Standard Operating Procedure for Management of Liquid Waste in Pharmaceutical Facilities

1) Purpose

The purpose of this SOP is to establish systematic procedures for the handling, segregation, treatment, and disposal of liquid waste generated in pharmaceutical facilities to ensure environmental safety and compliance with regulatory standards.

2) Scope

This SOP applies to all personnel involved in the generation, collection, treatment, and disposal of liquid waste in manufacturing units, laboratories, and other pharmaceutical operations.

3) Responsibilities

• Supervisors: Ensure the proper implementation of liquid waste management practices and compliance with this SOP.
• Operators: Collect, segregate, and transfer liquid waste as per the prescribed guidelines.
• Maintenance Personnel: Maintain the functionality of liquid waste treatment systems.
• Safety Officers: Monitor waste management practices and report any deviations.

4) Procedure

4.1 Classification of Liquid Waste

Liquid waste generated in pharmaceutical facilities must be categorized as follows:

1. Hazardous Liquid Waste:
   • Solvent waste from chemical processes
   • Liquid waste containing heavy metals or toxic substances

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2. Non-Hazardous Liquid Waste:
   • Cooling water from utility systems
   • Non-contaminated cleaning solutions
3. Biological Liquid Waste:
   • Liquid waste containing microbial or biological contaminants
4. Sanitary Liquid Waste:
   • Wastewater from employee restrooms and cafeterias

4.2 Collection and Segregation of Liquid Waste

1. Segregation at Source:
   • Ensure liquid waste is segregated at the point of generation using dedicated containers or tanks.
   • Label containers clearly with the type of waste (e.g., “Hazardous Solvent Waste,” “Biological Waste”).

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2. Collection Guidelines:
   • Use leak-proof, chemical-resistant containers for hazardous liquid waste.
   • Transfer non-hazardous liquid waste directly to designated holding tanks or drains connected to the treatment system.
   • Avoid mixing incompatible waste types (e.g., acids and bases).
3. Documentation:
   • Record the type, quantity, and source of liquid waste in the Liquid Waste Log (Annexure 1).

4.3 Storage of Liquid Waste

1. Storage Area Requirements:
   • Designate separate storage areas for hazardous and non-hazardous liquid waste.
   • Ensure areas are well-ventilated, labeled, and equipped with spill containment systems.

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2. Storage Containers:
   • Use corrosion-resistant containers for storing hazardous liquid waste.
   • Inspect containers regularly for leaks or damage and replace as needed.
3. Safety Precautions:
   • Store incompatible wastes separately to prevent chemical reactions.
   • Ensure storage areas are equipped with emergency spill kits and fire extinguishers.

4.4 Treatment of Liquid Waste

1. Pre-Treatment:
   • Filter solids and suspended particles using sedimentation or filtration systems.
   • Neutralize pH imbalances in acidic or alkaline waste streams before further treatment.

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2. Primary Treatment:
   • Use chemical precipitation or coagulation methods to remove heavy metals and suspended solids.
   • Apply oil-water separators to remove oils and greases from wastewater.
3. Secondary Treatment:
   • Apply biological treatment methods such as:
     • Aerobic digestion
     • Activated sludge processes
4. Tertiary Treatment:
   • Use advanced treatment methods such as reverse osmosis or UV disinfection to meet discharge standards.

4.5 Disposal of Treated Liquid Waste

1. Discharge Guidelines:
   • Ensure treated liquid waste complies with discharge standards for pH, BOD, COD, and heavy metal content.
   • Discharge compliant waste into municipal sewage systems or natural water bodies with approval from local authorities.

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2. Vendor Management:
   • Partner with authorized waste disposal vendors for hazardous liquid waste.
   • Obtain disposal certificates for compliance documentation.

4.6 Monitoring and Compliance

1. Conduct regular testing of liquid waste samples to monitor parameters such as:
   • pH levels
   • Biochemical Oxygen Demand (BOD)
   • Chemical Oxygen Demand (COD)
   • Heavy metal concentration

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2. Document test results and submit periodic reports to regulatory authorities.

4.7 Emergency Spill Management

1. In Case of Spills:
   • Isolate the affected area and contain the spill using absorbents or spill kits.
   • Notify the Safety Officer immediately.

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2. Decontamination:
   • Clean and disinfect the spill area thoroughly.
   • Dispose of spill cleanup materials as hazardous waste.

5) Abbreviations, if any

• BOD: Biochemical Oxygen Demand
• COD: Chemical Oxygen Demand
• PPE: Personal Protective Equipment

6) Documents, if any

• Liquid Waste Log
• Disposal Certificates
• Testing Reports

7) Reference, if any

• Environmental Protection Act (EPA) Guidelines
• Central Pollution Control Board (CPCB) Standards
• ISO 14001 Environmental Management Systems

8) SOP Version

Version: 1.0

Annexure

Template 1: Liquid Waste Log

 
 
 
Date
 
Waste Type
 
Quantity (Liters)
 
Source
 
Storage Location
 
Handled By
 
 
 
DD/MM/YYYY
 
Hazardous Solvent Waste
 
500
 
Production Unit 1
 
Storage Tank 3
 
John Doe