The biomedical waste is the waste that is generated during the diagnosis, treatment or immunization of
human beings or animals or in research activities pertaining thereto, or in the production or testing of
biological components. The different location or points of generation of waste in a health care
establishment are:
1. Operation theatres / wards / labour rooms
2. Dressing rooms
3. Injection rooms
4. Intensive Care Units
5. Dialysis room
6. Laboratory
7. Corridor
8. Compound of hospital or nursing home
Biomedical Waste Rules
The Government of India as contemplated under Section 6,8 and 25 of the Environment (Protection) Act,
1986, has made the Biomedical Wastes (Management & Handling) Rules, 1998.
The rules are applicable to every institution generating biomedical waste which includes hospitals,
nursing homes, clinic, dispensary, veterinary institutions, animal houses, pathological lab, blood bank, the
rules are applicable to even handlers.
Responsibilities of hospitals
It is mandatory for such institutions to:
Set up requisite biomedical waste treatment facilities like incinerators, autoclave and microwave
systems for treatment of the wastes, or ensure requisite treatment of the waste at a common
waste treatment facility
Make an application to the concerned authorities for grant of authorization. A fee as prescribed
shall accompany each application for grant of authorization
Submit a report to the prescribed authority by 31 January every year. The report should include
information about the categories and quantities of bio-medical wastes handled during the
preceding year.
Maintain records about the generation, collection, reception, storage, transportation, treatment,
disposal and / or any form of handling of bio-medical waste.
Categories of waste
The biomedical wastes are categorized into ten according to its characteristics taking into account
treatment and disposal. The different categories of waste as per the rule are given in Table 1.
Table 1
Waste Category
Category No. 1
Type of waste
Human Anatomical Waste (Human tissues,
incineration
Disinfecting (chemical
blades, glass,
treatment / autoclaving /
microwaving and mutilation /
shredding
Category No. 5
landfills
medicines)
Category No. 6
Incineration / autoclaving /
microwaving
Category No. 7
Category No. 8
Category No. 9
Disinfecting by chemical
treatment/ autoclaving /
shredding
Disinfecting by chemical
into drains
Category
No.10
The Schedule 1 of the Rules has laid down certain directions regarding segregation and storage to
ensure safe and hygienic handling of infectious and non-infectious waste. The segregation of
biomedical waste into various categories and storage in four different coloured containers are taking
into account the treatment and disposal facilities available (see Table 2). The Biomedical waste shall
be segregated into containers/bags at the point of generation in accordance with Schedule II prior to
its storage, transportation, treatment and disposal. The containers shall be labelled according to
Schedule III of the rule. Apart from the biomedical waste the general waste or the garbage generated
in health care establishments such as office waste, food waste and garden waste is advisable to be
stored in green coloured containers. The local bodies are duty bound to collect such general waste
stored in green coloured containers.
The Rules recommend different colour codes for waste containers in which different types of wastes
needs to be stored. Clinical and general wastes should be segregated at source and placed in colour
coded plastic bags and containers of definite specifications prior to collection and disposal. The
container should comprise of an inner plastic bag of varied colour depending on the type of waste. It
should be of a minimum gauge of 55 micron (if of low density) or 25 micron (if of high density), leak
proof and puncture proof, and should match the chosen outer container. The outer container is a
plastic bin with handles, and of a size which will depend on the amount of waste generated. The inner
polythene bag should fit into the container with one-fourth of the polythene bag turned over the rim.
Labelling has been recommended to indicate the type of waste, site of generation, name of generating
hospital or facility. This will allow the waste to be traced from the point of generation to the disposal
area. The containers are then to be transported in closed trolleys or wheeled containers that should be
designed for easy cleaning and draining. If for any reasons, it becomes necessary to store the waste
beyond such period, permission from the prescribed authority (established by the government of every
State and Union Territory) must be taken, and it must be ensured that it does not adversely affect
human health and the environment. Once collection occurs, then biomedical waste is stored in a
proper place. No untreated biomedical waste shall be stored beyond a period of 48 hours. Segregated
wastes of different categories need to be collected in identifiable containers. The duration of storage
should not exceed for 8-10 hours in big hospitals and 24 hours in other health care institutions. Each
container may be clearly labelled to show the ward or room where it is kept. The reason for this
labelling is that it may be necessary to trace the waste back to its source. Besides this, storage area
should be marked with a caution sign.
Table 2
Colour Coding
Yellow
Container
Plastic bag
Waste Category
Cat.1,Cat.2, Cat.3
and Cat.6
Red
Disinfected
Autoclaving/Micro waving/
container/plastic
Cat.7
Chemical treatment
Autoclaving/Micro waving/
bag
Blue/ White
Plastic bag/
Translucent
puncture proof
container
destruction/ shredding
Black
Plastic bag
Cat.10 (solid)
Transportation
Untreated biomedical waste shall be transported only in specially designed vehicles. The waste should
be transported for treatment either in trolleys or in covered wheelbarrows. Manual loading should be
avoided as far as possible. The bags / container containing biomedical wastes should be tied/ lidded
before transportation. Before transporting the bag containing biomedical wastes, it should be
accompanied with a signed document by Nurse/ Doctor mentioning date, shift, quantity and
destination. Special vehicles must be used so as to prevent access to, and direct contact with, the
waste by the transportation operators, the scavengers and the public. The transport containers should
be properly enclosed. The effects of traffic accidents should be considered in the design, and the driver
must be trained in the procedures he must follow in case of an accidental spillage. It should also be
possible to wash the interior of the containers thoroughly
Aprons, gowns, suits or other apparels: Apparel is worn to prevent contamination of clothing and
protect skin. It could be made of cloth or impermeable material such as plastic. People working in
incinerator chambers should have gowns or suits made of non-inflammable material.
Masks: Various types of masks, goggles, and face shields are worn alone or in combination, to
provide a protective barrier. It is mandatory for personnel working in the incinerator chamber to wear a
mask covering both nose and mouth, preferably a gas mask with filters.
Boots: Leg coverings, boots or shoe-covers provide greater protection to the skin when splashes or
large quantities of infected waste have to be handled. The boots should be rubber-soled and anti-skid
type. They should cover the leg up to the ankle.
Specifications of equipments
Incinerator: The biomedical waste incinerator shall meet the following operating and emission
standards:
(i) Operating standards
%CO2 x 100
CE =
% CO2 + % CO
3. The temperature of the primary chamber shall be 800 +/-50Oc
4. The secondary chamber gas residence time shall be at least 1 (one) second at 1050 +/- 50Oc
(ii) Emission standards: Waste to be incinerated not to be disinfected with chlorine containing
substances. Chlorinated plastics should not be incinerated. Toxic metals in incineration ash should
be limited to within regulatory quantities. Only low sulphur fuels like LDO/LSHS to be used as fuel
Deep Burial
A pit or trench should be dug about 2 m deep. It should be half filled with waste, and then
covered with lime within 50 cm of the surface, before filling the rest of the pit with soil.
It must be ensured that animals do not have access to burial sites. Covers of galvanized
iron/wire meshes may be used.
On each occasion, when wastes are added to the pit, a layer of 10cm of soil be added to cover
the wastes.
The deep burial site should be relatively impermeable and no shallow well should be close to the
site.
The pits should be distant from habitation, and sited so as to ensure that no contamination
occurs of any surface water or ground water. The area should not be prone to flooding or
erosion.
The location of the deep burial site will be authorised by the prescribed authority.
The institution shall maintain a record of all pits for deep burial.
Autoclaving
The basic objective of autoclaving is to disinfection and treating biomedical waste.
1. When operating a gravity flow autoclave, medical waste shall be subjected to:
a. A temperature of not less than 1210C and pressure of 15 pounds per square inch (psi)
for an autoclave residence time of not less than 60 minutes; or
b. A temperature of not less than 1350C and a pressure of 31 psi for an autoclave
A temperature of not less than 1490C and a pressure of 52 psi for an autoclave
residence time of not less than 30 minutes.
2. When operating a vacuum autoclave, medical waste shall be subjected to a minimum of one
pre vacuum pulse to purge the autoclave of all air. The waste shall be subjected to the
following
a. A temperature of not less than 1210C and a pressure of 15 psi for an autoclave
residence time of not less than 45 minutes; or
b. A temperature of not less than 1350C and a pressure of 31 psi for an autoclave
residence time of not less than 30 minutes.
3. Medical waste shall not be considered properly treated unless the time,
4. Temperature and pressure indicators indicate that the required time, temperature and pressure
are reached during the autoclave process. If for any reason, time, temperature or pressure
indicator indicates that the required temperature, pressure or residence time was not reached,
the entire load of medical waste must be autoclaved again until the proper temperature,
pressure and residence time were achieved.
5. Recording of operational parameters: Each autoclave shall have graphic or computer
recording devices which will automatically and continuously monitor and record dates, time of
day, load identification number and operating parameters through out the entire length of the
autoclave cycle.
6. Validation test:
7. Spore testing: The autoclave should completely and consistently kill the approved biological
indicator at the maximum design capacity of each autoclave unit. Biological indicator for
autoclave shall be Bacillus stearothermophilus spores using vials or spore strips, with at least
1*104 spores per million. Under no circumstances will an autoclave have minimum operating
parameters less than a residence time of 30 minutes, regardless of temperature and pressure,
a temperature less than 121 0C or a pressure less than 15 psi.
8. Routine tests: A chemical indicator strip/tape that changes colour when a certain temperature is
reached can be used to verify that a specific temperature has been achieved. It may be
necessary to use more than one strip over the waste package at different location to ensure
that the inner content of the package has been adequately autoclaved.
Microwave Treatment
1. Microwave treatment shall not be used for cytotoxic, hazardous or radioactive wastes, contaminated
animal carcasses, body parts and large metal items.
2. The microwave system shall comply with the efficacy tests/routine tests and a performance
Chemical Treatment
1 % hypochlorite solution can be used for chemical disinfection.
IMA has invested in IMAGE around Rs 3 crore for the project. This liability is being shared on a
cooperative basis by the affiliated institutions. However, this expenditure will amount to only one tenth
of the cost the institutions would incur if they choose an individual facility. Health care institutions can
affiliate with IMAGE by paying a non-refundable one time affiliation fee along with the duly filled up
prescribed application form. The affiliation fee is Rs. 1000/- per bed. The minimum affiliation fee for
clinics, laboratory, and diagnosis centre, dental clinics with two chairs, etc will be Rs. 5000/- only.
Government hospitals have been exempted from paying affiliation fee. IMAGE provides comprehensive
service to health care institutions by training hospital staff, advice and assistance in procuring
materials for installing a waste management system, collection of biomedical waste from hospitals in
colour coded bags, transportation in specially designed vehicles, treatment and final disposal in the
common facility. Thus infectious waste generated from hospitals is disposed off most scientifically
within 48 hours. The expenditure for service is by collecting daily charges.
As of today IMAGE serves in all the 14 districts of the state. More than 2500 health care establishments
are affiliated to IMAGE. This amounts to total bed strength of about 65000. Today IMAGE handles
more than half of the biomedical waste generated in Kerala. IMAGE consists of a common treatment
and disposal facility and a fleet of 28 specially designed vehicles which collect and transport biomedical
waste from all the affiliated hospitals everyday conforming to all the legal regulations. The treatment
facilities consist of three incinerators, two autoclaves, a plastic shredder, sharp pits, facility for storage
of incineration ash, waste water treatment plant, etc. The IMAGE has made an agreement with the
KEIL (Kerala Environmental Infrastructure Limited) Ernakulum for collecting and transporting to their
common facility all incineration ash and waste water treatment plant sludge. This is an institution of
excellence. This model is unique to Kerala and has propelled the state ahead of other states.
Training the staff of the institutions for scientific segregation of biomedical waste; provision to make
available colour coded bags and containers with emblem; daily collection of segregated and contained
biomedical waste from institutions; safe disposal of the biomedical waste in the plant as per the rules;
to make available monthly statement regarding the quantity of biomedical waste collected and disposed
on behalf of the institutions and facilitate to obtain Authorization from the State Pollution Control
Board, these are some of the services extended to health care facilities in the state by the IMAGE.