Standard Operating Procedure for Environmental Monitoring of Dispensing Area

Department	Elixir Department
SOP No.	SOP/ELX/017/2025
Supersedes	SOP/ELX/017/2022
Page No.	Page 1 of 8
Issue Date	13/04/2025
Effective Date	15/04/2025
Review Date	13/04/2026

1. Purpose

To establish a standard procedure for routine environmental monitoring of the dispensing area in the Elixir Department to ensure cleanliness, compliance with cGMP, and prevention of contamination during dispensing operations.

2. Scope

This SOP applies to all Class C and D dispensing areas where raw materials for elixir manufacturing are handled, and covers temperature, relative humidity (RH), particulate matter, and microbial monitoring.

3. Responsibilities

• Dispensing Operator:
  • Check temperature and humidity twice per shift and record in log.
• Engineering/Maintenance Staff:
  • Ensure proper functioning of HVAC systems and calibrate monitoring instruments.
• Quality Assurance (QA):
  • Perform particulate and microbial monitoring as per schedule.
  • Review all environmental records and initiate corrective actions when required.

4. Accountability

The Head of Quality Assurance is accountable for ensuring environmental parameters are monitored, maintained, and documented for all dispensing activities.

5. Procedure

5.1 Temperature and Humidity Monitoring

1. Use a calibrated digital thermo-hygrometer to monitor environmental conditions in the dispensing area.
2. Record readings twice per shift (e.g., 9:00 AM and 3:00 PM) in the Environmental Monitoring Log (Annexure-1).
3. Acceptable Limits:
   • Temperature: 20°C to 25°C
   • Relative Humidity: 45% to 60%
4. If values are out of range, inform the Engineering Department immediately and log deviation.

5.2 Differential Pressure Monitoring

1. Ensure the dispensing room maintains positive pressure compared to adjacent areas.
2. Use a calibrated magnahelic gauge or digital manometer.
3. Acceptable range: +10 to +15 Pascal.
4. Record once per shift in the logbook.

5.3 Microbial Monitoring

1. Perform monthly or batch-based active air sampling using a calibrated air sampler or settle plates.
2. Place settle plates at critical locations such as:
   • Weighing balance area
   • Under LAF units
   • Near doorways
3. Incubate plates at:
   • 30–35°C for 48 hours (bacterial count)
   • 20–25°C for 5 days (fungal count)
4. Limits for Grade D area:
   • Air sample: ≤200 cfu/m³
   • Settle plate: ≤50 cfu/4 hours
5. Record data in Microbial Monitoring Log (Annexure-2).

5.4 Particulate Monitoring

1. Use a calibrated laser particle counter to check airborne particulates quarterly or during HVAC maintenance.
2. Measure for 0.5µm and 5.0µm particles in:
   • Dispensing Room
   • Change Rooms
3. Acceptable limits (Grade D):
   • 0.5 µm: ≤3,520,000 particles/m³
   • 5.0 µm: ≤29,000 particles/m³
4. Record values and attach report to Environmental Monitoring Summary File.

5.5 Action in Case of Deviation

1. Immediately stop dispensing activity if limits exceed specified thresholds.
2. Initiate deviation form and root cause analysis.
3. Restart operation only after corrective actions are implemented and results are within acceptable limits.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• RH: Relative Humidity
• HVAC: Heating, Ventilation, and Air Conditioning
• cfu: Colony Forming Unit

7. Documents

1. Environmental Monitoring Log (Annexure-1)
2. Microbial Monitoring Log (Annexure-2)
3. Deviation Form (if required)

8. References

• WHO TRS 961 Annex 6 – GMP for HVAC Systems
• ISO 14644 – Cleanroom Classification
• 21 CFR Part 211 – cGMP Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Environmental Monitoring Log

Date	Time	Temperature (°C)	RH (%)	Pressure (Pa)	Checked By	Remarks
13/04/2025	09:00	23.1	52%	+12	Rajesh Kumar	Within Limits

Annexure-2: Microbial Monitoring Log

Date	Location	CFU Count	Plate Type	Incubated By	Reviewed By
01/04/2025	Dispensing Table	12 cfu	Settle Plate	Sunita Reddy	QA Manager

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
10/01/2022	1.0	Initial Version	New SOP	QA Head
13/04/2025	2.0	Added microbial and particle monitoring section	Regulatory Audit	QA Head