Inventory and management of process wastewater streams in a pharmaceutical production plant in Finland
Nurmi, Linda (2021)
Nurmi, Linda
2021
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https://urn.fi/URN:NBN:fi-fe2021073041849
https://urn.fi/URN:NBN:fi-fe2021073041849
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Pharmaceuticals and their effects on the environment have become continually a more and more interesting topic. Even though only 2% of all European API (Active Pharmaceutical Ingredient) discharges are from the pharmaceutical manufacturing plants, the Finnish environmental permit regulates reducing the amount of APIs released from the pharmaceutical industry into wastewater by various regulations. It is extremely important to understand the amount and location of the generated API discharges of the manufacturing processes in order to minimize the environmental risks caused by APIs. This study includes an inventory of the pharmaceutical wastewater. The inventory is based on the calculation of API losses and also it presents the locations and unit processes where API discharges are generated. After the sources and amounts of API discharges have been clarified, the entry of pharmaceuticals into process wastewater can be controlled by technical and practical solutions. When API discharge levels are known, it is possible to carry out a more detailed risk assessment of pharmaceuticals, which can be used to ensure that API discharges are below the maximum daily discharge limits.
In this study, the quantity and the quality of pharmaceutical wastewater are determined. The inventory of lost API masses are calculated by using process data from PI-sheets (Process Instruction Sheets). Based on the inflows and outflows, accumulated mass or product in the equipment is calculated by proportioning masses to the API concentration. The sufficiently of wastewater collection was qualitatively monitored by discrete samplings of wastewater of the Granulator 3. The concentration differences before and after cleaning processes of the Granulator 3 were detected from the results of wastewater samples. Based on the sample results, at least x% of accumulated API4 was led to the wastewater treatment plant from the cleaning program of Granulator 3. The results of the accumulated mass and the quality data from wastewater samples were used for defining estimated daily discharges. The estimated daily discharges and Predicted No-Effect Concentration values were used for risk assessment for all APIs of tablet and injection departments. Based on the sampling results and risk assessment, wastewater collection of rinsing phases of Granulator 3 is sufficient. Also, smaller sources of API discharges were studied by visual observing the effectiveness of pre-rinsing and taking samples from the rinsing water of weighing tools.
In this study, the quantity and the quality of pharmaceutical wastewater are determined. The inventory of lost API masses are calculated by using process data from PI-sheets (Process Instruction Sheets). Based on the inflows and outflows, accumulated mass or product in the equipment is calculated by proportioning masses to the API concentration. The sufficiently of wastewater collection was qualitatively monitored by discrete samplings of wastewater of the Granulator 3. The concentration differences before and after cleaning processes of the Granulator 3 were detected from the results of wastewater samples. Based on the sample results, at least x% of accumulated API4 was led to the wastewater treatment plant from the cleaning program of Granulator 3. The results of the accumulated mass and the quality data from wastewater samples were used for defining estimated daily discharges. The estimated daily discharges and Predicted No-Effect Concentration values were used for risk assessment for all APIs of tablet and injection departments. Based on the sampling results and risk assessment, wastewater collection of rinsing phases of Granulator 3 is sufficient. Also, smaller sources of API discharges were studied by visual observing the effectiveness of pre-rinsing and taking samples from the rinsing water of weighing tools.