Environmental monitoring and integrity verification instrumentation for cleanrooms and isolators, supporting ISO 14644 classification and ongoing contamination control. Cleanrooms and isolators are only as reliable as their ongoing monitoring program. Particle counts, pressure differentials, and glove or barrier integrity can drift gradually between formal requalification cycles, and a single undetected breach - a torn glove, a failed HEPA seal - can compromise an entire aseptic operation. Manufacturers need instrumentation that supports both scheduled classification testing and day-to-day contamination control monitoring.
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High Quality
Integrated factory strength to support all kinds of tape customization,with paper base,cloth base,glue,coating all raw material production capacity
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Advanced Equipment
Integrated factory strength to support all kinds of tape customization,with paper base,cloth base,glue,coating all raw material production capacity
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Professional Team
Integrated factory strength to support all kinds of tape customization,with paper base,cloth base,glue,coating all raw material production capacity
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Customer Service
Integrated factory strength to support all kinds of tape customization,with paper base,cloth base,glue,coating all raw material production capacity
Regulatory Basis
ISO 14644-1 and -2 define cleanroom classification and ongoing monitoring requirements based on particle concentration limits. EU GMP Annex 1 (2022) expands expectations around isolator and RABS barrier integrity as part of a documented contamination control strategy, including routine glove integrity testing. ISO 14644-3 covers the test methods used for classification and requalification.
Our Solutions
Our cleanroom and isolator instrumentation covers particle counters, differential pressure transmitters, glove integrity testers, filter integrity testers, TOC analyzers and container closure integrity (CCIT) testers, supporting both ISO 14644 classification testing and continuous contamination control monitoring inside isolators and RABS enclosures. Instruments are designed for both handheld portable routine patrol inspection and wall-mounted fixed online continuous monitoring, and integrate seamlessly with facility monitoring systems to centralize trend data, alarm logs and audit trails. As the manufacturer we offer full in-house R&D & production capability, 21 CFR Part 11 compliant digital audit traceability, customized hardware/software adaptation for pharmaceutical aseptic processes, long-term spare parts supply and global on-site validation & after-sales technical service, with superior cost performance compared with imported mainstream brands.
Case Study Summary
Aseptic injectable filling workshop needed to add routine glove integrity testing to its isolator qualification program following an internal contamination control strategy review. Regular scheduled leak detection eliminated hidden risks of microbial ingress through damaged gloves; all glove integrity test records are electronically archived with complete audit trails complying with 21 CFR Part 11. Isolator environmental qualification status remained stable long-term, contamination deviation incidents related to glove defects were completely eliminated, and the site successfully passed subsequent EU GMP recertification audit smoothly.
Product Center
Wireless Glove Integrity Tester WGT-1200
Multi-Point
Wireless Glove Integrity Tester WGT-2000
Glove Integrity Tester GT-2.0 (Online and Offline)
Wireless Glove Integrity Tester WGT-1000
FAQ
Q1: How often should isolator gloves be integrity tested?
A1: Frequency should be defined in a site's contamination control strategy and validated qualification program; EU GMP Annex 1 expects routine testing given gloves are a primary breach point in isolator barriers.
Q2: What is the difference between cleanroom classification and ongoing monitoring?
A2: Classification per ISO 14644-1 is a formal, periodic qualification of particle limits for a defined room state, while ongoing monitoring tracks real-time or routine trends between classification events to detect drift or excursions early.
Q3: Can one particle counter serve both cleanroom and isolator monitoring needs?
A3: Depending on sampling volume, port configuration, and software integration requirements, a single platform can often serve both, though isolators sometimes require smaller-footprint or remote-probe configurations.
Q4: What causes glove integrity failures in isolators?
A4: Common causes include mechanical wear from repetitive manipulation, chemical degradation from sporicidal agents, and puncture from sharp tools or components inside the isolator.