In the production of biologics and high‑value pharmaceutical products, even the smallest pinholes or seal defects in primary packaging – such as glass vials, ampoules, and pre‑filled syringes – can lead to serious liquid leakage or bacterial ingress, resulting in irreversible product safety risks and significant production losses.

Deterministic Methods Have Become the Industry Consensus

With the release of USP 1207.2, deterministic methods have replaced probabilistic methods (such as microbial challenge and dye ingress tests) as the mainstream choice for CCIT (Container Closure Integrity Testing). As one of the deterministic methods recommended by USP 1207.2, High Voltage Leak Detection (HVLD) is rapidly becoming the preferred solution for manufacturers of vaccines, biologics, and high‑value injectable products, thanks to its non‑destructive nature, high sensitivity, and in‑line full‑inspection capability.

Why Choose the HVLD High Voltage Discharge Method?

Traditional dye immersion or pressure decay tests often damage packaging components, resulting in unnecessary waste of compliant products. The HVLD micro‑leak tester completely overcomes these drawbacks:

100% Non‑Destructive Testing – Zero damage to compliant products; tested samples can proceed directly to subsequent packaging or shipment

Absolutely No Secondary Contamination – Fully physical electrical detection; no chemical reagents or media are introduced

Micron‑Level Precision Rejection – Utilizes the conductive liquid inside the container as a detection path, easily capturing micro‑pinholes and cracks that other methods struggle to detect (detection sensitivity up to 1‑3 μm)

Fully Automated High‑Speed Continuous Inspection – Specifically designed for high‑speed automated production lines; defective products are automatically rejected in‑line; no special chambers or vacuum pumps required, with extremely low maintenance costs

Technical Comparison: HVLD vs. Traditional Methods

Core Applications

This system is widely applicable to all non‑metallic packaging containing conductive liquids:

Glass vials for vaccines and biologics

Glass ampoules

Blow‑Fill‑Seal (BFS) containers

Pre‑filled syringes (PFS)

Various flexible IV bags

If you are looking for an HVLD CCIT solution that complies with USP 1207.2 requirements, please contact Sumspring for technical documentation or to schedule a live demo.