SOP Guide for Pharma

API Manufacturing: SOP for Confined Space Entry Procedure – V 2.0

Auditor

API Manufacturing: SOP for Confined Space Entry Procedure – V 2.0

Standard Operating Procedure for Confined Space Entry Procedure in API Manufacturing

Department API Manufacturing
SOP No. SOP/API/208/2025
Supersedes SOP/API/208/2022
Page No. Page 1 of 14
Issue Date 14/04/2025
Effective Date 16/04/2025
Review Date 14/04/2026

1. Purpose

To define the safe entry procedure for confined spaces in the API manufacturing facility. This SOP outlines the required controls, monitoring, PPE, permits, and documentation to prevent accidents, ensure employee safety, and comply with statutory and GMP guidelines.

2. Scope

This SOP applies to all personnel and contractors involved in operations that require entry into confined spaces such as reactors, tanks, pipelines, vessels, and utility

ducts within the API plant premises.

3. Responsibilities

  • Authorized Entrant: Performs tasks inside the confined space following all safety precautions.
  • Attendant: Monitors the entrant from outside and initiates emergency protocols if required.
  • Permit Issuer (Supervisor/EHS): Conducts hazard assessments, issues permits, and ensures isolation and gas testing.
  • EHS Officer: Maintains confined space entry records and oversees compliance.

4. Accountability

The Head of EHS is accountable for ensuring that no confined space is entered without a valid permit, and that all control measures and training protocols are followed.

See also  API Manufacturing: SOP for Management Review of Quality Metrics - V 2.0

5. Procedure

5.1 Identification of Confined Spaces

  1. Identify confined spaces using criteria such as:
    • Limited entry or exit
    • Poor natural ventilation
    • Not designed for continuous occupancy
  2. Maintain a Confined Space Register (Annexure-1).

5.2 Permit to Work System

  1. Entry must be authorized using the Confined Space Entry Permit (Annexure-2).
  2. The permit shall be valid only for a single shift or operation and must be renewed for subsequent work.

5.3 Pre-Entry Requirements

  1. Isolate all energy sources using:
    • Lock-out/Tag-out (LOTO) for electrical systems
    • Blinding of pipelines
    • Draining and flushing of tanks
  2. Ventilate the space using blowers for at least 30 minutes before entry.
  3. Test atmosphere using a calibrated multi-gas detector for:
    • Oxygen content (19.5%–23.5%)
    • LEL for flammable gases
    • Toxic gases (e.g., H2S, CO)
  4. Record gas test results in Annexure-3: Gas Testing Log.

5.4 Personal Protective Equipment (PPE)

  1. Mandatory PPE includes:
    • Full-body harness with lifeline
    • Helmet and safety shoes
    • Gas mask or SCBA for low oxygen or toxic environments
    • Gloves and protective overalls

5.5 Entry and Work Inside Confined Space

  1. Entrant must sign the permit before entry and report any abnormal condition to the attendant.
  2. Communication must be maintained through hand signals, two-way radios, or visual contact.
  3. Attendant shall not leave the post and must be trained to raise alarms or activate emergency plans.
See also  API Manufacturing: SOP for Handling of Incidental Lab Spills - V 2.0

5.6 Emergency Procedures

  1. If the entrant collapses or is unresponsive:
    • Do NOT enter without rescue equipment and second authorization
    • Use retrieval system to pull the entrant out
    • Notify emergency services and initiate first aid
  2. Complete Incident Report (Annexure-4) post-emergency.

5.7 Training

  1. All confined space personnel must receive annual training and demonstrate knowledge of:
    • Permit procedures
    • PPE usage
    • Emergency response drills
  2. Training attendance to be recorded in Annexure-5: Confined Space Training Log.

5.8 Closure of Entry

  1. On task completion:
    • Entrant signs out
    • Permit is marked as CLOSED by the permit issuer
    • Permit retained for record (minimum 2 years)

6. Abbreviations

  • SOP: Standard Operating Procedure
  • EHS: Environment, Health & Safety
  • LOTO: Lock Out Tag Out
  • LEL: Lower Explosive Limit
  • SCBA: Self-Contained Breathing Apparatus

7. Documents

  1. Confined Space Register – Annexure-1
  2. Confined Space Entry Permit – Annexure-2
  3. Gas Testing Log – Annexure-3
  4. Incident Report – Annexure-4
  5. Training Log – Annexure-5

See also  API Manufacturing: SOP for QA Role in Cleaning Validation - V 2.0

8. References

  • OSHA 1910.146 – Permit-Required Confined Spaces
  • Indian Factories Act – Safety Rules
  • ICH Q9 – Quality Risk 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: Confined Space Register

Space ID Location Type Hazards Identified
CS-101 Reactor Vessel Vertical Tank Low Oxygen, Toxic Vapors

Annexure-2: Confined Space Entry Permit

Permit No. CS-APR-012
Date 14/04/2025
Entry Location Solvent Recovery Tank
Permit Issuer Sunita Reddy
Entrant(s) Rajesh Kumar
Valid From 10:00 AM
Valid Until 06:00 PM

Annexure-3: Gas Testing Log

Date Location O2% LEL% H2S ppm Result Tested By
14/04/2025 CS-101 20.8 0 0 Safe Vinay Pawar

Annexure-4: Incident Report

Date Location Description Immediate Action Corrective Action
13/04/2025 Tank-2 Slip incident Area cordoned Anti-slip mats installed

Annexure-5: Confined Space Training Log

Employee Name Department Training Date Trainer Remarks
Ajay Verma Maintenance 10/03/2025 EHS Officer Trained

Revision History:

Revision Date Revision No. Details Reason Approved By
01/01/2022 1.0 Initial Release New SOP QA Head
14/04/2025 2.0 Annexures and gas testing protocol updated Annual Review QA Head
Exit mobile version