MK Versuchsanlagen GmbH & Co. KG, based in Mücke-Merlau (Hesse, Germany), has specialized since 1988 in metal-free laboratory systems, cleanroom technology, and automated Glove Testing Systems.

The company develops and manufactures customized solutions for the pharmaceutical, life sciences, semiconductor, and optics industries – from contamination-free cleanrooms made from metal-free materials to Glove Integrity Test Systems (GITS®), as well as custom software and Industry 4.0 electronics. Production is carried out entirely in-house, certified according to ISO 9001:2015 and at the highest quality level.

MK Versuchsanlagen is a family-owned company based in Mücke-Merlau (Hesse, Germany), founded in 1988 by Michael Keil. As managing director, he continues to shape the strategic direction and technological innovation of the company.

The management team combines deep technical expertise, years of industry experience, and a strong vision for quality, innovation, and customer proximity.

The company culture emphasizes personal responsibility, close cooperation with customers worldwide, and a strong focus on sustainable manufacturing “Made in Germany.”

All development, design, software and hardware engineering, and manufacturing are carried out by a dedicated team at the company’s headquarters in Central Hesse.

An automated Glove Testing System like our MK Glove Integrity Test System (GITS®) offers a fast, safe, and fully documented method for testing the integrity of gloves used in isolators or RABS (Restricted Access Barrier Systems) – without interrupting production (in-situ).

Your benefits at a glance:

• Time-saving: Simultaneous testing of all gloves – test times from 5 minutes (depending on material and glove size)
• GMP & Annex 1 compliant: Meets EU GMP Annex 1, FDA 21 CFR Part 11, and GAMP 5 requirements
• Traceability: Automated documentation, data transfer, and reports – integrable into your Contamination Control Strategy (CCS)
• Wireless operation: No disruptive cables, easy cleaning, compatible with H₂O₂ / VHP decontamination
• Smart features: RFID-based port and glove recognition and GLCS® for glove lifecycle monitoring and defect detection
• Flexible integration: Operates as a standalone system or can be fully integrated into existing setups

GITS® is a reliable Glove Testing System that improves efficiency while ensuring maximum safety.

Glove Testing Devices ensure the tightness and integrity of gloves used in isolators and RABS systems. These gloves form a critical barrier between product and operator – even minor leaks can lead to contamination or batch failure.

An automated Testing System enables:

• Reliable integrity testing before, during, or after production
• Compliance with regulatory requirements (e.g., EU GMP Annex 1)
• Complete documentation and traceability
• Safe pharmaceutical manufacturing without compromising product or personnel safety

In short: Glove Testers secure your processes, protect your products, and help maintain the highest quality standards.

Glove integrity is typically tested in cleanroom or isolator environments using automated pressure decay tests.

The glove is inflated with air for a defined period, and the system monitors how fast the pressure drops – which can indicate leaks such as microcracks or pinholes.

Modern systems like the MK Glove Integrity Test System (GITS®) perform these tests automatically, wirelessly, and software-assisted, including:

• RFID-based identification of glove and port
• Simultaneous testing of multiple gloves (e.g., on an isolator)
• Automated documentation and evaluation of all results
• Full compliance with GMP and Annex 1

This ensures that only compliant gloves are used in production – for maximum product safety and process reliability.

The Transfer System Tester (TST) is a specialized device for integrity testing of Rapid Transfer Ports (RTP), alpha ports, and beta containers.

It enables fast, automated testing via pressure decay and reliably detects even the smallest leaks.

As an RTP tester, the TST can be flexibly adapted to various RTP containers and port systems.

Thanks to integration options with existing systems such as GITS®4 or GLCS®, and features like WLAN and RFID recognition, the TST offers maximum process security, full traceability, and supports compliance with regulatory standards such as EU GMP Annex 1, 21 CFR Part 11, and GAMP 5 – all with minimal impact on production workflows.

The Glove Life Cycle System (GLCS®) enables complete traceability of glove usage within cleanrooms.

Using RFID technology, the software automatically documents storage, sterilization, aging, and cleaning of each glove.

If predefined limits are exceeded, the system issues warnings or blocks testing automatically.

This ensures that unsafe gloves are reliably identified, enabling compliant and safe glove use in accordance with GMP standards – while also highlighting early wear and reducing unnecessary glove consumption, thus supporting both process safety and environmental sustainability.

The Analysis & Reporting Tool (ART) is a centralized platform for generating and evaluating reports from GITS® and GLCS®.

It produces machine- and port-specific reports, audit trails, and freely configurable evaluations.

With centralized data collection, trends can be identified, weaknesses analyzed, and informed decisions made.

ART is 21 CFR Part 11-compliant, fully network-capable, and supports both electronic and automated printouts – ideal for audits and quality assurance documentation.