Standard Operating Procedure for Environmental Monitoring During Gel Material Dispensing
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/008/2025 |
| Supersedes | SOP/GM/008/2022 |
| Page No. | Page 1 of 12 |
| Issue Date | 02/06/2025 |
| Effective Date | 04/06/2025 |
| Review Date | 02/06/2026 |
1. Purpose
To lay down the procedure for performing environmental monitoring during the dispensing of raw materials used in gel manufacturing, ensuring adherence to Good Manufacturing Practices (GMP) and minimization of contamination risk.
2. Scope
This SOP applies to the environmental monitoring activities conducted in dispensing areas used for raw material handling in gel manufacturing facilities.
3. Responsibilities
- Production Chemist: Ensures cleanroom conditions are maintained and monitoring activities are supported during dispensing.
- QA Executive: Responsible for periodic review of environmental monitoring records and verifying compliance with limits.
- Microbiologist/EM Personnel: Executes sampling, testing, and documentation of environmental monitoring.
4. Accountability
The Head – Quality Assurance is accountable for the compliance and effective implementation of this SOP.
5. Procedure
5.1 Environmental Parameters to Monitor
- Temperature and Relative Humidity (RH)
- Viable Airborne Microbial Counts (settle plates, active air sampling)
- Non-viable particle count
- Surface microbial monitoring (contact plates/swab testing)
5.2 Frequency of Monitoring
- Daily monitoring of temperature and RH during dispensing activity.
- Viable and non-viable particulate monitoring: Before and after every dispensing session.
- Surface monitoring: At the end of every shift or batch, as applicable.
5.3 Monitoring Locations
- Dispensing booth (Class 100/ISO 5)
- Entry/exit points of dispensing room
- Weighing balance surfaces, floor, walls, operator gloves, and gowns
5.4 Monitoring Procedure
- Calibrate instruments (particle counter, data logger, EM pump) before use.
- Record temperature and humidity using calibrated hygrometers or data loggers.
- Place settle plates for 4-hour exposure near critical dispensing zones.
- Perform active air sampling using calibrated EM pumps (1,000 liters of air/sample).
- Perform surface monitoring with contact plates and swab sticks at designated sites.
- Label all plates with date, time, location, and initials.
5.5 Alert and Action Limits
Refer to the alert/action limits table defined as per WHO/ISO 14644-1 for Grade A/B cleanrooms. Immediate action shall be taken if action limits are exceeded, including investigation and documentation in deviation form.
5.6 Documentation
- Record all readings in the Environmental Monitoring Logbook (Annexure-1).
- Attach printed particle counter and data logger readings as supporting documents.
- Maintain a daily checklist of EM activities (Annexure-2).
5.7 Deviations and Corrective Actions
- Any deviation from the expected EM parameters must be documented in the Deviation Form (Annexure-3).
- Root cause investigation and CAPA shall be initiated for action limit breaches.
6. Abbreviations
- EM: Environmental Monitoring
- RH: Relative Humidity
- CAPA: Corrective and Preventive Action
- SOP: Standard Operating Procedure
7. Documents
- Environmental Monitoring Logbook – Annexure-1
- EM Checklist – Annexure-2
- Deviation Reporting Form – Annexure-3
8. References
- WHO TRS 961 Annex 6 – GMP for HVAC Systems
- ISO 14644-1: Cleanroom Standards
- Schedule M – Good Manufacturing Practices
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: Environmental Monitoring Logbook
| Date | Location | Temp (°C) | RH (%) | Viable Count (cfu) | Particle Count | Monitored By |
|---|---|---|---|---|---|---|
| 02/06/2025 | Dispensing Booth | 22.5 | 42 | 0 | 3,200 | EM Officer |
Annexure-2: EM Checklist
| Parameter | Status (✓/✗) | Remarks |
|---|---|---|
| Temp & RH Recorded | ✓ | Normal |
| Settle Plates Positioned | ✓ | Positioned at 4 locations |
| Surface Swab Done | ✓ | 5 points tested |
Annexure-3: Deviation Reporting Form
| Deviation No. | Date | Description | Corrective Action | Reviewed By |
|---|---|---|---|---|
| DEV/GM/005 | 02/06/2025 | RH exceeded 60% during dispensing | Dispensing paused and HVAC adjusted | QA Head |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/06/2022 | 1.0 | Initial release | New SOP implementation | QA Head |
| 02/06/2025 | 2.0 | Updated frequency and limits per ISO standards | Regulatory alignment | QA Head |