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 [...]
Leak detection is a critical aspect of quality assurance in the packaging industry. Packages need to be airtight and secure to protect their contents from contamination, moisture, or gas exchange that could compromise product quality. Whether it’s food, pharmaceuticals, electronics, or industrial goods, leak testing ensures the safety, integrity, and longevity of the product. But [...]
Nondestructive Leak Detector for Packages with vacuum decay method is specialized in the detection of leaks in ampoule, vial, injection bottle, freeze-dried powder injection bottle and pre-filled package.This test instrument conforms to many national and international standards: ASTM F2338, USP1207. The sample is placed in the sample feeder and automatically delivered into the test cell. [...]
Because of its high transparency, good sealing performance and characteristics such as no pollution and low cost, glass bottle packaging is favored by food enterprises, especially canned production enterprises and beverage production enterprises. In general, the glass bottles for food and drinks are sealed with mouth iron seal. Then, whether the combination of metal cover [...]
Abstract: The integrity testing of sterilization systems mainly involves visual inspection, dye penetration testing, bubble testing, etc., to verify the leakage of packaging. In domestic medical packaging registration application materials, the integrity testing items for packaging include dye penetration method for determining the sealing leakage test of breathable packaging, visual inspection, and bubble method for [...]
