The Sepha Multi-Q HD

The Sepha Multi-Q HD is a non-destructive, deterministic and reliable Container Closure Integrity (CCI) test system developed to detect leaks down to 1µm* in parenteral containers.

Manufacturers of parenteral containers including vials, ampoules, bottles, pre-filled syringes and blow fill seal strips, 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 and guarantee patient safety.

CCI is critical for parenteral applications as they often contain drugs that have a short shelf life and are highly sensitive to oxygen or moisture; even the smallest defect can affect sterility and efficacy of the drug. As the content is injected directly into the tissue or bloodstream, any compromised container can jeopardise patient safety. These applications often have a lower Maximum Allowable Leakage Limits (MALL) and require a higher level of sensitivity to demonstrate CCI. The Multi-Q HD has been developed to reach this sensitivity and offers a reliable solution down to 1µm*.

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.

The Sepha Multi-Q HD utilises vacuum decay according to ASTM F2338-09 standard test method, the FDA recognized consensus for non-destructive detection of leaks in packages by vacuum decay. The method is In line with new guidelines outlined in USP 1207 preferring deterministic and objective methods that provide reliable and repeatable results