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Container Closure Integrity & Visual Inspection Regulations, Theory, Test Methods and Applications of CCI Innovations including Hands-On Activities


One of the main purposes of a container closure system is to protect its contents from the surrounding environment. In the case of sterile products, this means maintaining the sterility of the product. The container-closure system may also need to protect the product from other potentially harmful agents such as light, moisture, and oxygen. This paper discusses container-closure integrity—maintaining the sterility of the product plus protecting the product from moisture and oxygen. It further discusses various test methods used to test for container-closure integrity.
The US Food and Drug Administration defines a container-closure system as the following:
“A container closure system refers to the sum of packaging components that together contain and protect the dosage form. This includes primary packaging components and secondary packaging components, if the latter are intended to provide additional protection to the drug product. A packaging system is equivalent to a container closure system”



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