Founded in Germany in 1988 by Michael Keil, MK METALFREE began as MK Versuchsanlagen und Laborbedarf. The company quickly specialized in metal-free workspaces and pharmaceutical testing technologies, gaining international recognition by 2006 and ISO certification in 2014.

In 2019, MK expanded to the U.S. with MK METALFREE Corp. in Phoenix, Arizona, becoming a global leader in glove testing systems. In 2025, MK METALFREE IRELAND Ltd. was established in Dublin, strengthening its presence in Ireland and the UK – key regions in the pharmaceutical industry.

Today, MK METALFREE designs and manufactures tailor-made systems for the pharmaceutical, life-science, semiconductor, and optics industries – from contamination-free cleanrooms built entirely of non-metallic materials to innovative Glove Integrity Test Systems. All products are developed and produced in-house, certified to ISO 9001:2015, and meet the highest quality standards – Made in Germany.

MK METALFREE, with sites in the USA (2019) and Ireland (2025), has its roots in MK Versuchsanlagen, founded in Germany in 1988 by Michael Keil. While legally independent, all systems are still developed and manufactured in Germany, ensuring the highest quality standards.

As managing director, Michael Keil continues to shape the company’s technological innovation and strategic direction. The management team combines deep technical expertise, decades of industry experience, and a strong vision for quality, innovation, and customer focus.

The company culture is defined by responsibility, close collaboration with international clients, and sustainable German manufacturing – values that drive MK METALFREE’s success worldwide.

Metal-free cleanrooms are laboratory or production environments built entirely without metallic components.
Instead of stainless steel or aluminum, MK METALFREE uses chemically resistant fiberglass-reinforced plastic (GRP) and other specialized materials.
Avoiding metals prevents even trace contamination — crucial for applications such as:

• Ultra-trace and trace analysis
• Pharmaceutical ingredient production or testing
• Semiconductor, optical, and environmental research

By eliminating metal sources, MK METALFREE ensures maximum cleanliness, accurate analytical results, and corrosion-free operation.

A metal-free cleanroom is designed without any metallic materials to completely avoid contamination or cross-contamination of sensitive samples and processes.
High-grade plastics, smooth and chemical-resistant surfaces, and modular, adaptable components ensure easy cleaning, maximum purity, and long-term reliability — ideal for demanding cleanroom applications.

The MK Mobile Labs from MK METALFREE are flexible laboratory containers designed for use in virtually any location — on the roof of a research facility, aboard an expedition vessel, or in remote field environments.
Their modular, metal-free design allows for quick deployment and minimal construction effort, often without the need for building permits.
They are ideal for projects that require mobility, limited space, or special safety and contamination-control conditions.

Every cleanroom by MK METALFREE is a custom-engineered solution — individually designed to meet your technical, spatial, and regulatory needs.
During a structured planning process, all critical factors are defined in advance: intended use, cleanroom classification, workflow design, and compliance requirements.
All components are produced in-house, ensuring flexibility and the highest quality standards.
From consultation and design to installation and commissioning, MK METALFREE accompanies you through every project stage as a turnkey solution from planning to implementation.

Laminar airflow — either vertical or horizontal — continuously flushes particles out of the workspace, maintaining an ultra-clean environment.
Air passes through HEPA or ULPA filters before entering the work zone, preventing contamination and ensuring stable, turbulence-free flow.
This approach allows for efficient removal of heat loads and chemical vapors while keeping operators and products safe.

The automated MK METALFREE Glove Integrity Test System (GITS®) provides a fast, safe, and fully documented way to test glove integrity in isolators or RABS systems — without interrupting production.

Your key benefits:

• Significant time savings through simultaneous multi-glove testing
• Fully compliant with EU GMP Annex 1, FDA 21 CFR Part 11, and GAMP 5
• Complete traceability through automated documentation and reporting
• Wireless, easy-to-clean design compatible with H₂O₂ / VHP decontamination
• RFID-based glove and port identification plus GLCS® integration
• Can operate stand-alone or be seamlessly integrated into existing systems

Glove testing equipment ensures the integrity of gloves used in isolators and RABS systems — a critical safety barrier between product and operator.
Automated systems from MK METALFREE provide reliable integrity testing before, during, and after production, fully compliant with GMP and Annex 1 standards.
They help prevent contamination, secure product quality, and protect both person and product.

Glove integrity is verified using automated pressure-decay tests.
Each glove is inflated for a defined period while the system monitors any drop in pressure — even micro-leaks can be detected.
The MK METALFREE Software GITS® performs these tests automatically and wirelessly, with full data logging, RFID-based glove identification, and multi-port testing.
All results are documented in compliance with GMP and Annex 1.

The Transfer System Tester (TST) from MK METALFREE is designed for rapid integrity testing of Rapid Transfer Ports (RTP), alpha ports and beta containers.
Using a pressure-decay method, the TST identifies even the smallest leaks quickly and accurately.
It can be integrated with systems like GITS® or GLCS®, offering maximum process safety, full traceability, and full compliance with EU GMP Annex 1, 21 CFR Part 11, and GAMP 5 — with minimal impact on production workflows.

GLCS® enables complete traceability of glove usage within cleanroom environments.
Using RFID technology, the system automatically records storage, sterilization, aging, and cleaning cycles of every glove.
If defined limits are exceeded, it automatically issues warnings or blocks testing.
This ensures that only safe gloves are used — enhancing compliance, process security, and sustainability by reducing unnecessary glove consumption.

The Analysis & Reporting Tool (ART) provides a centralized platform for evaluating and reporting data from GITS® and GLCS®.
It generates detailed machine- and port-specific reports, audit trails, and custom analyses.
Thanks to centralized data collection, trends can be identified early, weaknesses analyzed, and data-driven decisions made.
ART is fully network-capable, compliant with 21 CFR Part 11, and supports both digital and printed reports — ideal for audits and quality assurance documentation.