SOP Guide for Pharma

Elixir Department: SOP for Disposal of Waste After Equipment Cleaning – V 2.0

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Elixir Department: SOP for Disposal of Waste After Equipment Cleaning – V 2.0

Standard Operating Procedure for Disposal of Waste After Equipment Cleaning in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/175/2025
Supersedes SOP/ELX/175/2022
Page No. Page 1 of 9
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To lay down the procedure for safe and compliant disposal of waste generated after cleaning of equipment and accessories used in the manufacturing of elixirs, ensuring environmental protection and regulatory adherence.

2. Scope

This SOP applies to the disposal of solid, liquid, and hazardous waste resulting from the cleaning of mixing vessels, storage tanks, filling machines, pipelines, utensils, and other product-contact equipment in the Elixir Department.

3. Responsibilities

  • Production Operator:
    • Segregate and dispose of cleaning waste as per this SOP.
    • Ensure collection, labeling, and transfer of waste to designated areas.
  • QA Department:
    • Monitor and verify proper waste segregation and disposal records.
  • EHS (Environment, Health & Safety) Officer:
    • Ensure compliance with applicable environmental norms and waste handling guidelines.
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4. Accountability

The Production Head is accountable for correct waste disposal practices. The EHS Officer ensures safe environmental practices and regulatory reporting.

QA oversees documentation and compliance.

5. Procedure

5.1 Types of Waste Generated

  • Liquid Waste: Rinse water, leftover detergent solution, solvent washings.
  • Solid Waste: Used wipes, lint-free cloths, filters, containers, PPE.
  • Hazardous Waste: Alcohol-contaminated materials, solvent residues, detergent containers.

5.2 Waste Collection and Segregation

  1. Use separate color-coded containers:
    • Red bin – Hazardous waste
    • Blue bin – Recyclables (plastic detergent containers)
    • Yellow bin – Non-hazardous solid waste
    • Tank drain – Approved channel for aqueous waste (routed to ETP)
  2. Ensure containers are clearly labeled and covered when not in use.

5.3 Disposal of Liquid Waste

  1. Rinse water and detergent waste should be drained through the designated tank outlet connected to the Effluent Treatment Plant (ETP).
  2. Solvent washings should be collected in leak-proof, flame-resistant drums and labeled “Flammable – Waste Solvent.”
  3. Maintain solvent waste collection log (Annexure-1) and hand over to authorized hazardous waste handler.
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5.4 Disposal of Solid Waste

  1. Collect solid waste such as cloths, gloves, filters in designated bins.
  2. Seal the bin liners once full and transport them to the waste holding area.
  3. Dispose as per company’s approved waste disposal SOP and municipal guidelines.

5.5 Handling of Hazardous Waste

  1. Label all hazardous waste with hazard symbols, source of generation, and disposal date.
  2. Store in a designated area with restricted access and secondary containment.
  3. Coordinate with the authorized waste management vendor for scheduled disposal.

5.6 Documentation

  1. Record each waste disposal event in the Cleaning Waste Disposal Logbook (Annexure-2).
  2. Retain waste transfer receipts and consignment records as per retention policy.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • EHS: Environment, Health & Safety
  • ETP: Effluent Treatment Plant

7. Documents

  1. Solvent Waste Collection Log (Annexure-1)
  2. Cleaning Waste Disposal Logbook (Annexure-2)
  3. Waste Transfer Manifest
See also  Elixir Department: SOP for Disinfection of Product Contact Surfaces - V 2.0

8. References

  • 21 CFR Part 211 – GMP for Waste Disposal
  • Hazardous Waste Management Rules, India
  • WHO TRS 961 – Pharmaceutical Waste Management

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Solvent Waste Collection Log

Date Source Type of Solvent Quantity (L) Collected By Disposal Ref. No.
11/04/2025 Tank Cleaning IPA 25 Rajesh Kumar WMS/0425/01

Annexure-2: Cleaning Waste Disposal Logbook

Date Equipment Cleaned Type of Waste Disposal Method Disposed By Verified By (QA)
11/04/2025 MXR-ELX-14 Detergent Waste ETP Drain Sunita Reddy Neha Patil

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial SOP Release New SOP QA Head
11/04/2025 2.0 Added color-coded bin segregation and solvent waste tracking Regulatory Enhancement QA Head
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