Nelson Labs Expands Laboratory Capacity and Services at German Facility

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

Nelson Labs announced on Aug. 26, 2025 that it is expanding its state-of-the-art laboratory space at its Wiesbaden, Germany facility (1). The expansion comes as a response to what the company says is a growing demand for packaging and microbiological testing. The company provides microbiological testing, analytical chemistry testing, and advisory services to the pharmaceutical industry.

The Wiesbaden facility offers end-to-end sterility assurance services, including Sterigenics sterilization. Sterigenics, A Sotera Health company, is a provider of outsourced terminal sterilization and irradiation services for a variety of industries.

What new services will the expansion provide?

The investment will enhance the site’s packaging validation and microbiological testing capabilities for medical device and pharmaceutical customers. The facility will be fully operational throughout the expansion. Included in the expansion are four new laboratories for packaging testing services that will enhance current microbiological testing capacity. These labs will be able to perform endotoxin, bioburden, ethylene oxide residual testing, and biological indicator sterility testing. Packaging integrity services will also be introduced. A full suite of packaging testing services will include strength testing, integrity testing, container closure integrity testing, microbial barrier testing, aging studies, and distribution testing. Improvements will also be made to bioburden testing, featuring separate sample, personnel entry points and high efficiency particulate air (HEPA)-filtered air systems to ensure contamination control.

US cleanroom capacity expansion

In June 2025, Nelson Labs announced an expansion at its Salt Lake City headquarters to double the lab’s existing ISO-certified cleanroom capacity to support sterility assurance testing and align with the European Union’s good manufacturing practice requirements (2). Enhancements to the Salt Lake facility include a new isolator suite, zoned HEPA filtration, and upgraded laminar airflow systems.

Nelson Labs has more than 3000 customers and 12 facilities in the United States, Mexico, Asia, and Europe with more than 900 laboratory tests. Additionally, Regulatory Compliance Associates, a Nelson Labs company, provides regulatory consulting services.

In the August episode of Pharmaceutical Technology®’s Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, moderates a discussion between Piet Christiaens, PhD, scientific director, E&L expert at Nelson Labs, and Dennis Jenke, PhD, principal consultant for Nelson Labs and chief executive scientist, Triad Scientific Solutions, about extractables and leachables and the testing required for each (3).

Specifically, Christiaens and Jenke highlight the differences between the E and the L in E&L and how these two compounds play off each other. Jenke goes into detail about the requirements for leachable studies, while Christiaens provides clarification on what is necessary for extractables.

The episode is available on Aug. 28, 2025. Visit PharmTech.com to watch the discussion. https://www.pharmtech.com/view/ask-the-expert-studies-for-extractables-and-leachables

References

1. Nelson Labs. Nelson Labs Expands Laboratory Capacity and Services in Wiesbaden, Germany to Meet Growing Demand for Packaging and Microbiological Testing. Press Release. Aug. 27, 2025.
2. Nelson Labs. Nelson Labs to Double Cleanroom Capacity to Support Growing Demand for Sterility Assurance Services. Press Release. June 11, 2025.
3. Schniepp, S. and Haigney, S. Ask the Expert: Studies for Extractables and Leachables. PharmTech.com. Aug. 28, 2025.