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Cleanroom Monitoring

Cleanroom Monitoring

  1. Home
  2. Distribution
  3. Glove Testing Devices

  • Airborne Particle Counters
    • ApexZ
    • ApexR
    • ApexR with Pump
    • ApexP
    • Solair
    • Handheld
    • Remotes
    • Scan Air
  • Liquid Particle Counters
    • Vertex
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    • ActiveCount
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  • Real Time Monitoring Systems
  • Digital Aerosol Photometer
    • Digital Photometer Model 3991
    • Digital Photometer Model 3990
  • Aerosol Generator
    • Aerosol Generator Model 3990-01 (1 To 6 Laskin-Nozzles)
    • Aerosol Generator Model 3990-02 (Thermal)
    • Aerosol Generator Model 3990-03 (Built-in Compressor)
    • Aerosol Generator Model 3990-04(Salt Water)
  • Surface Particle Scanners
    • Sample Scanner
    • Particle Fallout Scanner
  • Glove Testing Devices

Glove Testing Devices

MK Versuchsanlagen
MK fully automatic glove testing device on an isolator glove port

MK glove testing devices test the gloves of isolators and RABS in place, quickly and without removing them. All gloves of an isolator can be tested at the same time, with wireless data transfer and computer-based records, so production loses as little time as possible.

The fully automatic third-generation system tests every glove of an isolator or RABS at the same time, stores the results wirelessly in a database and prepares them for your documentation.

Key features

  • Integrity test from about 5 minutes, depending on glove material and port size
  • GITS®4 software, compliant with GAMP 5, FDA 21 CFR Part 11 and EU GMP Annex 11
  • GLCS® glove lifecycle system for lifecycle monitoring and error detection
  • Recognises each port and glove by RFID
  • Full traceability with automatic reports
  • Easy to clean and compatible with H₂O₂ / VHP decontamination
  • Fits all port sizes, standalone or fully integrated
  • Made in Germany by an ISO 9001 certified manufacturer
  • Qualification service included

SimpleX is a fully automatic glove leak tester that works on its own, with no Wi-Fi, software or other infrastructure. It suits sites that need fast, simple leak testing with minimal documentation, at a lower cost.

  • Standalone: no Wi-Fi, software or infrastructure needed
  • Fits all standard port sizes
  • Ready to use out of the box: unpack, fit and test

Meeting EU GMP Annex 1

EU GMP Annex 1 asks for integrity testing of barrier systems and for leak testing of gloves at defined intervals, at least at the start and end of each batch. With MK glove testing devices, the GITS®4 software and the GLCS® system, these tests are carried out and documented in a traceable, GMP-compliant way:

  • Integrity testing of barrier systems
  • Leak testing of glove systems and isolators
  • Pressure decay tests for gloves, alpha ports and beta containers
  • Results documented for the Contamination Control Strategy (CCS), which also sets how often gloves are replaced

Talk to our team

Talk to us about your next validation or monitoring project.

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