Testing systems
Whether Glove Testing Devices or Transfer System Testers – with MK’s innovative testing systems, you can ensure the integrity of your barrier systems reliably and in compliance with standards. Our systems are specifically designed for use in pharmaceutical production environments and meet all requirements according to EU GMP Annex 1.
Benefit from intelligent technology, easy handling, and perfect system integration – Made in Germany.
Annex 1 Compliance – in Every Detail
Our systems are specifically designed to support your processes in a GMP-compliant manner and to provide complete documentation.
With GITS®4 and GLCS®3, you have full control at all times – from testing through to your Contamination Control Strategy (CCS).
Fully Automated Glove Testing Devices
Our MK glove testing systems enable fast, software-supported leak testing directly in the isolator or RABS – decentralized, simultaneous, and wireless. Whether fully automated with GITS®4 or simple and flexible with SimpleX – we offer the right solution for every requirement.
Your Advantages:
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Fully automated leak testing from just 5 minutes
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GITS®4 software: GAMP 5, FDA 21 CFR Part 11 & EU Annex 11 compliant
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Lifecycle monitoring with GLCS®
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RFID-based identification & complete traceability
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Easy to clean & VHP-compatible
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Compatible with all port sizes
With the Transfer System Tester, you can quickly and precisely test the leak-tightness of transfer systems of any size. Thanks to flexible adaptation, the system is suitable for beta ports, alpha ports, and other common interfaces. Also available as a “Connect” version with Wi-Fi and GITS®4 integration.
Highlights:
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Individually calibrated for each transfer system
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Rapid leak detection via pressure decay test
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Intuitive operation with direct result display
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Optional: Wi-Fi, RFID & software integration
Contact
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