The Sepha Multi-Q HD is a non-destructive, deterministic and reliable Container Closure Integrity (CCI) test system developed to detect leaks down to 1 micron in parenteral containers. More information: [ Ссылка ]

CCI testing 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 1 micron*.

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.

The vacuum decay test is a proven non-destructive, deterministic, sensitive, and reliable CCIT method to identify leaks in pharmaceutical containers. Newly developed advanced sensor technology enables the Multi-Q HD to detect defects down to 1 micron*. The ultra-sensitive technology has an improved signal-to-noise ratio that can pick up the slightest rise in pressure to detect even the smallest micron holes. The sensor is located at the point of measurement, which yields a faster response and more sensitive results.

*Dependent on container type and content

Interesting links:
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