Advancing Parenteral Product Safety: E-Scan MicroCurrent RTX CCI Automation

Parenteral products are administered into the body through injection, infusion, or implantation. They are a critical part of healthcare, and their safety and efficacy are of paramount importance. Parenteral products are typically packaged in vials, syringes, ampoules, or IV bags. The packaging material must be inert and compatible with the product, and it must be able to withstand the lifecycle - the rigors of manufacturing, shipping, and storage.

Container closure integrity Testing (CCIT) is a key quality control measure for parenteral products, as it ensures that the packaging is free from defects and that the product is protected from contamination. CCI testing can detect a variety of defects, including cracks, holes, and weak seals. CCI testing can be performed on individual packages or on batches of packages. It is typically performed at multiple stages in the manufacturing process, as well as before release to the market.

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Automated CCI Parenteral Package Inspection using E-Scan MicroCurrent RTX

Parenteral package inspection using E-Scan MicroCurrent RTX is a non-destructive, automated leak testing system for pre-filled syringes and other liquid-filled parenteral packages. It utilizes PTI's MicroCurrent HVLD technology, which applies a low-voltage DC current to the package and measures the resulting current flow. If there is a leak in the package, the current will flow to the exterior of the package, and the detector will register a fail signal.

The E-Scan MicroCurrent RTX is a highly sensitive and reliable leak test method that is effective across all parenteral products, including biologics and extremely low conductivity liquids such as sterile water for injection (WFI).? MicroCurrent HVLD technology is also listed in the USP < 1207 > guideline as a recommended deterministic container closure integrity test method for liquid-filled parenteral package inspection.

The E-Scan MicroCurrent RTX is a modular system that can be customized to meet the specific needs of each manufacturer. It can be used for batch release testing in the lab, on the production line, or in both environments. The test cycle is very fast, typically taking only a few seconds.

Benefits of using E-Scan MicroCurrent RTX

·???????? Non-destructive and fully automated

·???????? Highly sensitive and reliable

·???????? Effective across all parenteral products

·???????? Listed in USP < 1207 > as a recommended method

·???????? Modular system can be customized to meet specific needs

·???????? MicroCurrent technology scalable from the lab to production line

·???????? Very fast test cycle

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