Ensuring Patient Safety - The Critical Role of MicroCurrent HVLD in Biologics Container Closure Integrity

The pharmaceutical landscape is witnessing a paradigm shift towards biologics, a class of drugs derived from living organisms or their cellular components. Unlike traditional small-molecule pharmaceuticals, biologics offer unparalleled therapeutic potential for complex diseases. However, these life-saving treatments are highly susceptible to environmental factors. Given their complex structure and intricate biological activity, biologics are highly sensitive to:

·???????? Light: Exposure to light can induce protein aggregation and loss of potency.

·???????? Moisture: Fluctuations in moisture content can destabilize the biologic's structure and functionality.

·???????? Temperature: Biologics often require specific temperature ranges for optimal stability. Deviations can lead to denaturation and loss of efficacy.

·???????? Microbial Contamination: Even minute breaches in the CCI can introduce microorganisms, compromising product sterility and potentially causing life-threatening infections.

Therefore, maintaining a sterile and controlled environment throughout the product's journey, from manufacturing to administration, is critical. Guaranteeing the integrity of the container closure system (CCI) throughout the biologics lifecycle becomes paramount for both patient safety and treatment efficacy.

Container Closure Integrity (CCI) is the lifeblood of safe and effective biologics. It acts as the ultimate shield, protecting these sensitive drugs from external threats like light, moisture, and even microscopic leaks that could harbor harmful microbes. Maintaining a continuous CCI throughout a biologic's journey is paramount. Any breach can lead to product degradation, rendering it useless, or worse, introduce contamination that could endanger patient safety. Rigorous Container Closure Integrity testing (CCIT) is essential to ensure these crucial barriers remain intact, safeguarding both the quality of the biologic and ultimately, the well-being of patients.

E-Scan MicroCurrent HVLD: A Technological Leap

The E-Scan MicroCurrent technology is a revolutionary deterministic offline micro leak test instrument that utilizes a new class of HVLD technology to inspect vials, syringes, and other liquid filled parenteral products for container closure integrity. The E-Scan? technology is a MicroCurrent conductivity test method, HVLDmc, that is completely non-destructive to the container and product; exposing the package and product to lower voltage than other conductivity-based solutions.

The E-Scan MicroCurrent HVLD technology is often used in the pharmaceutical industry for detecting leaks in parenteral drug products, such as vials and syringes. E-Scan MicroCurrent HVLD technology is considered to be a reliable and efficient method for leak detection, ensuring the integrity of the drug product and patient safety.

The technology uses a non-contact and non-invasive test method that requires no sample preparation. The E-Scan Model 615 features a fast test cycle and simple operation. Additional benefits include quick changeover and easy recipe setup to accommodate a wide range of products and applications. E-Scan MicroCurrent HVLD technology can be migrated from laboratory to automated inline production applications.

Benefits of E-Scan MicroCurrent HVLD

·???????? 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 <1207> as recommended method for parenteral liquid package integrity testing.

·???????? Robust method and approximate 3x Signal-Noise-Ratio for a wide range of product classes and package formats.

·???????? Simplifies the inspection and validation process.

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