Standard Operating Procedure for Monitoring Airborne Microbial Contamination in Gel Manufacturing Area
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/147/2025 |
| Supersedes | SOP/GM/147/2022 |
| Page No. | Page 1 of 12 |
| Issue Date | 09/06/2025 |
| Effective Date | 11/06/2025 |
| Review Date | 09/06/2027 |
1. Purpose
To define the procedure for monitoring airborne microbial contamination in the gel manufacturing area using active and passive sampling methods in compliance with GMP guidelines.
2. Scope
This procedure is applicable to all classified cleanroom areas involved in gel manufacturing operations, including dispensing, preparation, filling, and packing zones.
3. Responsibilities
- Microbiology Department: Carries out monitoring activities, records results, and analyzes trends.
- Production Team: Facilitates access to sampling locations and maintains aseptic conditions during monitoring.
- Quality Assurance: Reviews monitoring records and takes
appropriate actions on deviations or OOT/OOS results.
4. Accountability
The Head – Quality Control is accountable for ensuring microbial monitoring is conducted as per regulatory standards and internal quality policies.
5. Procedure
5.1 Selection of Sampling Points
- Define sampling locations based on risk assessment, process flow, and area classification (Grade A, B, C, D).
- Prepare an Environmental Monitoring (EM) location map with unique codes.
5.2 Frequency of Monitoring
- Perform routine monitoring as per schedule: daily, weekly, monthly, or campaign-based depending on the classification.
- Conduct additional sampling during equipment breakdowns, maintenance, or after cleaning validation.
5.3 Monitoring Methods
- Active Air Sampling: Use calibrated air samplers (e.g., sieve-type or slit-to-agar) to collect a known volume of air onto agar plates.
- Passive Sampling (Settle Plates): Place open Petri dishes containing appropriate media for a predefined exposure period (typically 4 hours).
5.4 Media and Incubation
- Use Tryptic Soy Agar (TSA) and Sabouraud Dextrose Agar (SDA) as standard media.
- Incubate TSA plates at 30–35°C for 48–72 hours and SDA plates at 20–25°C for 5–7 days.
5.5 Acceptance Criteria
Refer to Annexure-3 for acceptance criteria based on cleanroom classification as per EU GMP Annex 1 and WHO TRS guidelines.
5.6 Documentation
- Record details in the Environmental Monitoring Logbook: area code, date, time, media lot number, sampler ID, and analyst signature.
- Retain raw data, plate photographs (if applicable), and colony counts in QC records.
5.7 Out of Limit (OOL) or OOS Results
- Initiate deviation report and perform root cause analysis.
- Re-sample area after cleaning and disinfection.
- Quarantine affected batches until investigation is complete.
6. Abbreviations
- EM: Environmental Monitoring
- OOT: Out of Trend
- OOS: Out of Specification
- TSA: Tryptic Soy Agar
- SDA: Sabouraud Dextrose Agar
7. Documents
- Environmental Monitoring Schedule
- Monitoring Logbook – Annexure-1
- Active Air Sampling Report – Annexure-2
- Acceptance Criteria Table – Annexure-3
8. References
- EU GMP Guidelines – Annex 1
- WHO TRS 961 Annex 6
- FDA Guidance for Industry on 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: Monitoring Logbook Format
| Date | Area Code | Media Type | Sampler ID | Incubation | CFU Count | Analyst |
|---|---|---|---|---|---|---|
Annexure-2: Active Air Sampling Report
| Sampling Date | Location | Volume (L) | Plate No. | Result (CFU/m3) | Remarks |
|---|---|---|---|---|---|
Annexure-3: Acceptance Criteria Based on Area Classification
| Cleanroom Grade | Settle Plate (CFU/4 hrs) | Active Air (CFU/m3) |
|---|---|---|
| Grade A | 1 | 1 |
| Grade B | 5 | 10 |
| Grade C | 25 | 100 |
| Grade D | 50 | 200 |
Revision History
| Revision Date | Revision No. | Change Description | Reason | Approved By |
|---|---|---|---|---|
| 22/04/2022 | 1.0 | Initial version | New SOP implementation | QA Head |
| 09/06/2025 | 2.0 | Added Annexures for acceptance criteria | Annual SOP review | QA Head |