What is a ”Closure”? It is the sealing mechanism for a container, in this context a container of pharmaceutical product. The container is typically a vial, a syringe, a cartridge or a bag. The drugs themselves may be liquid, freeze dried (lyophilized) or powder. The closure is usually a combination of several components, as minimum usually a rubber stopper with an aluminum crimp seal. Other components, such as tip caps for syringes or glass beads for agitation are sometimes also required.
In most cases these components are in direct contact with the drug products. Accordingly it is vital that they are free from particles, chemicals, endotoxins or any other contaminant. For freeze-dried product, they must be dry. To assist with insertion to the container, rubber stoppers are frequently coated with silicone oil or other surface treatment. This may be administed during stopper production or after the cleaning process.
This is the simply unique yet extremely effective concept that lies behind Getinge’s Closure Processing Systems. During the washing, rinsing and siliconizing (if required) steps, closures in the processing vessel are subjected to the gentle agitation of sterile filtered air passing through water. The combination of forceful airflow and constant water overflow ensures continuous removal of particles and contaminants.