Gel Manufacturing: SOP for Disinfection of Gel Manufacturing Area After Maintenance – V 2.0

Standard Operating Procedure for Disinfection of Gel Manufacturing Area After Maintenance

Department	Gel Manufacturing
SOP No.	SOP/GM/146/2025
Supersedes	SOP/GM/146/2022
Page No.	Page 1 of 11
Issue Date	09/06/2025
Effective Date	11/06/2025
Review Date	09/06/2027

1. Purpose

To establish a standard procedure for cleaning and disinfecting gel manufacturing areas after any maintenance activity, ensuring the area is free of contaminants and ready for production resumption.

2. Scope

This SOP applies to all classified rooms, equipment zones, and adjacent corridors in the gel manufacturing facility that undergo maintenance activities requiring entry by engineering or external personnel.

3. Responsibilities

Engineering Department: Notifies completion of maintenance and performs initial cleaning of their tools and work area.
Housekeeping Staff: Executes disinfection activities as per defined procedure.
Production Supervisor: Verifies completion

of disinfection and signs off clearance.

QA Executive: Performs final inspection and documents area release.

4. Accountability

The Head – Manufacturing is accountable for ensuring that post-maintenance disinfection is timely and effectively completed as per GMP standards.

5. Procedure

5.1 Preparation for Disinfection

Engineering personnel must inform production upon completion of maintenance activity.
All tools, debris, maintenance materials, and spare parts must be removed from the area.
Coverings, temporary partitions, and tapes used during maintenance must be dismantled.

5.2 Initial Dry Cleaning

Remove visible dirt, dust, or particles using sterile dry mops or vacuum cleaners with HEPA filters.
Wipe equipment surfaces using lint-free cleanroom wipes.

5.3 Disinfection Steps

Use freshly prepared 2.5% v/v Isopropyl Alcohol (IPA) solution or an approved disinfectant.
Apply the disinfectant starting from top to bottom: walls, equipment surfaces, floors.
Use separate mops for each surface to avoid cross-contamination.
Ensure wet contact time of at least 10 minutes or as recommended by the disinfectant manufacturer.
Use a 2-step method (cleaning followed by disinfection) in Grade B or Grade C areas.

5.4 Post-Disinfection Verification

Inspect the area for cleanliness, absence of residues, and intact surfaces.
Check environmental parameters (temperature, humidity) if sensors were disturbed.
Fill disinfection logbook with details of date, time, area cleaned, person responsible, and type of disinfectant used.

5.5 Clearance for Use

Production Supervisor inspects the area and signs the internal area clearance form.
QA Executive performs a final walkthrough and signs off for area release.

6. Abbreviations

IPA: Isopropyl Alcohol
GMP: Good Manufacturing Practice
QA: Quality Assurance

7. Documents

Disinfection Logbook – Annexure-1
Area Clearance Form – Annexure-2
Approved Disinfectant List – Annexure-3

8. References

WHO TRS 961 Annex 6: GMP for Pharmaceutical Products
EU GMP Volume 4 Annex 1: Manufacture of Sterile Medicinal Products
FDA Guidance for Industry: Aseptic Processing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Disinfection Logbook

Date	Time	Area	Disinfectant Used	Prepared By	Signature

Annexure-2: Area Clearance Form

Area
Maintenance Completed On
Disinfection Done By
Production Clearance	☐ Yes ☐ No
QA Clearance	☐ Yes ☐ No
Remarks

Annexure-3: Approved Disinfectant List

Disinfectant Name	Concentration	Contact Time	Applicable Area

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
12/07/2022	1.0	Initial release	New facility procedure	QA Head
09/06/2025	2.0	Updated to include Annexure for Area Clearance	Annual SOP Review	QA Head