高生理活性物質の製造施設における封じ込め

抄録

  We are engaging the engineering and construction of many pharmaceutical factories, and facing increasing demand for properly treating the substances with the high pharmacological activity or toxicity. After the agreement of ICH Q7A API Guideline, the discussions on several issues including the containment of hazardous substances were raised broadly. Clarifying the requirement for the containment and the provision against the cross contamination was found very difficult. Issues and steps of countermeasures to establish the basis of containment facility obtained through the experience of the engineering and construction of containment facility is described in this report.