Container Closure Integrity Testing – Sepha Multi-Q (vials, syringes, ampoules)
The Sepha Multi-Q is a non-destructive, deterministic and multi-functional Container Closure Integrity Testing system designed to detect leaks in non-porous, rigid or flexible packaging.
Manufacturers of pharmaceutical containers and medical devices are required to demonstrate the integrity of their container and closure systems (CC). The CC systems need to protect sterile products from potential contamination to ensure product safety throughout its shelf life. The Food and Drug Administration (FDA) and United States Pharmacopeia (USP) have implemented strict regulations for testing and verifying safety of these closure systems. The most common and more traditional methods used, are the dye ingress and microbial immersion methods. These destructive methods are subjective and time consuming, resulting in excessive waste.
New guidelines published by USP concentrate more on deterministic and objective methods that provide reliable and repeatable results. The Sepha Multi-Q offers a nondestructive CCIT method in line with ASTM standards to test liquid and lyophilized filled vials, filled bottles, liquid filled ampoules, pre-filled syringes, BFS and other containers and medical devices. Using vacuum and pressure decay methods, the system offers a reliable and deterministic quality control solution suitable for different products and container types.