Regulation – Safety – Documentation
Custom-designed installations with all-in-one service sales, engineering, own hosted design office, technical support, assembling, and qualification. Original technical solutions and safety equipment experienced in the nuclear medicine field are currently offered to secure operators, environments, and processes.
Jacomex fabrication unit enables high flexibility and an outstanding level of cleanability along with CIP-WIP devices. The design office makes it safe for built-in machines and instrumentation as well as to integrate various processes.
Normative framework:
Engineering (GEP) and Manufacturing (GMP) compliance. Compliance with FDA 21 CFR part 11 and computerized systems (GAMP5). IQ-OQ tested isolators (FAT/SAT) Incl. HDS (SDS, SMDS, SMT) and RTM. Validation after particle counting and recovery test, airflow laminarity, sequ. Steps, VHP cycles.
