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Biomedical Waste Management Authorization

1. Bio Medical Waste Management Rules 2016
2. Classification of Biomedical Waste and Their Segregation - Collection - Treatment - Processing and Disposal Options
3. Standards for Treatment of Biomedical Waste | Biomedical Waste Disposal
4. Operating and Emission Standards for Disposal by Plasma Pyrolysis or Gasification
5. Standards for Autoclaving of Bio-Medical Waste
6. Standards of Microwaving
7. Standards for Deep Burial
8. Standards for Efficacy Of Chemical Disinfection
9. Standards for Dry Heat Sterilization
10. Standards for Liquid Waste
11. Documents Required For Biomedical Waste Authorization / Certification

Bio medical Waste Management Rules 2016

Bio-medical Waste (Management & Handling) Rules, 1998 were notified by the Ministry of Environment & Forests (MoEF) under the Environment (Protection) Act, 1986. In exercise of the powers conferred by Section 6, 8 and 25 of the Environment (Protection) Act, 1986 (29 of 1986), and in supersession of the Bio-Medical Waste (Management and Handling) Rules, 1998 and further amendments made thereof, the Central Government vide G.S.R. 343(E) dated 28 th March, 2016 published the Bio-medical Waste Management Rules, 2016. These rules apply to all persons who generate, collect, receive, store, transport, treat, dispose, or handle bio medical waste in any form including hospitals, nursing homes, clinics, dispensaries, veterinary institutions, animal houses, pathological laboratories, blood banks, ayush hospitals, clinical establishments, research or educational institutions, health camps, medical or surgical camps, vaccination camps, blood donation camps, first aid rooms of schools, forensic laboratories and research labs.

The prescribed authority for enforcement of the provisions of these rules in respect of all the health care facilities located in any State/Union Territory is the respective State Pollution Control Board (SPCB)/ Pollution Control Committee (PCC) and in case of health care establishments of the Armed Forces under the Ministry of Defence shall be the Director General, Armed Forces Medical Services (DGAFMS). These rules stipulate duties of the Occupier or Operator of a Common Bio-medical Waste Treatment Facility as well as the identified authorities. According to these rules, every occupier or operator handling bio-medical waste, irrespective of the quantity is required to obtain authorisation from the respective prescribed authority i.e. State Pollution Control Board and Pollution Control Committee, as the case may be.

Classification of Biomedical Waste And Their Segregation - Collection - Treatment - Processing and Disposal Options

Category

Type of Waste

Type of Bag or
Container to be
used

Treatment and Disposal options

(1)

(2)

(3)

(4)

Yellow

(a) Human Anatomical
Waste:
Human tissues, organs,
body parts and fetus
below the viability
period (as per the
Medical Termination of
Pregnancy Act 1971,
amended from time to
time).

Yellow coloured
non-chlorinated
plastic bags

Incineration or Plasma Pyrolysis or
deep burial*

Yellow

(b)Animal Anatomical
Waste :
Experimental animal
carcasses, body parts,
organs, tissues,
including the waste
generated from
animals used in
experiments or testing
in veterinary hospitals
or colleges or animal
houses.

 

 

Yellow

(c) Soiled Waste:
Items contaminated
with blood, body fluids
like dressings, plaster
casts, cotton swabs and bags containing residual
or discarded blood and
blood components.

 

Incineration or Plasma Pyrolysis or
deep burial*
In absence of above facilities,
autoclaving or micro-waving/hydroclaving followed by shredding or
mutilation or combination of
sterilization and shredding. Treated
waste to be sent for energy recovery.

 

(d) Expired or
Discarded Medicines:
Pharmaceutical waste
like antibiotics,
cytotoxic drugs
including all items
contaminated with
cytotoxic drugs along
with glass or plastic
ampoules, vials etc.

Yellow coloured
non-chlorinated
plastic bags or
containers

Expired `cytotoxic drugs and items
contaminated with cytotoxic drugs to be
returned back to the manufacturer or
supplier for incineration at temperature
>1200 0C or to common bio-medical
waste treatment facility or hazardous
waste treatment, storage and disposal
facility for incineration at >12000C Or
Encapsulation or Plasma Pyrolysis at
>12000C.
All other discarded medicines shall be
either sent back to manufacturer or
disposed by incineration.

 

(e) Chemical Waste:
Chemicals used in
production of biological
and used or discarded
disinfectants.

Yellow coloured
containers or
non-chlorinated
plastic bags

Disposed of by incineration or Plasma
Pyrolysis or Encapsulation in
hazardous waste treatment, storage and
disposal facility.

 

(f) Chemical Liquid
Waste :
Liquid waste generated
due to use of chemicals
in production of
biological and used or
discarded disinfectants,
Silver X-ray film
developing liquid,
discarded Formalin,
infected secretions,
aspirated body
fluids, liquid from
laboratories and floor
washings, cleaning,
house-keeping and
disinfecting activities
etc.

Separate
collection
system leading
to effluent
treatment system

After resource recovery, the chemical
liquid waste shall be pre-treated before
mixing with other wastewater. The
combined discharge shall conform to
the discharge norms given in Schedule-
III.

 

(g) Discarded linen,
mattresses, beddings
contaminated with
blood or body fluid.

Non-chlorinated
yellow plastic
bags or suitable
packing material

Non- chlorinated chemical disinfection
followed by incineration or Plazma
Pyrolysis or for energy recovery.
In absence of above facilities, shredding
or mutilation or combination of
sterilization and shredding. Treated
waste to be sent for energy recovery or
incineration or Plazma Pyrolysis.

 

(h) Microbiology,
Biotechnology and
other clinical
laboratory waste:
Blood bags, Laboratory
cultures, stocks or
specimens of microorganisms,
live or
attenuated vaccines,
human and animal cell
cultures used in
research, industrial
laboratories, production
of biological, residual
toxins, dishes and
devices used for
cultures.

Autoclave safe
plastic bags or
containers

Pre-treat to sterilize with nonchlorinated
chemicals on-site as per
National AIDS Control Organisation or
World Health Organisation guidelines
thereafter for Incineration.

Red

Contaminated Waste
(Recyclable)
(a) Wastes generated
from disposable items
such as tubing, bottles,
intravenous tubes and
sets, catheters, urine
bags, syringes (without
needles and fixed needle
syringes) and
vaccutainers with their
needles cut) and gloves.

Red coloured
non-chlorinated
plastic bags or
containers

Autoclaving or micro-waving/
hydroclaving followed by shredding or
mutilation or combination of
sterilization and shredding. Treated
waste to be sent to registered or
authorized recyclers or for energy
recovery or plastics to diesel or fuel oil
or for road making, whichever is
possible.
Plastic waste should not be sent to
landfill sites.

White
(Translucent)

Waste sharps
including Metals:
Needles, syringes with
fixed needles, needles
from needle tip cutter or
burner, scalpels, blades,
or any other
contaminated sharp
object that may cause
puncture and cuts. This
includes both used,
discarded and
contaminated metal
sharps

Puncture proof,
Leak proof,
tamper proof
containers

Autoclaving or Dry Heat Sterilization
followed by shredding or mutilation or
encapsulation in metal container or
cement concrete; combination of
shredding cum autoclaving; and sent for
final disposal to iron foundries (having
consent to operate from the State
Pollution Control Boards or Pollution
Control Committees) or sanitary
landfill or designated concrete waste
sharp pit.

Blue

(a) Glassware:
Broken or discarded and
contaminated glass
including medicine vials
and ampoules except
those contaminated with
cytotoxic wastes.

Cardboard boxes
with blue
colored marking

Disinfection (by soaking the washed
glass waste after cleaning with
detergent and Sodium Hypochlorite
treatment) or through autoclaving or
microwaving or hydroclaving and then
sent for recycling.

Blue

(b) Metallic Body
Implants

Cardboard boxes
with blue
colored marking

 

Standards For Treatment of Biomedical Waste | Biomedical Waste Disposal

A. STANDARDS FOR INCINERATION:-

  • All incinerators shall meet the following operating and emission standards-

    • Operating Standards

      •  Combustion efficiency (CE) shall be at least 99.00%.

      • The Combustion efficiency is computed as follows:

                  %C02
       C.E. = ------------ X 100
             %C02 + % CO

  • The temperature of the primary chamber shall be a minimum of 800 0C and the secondary chamber shall be minimum of 10500C + or - 500C.

  • The secondary chamber gas residence time shall be at least two seconds.

B. Emission Standards

Sl. No.

Parameter

Standards 

 

 

 

Limiting concentration
in mg Nm3 unless
stated

Sampling Duration in minutes,
unless stated

1.

Particulate matter

50

30 or 1NM3 of sample volume,
whichever is more

2.

Nitrogen Oxides NO and
NO2 expressed asNO2

400

30 for online sampling or grab
sample

3.

HCl

50

30 or 1NM3 of sample volume,
whichever is more

4.

Total Dioxins and Furans

0.1ngTEQ/Nm3 (at 11%
O2)

8 hours or 5NM3 of sample volume,
whichever is more

5.

Hg and its compounds

0.05

2 hours or 1NM3 of sample volume,
whichever is more

C. Stack Height:

Minimum stack height shall be 30 meters above the ground and shall be attached with
the necessary monitoring facilities as per requirement of monitoring of ‘general parameters’ as notified
under the
Environment (Protection) Act, 1986 and in accordance with the Central Pollution Control
Board Guidelines of Emission Regulation Part-III.

Note:

  • The existing incinerators shall comply with the above within a period of two years from the date of the notification.

  • The existing incinerators shall comply with the standards for Dioxins and Furans of 0.1ngTEQ/Nm3, as given below within two years from the date of commencement of these rules.

  •  All upcoming common bio-medical waste treatment facilities having incineration facility or captive incinerator shall comply with standards for Dioxins and Furans.

  • The existing secondary combustion chambers of the incinerator and the pollution control devices shall be suitably retrofitted, if necessary, to achieve the emission limits.

  • Wastes to be incinerated shall not be chemically treated with any chlorinated disinfectants.

  • Ash from incineration of biomedical waste shall be disposed of at common hazardous waste treatment and disposal facility. However, it may be disposed of in municipal landfill, if the toxic metals in incineration ash are within the regulatory quantities as defined under the Hazardous Waste (Management and Handling and Transboundary Movement) Rules, 2008 as amended from time to time.

  • Only low Sulphur fuel like Light Diesel Oil or Low Sulphur Heavy Stock or Diesel, Compressed Natural Gas, Liquefied Natural Gas or Liquefied Petroleum Gas shall be used as fuel in the incinerator.

  • The occupier or operator of a common bio-medical waste treatment facility shall monitor the stack gaseous emissions (under optimum capacity of the incinerator) once in three months through a laboratory approved under the Environment (Protection) Act, 1986 and record of such analysis results shall be maintained and submitted to the prescribed authority. In case of dioxins and furans, monitoring should be done once in a year.

  • The occupier or operator of the common bio-medical waste treatment facility shall install continuous emission monitoring system for the parameters as stipulated by State Pollution Control Board or Pollution Control Committees in authorisation and transmit the data real time to the servers at State Pollution Control Board or Pollution Control Committees and Central Pollution Control Board.

  • All monitored values shall be corrected to 11% Oxygen on dry basis.

  • Incinerators (combustion chambers) shall be operated with such temperature, retention time and turbulence, as to achieve Total Organic Carbon content in the slag and bottom ashes less than 3% or their loss on ignition shall be less than 5% of the dry weight.

  • The occupier or operator of a common bio-medical waste incinerator shall use combustion gas analyzer to measure CO2, CO and O2.

2. OPERATING AND EMISSION STANDARDS FOR DISPOSAL BY PLASMA PYROLYSIS OR GASIFICATION

  • Operating Standards:

  • All the operators of the Plasma Pyrolysis or Gasification shall meet the following operating and emission

  • standards:

    • Combustion Efficiency (CE) shall be at least 99.99%.

    • The Combustion Efficiency is computed as follows.

                                   % CO2

              C.E =    ……………………… X 100

                            (% CO2 + % CO)

  • The temperature of the combustion chamber after plasma gasification shall be 1050 ± 50 o C with gas residence time of at least 2(two) second, with minimum 3 % Oxygen in the stack gas.

  • The Stack height should be minimum of 30 m above ground level and shall be attached with the necessary monitoring facilities as per requirement of monitoring of ‘general parameters’ as notified under the Environment (Protection) Act, 1986 and in accordance with the CPCB

Guidelines of Emission Regulation Part-III.

  • Air Emission Standards and Air Pollution Control Measures

    • Emission standards for incinerator, notified at Sl No.1 above in this Schedule, and revised from time to time, shall be applicable for the Plasma Pyrolysis or Gasification also.

    • Suitably designed air pollution control devices shall be installed or retrofitted with the ‘Plasma Pyrolysis or Gasification to achieve the above emission limits, if necessary.

    • Wastes to be treated using Plasma Pyrolysis or Gasification shall not be chemically treated with any chlorinated disinfectants and chlorinated plastics shall not be treated in the system.

  • Disposal of Ash Vitrified Material: The ash or vitrified material generated from the ‘Plasma Pyrolysis or Gasification shall be disposed off in accordance with the Hazardous Waste (Management, Handling and Transboundary Movement) Rules 2008 and revisions made thereafter in case the constituents exceed the limits prescribed under Schedule II of the said Rules or else in accordance with the provisions of the Environment (Protection) Act, 1986, whichever is applicable.

3. STANDARDS FOR AUTOCLAVING OF BIO-MEDICAL WASTE

The autoclave should be dedicated for the purposes of disinfecting and treating bio-medical waste.

  • When operating a gravity flow autoclave, medical waste shall be subjected to:

    • A temperature of not less than 121° C and pressure of 15 pounds per square inch (psi) for an autoclave residence time of not less than 60 minutes; or

    • a temperature of not less than 135° C and a pressure of 31 psi for an autoclave residence time of not less than 45 minutes; or

    • A temperature of not less than 149° C and a pressure of 52 psi for an autoclave residence time of not less than 30 minutes.

  • When operating a vacuum autoclave, medical waste shall be subjected to a minimum of three pre-vacuum pulse to purge the autoclave of all air. The air removed during the pre-vacuum, cycle should be decontaminated by means of HEPA and activated carbon filtration, steam treatment, or any other method to prevent release of pathogen. The waste shall be subjected to the following:

    • a temperature of not less than 121°C and pressure of 15 psi per an autoclave residence time of not less than 45 minutes; or

    • a temperature of not less than 135°C and a pressure of 31 psi for an autoclave residence time of not less than 30 minutes;

  • Medical waste shall not be considered as properly treated unless the time, temperature and pressure indicators indicate that the required time, temperature and pressure were reached during the autoclave process. If for any reasons, 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.

  • 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 throughout the entire length of the autoclave cycle.

  • Validation test for autoclave: The validation test shall use four biological indicator strips, one shall be used as a control and left at room temperature, and three shall be placed in the approximate center of three containers with the waste. Personal protective equipment (gloves, face mask and coveralls) shall be used when opening containers for the purpose of placing the biological indicators. At least one of the containers with a biological indicator should be placed in the most difficult location for steam to penetrate, generally the bottom center of the waste pile. The occupier or operator shall conduct this test three consecutive times to define the minimum operating conditions. The temperature, pressure and residence time at which all biological indicator vials or strips for three consecutive tests show complete inactivation of the spores shall define the minimum operating conditions for the autoclave. After determining the minimum temperature, pressure and residence time, the occupier or operator of a common biomedical waste treatment facility shall conduct this test once in three months and records in this regard shall be maintained.

  • Routine Test: A chemical indicator strip or 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 locations to ensure that the inner content of the package has been adequately autoclaved. The occupier or operator of a common bio medical waste treatment facility shall conduct this test during autoclaving of each batch and records in this regard shall be maintained.

  • 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 Geobacillusstearothermophilus spores using vials or spore Strips; with at least 1X106 spores. Under no circumstances will an autoclave have minimum operating parameters less than a residence time of 30 minutes, a temperature less than 121o C or a pressure less than 15 psi. The occupier or operator of a common bio medical waste treatment and disposal facility shall conduct this test at least once in every week and records in this regard shall be maintained.

4.STANDARDS OF MICROWAVING.-

  • Microwave treatment shall not be used for cytotoxic, hazardous or radioactive wastes, contaminated animal carcasses, body parts and large metal items.

  • The microwave system shall comply with the efficacy test or routine tests and a performance guarantee may be provided by the supplier before operation of the limit.

  • The microwave should completely and consistently kill the bacteria and other pathogenic organisms that are ensured by approved biological indicator at the maximum design capacity of each microwave unit. Biological indicators for microwave shall be Bacillus atrophaeusspores using vials or spore strips with at least 1 x 104sporesper detachable strip. The biological indicator shall be placed with waste and exposed to same conditions as the waste during a normal treatment cycle.

5. STANDARDS FOR DEEP BURIAL.-

  • A pit or trench should be dug about two meters deep. It should be half filled with waste, 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 any access to burial sites. Covers of galvanised iron or wire meshes may be used.

  • On each occasion, when wastes are added to the pit, a layer of 10 cm of soil shall be added to cover the wastes.

  • Burial must be performed under close and dedicated supervision.

  • 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 located so as to ensure that no contamination occurs to surface water or ground water. The area should not be prone to flooding or erosion.

  • The location of the deep burial site shall be authorised by the prescribed authority.

  • The institution shall maintain a record of all pits used for deep burial.

  • The ground water table level should be a minimum of six meters below the lower level of deep burial pit.

6. STANDARDS FOR EFFICACY OF CHEMICAL DISINFECTION

  • Microbial inactivation efficacy is equated to “Log10 kill” which is defined as the difference between the logarithms of number of test microorganisms before and after chemical treatment. Chemical disinfection methods shall demonstrate a 4 Log10 reduction or greater for Bacillus Subtilis (ATCC 19659) in chemical treatment systems.

7. STANDARDS FOR DRY HEAT STERILIZATION

  • Waste sharps can be treated by dry heat sterilization at a temperature not less than 1850C, at least for a residence period of 150 minutes in each cycle, which sterilization period of 90 minutes. There should be automatic recording system to monitor operating parameters.

    • Validation test for Shaprs sterilization unit

      • Waste shaprs sterilization unit should completely and consistently kill the biological indicator GeobacillusStearothermophillus or Bacillus Atropheausspoers using vials with at least log10 6 spores per ml. The test shall be carried out once in three months

    •  Routine test

      • A chemical indicator strip or 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 to ensure that the inner content of the sharps has been adequately disinfected. This test shall be performed once in week and records in this regard shall be maintained.

8. STANDARDS FOR LIQUID WASTE.-

  • The effluent generated or treated from the premises of occupier or operator of a common bio medical waste treatment and disposal facility, before discharge into the sewer should conform to the following limits-

                     PARAMETERS                                                 PERMISSIBLE LIMITS

                     pH                                                                           6.5-9.0

                     Suspended solids                                                   100 mg/l

                     Oil and grease                                                        10 mg/l

                     BOD                                                                        30 mg/l

                     COD                                                                        250 mg/l

                     Bio-assay test                                                         90% survival of fish after 96 hours in                                                                                                            100% effluent.

  • Sludge from Effluent Treatment Plant shall be given to common bio-medical waste treatment facility for incineration or to hazardous waste treatment, storage and disposal facility for disposal.

Documents Required For Biomedical Waste Authorization / Certification

For Proprietory | Partnership Concern

  • Proprietor Adhaar Card + PAN Card

  • Rent/Lease/proof of ownership of site

  • MCD License

  • Electricity Bill

  • Waste Collection Agreement

For Private Ltd | Public Ltd Company 

  •  All the above

  • Certificate of Incorporation (CIN)

  • MOA

  • Company PAN Card

  • Board Declaration for Authorized Signatory

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