What is container closure integrity?
What is container closure integrity?
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>).
What is CCI testing?
Container Closure Integrity testing (CCI testing) is a critical component of quality assurance for sterile dosage forms. Performing CCI testing can be problematic for some containers/devices due to their geometry and the inaccessibility of critical seals.
What is container closure system?
Container-Closure Systems Provide Critical Protection for Stability and Sterility. The container closure system for a drug product provides critical protection for stability and sterility. It consists of all components intended to seal and protect the package/delivery system and its contents.
Which test is used to assess the integrity of the seal on a glass container?
Container Closure Integrity Testing (CCIT) is an assay that evaluates the container closure and its ability of maintaining a seal to keep potential contaminants out. Potential contaminants include microorganisms, reactive gases, and other substances.
What is a sterility test?
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.
What is container pharmacy?
Container. A Pharmaceutical container is a device that holds the drug and may be in direct contact with product. If the container is in direct contact with the drugs it is called an immediate container. (or) It is a device which holds the drug (or) the drug product either directly (or) in a indirect form.
How does high voltage leak detection work?
HVLD operates by applying a high voltage potential to electrically conductive products inside non- or semi-conductive package materials. Pinholes are identified when electrical discharges are detected between products and device electrodes.
Which among the following test is performed for rubber closure testing?
5. 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 do you test seal integrity?
Gas leak test. For the positive pressure method of this test, an operator injects helium into a sealed package or adds helium to the package headspace upon sealing. After this, a mass spectrophotometer is used to identify and quantify the presence of helium in the surrounding enclosed space.
What is bioburden test?
Bioburden testing is a quality control process used during production to quantify microbial contamination in water, raw materials, or finished products to ensure the safety of a manufactured product.
What is the difference between bioburden and sterility?
Sterile is a condition of the death of all microbes (or exclusion of all live microbes) in a product. At the same time, bioburden is the quantification method for identifying the number of microorganisms in a sample.