What is CCIT?
Definition. For Container Closure Integrity Testing (CCIT) we mean the specific area of technology that investigates, with suitable methods and equipment, the actual integrity, that is the condition of sealing or hermetic closure, of a container, so that it is suitable for the purpose it is closed.
Is CCIT same as Leak Testing? No. Same of the testing and physical principles might be common to Container Closure Integrity Testing and Leak Testing; however, Leak Testing is intended to cover a broader range of applications, such as, for instance, the control of air or liquid tightness of pressurized or vacuum circuits in industry. The application field for CCIT is limited to the case when you want to test a container, rigid or partially rigid or flexible, filled and closed with a stopper or cap, or by thermal fusion or welding, in a way that can guarantee sealing.
Many are the types of containers subject to Container Closure Integrity Testing, in different industries:
Pharma:
Glass ampoules
BFS containers
Glass/plastic Cartridges
Bags for disposable bioreactor
Pouches or sachets for powder or ointment
Screwed cap vials
Prefilled glass syringes
Blister in plastic, paper, Alu
Bags for bulk API
Jars for ointments or cream
Vials with elastomeric stopper
Prefilled plastic syringes
Soft bags for Injectables
Cans for spray or inhalers
Medical devices: Blister or trays with porous/nonporous lid, jars, bags polyfoil with or w/o Alu foil.
Nutraceuticals and cosmetics: Containers subject to CCIT in these segments are basically the same as in Pharma.
Food and beverage: in this broad segment, containers are sachets, pouches, bags, boxes, cans, jars, bottles as well as single or multiple segment blisters.
Here needs and rules for Container Closure Integrity Testing are less strict and not defined by regulation, even though product volumes are very large and defects in container closure can cause heavy effects in terms of costs and reputation of the producer.
This review will be focused on containers for Pharma.
