Standard Operating Procedure (SOP)

1.0 Objective

To lay down the procedure for cleaning, sanitization, and verification activities required to resume aseptic area operations after any maintenance work, ensuring compliance with GMP and sterility assurance.

2.0 Scope

This SOP applies to all Grade A/B (ISO 5/6) aseptic manufacturing areas at [Company Name] after any planned or unplanned maintenance or repair work.

3.0 Responsibility

4.0 Definitions

• Aseptic Area: Controlled environment designed to prevent microbial contamination during sterile manufacturing.

• Grade A/B Area: Critical cleanroom zones where sterile products are exposed.

• Environmental Monitoring (EM): Routine assessment for microbial and particulate contamination.

5.0 Materials and Equipment Required

• Approved disinfectants (e.g., 70% IPA, sporicidal agent)

• Sterile lint-free wipes and mops

• HEPA filter integrity test kit (if applicable)

• Particle counter and microbial sampling devices

• PPE suitable for cleanroom entry

• Area release checklist/logbook

6.0 Procedure

6.1 Before Maintenance

1. Stop all production activity.

2. Inform QA and record maintenance request.

3. Protect product contact surfaces and critical equipment with sterile covers.

4. Declassify the area by removing “In Operation” status.

6.2 During Maintenance

1. Ensure only authorized personnel in proper cleanroom garments enter.

2. Limit access strictly to maintenance and QA personnel.

3. Record all tools and materials used.

4. Use cleaned/disinfected tools where feasible.

6.3 After Maintenance

1. Remove all tools, debris, and covers used during maintenance.

2. Perform initial rough cleaning to remove visible dirt/dust.

3. Conduct deep cleaning and disinfection of all surfaces, walls, floors, ceilings, and equipment with approved agents.

4. If applicable, replace or clean pre-filters and check HEPA filter status.

5. Allow proper contact time for disinfectants.

6. Reinstall critical equipment parts, sanitize again.

7. Allow a minimum rest/recovery period (e.g., 30–60 minutes) before performing environmental monitoring.

6.4 Environmental Monitoring (EM)

1. Perform particle count and microbial sampling (settle plates, contact plates, air sampling) at critical points.

2. Wait for EM results (as per SOP, e.g., 24–72 hours) or rapid test approval before area release.

3. If any result is out of specification (OOS), repeat cleaning and EM until acceptable.

6.5 Area Release

1. QA reviews cleaning records, maintenance log, and EM data.

2. Upon satisfactory results, QA issues “Area Release” approval.

3. Update area status to “Ready for Use” and document all approvals.

7.0 Documentation

• Maintenance Work Permit / Report

• Cleaning and Disinfection Checklist

• Environmental Monitoring Report

• Area Release Logbook

• Deviations/OOS (if any)

8.0 Abbreviations

• SOP: Standard Operating Procedure

• EM: Environmental Monitoring

• HEPA: High-Efficiency Particulate Air

• OOS: Out of Specification

• QA: Quality Assurance

• IPA: Isopropyl Alcohol

9.0 Annexures

• Annexure 1: Cleaning & Disinfection Checklist

• Annexure 2: Area Release Approval Form

• Annexure 3: EM Sampling Plan Template

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