India, the land of diversity! We are diversified in every aspect including culture, religion, language, race, eating habits, geography and political views. As such a diversified nation, it is also the largest and one of the most successful democracies of all time and the second-largest country in population in the world. And it is this largest democracy that is currently facing the brunt of this covid-19 pandemic and is getting its arm twisted by the horrible second wave which is claiming thousands of lives and almost crashing down the entire health care system of the country. But, it is truly said that “tough times don’t last, tough people do” and that is what this largest democracy with such diversity is showing the world. Despite of having record-breaking covid infections every day, the country is still maintaining a recovery rate at 88 % and a death rate below 2% which is also record making when compared in the top 10 covid affected countries.
This clearly shows the strong will of the people, the dedication of the health workers and effectiveness of the doctors and medical staff, the decision-making capacity of the government bodies, which has not let the system collapse under pressure. But one such sector which is not given its due credit is the pharmaceutical sector of India. India is not just the largest democracy but it is the largest provider of generic medicines globally. It is because of this capacity of the modern-day “sanjeevani” makers only that this health care system of India has not collapsed, the doctors are able to save lives and the government can boast to run the world’s largest vaccination drive of vaccinating around 1.3 billion people!! But every venture has a cost to pay.
Similarly, pharma industries have to scale up its production to meet the needs, which involves the usage of more raw materials, higher production rate and higher effluent flow with higher pollution. And, despite all such contributions, there will be no rebates from NGT and PCB in terms of effluent treatment. And one more problem is that most ETPs of industries are receiving higher effluent rates with existing capacity. Hence, bioremediation or biological wastewater treatment is one of the effective solutions to upgrade effluent treatment efficiency without any extra CAPEX.
More about biological wastewater treatment here https://organicabiotech.com/wastewater-treatment/.
Profile of Pharmaceutical industries: Manufacturing processes and Effluent profile
Before going directly on the solution part it is necessary to understand the manufacturing processes and profile of the effluent.
Pharmaceutical effluents consist of wide variety of products as the compounds are typically produced in batches generated in different operations, which also involves a good amount of water in processes like washing and extraction of machinery and equipment’s.
The pharmaceutical industry manufacturing can be divided into two stages as per their activity into Active pharmaceutical ingredient (API) and finished dosage form i.e. Formulation.
Based on processes involved in manufacturing, Pharma industries are further sub categorized as
- Fermentation Plants
- Synthesized Organics chemicals plant
- Fermentation/Synthesized Organic Chemical plants
- Natural Biological Product extractions (antibiotics/enzymes/Vitamins)
- Drug Mixing and Formulations.
Further classifications of the manufacturing process have been made to help understand the effluent profile. They are as follows:
- Chemical Synthesis Process: Chemical synthesis processes use organic and inorganic chemicals in batch operations to produce drugs with pharmacological action or intermediates. This process uses different techniques such as liquid-liquid extraction, Leaching, crystallization and filtration and is used in the production of antibiotics, antihistamines, Cardiovascular agents, CNS stimulants CNS depressants, hormones, Vitamins.
- Fermentation Process: It is basically a biochemical process that involves use of yeasts, lactic acid bacillus, bacillus to produce a compound. It involves processes which are Seed inoculation, Fermentation and product recovery. This process is used in the production of antibiotics, antineoplastic agents, nutrients, vitamins and steroids.
- Natural/Biological Extraction processes: It involves the processing of natural (plant and animal ) material to produce API. A large amount of water and solvents are required in such a process. It is used in the production of antineoplastic agents, enzymes and digestive aids, CNS depressants, haematological agents, insulin, vaccines.
- Compounding and formulation: the products obtained from above three processes are then formulated in usable forms like tablets, capsules and syrups.
With the above discussed manufacturing processes, each process has a particular set of compounds or by-products that are assimilated in biological wastewater treatment.
« Chemical Synthesis Process: Diverse wastewater are produced due to different chemical reactions. Wastewater with mother liquor including Organic solvent bases, Acids, bases, halides, nitrated sulphides, cyanides, metals may be generated. Wastewater from these processes generally have high COD, BOD and TDS
« Fermentation Process: A large amount of waste such as spent aqueous fermentation broth and dead cell waste is generated. The waste stream has a large quantity of unconsumed raw materials such as nutrient broth, metal salts, starch, nitrates and Phosphates with high COD, BOD, TSS with pH values ranging from 4 to 8.
« Natural/Biological Extraction processes: Solvents are used of a large scale to remove the lipophilic matter and to extract the desired product. The pH adjustment involves the usage of acids and bases in large quantities. Organic and inorganic pollutants are present with low boiling point organic solvents. Low BOD, COD and pH between 6 to 8.
Wastewater treatment in pharmaceutical industries:
It is very evident from the above paragraph that a single treatment approach is not suitable for wastewater treatment of pharmaceutical industries. It depends upon process, products, locality, and climate.
However, there are six general approaches employed to treat pharmaceutical wastewaters
- Recovery pf APIs present in wash water or solvents ex Nanofiltration.
- Physical-Chemical treatment or Primary treatment by sedimentation and floatation which contributes to 15-20% in the treatment
- Biological wastewater treatment ( aerobic and anaerobic ) in bioreactors which contributes up to 70 %
- Inactivation of active substances by UV oxidation in conjunction with O3 and H2O2.
- New hybrid technologies.
Current Pandemic and its effect on Effluent treatment:
Since the Covid-19 pandemic is on peak these days, the number of daily infections is soaring to thousands which is creating an overwhelming impact on the healthcare system. With more and more people needing medical assistance and getting hospitalized, the demand of medicines is increasing day by day, also the current vaccination programme and daily demand has kept pharma giants on their toes and pharma industries has no other option but to upscale their production. If we look this scenario revenue-wise then it is a profitable circumstance but at the same time it is making the treatment of wastewater difficult in the following ways:
- Higher Hydraulic load: The ETP’s are built to handle a certain quantity of effluent, but due to increase in production the incoming wastewater is also increased thereby exerting difficulties in the overall treatment process by reducing retention time for primary and biological wastewater treatment which decreases the treating capacity of ETP’s. This has also made industries to increase dosages of chemicals involved in processes thereby further disrupting chemical processes.
- Disrupted pH: Due to increasing wastewater levels it becomes difficult to handle and control pH levels
- Fluctuation in levels of compounds: Based on the effluent profile above which gave us an insight of compounds present which are basically solvent both Organic and inorganic, phenols, cyanides, anti-microbial compounds, aliphatic, bromides etc, we know that is takes a lot of time to ensure a proper process for an ETP at a particular concentration of such products. With the increase in effluent quantity, the levels of such compounds also get increased which makes effluent treatment difficult especially biological wastewater treatment. Because most of such compounds inhibit the growth of bacteria biology gets destroyed.
- Uncontrolled parameters: Due to such circumstances, the levels of BOD, COD, TDS and MLSS becomes uncontrollable.
- Damage to Membranes: In case of RO systems and MEE, the membranes gets damaged due to passage of less or untreated effluent especially by biological wastewater treatment.
Bioremediation for Pharma ETPs and its importance
In biological wastewater treatment, bioremediation is the use of microbes or microbial technologies to eliminate or degrade contaminants by exposing them directly to pollutants. In Bacterial Treatment of Pharmaceutical Industry Effluents, some authors say that biological wastewater treatment has a poor removal efficiency of pharmaceutical pollutants. A comparison with other methods such as physical and chemical represents a health risk due to the presence of antibiotic-resistant strains. Microorganisms have a natural capacity for degrading pollutants, and the process can be accelerated by introducing nutrients to autochthonous biodegrading microorganisms, known as bio enhancement, or by injecting an inoculum of the microorganism into the polluted region, known as bioaugmentation.
Numerous microorganisms, such as fungi, are effective in biological wastewater treatment, especially in the bioremediation of pharma effluent. Bacteria, on the other hand, are the most powerful species that demonstrate their ability.
Bacteria for Bioremediation:
Bacteria, as one of the oldest living creatures on the planet, are one of the most diverse animals, with a broad range of species living and surviving in a wide range of environments. In an anaerobic granular sludge membrane reactor, a study analyzing the dynamics of the bacterial population in the removal of pharmaceuticals such as bisoprolol, metoprolol, propranolol, venlafaxine, and others discovered a complex bacterial community. Proteobacteria, Bacteroidetes, and Actinobacteria are the most common phyla, with other bacterial classes such as Actinobacteria, Cyanobacteria, Firmicutes, Gemmatimonadetes, and others. Furthermore, some genera and species involved in the removal of pharmaceutical compounds like alprenolol, bisoprolol, metoprolol, propranolol, venlafaxine, salbutamol, fluoxetine, norfluoxetine, 17-estradiol, and gemfibrozil have been found to have a removal efficiency of 90% or higher. Apart from that, a significant number of pseudomonas and Actinobacteria, Chryseobacterium, Flavobacterium Pseudoxanthomonas genera are effective in biological wastewater treatment to the tune of 70-90 percent.
Why Bioremediation is necessary in current Scenario for Pharma sector:
As previously stated, biological wastewater treatment accounts for 60-70 percent of any ETP’s production. In the current situation, where the pharmaceutical industry must operate within established ETP capacities and time is a precious commodity, biological wastewater treatment with effective bioremediation might be able to save the day. Bioremediation would allow ETPs to update existing facilities without incurring additional CAPEX. Now the question is, how can bioremediation help? Well, we learned about its importance in the previous parts, especially the abilities of various bacteria genera to degrade various compounds.
Now, in order to incorporate an appropriate microbial technology for biological wastewater treatment, an optimal technology is one that administers several species of bacteria in a single dosage, resulting in a multi-dimensional approach to biological wastewater treatment.
Elevated levels of contaminants can be easily dealt with if various organisms are present in sufficient numbers. If the microbial population is high and heavy, shock loads can also be managed. Since bacteria are extremophiles, some species can tolerate a wide range of pH levels. Last but not least, if biological wastewater treatment is successful or the effluent biology is sound, the membrane life is extended. Bioremediation technology is thus very effective and appropriate, particularly in the current scenario for the treatment of biological wastewater from pharmaceutical industries.