Scope

This SOP applies to all HEPA filters installed in Grade A to D cleanroom zones within the Sterile Injectable Manufacturing facility.

3. Responsibilities

• Engineering Team: Conducts scheduled HEPA maintenance and coordinates integrity testing.
• Production Team: Ensures machine shutdown and area clearance during filter maintenance.
• Quality Assurance: Reviews reports and ensures adherence to validated procedures.

4. Accountability

The Head of Engineering is accountable for ensuring that HEPA filters are cleaned and maintained as per the defined schedule and tested for integrity as per GMP norms.

5. Procedure

5.1 Types of Maintenance

• Routine Cleaning: Surface vacuuming and external wiping of HEPA grills.
• Preventive Maintenance: Monthly airflow verification and semi-annual leak testing.
• Corrective Maintenance: Filter replacement if integrity test fails or airflow is inadequate.

5.2 Cleaning Schedule

1. HEPA grills shall be cleaned weekly using lint-free cloths soaked in 70% IPA.
2. Use a vacuum with HEPA-grade exhaust to remove particulate buildup on grills.
3. Grills shall not be removed unless replacement or detailed internal cleaning is required.

5.3 Preventive Maintenance and Integrity Testing

1. Conduct DOP/PAO challenge test for integrity every 6 months or after maintenance.
2. Verify air velocity and unidirectional airflow patterns using anemometers monthly.
3. Record all data in the HEPA Maintenance Log (Annexure-1).
4. Replace HEPA filters if they show damage, failed test, or excessive pressure drop.

5.4 Safety Precautions

• Wear sterile PPE during HEPA filter cleaning.
• Do not touch or lean against HEPA face panels to avoid surface damage.
• Ensure cleanroom integrity by completing cleaning quickly and efficiently.

5.5 Documentation

1. All maintenance activities shall be recorded in the logbook.
2. QA to review and approve entries before use of area post-maintenance.

6. Abbreviations

• HEPA: High-Efficiency Particulate Air
• IPA: Isopropyl Alcohol
• QA: Quality Assurance
• GMP: Good Manufacturing Practices
• DOP: Dioctyl Phthalate
• PAO: Polyalphaolefin

7. Documents

1. HEPA Filter Maintenance Log – Annexure-1
2. HEPA Filter Integrity Test Report – Annexure-2
3. HEPA Replacement Checklist – Annexure-3

8. References

• WHO TRS 961 Annex 6
• ISO 14644-1 and ISO 14644-3
• 21 CFR Part 211

9. SOP Version

Version: 2.0

10. Approval Section

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

11. Annexures

Annexure-1: HEPA Filter Maintenance Log

Date	Room No.	Activity	Performed By	Verified By
17/06/2025	Grade B – 102	Surface Cleaning	Rajesh Kumar	Anita Sharma

Annexure-2: HEPA Filter Integrity Test Report

Filter ID	Test Date	Type of Test	Result	Tested By
HF-203	10/06/2025	DOP Test	Pass	Sunil Mehra

Annexure-3: HEPA Replacement Checklist

Old Filter ID	New Filter ID	Replacement Date	Installed By	QA Approval
HF-197	HF-212	01/06/2025	Ajay Verma	Priya Kapoor

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Issue	New SOP	QA Head
18/06/2025	2.0	Revised to include Annexure-3 checklist	Annual Review	QA Head