Vacuum Leakage Tester: Ensuring Package Integrity in Compliance with USP 1207 Understanding the Vacuum Leakage Tester The vacuum leakage tester is a critical instrument for detecting leaks in sealed packaging across industries such as pharmaceuticals, food, and medical devices. It plays a crucial role in Container Closure Integrity Testing (CCIT), ensuring that products remain uncontaminated throughout their shelf life. The vacuum decay method, an industry-preferred approach, offers a non-destructive, reliable, and quantitative solution for detecting micro leaks. CCIT Testing Requirements and Leak Test as per USP 1207 USP 1207 outlines the methods and regulatory expectations for Container Closure Integrity Testing (CCIT). The vacuum decay test, recommended under USP 1207, is […]
Syringes are essential medical devices used for drug administration, requiring precise and reliable performance. A syringe leak tester ensures the integrity of the plunger stopper seal, preventing air leakage that could compromise medication delivery. Without proper testing, air bubbles may form within the syringe, leading to inaccurate dosing or serious medical complications.
Balloon Burst TesterASTM F2054 Positive Pressure Leak Test Understanding the Balloon Burst Tester A balloon burst tester is an essential instrument used to assess the burst strength of flexible packaging materials. This device helps manufacturers and quality control professionals evaluate the durability of sealed packages under internal pressurization, ensuring they can withstand pressure variations encountered during transportation and storage. By utilizing controlled air pressure, the tester detects weaknesses in package seals, helping to prevent leaks and product contamination. Main Parameter Main Parameter – Balloon Burst Tester Technical Feature Technical Feature – Balloon Burst Tester Positive Pressure Leak Test and ASTM F2054 The positive pressure leak test is a widely used […]
「医薬品包装における漏れ検出は、製品の安全性と有効性を確保するために不可欠です」 メチレンブルー漏れ試験法は、ブリスター包装の完全性を評価するために広く使用されています。医薬品の保護バリアを損なう可能性のある微細な漏れを検出するのに役立ちます。この方法は、ASTM D3078 や USP 1207 などの標準に準拠しており、規制への準拠と高品質の包装を保証します。 メチレンブルー漏れ試験法とは? メチレンブルー漏れ試験法は、ブリスターパック、サシェ、その他の医薬品包装のシールの完全性を評価するために使用される非破壊検査プロセスです。このテストでは、サンプルをメチレンブルー溶液に浸し、真空を適用して漏れを検出します。 […]
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