Beyond the Basics - Advanced Leak Detection Techniques for Prefilled Syringes

Ensuring the integrity of prefilled syringes is paramount in the pharmaceutical and biologics industries, where even the smallest leak can compromise the sterility and efficacy of the drug product. Leak detection is an essential part of the Container Closure Integrity Testing (CCIT) process, which verifies that a package is properly sealed and maintains its sterility over its intended shelf life until it reaches the patient.?

Prefilled syringes (PFS) offer numerous advantages over traditional vial-and-syringe systems, such as improved patient safety, ease of use, and dosage accuracy. However, these benefits come with the responsibility of ensuring the package integrity of these devices. Leak testing for pre-filled syringes is critical to detect any compromise in the container closure system that could lead to contamination, oxidation, or loss of potency. Traditional methods like dye ingress or microbial immersion are being complemented and sometimes replaced by more advanced, non-destructive testing methods.

Pre-filled Syringe Leak Testing Methods

1. Vacuum Decay technology:

Vacuum Decay technology is a non-destructive container closure integrity solution capable of detecting leaks in nonporous, rigid or flexible packages. Vacuum Decay leak testing is conducted by placing a sample package in a well-fitting evacuation chamber, which is provided with an external vacuum source. The vacuum levels as well as the change in vacuum over a fixed test time are closely observed using single or dual vacuum transducer technology. Changes in vacuum level beyond a predetermined pass/fail limit indicate defects within the package. VeriPac Vacuum Decay series can non-destructively test packaging down to sub-micron leak rates - making it an excellent alternative to destructive testing methods.

2. MicroCurrent HVLD Technology

PTI’s MicroCurrent is patented unique CCI technology that has revolutionized the conventional high voltage leak detection method. It is a non-invasive and deterministic container closure integrity testing method that is effective across all parenteral and biologic products including low conductivity liquids such as sterile water for injection. The Microcurrent HVLD test method is highly effective in detecting the presence and location of pinholes, micro-cracks, stopper/plunger leaks, non-visible leaks under crimping and many other defects across applications like pre-filled syringes, vials, cartridges, ampoules, BFS, bottles and pouches. A unique mode of Microcurrent HVLD uses about 50% less voltage and reduces the exposure of product and environment to less than 5% of the voltage when compared to conventional HVLD solutions. The E-scan HVLD series is a leading solution of sturdy container closure integrity test equipment.

As the pharmaceutical industry continues to innovate, ensuring the integrity of pre-filled syringes through advanced leak detection techniques remains critical. Both MicroCurrent HVLD and Vacuum Decay Technology offer robust, sensitive, and non-destructive methods for detecting leaks, thereby ensuring the safety and efficacy of drug products. Employing these advanced techniques not only enhances product quality but also supports compliance with regulatory standards, ultimately protecting patient health.

Incorporating these technologies into the CCIT process allows manufacturers to maintain high standards of package integrity, ensuring that pre-filled syringes remain a reliable and safe option for drug delivery.

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