Modular-Lab Cassettes

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.

CE-Conformity Certificates are available and will be provided on request. Please use the contact form to get in touch.

Key Features

Wide Range of Customization services for cassettes

Benefits through specification

Detail Information

General Information

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