Environmental risk assessment for the galenical formulation of solid medicinal products at Roche Basle, Switzerland.
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.
Hoerger
Corinne C
CC
Corporate Safety, Health and Environmental Protection Department, F Hoffmann-La Roche, CH-4070 Basle, Switzerland.
Dörr
Benno
B
Schlienger
Claude
C
Straubt
Jürg O
JO
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
D007220:Industrial Waste; D004364:Pharmaceutical Preparations