Standard Operating Procedure for Disposal of Residual Solvents in Manufacturing

1) Purpose

The purpose of this SOP is to establish guidelines for the safe handling, collection, storage, and disposal of residual solvents generated in pharmaceutical and chemical manufacturing processes. This ensures worker safety, environmental protection, and compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in solvent handling, management, and disposal across manufacturing units, laboratories, and storage areas.

3) Responsibilities

• Supervisors: Ensure proper implementation of solvent disposal procedures and provide training to employees.
• Operators: Collect, handle, and transfer residual solvents as per guidelines.
• Waste Management Personnel: Monitor, store, and arrange for safe disposal through authorized vendors.
• Safety Officers: Conduct regular audits, monitor compliance, and report any deviations.

4) Procedure

4.1 Identification and Classification of Residual Solvents

Residual solvents are classified into three categories based on ICH Guidelines:

1. Class 1 Solvents (Toxic):
   • Benzene, Carbon Tetrachloride
   • 1,1-Dichloroethane

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2. Class 2 Solvents (Non-Genotoxic, Limited Exposure):
   • Acetonitrile, Methanol, Toluene
   • Hexane, Methylene Chloride
3. Class 3 Solvents (Low Toxicity):
   • Ethanol, Acetone, Isopropanol
   • Ethyl Acetate

4.2 Collection and Segregation of Residual Solvents

1. Segregation Process:
   • Segregate solvents based on their class (Class 1, 2, and 3).
   • Do not mix incompatible solvents (e.g., acids and flammables).
   • Label all containers with solvent name, hazard class, and date of generation.

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2. Collection Guidelines:
   • Collect residual solvents in dedicated, sealed, and chemical-resistant containers.
   • Use red containers for Class 1 solvents, yellow for Class 2, and blue for Class 3 solvents.
   • Keep solvent containers in designated fume hood areas while filling to avoid vapor exposure.
3. Spill Prevention:
   • Use funnels and spill trays to prevent leaks during collection.
   • Immediately clean up any spills using absorbent materials and dispose of them as hazardous waste.

4.3 Storage of Residual Solvents

1. Storage Area Requirements:
   • Store solvent containers in a designated, well-ventilated, and fire-resistant storage room.
   • Maintain appropriate temperature control (as per solvent MSDS).
   • Equip the storage area with explosion-proof ventilation and fire suppression systems.

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2. Storage Containers:
   • Use sealed, leak-proof, and clearly labeled containers.
   • Ground and bond containers to prevent static discharge during transfers.
3. Inventory Management:
   • Maintain an updated Residual Solvent Storage Log (Annexure 1).
   • Conduct weekly inspections to identify any leaks, spills, or damaged containers.

4.4 Transportation of Residual Solvents

1. Internal Transport:
   • Transport solvent containers using grounded and spill-proof trolleys.
   • Ensure personnel wear appropriate PPE (gloves, goggles, respirators).

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2. External Transport:
   • Coordinate with licensed hazardous waste disposal vendors.
   • Ensure solvent containers are labeled and transported in compliance with hazardous waste regulations.
   • Obtain waste transport manifests for every shipment.

4.5 Disposal of Residual Solvents

Follow approved disposal methods based on solvent class:

1. Class 1 Solvents (Toxic):
   • Dispose through high-temperature incineration (at licensed facilities).
   • Ensure emissions comply with environmental regulations.

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2. Class 2 Solvents (Moderate Hazard):
   • Send for solvent recovery or recycling via distillation methods.
   • Dispose of unrecyclable portions through incineration.
3. Class 3 Solvents (Low Hazard):
   • Recycle or reuse for non-critical cleaning processes.
   • Dispose of remaining waste through authorized facilities.

4.6 Emergency Spill Management

1. Immediate Response:
   • Evacuate the area and notify the Safety Officer.
   • Contain the spill using spill kits (absorbents like sand or vermiculite).
   • Wear appropriate PPE (gloves, goggles, respirators) during cleanup.

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2. Disposal of Spill Residue:
   • Dispose of absorbent materials and contaminated PPE as hazardous waste.
3. Reporting:
   • Document the incident in the Spill Incident Log (Annexure 2).

4.7 Record-Keeping and Reporting

1. Maintain accurate records of all solvent waste generation, storage, and disposal activities.
2. Submit solvent disposal certificates and waste transport manifests to the Safety Officer for regulatory audits.

5) Abbreviations, if any

• PPE: Personal Protective Equipment
• MSDS: Material Safety Data Sheet
• ICH: International Council for Harmonisation

6) Documents, if any

• Residual Solvent Storage Log
• Spill Incident Log
• Waste Disposal Certificates

7) Reference, if any

• ICH Q3C Guidelines on Residual Solvents
• EPA Hazardous Waste Disposal Regulations
• OSHA Chemical Hazard Safety Standards

8) SOP Version

Version: 1.0

Annexure

Template 1: Residual Solvent Storage Log

Date	Solvent Name	Class	Quantity (Liters)	Storage Location	Handled By
DD/MM/YYYY	Acetonitrile	Class 2	50	Hazardous Storage Area	John Doe

Template 2: Spill Incident Log

Date	Solvent Name	Quantity Spilled	Location	Action Taken	Reported By
DD/MM/YYYY	Methanol	10 Liters	Lab 2	Contained and Absorbed	Jane Smith