title: Environmental risk assessment for the galenical formulation of solid medicinal products at Roche Basle, Switzerland.
abstract: An environmental risk assessment for losses to wastewater from galenical manufacturing at solid medicinal products at F. Hoffmann-La Roche in Basle, Switzerland, was performed based on an annual total materials balance. This balance resulted in a loss factor of 0.2% relative to the sum of all starting materials, which was later confirmed as valid by analysis for 1 specific active pharmaceutical ingredient (API). The initial risk assessment for all 25 different APIs formulated resulted in no evident risk for the wastewater treatment plant, based on biodegradation no-effect data. However, based on acute ecotoxicity data, potential risk to the local receiving water, the River Rhine, was identified from 1 single API, the antibiotic sulfamethoxazole (SMX). A refinement of the risk assessment for SMX, based on chronic ecotoxicity data, or the predicted no-effect concentration (PNEC), and documented sewage works degradability, or the predicted environmental concentration (PEC), led to a significant decrease of the initial PEC/PNEC ratio to well below 1. In view of this refinement, the final conclusion is that the galenical production investigated poses no significant risk to the environment.
authors.affiliation: Corporate Safety, Health and Environmental Protection Department, F Hoffmann-La Roche, CH-4070 Basle, Switzerland.
authors.forename: Corinne C
authors.initials: CC
authors.lastname: Hoerger
authors.forename: Benno
authors.initials: B
authors.lastname: Dörr
authors.forename: Claude
authors.initials: C
authors.lastname: Schlienger
authors.forename: Jürg O
authors.initials: JO
authors.lastname: Straubt
mesh_terms: D004339:Drug Compounding; D004345:Drug Industry; D004784:Environmental Monitoring; D007220:Industrial Waste; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D012307:Risk Factors; D045483:Rivers; D013557:Switzerland; D014865:Waste Disposal, Fluid; D014877:Water Pollution, Chemical
chemical_list: D007220:Industrial Waste; D004364:Pharmaceutical Preparations