Geosyntec has conducted numerous PiE impact assessments for our pharmaceutical sector clients and have developed a quantitative methodology for a cost-effective PiE Impact Desktop Study approach specifically for evaluating potential PiE impacts related to a client’s manufacturing supply-chain.
Geosyntec has proven capabilities in the assessment of PiE-related risks related to API releases into process wastewater, off-site wastewater treatment plants, and receiving waters such as: rivers, bays, and the oceans from API manufacturers and Liquid and Solid Dose drug product facilities. Our experts are practitioners in the quantifying of the API Predicted Environmental Concentration (PEC). Using this data and the appropriate Predicted No Effect Concentration (PNEC) criteria, we compute the Risk Quotient (RQ), a ratio of the PEC to the PNEC, in order to quantify the relative PiE-related risk in that environmental medium.
Using a best-practice approach, Geosyntec helps our clients understand PiE-related risks and the risks for their Suppliers. In-conjunction with our PiE Impact Desktop Study approach with a focus on deriving accurate Risk Quotient (RQ) for a given API. Geosyntec has a strong consultancy focused on applied best-practices with a goal to eliminate pharmaceuticals in the environment. Our practice group has applied experience in identifying potential PiE impact sources within the manufacturing space. At the request of the client, a qualified team can conduct a coordinated on-site audit against these technical elements and to verify the read-outs of the PiE Desktop Impact Study assessment and to verify potential source areas of PiE.
Several of our practitioners can provide in-house expertise related to understanding the potential ecotoxicological effects of pharmaceutical compounds and personal care products on non-target aquatic and terrestrial biota, integrating potential unintended risks to ecological resources across increasing levels of biological organization. Geosyntec ecotoxicologists work with several universities, commercial laboratories and non-profits facilities to support ecological toxicity testing and perform ecological risk assessments. Our practitioners have experience designing and evaluating toxicological studies, analyzing and interpreting toxicity testing data, and developing/evaluating toxicity values, including PNECs, species sensitivity distributions, no observed effect concentrations, hazard effect concentrations, etc.
Geosyntec has proven experience within the pharmaceutical and biotechnology sector and provides for specialized solutions to our clients’ most challenging environmental wastewater and water management, infrastructure, and environmental remediation challenges, with a critical focus on PiE. Our process engineering and design practice specialists help clients from initial concept development through-to engineering design and then through-to construction, start-up, validation and operation. Finally, Geosyntec practitioners can optimize existing processes in pharmaceutical manufacturing and recommend point of generation treatment alternatives that help clients reduce potential liabilities related to PiE.