Standard Operating Procedure for Incineration of Pharmaceutical Waste

1) Purpose

The purpose of this SOP is to provide clear guidelines for the safe and compliant incineration of pharmaceutical waste to ensure environmental safety, worker protection, and adherence to regulatory standards.

2) Scope

This SOP applies to all departments involved in the collection, storage, transportation, and incineration of pharmaceutical waste generated in manufacturing units, laboratories, warehouses, and healthcare facilities.

3) Responsibilities

• Supervisors: Ensure proper implementation of pharmaceutical waste incineration procedures and compliance with regulatory requirements.
• Operators: Collect, segregate, and transport waste to the incineration site as per this SOP.
• Waste Management Personnel: Monitor and coordinate safe incineration with authorized facilities.
• Safety Officers: Conduct audits and ensure adherence to environmental and safety standards.

4) Procedure

4.1 Classification of Pharmaceutical Waste

Pharmaceutical waste is categorized as follows:

1. Expired Pharmaceuticals: Tablets, capsules, syrups, and injectable drugs.
2. Contaminated Pharmaceuticals: Medicines exposed to contamination or spillage.
3. Unusable Chemicals and Reagents: Expired reagents, solvents, and analytical chemicals.
4. Sharps Waste: Syringes, needles, ampoules, and broken glassware containing drug residues.
5. Hazardous Pharmaceutical Waste: Cytotoxic drugs, hormonal medicines, and antibiotics.

4.2 Segregation and Collection of Pharmaceutical Waste

1. Segregation Process:
   • Segregate pharmaceutical waste at the point of generation into appropriate categories.
   • Do not mix hazardous pharmaceutical waste with general or non-hazardous waste.

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2. Color-Coded Containers:
   • Red: Contaminated and hazardous pharmaceutical waste
   • Yellow: Expired pharmaceuticals and cytotoxic drugs
   • White: Sharps waste (e.g., syringes, needles)
3. Labeling:
   • Clearly label all containers with:
     • Type of waste
     • Date of collection
     • Hazard warnings (e.g., Biohazard, Toxic, Flammable)
4. Documentation:
   • Record details of waste collected in the Pharmaceutical Waste Log (Annexure 1).

4.3 Storage of Pharmaceutical Waste

1. Storage Area Requirements:
   • Designate a secure, ventilated, and isolated area for temporary storage of pharmaceutical waste.
   • Ensure containers are leak-proof, sealed, and labeled appropriately.

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2. Storage Duration:
   • Do not store pharmaceutical waste for more than 7 days before disposal.
3. Safety Precautions:
   • Ensure no food or drink is consumed in the storage area.
   • Keep incompatible waste (e.g., flammable and reactive chemicals) stored separately.

4.4 Transportation of Pharmaceutical Waste

1. Internal Transportation:
   • Transport pharmaceutical waste using wheeled, spill-proof trolleys.
   • Ensure waste containers remain sealed during transportation.

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2. External Transportation:
   • Engage authorized hazardous waste transport vendors for external transport.
   • Maintain transport manifests and ensure containers meet regulatory transport guidelines.

4.5 Incineration of Pharmaceutical Waste

Pharmaceutical waste must be disposed of through incineration at an authorized waste disposal facility:

1. Approved Facilities:
   • Partner with government-approved incineration plants equipped for pharmaceutical waste disposal.
   • Verify the facility’s compliance with emission control standards.

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2. Incineration Process:
   • Ensure the incinerator operates at a minimum of 850°C to destroy hazardous pharmaceuticals and 1200°C for cytotoxic waste.
   • Confirm emissions meet air quality standards as per CPCB (Central Pollution Control Board) and EPA guidelines.
3. Disposal Verification:
   • Obtain disposal certificates from the incineration facility.
   • Document disposal activities in the Pharmaceutical Waste Disposal Log (Annexure 2).

4.6 Emergency Preparedness

1. Spill Response:
   • In case of pharmaceutical waste spills, isolate the area and notify the Safety Officer.
   • Use spill kits and absorbents to contain and clean the spill.

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2. Fire Safety:
   • Ensure fire extinguishers (Class B) are readily available in the storage and incineration areas.
   • Conduct regular fire safety drills.

4.7 Record-Keeping and Compliance

1. Documentation:
   • Maintain records of pharmaceutical waste generation, storage, transportation, and disposal.
   • Retain disposal certificates for compliance audits.

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2. Audit Compliance:
   • Conduct regular internal audits to ensure adherence to this SOP and regulatory standards.
   • Report any non-compliance to the Safety Officer for corrective action.

5) Abbreviations, if any

• PPE: Personal Protective Equipment
• CPCB: Central Pollution Control Board
• EPA: Environmental Protection Agency

6) Documents, if any

• Pharmaceutical Waste Log
• Disposal Certificates
• Waste Transport Manifests

7) Reference, if any

• Biomedical Waste Management Rules, 2016
• EPA Hazardous Waste Guidelines
• CPCB Emission Standards for Incinerators

8) SOP Version

Version: 1.0

Annexure

Template 1: Pharmaceutical Waste Log

 
 
 
Date
 
Waste Type
 
Quantity
 
Storage Location
 
Handled By
 
 
 
DD/MM/YYYY
 
Expired Medicines
 
30 Kg
 
Storage Room 2
 
John Doe
 
 
 

Template 2: Disposal Log

 
 
 
Date
 
Waste Type
 
Quantity
 
Disposal Method
 
Facility Name
 
Certificate Number
 
 
 
DD/MM/YYYY
 
Cytotoxic Drugs
 
20 Kg
 
High-Temperature Incineration
 
XYZ Incineration Plant
 
CERT-12345