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CHAPTER 1
INTRODUCTION
1.1 General
Studies in many countries have demonstrated the presence of pharmaceutical products at
trace levels in water streams and waste waters. The pharmaceutical compounds may enter the
environment by different routes such as discharge of treated wastewater, seepage from
landfills sites, sewer lines, runoff from animal wastes etc. Even though the environmental
impact of pharmaceuticals in the environment at trace levels has not been clearly determined,
the precautionary principle calls for action in the face of uncertainty. Even though risk from
exposure to pharmaceuticals in drinking water is minimal, information about characterization
of pharmaceuticals is still lacking. (Patneedi, 2015)
Several studies have demonstrated that certain pharmaceutical chemical compounds are being
dispersed in the environment. It has also been established that the origin of such
Emissions are mainly due to consumers use and actions and not to manufacturing operations.
Large amounts of pharmaceutical products are discarded as their expiration date passes or
They become unwanted. At this time, the correct disposal method of waste product is not
clear to the general public. Consequently, waste is discharged through sewage systems or
sent to landfills in the household waste. (Gualetro 2005)
Pharmaceutical chemicals can enter into the environment by a number of passages such as
Disposal by pharmacies
Veterinary use as medicine as well as additives to animal food; which is excreted into
soil or soil or surface waters
Release from aquaculture which has medicated feed, as well as excretion from the
aquaculture
Even in many developing countries like India the physician samples which are given
by companies to medical representatives for sales promotion purpose; Many times we
read in local newspaper that such expired/unused drug products found across road
side.
Most common routes of pharmaceuticals entering the environment are shown in Figure
1. Source: Kadam.(2016)
Pharmaceutical company must establish its own health, safety and environmental policies
covering the key principles established at the corporate level and must maintain appropriate
arrangements to facilitate and monitor effective implementation on the generation of
pharmaceutical bi products which are wastes. Also provide information, instructions, training
and supervision for all staff so that they can carry out their duties in all environmentally
responsible manners. Corporate safety and environmental engineering groups should work
with manufacturing executives to improve process safety, waste management, pollution
control and environmental stewardship. Ensure that new construction projects and buildings
comply with all environmental regulations during construction and operations.
Identify all regulatory and environmental quality requirements in the selection of chemicals
and raw materials, manufacturing scale-up processes and in working directly with R&D and
production facilities to select waste management and pollution prevention strategies.
1.4 Objectives
Reducing the environmental impact of manufacturing. Sustainable manufacturing practices
aim to reduce waste, energy, and water use across the value chain. Green manufacturing
reducing energy, water, and waste in direct operations are important elements of a green
manufacturing program.
Currently there is no Bureau of Indian Standards (BIS)/ regulations limiting the levels of
pharmaceuticals in wastewater or drinking water. However, the United States Environmental
Protection Agency has added four pharmaceutical compounds, which extensively used by
human, to the most recent contaminant (Patneedi 2015).
Currently, pharmaceutical compounds are being merged into the environment in extremely
large quantities regularly and present system of regulations of their release is not able to
control the untreated or partially treated pharma effluents. The impacts of drugs are entering
into and occurring on ecosystems, biota and humans. The side effects on human, aquatic and
animal health need to be investigated through thorough safety and toxicological studies.
Sincere efforts are required to reduce the problem along with some adequate regulations to
monitor or to control them. Water quality guidelines enforced in India needs to include
analysis of most commonly used pharmaceutical compounds in drinking water sources.
Moreover, the latest remedial measures need to be adopted at large in effluent treatment
plants of pharmaceutical industrial units to check long term environmental and health
hazards.
The following are the some of important aspects which should take under
consideration-
First: Minimization/reduction
Second: Reuse
Third: Recycling
Public awareness
Proper Disposal
CHAPTER 2
PROPERTIES OF PHARMACEUTICAL EFFLUENTS
2.1 Pharmaceuticals as pollutants
During the last three decades, the impact of chemical pollution has focused almost
exclusively on the conventional “priority” pollutants (e.g. pesticides), however this is just one
piece of the larger puzzle (Daughton 1999). The occurrence of pharmaceutical products in the
environment has gained increasingly attention since the 1980s; however its occurrence has
become more widely evident since the 1990s because the continual improvement in chemical
analysis methodologies (Daughton 2003).
Pharmaceuticals do not usually persist in the environment but continuous input into the
environment keep concentrations relatively constant. As it will be described later, many drugs
have been detected in various water streams through out several countries. However, their
concentrations are usually below the therapeutic level (e.g. ng/l, µg/l). The risks and effects
of these substances in these concentrations in the environment have not been determined yet.
However, this issue continues to be viewed with concern due to some of the properties that
many pharmaceuticals have: biological activity, lipophilic nature and resistance to
biodegradation (Valagaleti, 2002).
Table 2.1 Pharmacology and Eco pharmacology: Source Kummerer (2014)
Handling and storage of hazardous chemicals including ware houses, godowns, tank
forms in ports/fuel depots/docks.
Volatile organic compounds (VOCs). The most common VOCs include methanol,
dichloromethane, toluene, ethylene glycol, N,Ndimethylformamide ,and acetonitrile.
Effluents, especially those that are not easily biodegradable and toxic in nature. The
effluent releases could go directly to streams, rivers, lakes, oceans, or other bodies of
water.
The releases due to runoff, including storm water runoff, could also be a potential
hazard.
The toxic releases from the pharmaceuticals industry includes on-site discharge of a toxic
chemical to the environment. This includes emissions to the air, discharges to bodies of
water, releases at the facility to land, as well as contained disposal into underground injection
wells.
Heavy metals
Chemical Spills
Air Pollution –releases of gaseous, fumes, dust, particulates to atmosphere, poor air
quality.
Land /Soil Pollution –Spillage, chemicals, oils, lubricants leakages to land /soil –
seepage causation of non fertility to soil /lands, dumping or disposal of incinerated
sludge unauthorized.
Odour :-spillage of blood, bio medical waste and culture burning in autoclave etc -
poor effect on ambient air quality, -leading to mass air pollution and hazards to
neighbourhood –plants, trees, human, animals etc .
Heat Stress :-Uncontrolled work environment , high temp , exothermic reactions , use
of solvents , -very dangerous occupational hazard and also affecting environment.
The mystery of pharmaceutical occurrence in drinking water has particularly concerned the
public health. While unpleasant human health results from the existing levels of drugs and
pharmaceuticals in drinking water are highly unlikely, the resulting impacts to aquatic
ecosystems are more dangerous. Moreover, pharmaceuticals have been detected in waters for
more than four decades. In the past decade, the number of papers on the analysis of drugs or
pharmaceuticals in drinking water sources has increased considerably.
and effluents, and these have been identified as a major source of pharmaceuticals in
drinking-water.
Routine monitoring programmes to test drinking-water for pharmaceuticals have not been
implemented, as is the case for regulated chemical and microbial parameters. Generally, data
on the occurrence of pharmaceuticals in drinking-water have resulted from ad hoc surveys or
targeted research projects and investigations. Available studies have reported that
concentrations of pharmaceuticals in surface waters, groundwater and partially treated water
are typically less than 0.1 µg/l (or 100 ng/l), and concentrations in treated water are generally
below 0.05 µg/l (or 50 ng/l).
Figure 2.1: Fate and transport of pharmaceuticals in the environment (Ternes, 1998)
Analysis of the results indicated that appreciable adverse health impacts to humans
are very unlikely from exposure to the trace concentrations of pharmaceuticals that could
potentially be found in drinking-water. Concentrations of pharmaceuticals in drinking-water
are generally more than 1000-fold below the MTD, which is the lowest clinically active
dosage. The findings from these three case-studies are in line with the evidence published
over the past decade, which suggests that appreciable risks to health arising from exposure to
trace levels of pharmaceuticals in drinking
Figure 2.2 Treatment technologies for removal of pharmaceuticals from drinking water
(Source Internet)
Adapting the water safety plan approach to the context of pharmaceuticals in drinking-water
means that preventing pharmaceuticals from entering the water supply cycle during their
production, consumption (i.e. excretion) and disposal is a pragmatic and effective means of
risk management. Preventive measures need to be applied as close as possible to the source of
the risk and hazard. Inappropriate disposal practices, such as flushing unwanted or excess
drugs down toilets and sinks and discarding them into household waste, are common and may
be the main contributors to pharmaceuticals in wastewater and other environmental
media, such as surface waters and landfill leachate.
Occupational cancer
CHAPTER 3
LIFE CYCLE ASSESSMENT
3.1 Life cycle assessment
The life cycle of a pharmaceutical drug product is described in Figure 5 (adapted from
Valagaleti, 2002). It can be seen that there may be releases to the environment during the
following stages: API synthesis, extraction and purification; commercial scale manufacture;
human clinical studies and use/disposal of unwanted pharmaceuticals. Gualtero(2005)
The Flow diagram is taken from Gualetro.S (2005) it shows life cycle of pharmaceutical
waste
Figure 3.1. Life cycle of a pharmaceutical product. Adapted from (Valagaleti, 2002).
Studies have been revealed that the presence of pharmaceuticals and personal care products
have increased their number in the streams and water bodies in the countries like USA
Canada China and India
There are several elements to consider when assessing the pharmaceutical sector's
environmental footprint. One is the energy used during production and processing. Another is
the generation of waste-solid, liquid or airborne – from the manufacturing process. While
pharmaceutical contamination of water has only recently permeated the public consciousness,
it has been on the scientific community's radar for decades. There is now a compelling body
of research on the negative effects resulting from the accumulation of pharmaceuticals in the
environment, which range from the near elimination of entire species to the feminisation of
fish and the spread of antimicrobial resistance (AMR).
Take unused, unneeded, or expired prescription drugs out of their original containers
and throw them in the trash.
Mix the prescription drugs with an undesirable substance, like used coffee grounds or
kitty litter. Putting them in impermeable, non-descript containers, such as empty cans
or sealable bags, will further ensure the drugs are not diverted.
Flush prescription drugs down the toilet only if the accompanying patient information
specifically instructs doing so.
Community drug take-back programs that allow the public to bring unused drugs to a
central Location for proper disposal.
There are various disposal methods which are described here and summarized in Table 1.
Table 3.1Summary of disposal methods in and after emergencies Source: Kadam et al., (2016)
Disposal methods Types of pharmaceutical Comments
Return to donor or All bulk waste pharmaceuticals, Usually not practical-transfrontier
manufacturer, trans frontier particularly antineoplastics. procedures
transfer for disposal may be time consuming
High temperature incineration with Solids, semisolids, powders, Expensive.
temperatures greatly in Antineoplastics, controlled substances.
excess of 1200°C
Medium temperature Incineration with In the absence of high temperature Antineoplastics best incinerated at high
two-chamber incinerator with minimum Incinerators, solids, semi-solids, powders. temperature.
temperature of 850°C. Cement kiln Controlled substances.
incineration
Immobilization
Waste encapsulation Solids, semi-solids, powders, liquids, antineoplastic, controlled
substances.
Inertization Solids, semi-solids, powders,
Antineoplastic, controlled substances.
Landfill
Highly engineered sanitary Limited quantities of untreated solids, semi-solids and powders.
landfill Disposal of waste pharmaceuticals after
Immobilization preferable. PVC plastics.
Engineered landfill plastics. Waste solids, semi-solids and powders, preferably after
immobilization. PVC
Open uncontrolled non engineered dump As last resort untreated solids, semisolids, Not for untreated
powders-must be covered immediately Controlled substances.
with municipal waste. Immobilization of
solids, semi-solids, powders is preferable.
Sewer Diluted liquids, syrups, intravenous Antineoplastics, and
. fluids, small quantities of diluted undiluted disinfectants
disinfectants (supervised). and antiseptics not
recommended
Fast-flowing watercourse Diluted liquids, syrups, intravenous Antineoplastics, and
fluids; small quantities of diluted undiluted disinfectants
Disinfectants (supervised). and antiseptics not
Recommended.
Burning in open containers As last resort, packaging, paper, Not acceptable for PVC
Cardboard. plastics or
Pharmaceuticals.
Chemical decomposition Not recommended unless special Not practical for quantities over 50 kg.
chemical expertise and materials
available.
Tablets Capsules
Up to 50 tablets or capsules soak in about 100 ml of water and collect the same in a polyethylene
bag containing used Tea/Coffee grind. Seal the bag and put in trash. Big quantity-Pulverize using
heavy duty crusher. Collect in a poly bag and seal. Dispose it in high temperature incinerator
(Temp. 850°C to 1200°C)/approved site for solid waste disposal by the Pollution Control Board of
the State.
Injectables ampoules/vials:
Up to 50 Injectables-ampoules/vials: Ampoules/Vials (up to 10 ml)-break ampoules/ open vials
and collect liquid in a polyethylene bag containing used Tea/Coffee grind. Seal the bag and put in
trash. For bigger quantities, use heavy duty crusher to separate liquid and dilute it with water and
transfer it to Effluent Treatment Plant (ETP) of the manufacturing unit. Broken glass/vials (after
removal of label), rubber stoppers and seals should be disposed off as scrap. Powder Injectables
(in Vials/Ampoules) to be disposed off in an incinerator as indicated above.
Oral liquids and Intravenous fluids
Small quantity–Dilute the liquid with water and drain it. For bigger quantity, dilute collected liquid
with water and transfer it to ETP of the manufacturing unit. Liquids with high solid contents to be
disposed off in an incinerator as indicated above.
Semi solids:
Small quantity, mix it with used Tea/Coffee grind in a polyethylene bag. Seal the bag and put in a
trash. De-shape the containers/remove the label and discard the containers. Semisolids in bigger
quantity to be disposed off in an incinerator mentioned earlier. Containers- Tubes to be de-shaped
and remove the label from glass/plastic container before disposal as a scrap.
Anti-infectives-β-lactams:
Small quantity of all β-lactam antibiotics to be destroyed by soaking in 1N Sodium Hydroxide for
30 mins or 1% Hydroxylamine in Water for 10 mins and trash. Bigger quantity to be disposed off
in an incinerator (Temp. 850°C to 1200°C) indicated above.
Anti-infectives-others:
Inefficient and insecure sorting and disposal may allow drugs beyond their expiry date
to be diverted for resale to the general public. In some countries scavenging in
unprotected insecure landfills is a hazard.
In the absence of suitable disposal sites and qualified personnel to supervise disposal,
unwanted pharmaceuticals present no risk, provided they are securely stored in dry
conditions. If stored in their original packing there is a risk of diversion and to avoid
this they are best stored in drums with the pharmaceuticals immobilized.
CHAPTER 4
POLLUTION PREVENTION MEASURES
4.1 Minimization and Reduction
Waste minimization
Significant reduction of the waste generated in health-care establishments and research
facilities may be encouraged by the implementation of certain policies and practices,
including the following: WHO/CDS/VPH/92.104
Source reduction: measures such as purchasing restrictions to ensure the selection of
methods or supplies that are less wasteful or generate less hazardous waste.
Recyclable products: use of materials that may be recycled, either on-site or off-site.
Good management and control practices: apply particularly to the purchase and use of
chemicals and pharmaceuticals.
Waste segregation: careful segregation (separation) of waste matter into different categories.
Careful management of stores will prevent the accumulation of large quantities of outdated
chemicals or pharmaceuticals and limit the waste to the packaging (boxes, bottles, etc.) plus
residues of the products remaining in the containers. These small amounts of chemical or
pharmaceutical waste can be disposed of easily and relatively cheaply, whereas disposing of
larger amounts requires costly and specialized treatment, which underlines the importance of
waste minimization.
Waste minimization usually benefits the waste producer: costs for both the purchase of goods
and for waste treatment and disposal are reduced and the liabilities associated with the
disposal of hazardous waste are lessened.
Reducing the toxicity of waste is also beneficial, by reducing the problems associated with its
treatment or disposal. For example, the Supply Officer could investigate the possibilities of
purchasing PVC-free plastics that may be recycled or of goods supplied without unnecessary
packaging.
Examples of policies and practices that encourage waste minimization
WHO/CDS/VPH/92.104
Source reduction
• Purchasing reductions: selection of supplies that are less wasteful or less hazardous.
• Use of physical rather than chemical cleaning methods (e.g. steam disinfection instead of
chemical disinfection).
• Prevention of wastage of products, e.g. in nursing and cleaning activities.
Management and control measures at hospital level
• Centralized purchasing of hazardous chemicals.
• Monitoring of chemical flows within the health facility from receipt as raw materials to
disposal as hazardous wastes.
Stock management of chemical and pharmaceutical products
• Frequent ordering of relatively small quantities rather than large amounts at one time
(applicable in particular to unstable products).
• Use of the oldest batch of a product first.
• Use of all the contents of each container.
• Checking of the expiry date of all products at the time of delivery.
Long-term radionuclides conditioned as pins, needles, or seeds and used for radiotherapy may
be reused after sterilization. Special measures must be applied in the case of potential or
proven contamination with the causative agents of transmissible spongiform
encephalopathies (also known as prion diseases). These measures, which are capable of
reducing or eliminating infectivity, are described in detail in a WHO document In temperate
climates, the heat generated by on-site incinerators may be an attractive and cost-effective
option for heating hospital premises.
Thermal sterilization
• Dry sterilization
Exposure to 160 °C for 120 minutes or 170 °C for 60 minutes in a “Poupinel” oven.
• Wet sterilization
Exposure to saturated steam at 121°C for 30 minutes in an autoclave.
Chemical sterilization
• Ethylene oxide
Exposure to an atmosphere saturated with ethylene oxide for 3–8 hours, at 50–60°C, in a
reactor tank; the so-called “gas-sterilizer” tank should be dry before injection of the ethylene
oxide. Ethylene oxide is a very hazardous chemical; this process should therefore be
undertaken only by highly trained and adequately protected technical personnel.
• Glutaraldehyde
Exposure to a glutaraldehyde solution for 30 minutes. This process is safer for the operators
than the use of ethylene oxide but is microbiologically less efficient.
Pollution Control Board Consent To operate –a) WATER ACT 1974 , b) AIR ACT -
1984
Noise Monitoring
Petroleum products storage on site –type ,storage , and License –class A solvents ,
Class B chemicals , HSD , LPG stock etc
EPR & ERT –Emergency Preparedness & Response , Emergency Response Team
OHC –Occupational Health Centre , with Visiting Doctor & Male Nurse
CHAPTER 5
CASE STUDY
The information in the report is collected, studied and extracted from the different sources
such as from “The Industrial Ecology of Pharmaceutical Raw Materials and Finished
Products with and Emphasis on Supply Chain Management” by Velagaleti, R. Burns, P
(2002).
The Case study consist of The Pharmaceutical waste Generation, their contents and
percentage in the various sources of environment. Their affect to the animal, plants, human
and the aquatic life. The brief methods to disposal of these pharmaceutical hazardous waste
using available latest technologies. Life cycle assessment and environmental pollution acts
and programs.
The presence of pharmaceuticals in the drinking water is studied and represented in the report
by extracting form WHO article. Environmental pollution prevention measures such as Waste
treatment consist of Waste generation, Waste Segrigation, Reduce, Reuse, Recovery
technique. Various Pollution prevention acts in the National level and state level are reported.
CHAPTER 6
The occurrence of pharmaceuticals in the environment at trace levels is a fact. Reviewing the
life cycle of pharmaceutical products, it can be determined that releases from manufacturing
facilities are usually very low due to the fact that these processes are normally very well
contained. However, it has been determined that a large amount of these substances come
from the disposal of unwanted pharmaceuticals in the environment by the public.
Thousands of tons of unwanted pharmaceuticals may be generated annually in the part of that
amount is either disposed down the sink/toilet or sent to landfills. Even though the impact of
pharmaceuticals in the environment at trace levels has not been clearly determined, there are
many pollution prevention measures that could be implemented in a precautionary way.
These measures follow the hierarchy of: minimize/reduce, reuse/recycle and finally proper
disposal. Many of these measures would also contribute to the reduction of Health Care Cost.
Currently, pharmaceutical compounds are being merged into the environment in extremely
large quantities regularly and present system of regulations of their release is not able to
control the untreated or partially treated pharma effluents. The impacts of drugs are entering
into and occurring on ecosystems, biota and humans. The side effects on human, aquatic and
animal health need to be investigated through thorough safety and toxicological studies.
Sincere efforts are required to reduce the problem along with some adequate regulations to
monitor or to control them. Water quality guidelines enforced in India needs to include
analysis of most commonly used pharmaceutical compounds in drinking water sources.
Moreover, the latest remedial measures need to be adopted at large in effluent treatment
plants of pharmaceutical industrial units to check long term environmental and health
hazards.
REFERENCES