where a quick vacuum-based test will be performed. Along with the quantitative test result data, a clear PASS/FAIL result is shown. In order to maintain continuous flow and seamless downstream processing, the packages will then be returned to the product line. Rejects are automatically taken off the production line.
Benefits of VeriPac LPX
- Automated testing enables the highest level of container quality assurance.
- Deterministic, quantitative test method.
- ASTM Test Method F2338 and FDA standard.
- Highly accurate test results - low false positives and false negatives.
- Non-destructive, non-subjective, no sample preparation.
- USP <1207> complaint.
CCI testing is used to evaluate the sealing of the product container and detect any leaks, breaches, or defects in the packaging. This is important because parenteral products are sensitive to environmental factors such as temperature and pressure changes, and any breaches in the packaging could result in contamination or degradation of the product.
Overall, automated CCI testing is an important tool for ensuring the safety and quality of parenteral products, and is increasingly being used by manufacturers to ensure that their products meet regulatory requirements and industry standards.