News & analysis on the clinical development and manufacture of large molecule drugs
Sepha looks to high performance leak testing
By Jane Byrne
- Last updated on
Sepha says it has achieved micro leak detection down to one-micron (1µm) with the development of a new high-performance leak tester for Container Closure Integrity Testing (CCIT) applications.
Utilizing the vacuum decay test method, the new Multi-Q HD unit is designed to enable ultra-sensitive, non-destructive detection of defects in pharmaceutical containers, said the Belfast, Northern Ireland headquartered developer.
This enhanced testing functionality responds to demand from parenteral formats, which are experiencing unprecedented growth on the back of international Covid-19 vaccination programs, according to Sepha.
Building on the company's established Multi-Q leak testing platform, the Sepha Multi-Q HD is a standalone, lab scale leak test system that can be used in combination with interchangeable attachments to fit the full range of parenteral container types in the marketplace currently including glass or plastic vials, ampoules, pre-filled syringes, bottles and Blow Fill Seal (BFS) containers.
The company maintains that its compact, bench-top design means it can be used in the lab during drug development or for in-process batch testing to verify the integrity of containers being manufactured on the production line.
Whilst the Multi-Q HD can be configured to perform a variety of non-destructive, deterministic tests, such as pressure decay, Sepha expects that it will primarily be used for applications which require a vacuum decay test.
The Multi-Q HD allows manufacturers to test in accordance with the ASTM Standard Test Method F2338-09 for vacuum decay in line with FDA consensus and USP 1207 guidelines. This nondestructive and deterministic test method provides quick, reliable and repeatable results without any damage to the product or packaging, said Sepha.
Explaining the context to the development of the new Multi-Q HD, Sepha MD, Paul Smith, commented: “Testing to 5µm used to be the benchmark for CCIT, but in recent years, we have witnessed a drive from the industry to raise the bar for increased integrity test sensitivity. Since the pandemic, this trend has really gained momentum.
“Intercepting defective containers before they reach end-users or patients is important for any pharmaceutical, but for short shelf life, highly sensitive, injectable products it is absolutely crucial.
“Ingress of air through micro cracks and pinholes has implications for product efficacy and safety, therefore pharmaceutical manufacturers cannot afford to be anything less than 100% confident in the integrity of their parenteral formats. We view it as our responsibility to provide the technology that can instill this level of confidence. With this in mind, we set ourselves the target of guaranteeing micro leak detection down to 1µm and we are proud and delighted to report that we have achieved that goal.”