The Business & Biodiversity Resource Centre

Summary of Pharmaceutical Production Processes and their Environmental Effects

Issue	Possible impact on biodiversity	Caused by	Possible Sources
Eco- toxicity	Endocrine inhibitors can reduce respiratory function, possibly poisonous to flora and fauna.	Toluene, methanol, acetonitrile,chloride, chloroform, cyanide compounds, etc.	Reactor residues, spent solvents, dryers, evaporation (biological extraction), manways, material transfers, fugitive emissions, filtering systems, purification tanks.
Eutrophication	Can cause algal blooms that deplete oxygen from the water and reduce the penetration of light. Can kill fish, plants, etc.	Emissions of nitrogen (ammonia), phosphorus and sulphur that may enter water bodies.	Reactor residues, surfactants and detergents from washing, air vents, and wastewater releases particularly from the fermentation process and where ammonia is used
Bioaccumulation	Chemicals build up in the food chain and can cause poisoning or the alteration of behaviour.	Dioxins, metals, benzo(a)pyrene, vitamin A	Reactor residues, the fermentation process, combustion of contaminated batches or fuels, metal salts in wastewater, disposal of contaminated batches.
De-oxygenation (BOS, COD)	Deplete oxygen source in water, biota can die. Can lead to anaerobic conditions in water.	Organic compounds (starches, sugars), inorganic compounds, microbes.	Residues in wastewater from tableting and encapsulation, extraction and fermentation. Residues in filter cake and spent solvents.
Turbidity	Decreases light that can penetrate water, can cause death of plants and algae, reduces ability of fish to absorb oxygen, harbors microbes from harm from UV light.	Particles in effluent, or high velocity ejection of wastewater.	Waste water emissions in all processes, particularly from the fermentation process.
Tetragenicity /Spontaneous abortion	Affects ability to breed and sustain populations.	Toluene, acetonitrile.	Reactor residues, spent solvents.
Carcinogenicity	Can cause death of animals.	Benzenes, methyl chloride, formaldehyde (from the breakdown of methanol), Ethylene oxide, Hydrazine	Reactor residues, spent solvents.
Climate Change	Change of climatic conditions may cause extinctions.	Methane CO2, CO, NOx, SOx, HFC 134(a)	Reactor residues, combustion, fermentation, power consumption, transportation.
Ground level ozone	Causes discolouring of leaves, affects photosynthesis, affects lung capacity of animals.	Ozone and precursors such as NOx, and VOC’s	VOC emissions from reactor vents, manways, material loading and unloading, acid gases, fugitive emissions from pumps, valves and tanks, filtering systems, purifications tanks, dryers, from extraction chemicals.
Acid rain	Burns plants, changes soil – nutrient equilibriums	NOx, SOx.	High temperature combustion, fermentation
Temperature change	Algal blooms, death of organisms.	Emission of warmer or cooler water than ambient.	Thermal waste from reactor vessel, fermentation plants and cleaning processes.
Salinization	Death of organisms	Salts	Biological extraction, wastewater from most processes.

In addition to production pollution, residual products in the environment have been identified as a threat to ecosystem health. Product that has not been absorbed by the body is excreted and transferred to the environment after passing through sewage treatment systems, this is known as residual product. Some medicines are transferred in trace amounts to surface waters and are then capable of interacting with the endocrine systems of aquatic animals. More information can be found on the Environment Agency website.