This document specifies the requirements for shielded cells to be used in a radiopharmacy production laboratory operating compliant to EU-GMP requirements as defined in EudraLex — Volume 4 — Good manufacturing practice (GMP) guidelines. The laboratory is being constructed and is located in an academic environment with the primary aim to produce radiopharmaceuticals for clinical trials rather than marketed products. Besides GMP compliance flexibility with regard to non-standard, complex and bulky synthesis equipment are of key importance. For details see requirement specification PSI-GS22-001 Rev. 1.5.

This document specifies the requirements for shielded cells to be used in a radiopharmacy production laboratory operating compliant to EU-GMP requirements as defined in EudraLex — Volume 4 — Good manufacturing practice (GMP) guidelines. The laboratory is being constructed and is located in an academic environment with the primary aim to produce radiopharmaceuticals for clinical trials rather than marketed products. Besides GMP compliance flexibility with regard to non-standard, complex and bulky synthesis equipment are of key importance. For details see requirement specification PSI-GS22-001 Rev. 1.5.