In the quality control of sterile pharmaceutical products, package seals serve as the core barrier to guarantee product sterility and stability. Tiny seal gaps, crimping defects and loose connections are invisible to the naked eye. Nevertheless, they may allow ingress of moisture, oxygen and microorganisms, triggering drug deterioration, shortened shelf‑life and non‑conforming batches. Therefore, accurate, stable and quantifiable container closure integrity testing has become an essential procedure for pharmaceutical enterprises throughout R&D validation, batch release and stability study of retained samples.
Vacuum decay has become one of the mainstream testing methods in the industry, replacing empirical approaches such as visual inspection and dye immersion. It delivers quantifiable and repeatable results to support full‑process pharmaceutical quality control. Tailored to customer requirements, Neuronbc launches its flagship model, the MFT‑600 Vacuum Decay Container Closure Integrity Tester. Adopting the vacuum decay principle, the instrument is highly suitable for routine testing of mainstream sterile products including lyophilized formulations and liquid injections. It covers application scenarios such as packaging selection evaluation and process optimization in the R&D phase, finished‑product batch release, stability monitoring of retained samples, and packaging material change validation.
Equipped with a high‑precision differential pressure sensor, the MFT‑600 achieves superior accuracy and stability. It can precisely capture micro‑scale leakage defects, generating authentic, traceable and repeatable raw data for method establishment, process validation, data archiving and quality traceability. It upgrades seal integrity control from empirical judgement to data‑driven quality management.
Developed for compliant workflows in pharmaceutical laboratories and production QC stations, the instrument is built with a comprehensive data management system featuring audit trails. It stores massive test records and operation logs, fully documenting operator activities, test parameters, results and timestamps for full‑chain traceability and non‑repudiation. Test reports can be exported via USB flash drive or printed directly on‑site.
Boasting a compact footprint and a weight of only 19 kg, the unit can be deployed flexibly in R&D laboratories as well as production QC workstations. From preliminary packaging exploration and finished‑product quality gatekeeping to long‑term seal monitoring of retained samples, the MFT‑800 delivers definitive testing performance with combined positive‑ and negative‑pressure modes. It helps manufacturers build a scientific and reproducible evaluation system for container closure integrity and safeguards the packaging safety of sterile pharmaceuticals.
Packaging structures feature distinct sealing properties, and a single testing method often fails to cover all product requirements. To better serve customers with diversified product lines and packaging types that require both positive‑pressure and negative‑pressure testing, Neuronbc introduces the MFT‑800 Dual‑Mode Container Closure Integrity Tester. Integrating both vacuum decay and pressure decay principles, one single device supports two test modes without additional equipment or platform replacement. It fulfills one‑stop seal validation demands for a wide range of pharmaceutical packaging materials, perfectly matching routine testing and method development work for comprehensive pharmaceutical manufacturers, CDMOs and third‑party testing laboratories.
18600288605
Address : Room 501,No.2 Building of Ziyuguoji, Yinhe South Street,Shijingshan District, Beijing
TEL : 0086-10-56299356-806 / +86 18610813447 / +86 18600199884 / +86 13520602985
FAX : 0086-10-68705659
Email : lily@neuron-biotech.com / amanda@neuron-biotech.com / peter@neuron-biotech.com
Teams. : shichangbu@neuron-biotech.com / peter@neuron-biotech.com / +86 13581602592
WhatsApp : +86 18600199884 / +86 18610813447 / +86 13520848528
WeChat : +86 18600199884 / +86 18610813447 / +86 13581602592
Facebook : lily@neuron-biotech.com