Qualified & Certified
Rotem, a longtime world leader in consumables for PET imaging, supplies cyclotrons around the world with complete packages for radiotracer production. Our product line is centered on Oxygen-18 enriched water, plastic cassettes, precursors and full reagent kits for various synthesis modules.
All products are cGMP certified by EU & PIC/S and are manufactured at our US FDA-inspected facility. Production is supported by Rotem’s ISO 17025 certified analytical lab with a wide array of equipment and QC method development capabilities. Rotem’s Mannose Triflate holds a certificate of suitability from the EDQM. Users enjoy full technical and regulatory support from our highly qualified staff.
Radiation Detection Division – Commitment to the Environment Rotem’s Radiation Detection Division is dedicated to providing high quality engineered hardware solutions that meet environmental regulations, including EU Directive 2002/95/EC and subsequent amendments of the European Parliament and of the Council of the use of certain hazardous substances in electrical and electronic equipment (WEEE). We have […]
The ISO 9000 family addresses various aspects of quality management and contains some of ISO’s best known standards. The standards provide guidance and tools for companies and organizations who want to ensure that their products and services consistently meet customer’s requirements, and that quality is consistently improved. Download ISO 9001 English Download ISO 9001 Hebrew