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>).30 Sept 2016
What is a container closure system?
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.
What is CCIT in pharmaceutical industry?
For the long-term stability of a lyophilized drug product, the container closure and integrity is a critical aspect. Various parameters are to be investigated during container closure integrity testing (CCIT) in order to assure the optimal performance of the primary packaging.
What is dye ingress testing?
For routine testing, the dye ingress method uses ten test samples and three positive controls. The samples are placed in a vacuum chamber with dye and either pressure or vacuum is applied to the samples. The positive controls are punctured with a microtube to allow dye into the vials.
What are closures in pharmaceutical?
Pharmaceutical closures, also known as stoppers or bungs, are an important part of the final packaging of pharmaceutical preparations, particularly those that are intended to be sterile. The most commonly used type of stopper is the elastomeric closure.30 Nov 2012
Containers refers to storage media in which product is placed & enclosed & it is in direct contact with the drug. ( glass, plastic) Closures is a device tightly pack the container to exclude O2, co2, moisture & micro o/s & prevent loss of water & volatile substance from the product during transport & handling.7 Apr 2017
What is rubber closure?
Rubber Closures (Stoppers) provides a barrier between the neck of a vial and the vial contents and thus maintains sterility and prevents contamination. It creates air- and fluid-proof seal in containers. Rubber Stoppers are available in Synthetic and Natural Polymers.
What is a closure in packaging?
Introduction: the role of packaging closures. A closure can be defined broadly as any method for closing a pack so that the product is properly contained and protected. A more specific definition is a device that seals a product within a pack but which can be removed to allow the product to be accessed.
What are closure liners?
The liners are supplied friction fit into closures and adhere to the bottle finish when the closure is applied. Pressure sensitive liners are coated with pockets of adhesive. When the closure is applied to the container, the pockets of adhesive rupture between the closure and finish of the bottle or jar.14 Jun 2021
They are very commonly used as packaging materials for most types of pharmaceutical dosage forms due to the several advantages they possess over glass containers.
What are drug containers called?
Many medicines are repackaged into monitored dosage systems ("blister packs") or plastic compartmentalised containers ("pill boxes") to aid medication adherence and safe administration, particularly in residential care facilities.5 Sept 2014