Services for Customization and Process Development
Benefit from our experience in developing of automated processes and manufacturing of cassettes according to your specifications including the use of pre-defined parts such as filters, cartridges and more.
Eckert & Ziegler Eurotope GmbH offers a wide range of customization services for cassettes using their proprietary Modular-Lab technology. Customers benefit from a proven and reliable technology, the option to use parts based on their own development (e.g. filters and cartridges) according to their specifications and the long-term experience in the automation of manual processes. Each development for the automated tracer production covers basic process steps including tech-transfer, feasibility, optimization and confirmation of performance by execution of master-batches, accompanied by a quality control validation.
The development results in the design of a Modular-Lab synthesis cassette and associated software process, both ensuring reproducible tracer production runs. Synthesis cassettes will be assembled under GMP-compliant conditions in Eckert & Ziegler’s clean rooms. Extensive documentation will support the registration of a potential clinical trial and its safe conduct, facilitating interaction with competent authorities. Required changes and improvements can be easily introduced by full control of the in-house production and quality assurance department. All services can be customized and extended according to individual specifications.
Offered customization services may include:
• Process development for automated synthesis on Modular-Lab PharmTracer, Modular-Lab eazy or KitLab for alpha, beta and gamma emitting radiotracers including hardware, software, cassette, reagents, manuals, quality control process and validation for easy transfer to production sites
• Framework agreements for preferred supply and production slots
• Quality assurance agreements providing auditing rights, additional validation, test samples and more
• Certification of suitability for raw materials
• Enhanced incoming goods inspections according to predefined specifications
• Shelf-life studies to ensure sterility or performance
• In-process monitoring of production according to individual checklists
• Extractables/Leachables studies using partner network
• Enhanced documentation including Certificate of Analysis (CoA) and conformity (CoC) for batches and reagents, proof of sterilization, batch reports and more
• Enhanced GMP compliance using barcode plausibility check in the application software
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