environmental conditions that prevent contamination and maintain product quality.

2. Scope

This SOP is applicable to the dispensing areas in the Gel Manufacturing department, specifically during raw material handling activities. It covers monitoring of viable and non-viable particulate counts, temperature, humidity, and differential pressure.

3. Responsibilities

• Environmental Monitoring (EM) Technician: Conducts scheduled monitoring and documents results.
• Production Operator: Supports monitoring by ensuring area cleanliness and readiness.
• QA Officer: Reviews monitoring data and ensures compliance with alert/action limits.

4. Accountability

The Head of Quality Assurance is accountable for the implementation of environmental monitoring protocols and ensuring corrective actions in case of deviations.

5. Procedure

5.1 Monitoring Schedule and Requirements

1. Perform environmental monitoring during:
   • Start of dispensing operations
   • Mid-point of long operations (>4 hours)
   • End of dispensing operation
2. Monitoring frequency must be increased during critical operations or if past excursions were recorded.

5.2 Parameters to Monitor

1. Temperature: Maintain between 20°C–25°C
2. Relative Humidity: Maintain below 60%
3. Differential Pressure: Maintain minimum 15 Pa between classified areas
4. Non-Viable Particles: ≤ 3520 particles/m³ (≥0.5 µm for ISO 8)
5. Viable Microbial Count: ≤ 100 CFU/m³ for air, ≤ 5 CFU/plate for surface

5.3 Instruments Used

1. Temperature and RH Monitor
2. Differential Pressure Gauge
3. Airborne Particle Counter (calibrated)
4. Settle Plates, Contact Plates, Swabs

5.4 Monitoring Steps

1. Calibrate and sanitize instruments before use.
2. Record differential pressure at room entry and exit.
3. Measure and document temperature and humidity using digital meters and record in Environmental Monitoring Log (Annexure-1).
4. Perform:
   • Non-viable particle count using particle counter for 1-minute sampling at 1 meter height
   • Viable air sampling using settle plates exposed for 4 hours
   • Surface monitoring using contact plates at critical surfaces (e.g., balance top, scoops)
5. Label and incubate plates at 30–35°C for 72 hours, followed by 20–25°C for 48 hours.

5.5 Acceptance Criteria

1. If readings fall within alert limits, continue operations.
2. If readings exceed alert but within action limits, perform cleaning and repeat monitoring.
3. If readings exceed action limits:
   • Stop dispensing
   • Inform QA and initiate deviation report
   • Perform root cause analysis and corrective action

5.6 Documentation

1. All data to be recorded in Annexure-1: Environmental Monitoring Log.
2. Deviation events to be documented in Annexure-2: Deviation Report Form.
3. Ensure traceability of plates with unique identification numbers and location codes.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• CFU: Colony Forming Units
• EM: Environmental Monitoring

7. Documents

1. Environmental Monitoring Log – Annexure-1
2. Deviation Report Form – Annexure-2

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 Log

Date	Time	Temp (°C)	RH (%)	Part. Count (≥0.5µm)	CFU/m³	CFU/plate	Checked By
02/06/2025	10:00 AM	22	42	3200	80	3	Vinay Pawar

Annexure-2: Deviation Report Form

Date	02/06/2025
Area	Dispensing Booth 1
Observed Parameter	CFU count exceeded action limit
Immediate Action	Stopped operation, disinfected area
Root Cause	HEPA filter leakage
Corrective Action	Filter replaced and validated
Approved By	QA Manager

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	New SOP	QA Head
02/06/2025	2.0	Enhanced monitoring frequency and included deviation reporting form	Annual Review	QA Head