current Good Manufacturing Practices (cGMP), WHO, and ICH standards.

2. Scope

This SOP applies to all vertical and horizontal autoclaves used for sterilizing materials and equipment within the sterile production area at [Facility Name].

3. Responsibilities

• Production Operator: Carry out cleaning activities as per this SOP.
• Maintenance Technician: Support in drain line flushing, mechanical access, or troubleshooting.
• QA Officer: Conduct visual inspection and review of cleaning records.
• Validation Team: Perform periodic cleaning validation studies.

4. Accountability

The Production Manager is accountable for ensuring the autoclaves are cleaned and documented before reuse or after scheduled maintenance.

5. Procedure

5.1 General Precautions

1. Ensure that the autoclave is not in operation and has cooled to ambient temperature.
2. Use appropriate personal protective equipment (PPE) before cleaning.
3. Affix a status label “Under Cleaning” to the autoclave control panel.

5.2 Internal Cleaning

1. Open the chamber door and inspect for visible residues or water spots.
2. Use sterile lint-free cloths and WFI to wipe all internal stainless steel surfaces, including walls, floor, and racks.
3. For stubborn spots, use approved non-abrasive cleaning detergent prepared in WFI (0.5% concentration).
4. Rinse thoroughly with WFI until no visible foam or detergent residue remains.

5.3 Cleaning of Drain Line and Valves

1. Flush the autoclave drain line with WFI.
2. Remove and clean the drain filters with 70% IPA; reinstall after drying.
3. Operate valves manually (if safe) to ensure they are clean and functional.

5.4 External Surface Cleaning

1. Clean the outer panels and control panel surface using 70% IPA.
2. Wipe handles, door seals, hinges, and gaskets thoroughly.

5.5 Cleaning Frequency

• Routine Cleaning: Daily (at end of last sterilization cycle).
• Weekly Cleaning: Include drain flushing and filter inspection.
• Changeover Cleaning: Required between different product campaigns.

5.6 Visual Inspection and Approval

1. After cleaning, QA Officer will inspect the chamber and external surfaces.
2. Record visual status in Annexure-2.
3. If accepted, update the status label to “Cleaned & Ready.”

5.7 Documentation

1. All cleaning steps must be recorded in the Autoclave Cleaning Log (Annexure-1).
2. QA sign-off must be documented prior to the next sterilization cycle.

6. Abbreviations

• SOP: Standard Operating Procedure
• WFI: Water for Injection
• IPA: Isopropyl Alcohol
• QA: Quality Assurance
• cGMP: Current Good Manufacturing Practice

7. Documents

1. Autoclave Cleaning Log – Annexure-1
2. Visual Inspection Report – Annexure-2

8. References

• WHO Technical Report Series 961 – GMP for Sterile Products
• ICH Q9 – Quality Risk Management
• 21 CFR Part 211 – cGMP for Finished Pharmaceuticals

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Production Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Autoclave Cleaning Log

Date	Autoclave ID	Cleaning Type	Performed By	Remarks
18/06/2025	AUTO-01	Routine	Rahul Shinde	No residue

Annexure-2: Visual Inspection Report

Date	Inspector	Chamber Condition	External Condition	Status
18/06/2025	Sunita Reddy	Clean	Clean	Approved

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	New SOP	QA Head
18/06/2025	2.0	Drain line and visual log added	Annual Review	QA Head