What is CCit testing?

Container Closure Integrity Testing (CCIT), commonly referred to as leak detection, is a non-destructive packaging inspection system to maintain an aseptic barrier against potential contaminants.

What is CCit in pharma?

Container Closure Integrity Testing (CCIT) is an assay that evaluates the adequacy of container closure systems to maintain a sterile barrier against potential contaminants. Contaminants that could potentially cross a container closure barrier include microorganisms, reactive gases, and other substances (USP <1207>).

Which test is performed to check the integrity of ampoules?

Pressure Decay Non-destructive, reliable and repeatable test method, ideal for testing the integrity of lyophilized and liquid filled vials, ampoules, bottles and other containers. The device shows a pass/fail result in 10 seconds and can identify leaks and channel leaks as low as 5µm.

What is container closure integrity testing?

Container Closure Integrity Testing is performed to evaluate the adequacy of a closure in maintaining a sterile barrier. Of primary concern is whether the container can provide an effective barrier against ingress of microorganisms and other substances that may compromise or contaminate the product.

What is sterility testing?

What is sterility testing? Sterility testing is designed to demonstrate the presence or absence of extraneous viable contaminating microorganisms in biological parenterals designed for human use. The sterility assay is 14 days allowing for an appropriate incubation period to detect slower-growing microorganisms.

What is the procedure to perform leak test?

The leak test is performed by immersing a part, usually a sandwich composite structure, in a hot water tank. The temperature of the water induces the expansion of air in the structure, and if a crack or a delamination is present, gas bubbles escape the structure and are immediately detected by visual inspection.

Which among the following test is performed for rubber closure testing?

Compatibility test: This test is performed to check the compatibility of the rubber closures with various types of the substances, since it is necessary to ensure that there is no interaction between the contents of the bottle and the closure. 6.

How does high voltage leak detection work?

The principle of high voltage leak detection is based on quantitative electrical conductivity measurements. The technology is simple. By passing a high-voltage probe (or brush) along the exterior of a container, a defect (as small as 1 micron!) results in an increase of recorded electrical conductivity.

What is the importance of conducting tests for containers?

Both primary (consumer) packages and shipping containers have a risk of being dropped or being impacted by other items. Package integrity and product protection are important packaging functions. Tests are conducted to measure the resistance of packages and products to controlled laboratory shock and impact.

What are the methods of sterility testing?

The USP describes three general methods for sterility testing: 1) Membrane Filtration, 2) Direct Transfer (Product Immersion); and 3) Product Flush.

How long does sterility testing take?

14 days
Sterility testing is an essential procedure as part of pharmaceutical manufacturing, and can be one of the most time-consuming quality tests. The test, typically 14 days in length is often a bottleneck in the manufacturing process.

What is the difference between pressure test and leak test?

The pressure test is usually performed at 1.1 to 1.5 times the design pressure of the system. The code leak test is applied to test the pressure boundary of the piping system and not the isolation points in the system, such as the seats or seal in valves.

What does CCIT stand for in container integrity testing?

CCIT specializes in feasibility studies and test method development for all container closure integrity and package quality testing projects. Our clients leave with more than just a test method or piece of equipment.

Why is it important to know about CCIT?

Is a deterministic testing procedure, so it is less subject to error, is repeatable and gives quantitative and predictable results. CCIT detect defects that demonstrate breach of the container and/or closure system. Patient and consumer health and safety is the principal reason why testing methods are put into place.

What should be the validation method for CCIT?

Validation of methods should be specific to the product container and closure system or product type. The method of CCIT chosen will vary according to the desired result like the leak rate measurement of the entire container, potential for microbial ingress, detection of presence of leak paths etc.

What do you need to know about container closure integrity testing?

Overview Container Closure Integrity Testing (CCIT) is an assay that evaluates the adequacy of container closure systems to maintain a sterile barrier against potential contaminants. Contaminants that could potentially cross a container closure barrier include microorganisms, reactive gases, and other substances (USP <1207>).