SOP Guide for Pharma

API Manufacturing: SOP for Cleaning and Shutdown of QC Equipment – V 2.0

Auditor

API Manufacturing: SOP for Cleaning and Shutdown of QC Equipment – V 2.0

Standard Operating Procedure for Cleaning and Shutdown of QC Equipment in API Manufacturing

Department API Manufacturing
SOP No. SOP/API/160/2025
Supersedes SOP/API/160/2022
Page No. Page 1 of 12
Issue Date 14/04/2025
Effective Date 16/04/2025
Review Date 14/04/2026

1. Purpose

To establish a systematic approach for cleaning and shutdown of Quality Control (QC) laboratory equipment to ensure equipment readiness, prevent cross-contamination, and maintain Good Laboratory Practices (GLP) and GMP compliance.

2. Scope

This SOP applies to all major laboratory instruments and equipment used in the QC laboratory including HPLC, GC, UV-Vis Spectrophotometer,

FTIR, Dissolution Apparatus, Balances, and Karl Fischer Titrators.

3. Responsibilities

  • QC Analyst: Perform equipment cleaning and shutdown as per defined schedule and fill cleaning logs.
  • QC Supervisor: Review cleaning records and ensure compliance with equipment shutdown SOPs.
  • QA Officer: Verify and audit the cleaning logbook entries during routine compliance checks.

4. Accountability

The Head of Quality Control is accountable for ensuring adherence to equipment cleaning and shutdown procedures, including documentation, frequency, and validation.

See also  API Manufacturing: SOP for Documentation and Yield Calculation for Solvent Recovery - V 2.0

5. Procedure

5.1 General Guidelines

  1. All equipment must be cleaned:
    • After each use
    • Before long idle periods (e.g., weekends or holidays)
    • Prior to maintenance or relocation
  2. Use only approved cleaning agents as listed in the Equipment Cleaning Master List (Annexure-1).
  3. Follow equipment-specific SOPs where applicable for critical components (e.g., columns, probes).

5.2 Cleaning Procedure for General Laboratory Equipment

  1. Switch off equipment before cleaning unless otherwise specified in equipment manual.
  2. Wear appropriate PPE such as gloves, goggles, and lab coat during cleaning.
  3. Use lint-free cloth and 70% IPA for surface cleaning.
  4. Do not spray cleaning solution directly onto equipment. Apply to cloth first.
  5. Clean the outer casing, control panels, trays, and sample holders carefully.
  6. Dry surfaces using a clean, lint-free dry cloth.

5.3 Shutdown Procedure for Specific Equipment

5.3.1 HPLC System

  1. Flush system with HPLC-grade water followed by isopropanol if buffer was used.
  2. Remove column and store in appropriate solvent as per manufacturer’s recommendation.
  3. Switch off detector, pump, and autosampler in sequence.
  4. Log shutdown activity in the HPLC Logbook (Annexure-2).

5.3.2 UV-Vis Spectrophotometer

  1. Clean sample compartment using dry tissue and brush.
  2. Switch off lamp and instrument using software or main power.
  3. Cover instrument with dust cover.

5.3.3 Balances

  1. Turn off the balance display.
  2. Gently clean weighing pan and surrounding area using brush or tissue.
  3. Verify calibration weights are stored properly.
See also  API Manufacturing: SOP for Calibration and Maintenance of pH Meter - V 2.0

5.3.4 Karl Fischer Titrator

  1. Dispose used titrant and solvents as per solvent disposal SOP.
  2. Flush burette with dry methanol and leave dry.
  3. Shutdown software and disconnect from power.

5.3.5 FTIR System

  1. Wipe ATR crystal or KBr window with ethanol and dry with tissue.
  2. Switch off source, then computer, then main unit.

5.4 Cleaning and Shutdown Frequency

Equipment Cleaning Frequency Shutdown Frequency
HPLC After each analysis Daily or end of use
UV-Vis Weekly Daily
Balances Daily NA
FTIR Weekly Weekly
KF Titrator After use After each use

5.5 Documentation

  1. Make entries in Equipment Cleaning and Shutdown Log (Annexure-3).
  2. Include:
    • Date and time of cleaning
    • Name of analyst
    • Type of equipment
    • Cleaning agent used
    • Remarks or issues observed
  3. QC Supervisor must review and sign log weekly.

5.6 Deviations and Corrective Action

  1. Any missed cleaning or observed equipment residue must be reported using the Deviation Form.
  2. Initiate CAPA for repeated missed cleanings or shutdown failures.

5.7 Cleaning Agent Selection

  1. Use only validated cleaning agents compatible with equipment material.
  2. Refer to Annexure-1 for cleaning agent matrix.
  3. Maintain cleaning agent MSDS in laboratory file.

6. Abbreviations

  • QC: Quality Control
  • GLP: Good Laboratory Practices
  • GMP: Good Manufacturing Practices
  • IPA: Isopropyl Alcohol
  • CAPA: Corrective and Preventive Action
See also  API Manufacturing: SOP for Complaint Handling and Investigation - V 2.0

7. Documents

  1. Equipment Cleaning Master List (Annexure-1)
  2. HPLC Shutdown Logbook (Annexure-2)
  3. Cleaning and Shutdown Log (Annexure-3)
  4. Deviation Form (if applicable)

8. References

  • ICH Q10 – Pharmaceutical Quality System
  • 21 CFR Part 211 – Subpart D: Equipment
  • WHO TRS No. 986 – Good Laboratory Practices

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Equipment Cleaning Agent Matrix

Equipment Cleaning Agent Remarks
HPLC IPA and Water Flush lines before shutdown
Balance Dry Brush No liquids
UV-Vis Lint-free cloth Clean compartment only

Annexure-2: HPLC Shutdown Logbook

Date Instrument ID Column Removed Flushed Remarks Initials
13/04/2025 HPLC-02 Yes Yes No issues RK

Annexure-3: Cleaning and Shutdown Log

Date Equipment Cleaned By Shutdown Time Remarks
13/04/2025 UV-01 SR 18:10 Clean and covered

Revision History:

Revision Date Revision No. Details Reason Approved By
01/01/2022 1.0 Initial Version New SOP Implementation QA Head
14/04/2025 2.0 Integrated shutdown log format GMP Compliance QA Head
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