to all isolators used in sterile areas of the facility for aseptic manufacturing operations, including those used in filling lines, compounding operations, and sampling procedures.

3. Responsibilities

• Production Operator: Carries out the sanitization as per the SOP.
• Engineering: Ensures proper functioning of isolator systems and environmental controls.
• QA Officer: Monitors compliance with procedure and approves sanitization records.

4. Accountability

The Head of Production and Head of QA are accountable for the proper execution and verification of isolator sanitization activities.

5. Procedure

5.1 Preparation for Sanitization

1. Ensure isolator is shut down and power to glove ports and internal fans is turned off.
2. Verify isolator chamber is empty and free from manufacturing components or product remnants.
3. Check the availability of sanitizing agents, cleaning tools, and personal protective equipment (PPE).
4. Wear approved sterile PPE before entering the Grade B/C area where the isolator is located.

5.2 Cleaning Before Sanitization

1. Using a sterile lint-free cloth soaked in Water for Injection (WFI), clean all internal isolator surfaces including walls, glass, and stainless steel surfaces.
2. Remove residues, visible particles, and any dried product using a non-abrasive motion.
3. Change the cloth when visibly dirty or after each major surface to avoid cross-contamination.
4. Allow to dry or wipe with a dry sterile cloth if required.

5.3 Sanitization with Disinfectants

1. Use an approved sporicidal disinfectant (e.g., Hydrogen Peroxide, Peracetic Acid) as per the disinfectant rotation policy.
2. Spray or fog the disinfectant using validated equipment designed for isolators or vaporized hydrogen peroxide (VHP) systems.
3. Ensure full coverage including glove ports, viewing window interiors, air intake filters, and floor plates.
4. Maintain the required contact time (e.g., 30 minutes) as specified in the MSDS/SOP for the disinfectant.
5. Ventilate the isolator post-fumigation if required and ensure all vapors are neutralized.

5.4 Post-Sanitization Checks

1. Visually inspect all internal areas of the isolator to ensure no chemical residues remain.
2. Perform swab tests at predefined locations (Annexure-1) for microbial monitoring post-sanitization.
3. Record results in the Isolator Sanitization Log (Annexure-2).
4. Label the isolator with “SANITIZED” status tag along with date/time and initials of the operator and QA reviewer.

5.5 Frequency

• Routine sanitization: Before start of each aseptic operation batch.
• In case of product changeover, or observed contamination or as per validated frequency.

5.6 Safety Precautions

1. Refer to the Safety Data Sheet (SDS) of the disinfectant before use.
2. Ensure isolator chamber is sealed before fumigation or fogging starts.
3. Never reuse disinfectant solutions beyond their validated hold time.

6. Abbreviations

• SOP: Standard Operating Procedure
• PPE: Personal Protective Equipment
• QA: Quality Assurance
• WFI: Water for Injection
• MSDS: Material Safety Data Sheet
• VHP: Vaporized Hydrogen Peroxide

7. Documents

1. Annexure-1: Isolator Microbial Monitoring Locations
2. Annexure-2: Isolator Sanitization Log
3. Annexure-3: Disinfectant Usage Record

8. References

• EU GMP Annex 1: Manufacture of Sterile Medicinal Products
• USP <797>: Pharmaceutical Compounding — Sterile Preparations
• 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: Isolator Microbial Monitoring Locations

Location	Swab ID	Result (cfu)	Limit	Status
Left Wall	SWB-01	0	≤1	Pass
Glove Port 1	SWB-02	0	≤1	Pass

Annexure-2: Isolator Sanitization Log

Date	Isolator ID	Disinfectant Used	Operator	QA Reviewer
23/06/2025	ISO-01	Hydrogen Peroxide	Ravi Kumar	Meena Gupta

Annexure-3: Disinfectant Usage Record

Batch No.	Preparation Date	Expiry	Used For	Prepared By
HP202506	22/06/2025	23/06/2025	ISO-01	Sunil Mehta

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial version	New SOP	Head QA
24/06/2025	2.0	Included VHP method and updated disinfection policy	Annual Review	Head QA