Biomedical Waste Management Authorization

Bio-Medical waste also known as clinical waste, bio-hazardous waste, regulated medical waste, infectious medical waste, and healthcare waste refers to any kind of waste that includes infectious material (or substance that’s possibly infectious). This classification includes waste generated by healthcare facilities like hospitals, physician’s offices, dental practices, medical research facilities, laboratories, and veterinary clinics.

Bio-Medical waste can hold bodily fluids like blood or other contaminants Bio-medical Waste (Management & Handling) Rules, 1998 notified by the Ministry of Environment & Forests (MoEF) under the Environment (Protection) Act, 1986. These rules apply to all persons who generate, collect, receive, store, transport, treat, dispose of, or handle biomedical 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.

Examples of Biomedical Waste:

• Everything that is saturated in the blood (gauze, gloves, gowns, etc.)
• Animal or human tissues originated during procedures
• Cultures of infectious agents/diseases
• Waste formed in patient’s rooms with infectious diseases
• Waste vaccines

Who Needs a Bio-medical Waste Authorization?

According to the Bio-medical Waste Management Rules, 2016, Every person who is involved in the generation, collection, storage, transportation, reception, recycling, and disposal is required to have authorization.

Additionally, the person has to obtain authorization for consent to establish & consent to operate from the concerned state. The person engaged in the activities related to biomedical is required to obtain consent to establish prior to the establishment of the facility.

Treatment Standards

Bio-Medical Waste Categories & Disposal Method?

Generally, it becomes a difficult task to identify and segregate every item of medical waste from a solid waste stream. Thus, according to Bio-Medical Waste (Management and Handling) Rules, 1998 bio-medical waste is characterized into groups, which are amenable to specific treatments/disposal procedures. 

Standards for Treatment of Biomedical Waste | Biomedical Waste Disposal

Standards for Incineration: Operating Standards: All incinerators shall meet the following operating and emission standards-The Combustion efficiency is computed as follows. Combustion efficiency (CE) shall be at least 99.00%. %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 a minimum of 10500C + or - 500C. The secondary chamber gas residence time shall be at least two seconds. Emission Standards

Standards for Treatment of Biomedical Waste | Biomedical Waste Disposal

Operating Standards:

• All incinerators shall meet the following operating and emission standards-
• The Combustion efficiency is computed as follows.
• Combustion efficiency (CE) shall be at least 99.00%.

                  %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 a minimum of 10500C + or - 500C.
• The secondary chamber gas residence time shall be at least two seconds. 

• Emission Standards

Stack Height:

The minimum stack height shall be 30 meters above the ground and shall be attached with the necessary monitoring facilities as per the 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 facilities or captive incinerators 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 the incineration of biomedical waste shall be disposed of at a common hazardous waste treatment and disposal facility. However, it may be disposed of in a 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 the optimum capacity of the incinerator) once in three months through a laboratory approved under the Environment (Protection) Act, 1986 and record such analysis results shall be maintained and submitted to the prescribed authority. In the case of dioxins and furans, monitoring should be done once a year.
• The occupier or operator of the common bio-medical waste treatment facility shall install a continuous emission monitoring system for the parameters as stipulated by State Pollution Control Board or Pollution Control Committees in authorization and transmit the data in 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 a 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 a combustion gas analyzer to measure CO2, CO, and O2.

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 ± 50oC with a gas residence time of at least 2(two) seconds, with a minimum of 3 % Oxygen in the stack gas.
• The Stack height should be a minimum of 30 m above ground level and shall be attached with the necessary monitoring facilities as per the 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 incinerators, notified at SL No.1 above in this Schedule, and revised from time to time, shall be applicable for Plasma Pyrolysis or Gasification also.
• Suitably designed air pollution control devices shall be installed or retrofitted with ‘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 of in accordance with the Hazardous Waste (Management, Handling, and Trans-boundary 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.

Standards for Autoclaving of Bio-Medical Waste

The autoclave should be dedicated to 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 pulses 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 the release of pathogens. The waste shall be subjected to the following:

A temperature of not less than 121°C and pressure of 15 psi per 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 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 reason, the time-temperature or pressure indicator indicates that the required temperature, pressure, or residence time was not reached, an 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 masks, 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 color 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. The biological indicator for autoclave shall be Geobacillus Stearothermophilus 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 121oC, or 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 every week and records in this regard shall be maintained.

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 the approved biological indicators at the maximum design capacity of each microwave unit. Biological indicators for microwave shall be Bacillus atrophaeus spores using vials or spore strips with at least 1 x 104 spores per detachable strip. The biological indicator shall be placed with waste and exposed to the same conditions as the waste during a normal treatment cycle.

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 galvanized 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 groundwater. The area should not be prone to flooding or erosion.
• The location of the deep burial site shall be authorized by the prescribed authority.
• The institution shall maintain a record of all pits used for deep burial.
• The groundwater table level should be a minimum of six meters below the lower level of the deep burial pit.

Standards for Efficacy of Chemical Disinfection

Microbial inactivation efficacy is equated to “Log10 kill” which is defined as the difference between the logarithms of a 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.

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 a sterilization period of 90 minutes. There should be an automatic recording system to monitor operating parameters.

Validation Test for Sharps Sterilization Unit

Waste sharps sterilization unit should completely and consistently kill the biological indicator Geobacillus Stearothermophillus or Bacillus atrophaeus spores 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 color 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 a week and records in this regard shall be maintained.

For Non-bedded facilities:

• Authorized Signatory Aadhar Card & PAN Card
• Rent/Lease/proof of ownership of the site
• MCD License
• Electricity Bill
• Waste Collection Agreement
• GPS coordinates of HCF or CBWTF

For Bedded facilities:

• All of the above
• Company PAN Card
• Board Declaration for Authorized Signatory
• Valid CTE/CTO under Water & Air Act