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.

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.

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

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