Over the years, there has been a steady increase in the demand for pre-filled syringes for injectable drug products that can be self-administered. However, considering the complex nature of pre-filled syringes, Container Closure Integrity assurance can be quite challenging. Container Closure Integrity is understood as the ability of containers to maintain a sterile barrier against possible contamination. A leak or breach in the sterile barrier can rapidly convert a lifesaving drug into a threat for patients. Parenteral products are the highest risk of all packaging formats. Vials, ampoules, and pre-filled syringes have the highest potential for microbial growth, and the risk to the end patient amplifies the focus needed on CCI for these applications.
High Voltage Leak Detection (HVLD) has been in the market for decades. However, PTI’s MicroCurrent technology has revolutionized HVLD. MicroCurrent HVLD aims to achieve a high level of CCI assurance across the entire range of parenteral products. High Voltage Leak Detection is a deterministic test method included in USP 1207, and is an established and reliable solution for all liquid filled parenteral products.
Pre-filled syringe testing using HVLDmc (E-Scan 655) technology
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 a non-destructive conductivity test method, exposing the package and product to lower voltage than other conductivity-based solutions.
The E-Scan 655 features a fast test cycle and simple operation. It can accommodate a wide range of applications and products, including low conductivity sterile water for injection (WFI) and proteinaceous products with suspensions. The technology uses a non-contact, non-invasive test method that requires no sample preparation. Additional benefit include ability to migrate from laboratory to 100% inline testing applications at high production speeds.
The E-Scan testing process uses a set of electrode probes to scan a non-conductive container that is sealed. The container material can be glass, plastic, or poly laminate. The container or package must contain liquid (minimum fill 30%). In the presence of a pinhole, crack, or other defects, there will be a resistance differential and change in current flow, indicating a breach in the container. The approximate defect location can be identified.
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
pre-filled syringe testing, Parenteral Product Leak Testing, container closure integrity testing, CCI, E-scan 655, microcurrent HVLD technology