ensure compliance with regulatory standards.

2. Scope

This SOP applies to all personnel involved in aseptic operations using horizontal and vertical laminar airflow cabinets within the sterile production areas.

3. Responsibilities

• Production Operator: Responsible for pre-use checks, operation, cleaning, and basic maintenance of LFC.
• Production Supervisor: Ensures compliance with the operation schedule and monitors usage logs.
• QA Officer: Performs periodic checks and ensures proper documentation and environmental monitoring.

4. Accountability

The Head of Production is accountable for ensuring the proper use and maintenance of laminar flow cabinets during aseptic processing.

5. Procedure

5.1 Pre-Use Verification

1. Ensure the cabinet is labeled “CLEANED” with the date and time of cleaning.
2. Confirm that HEPA filters are within the valid usage period.
3. Switch on the UV lamp (if present) for 30 minutes prior to usage.
4. Turn off the UV lamp and turn on the fluorescent light and airflow blower before initiating aseptic activities.

5.2 Material and Personnel Preparation

1. Ensure all personnel entering the aseptic area follow full gowning procedures as per SOP/SIM/015/2025.
2. Disinfect all materials using 70% IPA or validated sporicidal agent before introducing into LFC.
3. Allow all disinfected materials to remain in the LFC for at least 5 minutes prior to use.

5.3 Operation During Aseptic Processing

1. Do not block the rear airflow grills of the cabinet.
2. Place materials in a unidirectional workflow: from clean to used side.
3. Minimize movements to avoid air turbulence inside the cabinet.
4. Use only sterile gloves and avoid touching the HEPA grill or working surface directly.

5.4 Monitoring and Controls

1. Record operational parameters (e.g., airflow velocity, pressure differentials) once every shift.
2. Environmental monitoring (settle plates, swabs) must be conducted weekly as per SOP/QA/EM/025/2025.

5.5 Post-Use Procedure

1. Remove all materials, clean surfaces with 70% IPA from back to front and top to bottom.
2. Switch off the fluorescent light and airflow blower after 15 minutes of idle operation.
3. Cover the LFC with sterile drape and label it “CLEANED”.
4. Log usage and cleaning in the LFC Usage Log (Annexure-1).

5.6 Preventive Maintenance

1. Ensure filter integrity is tested every 6 months by Engineering and recorded in Maintenance Log (Annexure-2).
2. Any malfunction should be reported to Engineering and QA immediately.

6. Abbreviations

• SOP: Standard Operating Procedure
• LFC: Laminar Flow Cabinet
• HEPA: High Efficiency Particulate Air
• IPA: Isopropyl Alcohol
• QA: Quality Assurance

7. Documents

1. LFC Usage Log – Annexure-1
2. LFC Preventive Maintenance Log – Annexure-2

8. References

• EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
• ISO 14644 – Cleanroom and Associated Controlled Environments
• WHO TRS 961 – Technical Report Series on GMP

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: LFC Usage Log

Date	Operator Name	Start Time	End Time	Cleaning Verified By
18/06/2025	Sunita Reddy	09:00	11:30	Rajesh Kumar

Annexure-2: LFC Preventive Maintenance Log

Date	Checked By	Filter Integrity Status	Remarks
01/06/2025	Vinay Pawar	Pass	No issues found

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/04/2022	1.0	Initial Issue	New Cabinet Operation SOP	QA Head
18/06/2025	2.0	Updated with preventive maintenance and LFC logs	Annual Review	QA Head