Scope

This SOP is applicable to all vertical and horizontal LFCs used for aseptic manufacturing, sampling, dispensing, or quality control operations in the sterile injectable manufacturing facility of [Company Name].

3. Responsibilities

• Production Operator: Responsible for executing cleaning activity as per the defined procedure.
• Quality Assurance: Responsible for verifying cleanliness and recording observations.
• Maintenance Team: Provides assistance in case of physical damage or HEPA filter-related issues.

4. Accountability

The Production Head shall ensure that the LFCs are cleaned as per the SOP before and after every operation and during periodic intervals, as required.

5. Procedure

5.1 General Precautions

1. Ensure power to the LFC is turned off before cleaning.
2. Wear appropriate PPE: sterile gloves, face mask, cleanroom suit.
3. Use lint-free sterile wipes and approved disinfectants (70% IPA or sporicidal agents).

5.2 Cleaning Frequency

• Before use: Wipe all surfaces with 70% IPA.
• After use: Disinfect entire working area using validated biocidal solution.
• At end of shift: Full wipe down with disinfectant + record completion.
• Weekly: Deep cleaning and inspection of pre-filters.

5.3 Stepwise Cleaning Process

1. Start from top rear panel and move downwards to minimize cross-contamination.
2. Wipe back wall, side panels, and work table using sterile wipes soaked in 70% IPA.
3. Clean HEPA filter grill surface gently without applying pressure.
4. Clean UV lamp casing and light panel (if applicable).
5. Wipe sash or glass shield (if vertical cabinet) from top to bottom.
6. Allow surfaces to air dry before resuming operation.

5.4 Handling of Cleaning Agents

1. Use only approved disinfectants and cleaning materials as listed in Annexure-1.
2. Rotate disinfectants weekly to prevent resistance.

5.5 Cleaning Post-Maintenance or Filter Replacement

1. Perform deep cleaning with 0.5% detergent followed by two rounds of 70% IPA wiping.
2. Record cleaning in Annexure-2 and obtain QA approval before reuse.

5.6 Documentation

1. All cleaning activities must be recorded in LFC Cleaning Log (Annexure-2).
2. Supervisor and QA Officer shall verify entries daily.

6. Abbreviations

• SOP: Standard Operating Procedure
• IPA: Isopropyl Alcohol
• LFC: Laminar Flow Cabinet
• QA: Quality Assurance
• PPE: Personal Protective Equipment

7. Documents

1. List of Approved Disinfectants – Annexure-1
2. LFC Cleaning Log – Annexure-2

8. References

• WHO Annex 6, TRS 961 – GMP for Sterile Pharmaceutical Products
• ICH Q9 – Quality Risk Management
• 21 CFR Part 211 – US cGMP Guidelines

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: List of Approved Disinfectants

Disinfectant Name	Concentration	Rotation Frequency	Prepared By
Isopropyl Alcohol	70%	Daily	Rajesh Kumar
Sporicidal Agent A	0.5%	Weekly	Sunita Reddy

Annexure-2: LFC Cleaning Log

Date	Cabinet ID	Shift	Cleaning Type	Cleaned By	QA Verified
18/06/2025	LFC-01	Morning	Routine	Vikram Desai	Yes
18/06/2025	LFC-01	Evening	After Use	Rohit Jha	Yes

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial version	New SOP	QA Head
18/06/2025	2.0	Added disinfectant rotation & annexures	Annual Review	QA Head