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Did you know that majority of defects in high-risk pharmaceuticals including pre-filled syringes are caused by seal defects, attributed to both process and personnel error? While micro leaks pose a risk, the primary causes of defects are larger seal related quality deviations.

As the pharmaceutical industry is constantly seeking opportunities to develop convenient drug delivery methods, pre-filled syringes have come up as practical and reliable source for unit dose medication. The demand for glass syringes faded as the industry moved towards plastic and disposable syringes. Pre-filled syringes are applied across a wide range of medical sector including vaccines, blood stimulants, and therapeutic proteins.

Convenience in use and reduced dosage errors are the primary benefits associated with pre-filled syringes. They make injections easier and safer for both doctors and patients. In addition, pharmaceutical companies are able to minimize drug waste and increase product life span- which are important factors, particularly with costly biopharmaceuticals. However, considering the fact that pre-filled syringes are complicated combination products, manufacturers face a number of challenges in terms of quality control and stability concerns. Therefore, pharmaceutical package testing demands sound knowledge of various CCI testing methods. In this blog, we will understand how Microcurrent HVLD technology offers reliable seal quality testing of pre-filled syringes.

MicroCurrent HVLD Technology for CCI testing of pre-filled syringes.

High voltage leak detection (HVLD) has been a common technology in the market for decades. The latest evolution of HVLD, MicroCurrent technology, aims to achieve a high level of CCI assurance across the entire range of parenteral products. High voltage leak detection is a method included in USP 1207 as a deterministic test methodology and is an established and reliable solution for all liquid filled parenteral products.

HVLD operates on the simple property of electrical current. The package barrier must be non-conductive and would resist voltage from passing through, while the package contents should generally be able to carry voltage. Liquid products with a conductivity of 5 microsiemens and greater meet the requirement for PTI’s MicroCurrent HVLD

The E-Scan 655 is a Microcurrent HVLD technology-based leak test instrument used to inspect vials, syringes, and other liquid filled parenteral products. It is completely non-destructive to the container and product; exposing the package and product to lower voltage than other conductivity-based solutions. The technology uses a non-contact and non-invasive test method that requires no sample preparation. E-Scan 655 can be used with a wide range of liquid-based products including low conductivity sterile water for injection (WFI) and proteinaceous products with suspensions.

Benefits of MicroCurrent HVLD technology

• Non-destructive, non-invasive, no sample preparation.
• High level of repeatability and accuracy.
• Effective across all parenteral products, including extremely low conductivity liquids (WFI).
• Lower voltage exposure produces no ozone, eliminating risk to the product and environment.
• Listed in USP Chapter as recommended method for parenteral liquid package inspection.
• Robust method and approximate 3x Signal-Noise-Ratio for a wide range of product classes and package formats.
• Simplifies the inspection and validation process.