Jan 2022

Understanding Pre-Filled Syringes Leak Detection Using Helium Mass Spectrometry


The use of pre-filled syringes (PFS) as a container solution for pharmaceutical products has increased significantly in recent years. It is expected that this trend will accelerate in the future decades. Pre-filled syringes have the benefit of reducing pharmaceutical waste and extending the life of the product for the pharmaceutical industry. In general, pre-filled syringes are recognized as an effective, reliable, and convenient way to dispense drugs. In addition, many injections can be self-administered without worrying about being completely transferred from a vial. It provides a safe and effective option for patients in need of long-term pharmaceutical therapies.

When compared to the conventional vial, pre-filled syringes provide extra complexity in the field of container closure integrity (CCI) inspection. The advantages of pre-filled syringes include ease of use compared to conventional vial packaging. Pre-filled syringes eliminate the necessary procedures before you use the drug in a vial. In addition, since pre-filled syringes contain the correct dose, it helps to avoid dosing errors.

Leak Testing Pre-Filled Syringes Using Helium Mass Spectrometry

The device that detects and monitors leaks within and outside a product is called Mass Spectrometer Leak Detector. This approach makes use of helium as a tracer gas, which is utilized to fill a product coupled to a detector. Helium mass spectrometry is widely known for its suitability for non-porous packaging like vials and pre-filled syringes.

The leak detector works on the basis of a sector field mass spectrometer. In a vacuum, analyzed entering gases (Helium) are ionized. Helium ions are accelerated and separated in a magnetic field using increased voltage. Using a specific detector, the ion current is converted to an electric current. The current is accelerated and displayed on the screen by leak detection units. The current measured is proportional to both, the helium concentration and the measured leakage.

Benefits of Helium Leak Testing

  • Leaks may be detected and quantified with a high degree of sensitivity.
  • Due to the inert properties of helium, it does not affect the substances under test.
  • The testing is mostly conducted in a dry, temperature-independent environment.
  • Helium leak testing has a shorter cycle time, which lowers the cost and overall processing time.

For non-porous packaging including vials, pre-filled syringes, and cartridges, helium mass spectrometry has emerged as the new leak detection standard. Unlike probabilistic traditional methods, helium leak detection methods are preferred by manufacturers and regulators for their high sensitivity, fast test time, and detection capability. Pharmaceutical industries usually choose this process during the evaluation and eligibility stages of a new packaging process, where MALL plays an important role.

helium mass spectrometry, helium leak testing, helium leak detection, helium leak detection methods, helium leak detector
Popup Popup