Premium
Environmental risk assessment for the galenical formulation of solid medicinal products at roche basle, switzerland
Author(s) -
Hoerger Corinne C,
Dörr Benno,
Schlienger Claude,
Straub Jürg O
Publication year - 2009
Publication title -
integrated environmental assessment and management
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.665
H-Index - 57
eISSN - 1551-3793
pISSN - 1551-3777
DOI - 10.1897/ieam_2008-049.1
Subject(s) - ecotoxicity , environmental science , environmental risk assessment , wastewater , risk assessment , sewage , material balance , sewage treatment , waste management , environmental engineering , environmental chemistry , chemistry , engineering , toxicity , computer security , process engineering , computer science , organic chemistry
Abstract An environmental risk assessment for losses to wastewater from galenical manufacturing of 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.