Moqlero is expanding into the United States – alongside one of the world's largest pharmaceutical companies.
Entering the U.S. market marks another strategic milestone for Moqlero. The occasion is a major new project by one of our long-standing customers – a globally leading pharmaceutical group – building a state-of-the-art production site on U.S. soil. From day one, Moqlero will be deployed there as the binding platform for cleanroom qualification, periodic recertification, and discontinuous monitoring.
A New Production Site for Highly Regulated Drug Products
The pharmaceutical manufacturer is planning a brand-new production site for highly regulated active ingredients and drug products. The investment volume is in the billion-dollar range and underlines the strategic importance of the site for global supply security. The plans include qualified cleanroom zones from Grade A to Grade D – designed for the highest GMP requirements, international inspection readiness, and long-term scalability.
Completion by 2029
Completion of the new production site is planned by 2029. During this time, Moqlero will support the project closely – from the initial qualification of the cleanrooms to the commissioning of mobile particle counters and environmental measurement technology, through to routine monitoring and periodic recertification in ongoing GMP operations. Close collaboration with our customer's engineering, validation, and QA teams ensures that Moqlero is seamlessly aligned with the local processes.
Entering the U.S. Market: What This Means for Moqlero
With this major project, Moqlero is being deployed for the first time at a U.S. production site of a global pharmaceutical group. The regulatory requirements of the U.S. FDA like data integrity according to ALCOA++ or full audit readiness for GMP inspections have always been met by Moqlero out of the box. What is genuinely new for the U.S. market is the end-to-end support for particle measurements in cubic feet (ft³) – the unit commonly used in North America. This allows measurement data, evaluations, and signed reports to be documented locally in exactly the unit that the U.S. pharmaceutical industry and FDA inspectors are accustomed to.
With its entry into the U.S. market, Moqlero is becoming a globally deployable platform for digital cleanroom qualification – across continents, plants, and regulators!