Find out how Eckert & Ziegler has transformed radiopharmaceutical production through 15 years of expertise and innovation in synthesis cassettes.
Understand the challenges towards manufacturing the highest quality cassettes for radiolabeling and gain insights into our manufacturing processes.
As a pioneer for the radiopharmaceutical world, Eckert & Ziegler enables efficient, safe and GMP-compliant radiopharmaceutical production through innovative radiosynthesis systems with versatile cassettes. Our commitment to quality and flexibility offers customers tailored solutions that streamline workflows and enhance product reliability. The following paragraphs will introduce challenges and solutions of our mission to support your work with radiopharmaceuticals.
For almost more two decades, we at Eckert & Ziegler have been designing, constructing and manufacturing synthesis systems for the development and routine production of radiopharmaceuticals. Our activities in Berlin, Germany, not only contribute to innovative drug research but also to patient care worldwide.
Fifteen years ago, we revolutionized the market by launching our first cassette-based radiosynthesizer using the Modular-Lab technology. Since then, sterile cassettes have proved to be essential for the safe and efficient production of radiopharmaceuticals under Good Manufacturing Practice (GMP) conditions. In this article, we offer you insights into our meticulous cleanroom operations and highlight the distinctive features of our cassette production.
The advantage of synthesis cassettes
The transfer of liquids and chemicals, previously using permanently installed flow paths, is converted to external lines on so-called disposable synthesis cassettes based on manifolds. This breakthrough eliminates the need for cleaning routines to avoid cross-contamination, thus also enabling accelerated routine production of radiotracers. By simply replacing the used cassette with a new one, whether of the same or different type, a new synthesis process can instantly be started.
Since 2006, Eckert & Ziegler has been a reliable partner for hundreds of hospitals, research institutes and pharmaceutical companies in the radiopharmaceutical field. We have consistently set new standards through continuous process improvements, material advancements and the commissioning of a state-of-the-art clean room.
In 2023, over 50 different cassette types were manufactured and shipped to a large number of customers worldwide. The historical portfolio comprises more than 200 distinct cassette types, with tens of thousands of units assembled and distributed annually.
These figures reflect our expansive expertise and the success of Eckert & Ziegler’s synthesis products. We are committed to continuous innovation and always challenge ourselves to set even higher quality standards.
The production of synthesis cassettes at Eckert & Ziegler takes place in cutting-edge clean rooms in Berlin, Germany. Here, every cassette is assembled by hand, offering exceptional flexibility in the choice of components and design. This flexibility is also reflected in the broad portfolio of cassettes, which ranges from Modular-Lab PharmTracer manifolds to Modular-Lab Eazy trays and KitLab tubing based systems.
Manual assembly also allows for smaller batch sizes and customized solutions, tailored to your specific needs. This is ensured by close cooperation with the sales department, which coordinates individual minimum order quantities if required.
Every cassette we produce undergoes assembly, quality inspection, gamma-sterilization and vacuum-packaging under GMP-compliant cleanroom conditions. The entire process is subject to strict regulations to ensure that the cassettes are optimally suited for use in radiopharmacy. The materials we use are resistant to most chemicals and free from animal derived ingredients. Eckert & Ziegler guarantees a shelf life of 18 months.
Our validated sterilization process, routinely reviewed and supported by long-standing partnerships with external service providers, guarantees the highest sterility standards. We continuously monitor our clean rooms to ensure that the particle load complies with class D requirements. Additional class C cleanroom features have been integrated for enhanced safety.
In recent years, the production processes on the premises have been successfully audited several times by external pharmaceutical companies and institutions affirming our commitment to excellence.
The production of our synthesis cassettes demands the highest level of precision and expertise. We rely on a team of well-trained and experienced employees capable of handling a wide range of cassette types. The ISO 9001 certification of Eckert & Ziegler Eurotope underscores thorough documentation and process reliability. This also includes that the training status of all relevant employees always meets the strictest requirements, ensuring that only suitably qualified personnel are involved in the assembly and quality control process.
Production is carried out strictly in accordance with defined documents, standard operating procedures (SOP) and assembly lists, which ensures consistently high quality.
With years of experience managing thousands of items from hundreds of suppliers, we have developed a responsive and efficient logistics system. Our in-house purchasing and warehousing capabilities enable quick responses to customer requests and the seamless integration of new components into our portfolio.
Many items in demand are readily available in stock and our internal validation consistently ensures that the cassettes maintain their shelf life of 18 months. Retention samples are regularly tested to confirm this.
The quality of our synthesis cassettes is of the utmost importance to Eckert & Ziegler. Each cassette is double vacuum-packed, making it ideal for use in clean rooms and hot cells. Before sterilization, we conduct a thorough quality control (QC) process.
We carry out incoming goods inspections on the raw materials to ensure that only suitable products are processed. During production, various In-Process-Controls (IPC) and finally a 100% visual inspection are carried out to verify proper assembly, correct part connections as well as the check for particals. We have continually optimized our QC process over the years, and today, as one result, QC functions as an independent department, minimizing internal conflicts of interest.
Synthesis cassettes from Eckert & Ziegler are the result of 15 years of continuous development and quality improvement. With its flexible production, strict guidelines and highly qualified staff, we have established ourselves as a reliable partner in the Radiopharma world and beyond. Our tailor-made solutions empower you to optimize processes and produce safe, highest-quality radiopharmaceuticals with GMP-compliance.
We are happy to discuss your project and customize cassettes according to your individual requirements.
Get in touch with us today!
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