发布时间:2024-04-22 发布者:
This production base mainly produces parenteral specialty drugs (injections). As part of adjusting the production direction, a workshop was closed in order to switch to producing another special drug. Before the shutdown, the workshop used 8 different active ingredients to produce drugs, all of which were highly toxic.
Before the production transition, CURIUM analyzed the pollution status of the entire production environment (process equipment, clean room, ventilation network, fluid network), determined the tracer and the pollution threshold to be achieved based on the future use purpose of the equipment, and developed a sampling plan. The selection of tracers, sampling methods, and interpretation of results all consider cost optimization and planning optimization.
CURIUM subsequently drafted a decontamination operation procedure for the equipment that needs to be decontaminated. CURIUM conducted quality and safety audits on alternative construction companies and ultimately chose construction disclosure. After the construction was completed, CURIUM conducted an inspection to verify the completion of decontamination.