Procedure for Steam Sterilization Validation

Department	Quality Assurance (QA)/Validation/Engineering/Production
SOP No.	SOP/Ointment/144
Supersedes	V 1.0
Page No.	Page X of Y
Issue Date	[Insert Issue Date]
Effective Date	[Insert Effective Date]
Review Date	[Insert Review Date]

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the systematic approach for validating steam sterilization processes used in pharmaceutical manufacturing. Steam sterilization validation ensures that autoclaves and sterilizers effectively eliminate microbial contamination, meeting regulatory standards.

2. Scope

This SOP applies to all personnel in the Quality Assurance (QA), Validation, Engineering, and Production departments responsible for steam sterilization process qualification, validation, and routine monitoring.

3. Responsibilities

• QA Officer: Ensures compliance with steam sterilization validation protocols.
• Validation Team: Develops and executes steam sterilization validation protocols.
• Engineering Team: Maintains autoclaves and steam sterilization equipment.
• Production Supervisor: Ensures validated sterilization cycles are followed.
• QA Manager: Reviews and approves steam sterilization validation reports.

4. Accountability

The QA and Engineering Managers are accountable for ensuring that steam sterilization validation is conducted as per GMP, FDA, ICH, and WHO guidelines.

5. Procedure

5.1 Phases of Steam Sterilization Validation

Steam sterilization validation consists of three key phases:

• Installation Qualification (IQ): Ensures autoclave and sterilization equipment are installed according to specifications.
• Operational Qualification (OQ): Confirms that steam sterilization equipment operates within required parameters.
• Performance Qualification (PQ): Verifies that steam sterilization effectively eliminates microbial contaminants under real conditions.

5.2 Installation Qualification (IQ)

• Verify the installation of sterilization equipment, including:
  • Autoclaves and steam sterilizers
  • Steam generators
  • Temperature and pressure monitoring sensors
  • Steam distribution lines
• Check system piping for leaks and contamination risks.
• Ensure calibration of pressure, temperature, and time monitoring devices.
• Document installation records and approve IQ reports.

5.3 Operational Qualification (OQ)

• Test the sterilization cycle parameters under standard conditions.
• Monitor critical parameters such as:
  • Temperature uniformity across sterilization chamber
  • Steam penetration efficiency
  • Pressure consistency
  • Cycle time validation
• Use biological indicators (BIs) and chemical indicators (CIs) to confirm sterilization effectiveness.
• Perform Bowie-Dick tests for steam penetration.
• Record OQ data and approve reports before proceeding to PQ.

5.4 Performance Qualification (PQ)

• Assess sterilization cycle performance over an extended period.
• Monitor sterilization parameters for at least three consecutive runs.
• Confirm complete inactivation of biological indicators (Geobacillus stearothermophilus spores).
• Ensure sterility assurance level (SAL) of at least 10⁻⁶.
• Document and approve PQ results before final validation approval.

5.5 Routine Monitoring and Revalidation

• Schedule routine sterilization cycle monitoring.
• Conduct periodic revalidation after major maintenance or modifications.
• Ensure continuous logging of temperature, pressure, and exposure times.

5.6 Handling Deviations

• If sterilization fails validation criteria:
  • Identify root cause and document findings.
  • Implement corrective and preventive actions (CAPA).
  • Requalify the sterilization cycle after adjustments.
• Maintain deviation records for regulatory audits.

5.7 Documentation and Review

• Maintain all validation records in the Steam Sterilization Validation Log.
• QA must review and approve all validation reports.
• Ensure records are available for regulatory inspections.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• IQ – Installation Qualification
• OQ – Operational Qualification
• PQ – Performance Qualification
• CAPA – Corrective and Preventive Actions
• SAL – Sterility Assurance Level
• BIs – Biological Indicators
• CIs – Chemical Indicators

7. Documents

• Steam Sterilization Validation Protocol (Annexure-1)
• Steam Sterilization Validation Log (Annexure-2)

8. References

• ICH Q7 – Good Manufacturing Practice Guide
• WHO Guidelines for Sterilization Validation
• US FDA Guidance on Sterilization Processes
• ISO 17665-1: Sterilization of Healthcare Products—Moist Heat

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Steam Sterilization Validation Protocol

Sterilization Parameter	Validation Phase	Test Method	Acceptance Criteria
Temperature Uniformity	OQ	Thermocouple Monitoring	± 2°C
Biological Indicator Inactivation	PQ	Spore Testing	SAL 10⁻⁶

Annexure-2: Steam Sterilization Validation Log

Date	System ID	Validation Phase	Test Performed	Result	Reviewed By
01/02/2025	AUTOCLAVE-1001	IQ	Installation Verification	Pass	QA Manager
02/02/2025	AUTOCLAVE-2002	PQ	Biological Indicator Testing	Pass	QA Manager