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Standard Operating Procedure for Waste Disposal in Pharmaceutical plants. Waste can be classified as Hazardous Waste, E-Waste, Biological Waste, etc.

SOP for Disposal of Waste Materials in Pharma

1.0      Purpose :

• • The purpose of the SOP to provide the written guidelines for the disposal of various types of waste material generated in the pharmaceutical manufacturing plant.

2.0      Scope:

• • This procedure is applicable to various departments in the pharmaceutical plant for the disposal of waste materials.

3.0      References,Attachments & Annexures :

• • References:

• • Inhouse

• • Hazardous waste (Management, Handling Transboundary Movement), Rules 2008

• • E-Waste (Management & Handling), Rules 2011

• • Bio-medical Waste (Management & Handling), Rules 1998

• • Batteries (Management & Handling) Rules, 2001

• • Attachments:

• • Attachment-1: Waste disposal slip

• • Annexures:

• • Annexure – 1: Waste disposal matrix

• • Annexure – 2: TREM Card

4.0      Responsibilities:

• • User Department:

• • Ensure waste disposal is done as per SOP.

• • Head-Environment Health and Safety (EHS) :

• • To train all user Dept.s regarding Waste disposal procedure.

• • Regulatory Affairs, Quality Head and Plant Head:

• • To review and approve the SOP.

5.0      Distribution of Waste Disposal SOP:

• • Quality Assurance

• • Quality Control

• • Production

• • Warehouse

• • Maintenance

• • Environment, Health & Safety

• • Personnel & Administration

6.0      Abbreviations & Definitions of Terms :

• • Abbreviations:

• • SOP: Standard Operating Procedure

• • EHS: Environment, Health & Safety

• • ETP: Effluent Treatment Plant

• • PPE: Personal Protective Equipment.

• • SPCB: State Pollution Control Board

• • TREM: Transport Emergency Card

• • MSDS: Material Safety Data Sheet

• • SDS: Safety Data Sheet

• • HDPE: High-Density Polyethylene

• • TSDF: Treatment Storage Disposal Facility

• • Definitions of terms:

• • Hazardous Waste: Hazardous waste is defined as any waste, excluding domestic and radioactive waste, which because of quantity physical-chemical and infectious characteristics can cause a significant hazard to human health or the environment, when in properly treated stored, transported or disposed of.

• • E-Waste: E-Waste comprises of wastes generated from used electronic devices and household appliances that are not fit for their original intended use and are destined for recovery, recycling or destruction.

• • Biological Waste: All waste that has come in to contact with any biological commodity is considered as biological Waste. Any preparation made from organisms or micro-organisms or products of metabolism and biochemical reactions intended for use in the diagnosis, immunization or the treatment of human beings or animals or in research activities pertaining thereto.

7.0      Procedure For Waste Disposal:

• • The details of waste generated & treatment within the factory premises and its mode of disposal is as per

• • • Hazardous Waste (Management& Handling), Rules 1998,

• • • E-Waste (Management & Handling), Rules 2011 &

• • • Bio-medical Waste (Management & Handling), Rules 1998,

• • • Batteries (Management & Handling) Rules, 2001.

• • Appropriate PPE’s must be worn at the time handling, treatment and disposal of the Hazardous Waste Material & Signs, Labels and Markings should be properly done.

• • FOR DISPOSAL OF FINISHED PRODUCT ( POWDER, TABLETS, CAPSULES) :

• • Processing waste material (Powder, Tablets, Capsules) shall be collected in a container & crushed the same to powder form & were not possible to crush then add some water just to make a slurry.

• • In case of discarded blister/strip / Alu-Alu packs (Aluminum and PVC containing tablets and capsules), sachets/bottles containing powder, the contents of the above-mentioned packs shall be collected in a container & crushed the same to powder form, where this is not possible to crush then add some water just to make slurry.

• • Crushed powder & slurry shall be sent by respective user departments with proper labels for disposal to the EHS department.

• • An officer of the respective user department shall accompany the waste material for disposal.

• • Stored hazardous waste material will be sent for further treatment to an approved waste disposal facility by the State Pollution Control Board (SPCB).

• • Use all the required PPE’s during handling of the hazardous waste.

• • FOR DISPOSAL OF REJECTED / OUTDATED LABORATORY CHEMICALS :

• • Concerned Persons must use appropriate PPE’s during handling the laboratory chemicals / hazardous waste.

• • Rejected / outdated laboratory chemicals to be disposed of as per the following instruction given below or instructions as per MSDS / SDS.

• • Liquid Chemical: Before considering drain disposal, be certain that the sewer flows to the ETP (Effluent Treatment Plant). Check with the EHS authority to determine what substances are acceptable for drain disposal.

• • For compounds not suitable for drain disposal, Label and package the compound and disposed as per SOP along with waste disposal slip.

• • For certain laboratory ‘liquid chemicals’ – Drain carefully with a continuous flow of water into the sink with the intimation of the area in charge/shift in-charge ETP (EHS Department)

• • DRAIN DISPOSAL RESTRICTIONS: if the following general requirements not meet.

• • The solution must have a pH between 5.5 – 9.5

• • Avoid the solutions containing Oil are permitted.

• • No solutions at a temperature of greater than 40 Degrees Centigrade are permitted.

• • No solutions containing ashes, sand, mud, metal powder, glass tar, plastic, wood or paper are permitted.

• • FOR E-WASTE :

• • E–Waste should be collected and segregated, by the respective user, the department shall accompany the waste material for disposal to the EHS department along with Waste Disposal Slip.

• • FOR DISPOSAL OF  BATTERIES :

• • Waste batteries should be collected and segregated by the respective department and send to the existing vendor with buyback policy/battery recyclers.

• • FOR WASTE DISPOSAL OF BIO-MEDICAL  :

• • Bio-medical waste should be segregated into containers/bags at the point of a generation & ensure leak-proof, special closable and labeled & shall be sent by respective user department for disposal to the EHS department.

• • Bio-medical waste shall not be mix with other wastes.

WASTE DISPOSAL SLIP

 Date:                                                                                                   Department :

 Total nos of packets / Bags/ Drums :-__________________________

Remarks :_____________________________________________

 Issued by Name:-                                                 Received by Name : –    

(User Department)                                                    (EHS Department)

   (Sign/Date)   :                                                                  (Sign/Date):

WASTE DISPOSAL MATRIX

Continue…

FORM 11

TRANSPORT EMERGENCY (TREM) CARD

Hazardous Waste to be sent for further treatment at the TSDF site.

• Characteristics of Hazardous Waste :

• • a) Types of Waste.______________________________________

• • b) Physical Properties___________________________________

• • c) Chemical Properties___________________________________

• • • Organic / Inorganic Content, Neutral pH

• • • Ash-inorganic content, Neutral pH

• • • Precipitated / coagulated Sludge mostly inorganic content, Neutral pH

Note – Use proper PPE’s (Personal ProtectiveEquipments) like Hand Gloves, Gumboot, Helmet, Mask, Safety Goggles & follow the work instruction as per MSDS / SDS.

• •  d) First Aid Requirements

• • If swallowed, DO NOT INDUCE VOMITING, give plenty of water for drinking. Never give anything by mouth to an unconscious person.

• • If inhaled & feel suffocated, move to fresh air area or give artificial respiration.

• • In case contact with skin, flush with plenty of water for at least 15 minutes and wipe with a clean cloth.

• • Remove the contaminated clothing and wash clothing before reuse.

• • In all the above cases get MEDICAL attention immediately.

• • Procedure to be followed in case of fire :

• • In case of fire, Use extinguishers media like the sand of extinguishing the fire.

• • In case of emergency or fire, contact immediately to :

• • Fire Station – 101 & Police Station – 100

• • Procedure to be followed in case of Spillage/accidents/explosion:

• • For spillage control, put sand on the spilled area, Collect the mass in the HDPE drum and send for disposal. All PPE’s to be worn while in operation.

Note: In case of spillage of spent organic solvents, the following action should be taken immediately by the transporter and waste originating site.

• • Immediately contact the waste originating site regarding the accident.

• • The affected area should be barricaded.

• • Team with competent person should reach at the place of accident..

• • Dig out affected soil till good soil is observed and fill up it HDPE woven bags and send for disposal.

• • All appropriate PPE’s ( Like Hand Gloves, Gum Boots, Safety Googles) to be worn while Operation.

• • For Expert Services, Please Contact :_____________________________.

Related: SOP For Operation of Effluent Treatment Plant (ETP) and Sewage Treatment Plant (STP)