Product Description

Product Overview

ST‑ML01 Non‑Destructive Micro‑Leak Seal Tester adopts vacuum decay method (standard) and optional pressure decay method for non‑destructive seal integrity testing. It is developed in compliance with ASTM F2338, USP 1207, YY/T 0681.18 and GB/T 15171‑2025 standards. It is widely used for micro‑leak detection of ampoules, vials, cartridge vials, pre‑filled syringes, freeze‑dried powder injection containers, medical blister packs and high‑value food & cosmetic packages. No sample destruction occurs during testing; tested samples can be re‑entered into production or released, effectively reducing sample loss for pharmaceutical and biotech products.

Product Features

• 7‑inch color touch‑screen, intelligent data processing, real‑time test curve display and automatic data statistics.
• Dual‑sensor principle: vacuum decay (standard) and pressure decay (optional), monitoring pressure and time variation for leak identification.
• Trace‑level high‑precision pressure sensor captures ultra‑small pressure variations; imported pneumatic components ensure stable and reliable performance.
• Multi‑level pre‑set vacuum levels for gradient testing.
• Fully automatic test execution: the instrument automatically terminates the test and gives pass/fail judgement.
• Adjustable vacuum, hold‑time and infiltration time; parameters saved in database for consistent repeatable test conditions.
• Two‑part test chamber design: lower chamber holds samples, upper chamber serves as sealing cover. Force‑amplifying lever with positioning‑lock mechanism enables easy clamping and reliable sealing performance.
• Stainless‑steel enclosure, disinfectable and durable.
• Built‑in micro printer and dual USB ports for convenient data export and transfer.
• GMP‑compliant system: four‑level user permission management, audit trail, electronic signature and data backup & restore functions for full data traceability

Test Principle

Vacuum Decay Method (Standard)

Place sample inside the test chamber. Evacuate the chamber to target vacuum level and stabilize. The high‑precision pressure sensor continuously monitors pressure changes inside the chamber. If the sample has leakage, external gas penetrates into the chamber and causes pressure rise. The system calculates leak rate and gives pass/fail result by comparing measured pressure variation against threshold value.

Pressure Decay Method (Optional)

Apply positive pressure inside the sample. The sensor monitors pressure drop over time to detect internal‑to‑external leakage, suitable for special samples with limited head‑space volume for cross‑validation testing.

Reference Standards

ASTM F2338, USP 1207, YY/T 0681.18, YBB00032004‑2015, GB/T 15171‑2025, Guidance on Seal Integrity Testing for Sterile Pharmaceutical Products (9620)

Standard & Optional Configuration

Standard Configuration: Main unit, standard test chamber, lever clamping assembly, built‑in printer, power cable, operation manual. Optional Accessories: Custom‑size test chambers for special samples, pressure‑decay module, PC software, special‑purpose fixtures.