To accelerate time-to-market for life-saving therapies, manufacturers must move toward data-driven Container Closure System (CCS) qualification. By leveraging high-precision, nondestructive testing, teams can ensure regulatory compliance and patient safety throughout the product lifecycle. The Challenge: Biologic Sensitivity Biologics (vaccines, monoclonal antibodies) are highly sensitive. Infinitesimal ingress of oxygen or microbes can trigger protein aggregation or [...]

Sterile Barrier System (SBS) is the minimum package that prevents the ingress of microorganisms and allows aseptic presentation of the product at the point of use. To maintain the highest levels of safety, manufacturers are increasingly turning to advanced instrumentation like the Labthink C660B and C660M to validate and monitor their packaging performance. This article [...]

Understanding the accuracy of leak detection is fundamental for ensuring product safety and shelf life. As a supplier, we know that precise leak data helps you prevent costly recalls and maintain brand reputation. This article explains the factors that influence the reliability of leak detection methods. Our goal is to provide clear, factual information to support your quality control decisions.

A vacuum leak test is a non-destructive quality control procedure used to identify and locate leaks in sealed packages or containers. The test involves placing the packaged item inside a sealed chamber and evacuating the air to create a vacuum. If a leak is present, air or gas will escape from the package into the chamber. This is detected either by a pressure rise in the evacuated chamber in the Vacuum Decay method setup, or by observing bubbles escaping from the package while submerged in a water bath in the Bubble Emission method setup. This method is essential for verifying the seal integrity of packaging, ensuring it protects the contents from environmental factors. The reliability of this test depends on the use of calibrated precision test instruments to apply and monitor the vacuum level accurately. It is widely applied in industries like food, pharmaceuticals, and medical devices to prevent contamination and preserve product shelf life.

CCIT testing is used to evaluate pharmaceutical packaging such as vials, syringes, auto injectors and IV bags for sterile barrier integrity breaches. Refer to test mothod of container closure integrity testing described in USP <1207>, Labthink developped a highly sensitive leak detection system for various types of liquid-filled packaging including, but not limited to pre-filled [...]

Prefilled syringes (PFSs) have gained increasing preference over traditional vial-based container closure systems (CCSs) for injectable drug products, particularly in scenarios requiring facilitated or self-administered therapies. However, compared to conventional CCSs composed of vials, rubber stoppers, and crimp caps, PFSs exhibit significantly greater structural complexity. This complexity introduces unique challenges in container closure integrity (CCI) [...]

IV bags can be effectively tested using Labthink Vacuum Decay technology. Labthink Vacuum Decay technology is capable of detecting package leaks using C690 series package non-destructive leak test systems. The test is conducted by drawing vacuum on the IV bag in the test chamber and monitoring for any changes in vacuum level. In case of [...]

In the pharmaceutical industry, the integrity of packaging is paramount to ensure that sterile products remain free from contamination and degradation. Micro leak testing of vials and ampoules is a critical quality control process, especially for injectable drugs, vaccines, and biologics, where even a small leak can compromise the safety and efficacy of the product. [...]

Introduction In the pharmaceutical industry, Container Closure Integrity Testing (CCIT) is essential to ensure that primary packaging containers such as ampoules, vials, prefilled syringes, and cartridges maintain a sterile barrier against contaminants. Any breach in container integrity can compromise product sterility, leading to drug degradation, contamination, and regulatory non-compliance. For small-volume pharmaceutical containers, CCIT methods [...]

Introduction Ampoules are widely used in pharmaceutical and medical industries to package liquid drugs, ensuring sterility and product safety. A critical aspect of ampoule packaging is leak integrity, as even the slightest leakage can compromise the sterility and effectiveness of the medication. To ensure high-quality packaging, non-destructive leak testing has become the preferred method, allowing [...]