environments within the sterile manufacturing facility, including aseptic filling, preparation areas, airlocks, change rooms, and support areas.

3. Responsibilities

• Microbiology/QA Personnel: Responsible for environmental monitoring (viable and non-viable).
• Engineering: Ensures HVAC system performance and calibration of sensors.
• Production: Maintains cleanliness and notifies any deviation in environmental parameters.

4. Accountability

The Head – Quality Assurance is accountable for ensuring proper monitoring, data review, and compliance with environmental requirements.

5. Procedure

5.1 Temperature and Humidity Monitoring

1. Digital sensors shall continuously record temperature and humidity via a Building Management System (BMS).
2. Daily manual cross-verification shall be done using calibrated hygrometers and thermometers.
3. Record values in Annexure-1: Temperature and Humidity Log.
4. Acceptable range: 18°C to 25°C and RH 40%–60% for manufacturing areas unless otherwise specified in product requirements.

5.2 Differential Pressure Monitoring

1. Magnehelic gauges or electronic sensors shall monitor pressure differentials between classified areas.
2. Daily verification shall ensure pressure gradient is maintained:
   • Grade B to C: +10 to +15 Pascal
   • Grade C to D: +10 to +15 Pascal
3. Record values in Annexure-2: Differential Pressure Log.

5.3 Particulate Monitoring (Non-Viable)

1. Conduct particle count using calibrated particle counters per ISO 14644 standards.
2. Frequency:
   • Grade A: Daily (during operation)
   • Grade B: Weekly
   • Grade C/D: Monthly
3. Record results in Annexure-3: Particulate Monitoring Report.

5.4 Microbiological Monitoring (Viable)

1. Use settle plates, swabs, contact plates, and air samplers as per EM schedule.
2. Exposure time and site numbers to follow validated protocol.
3. Document all results in Annexure-4: Microbiological Monitoring Record.

5.5 Alarm and Deviation Handling

1. Any out-of-specification reading must trigger a visual/auditory alarm.
2. Initiate deviation as per SOP/QA/045/2025 and investigate root cause.
3. Document CAPA and ensure restoration within limits.

5.6 Trend Analysis

1. QA shall review environmental monitoring data monthly.
2. Analyze for recurring excursions, seasonal trends, and system failures.
3. Document analysis in Annexure-5: Monthly Trend Report.

6. Abbreviations

• SOP: Standard Operating Procedure
• BMS: Building Management System
• RH: Relative Humidity
• QA: Quality Assurance
• HVAC: Heating, Ventilation and Air Conditioning

7. Documents

1. Temperature and Humidity Log – Annexure-1
2. Differential Pressure Log – Annexure-2
3. Particulate Monitoring Report – Annexure-3
4. Microbiological Monitoring Record – Annexure-4
5. Monthly Trend Report – Annexure-5

8. References

• EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
• WHO TRS 961 – Environmental Monitoring Guidelines
• ISO 14644-1: Cleanrooms and Associated Controlled Environments

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Manufacturing Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Temperature and Humidity Log

Date	Area	Temp (°C)	RH (%)	Checked By
18/06/2025	Filling Room	21.5	48	Ravi Shankar

Annexure-2: Differential Pressure Log

Date	From Area	To Area	Pressure (Pa)	Checked By
18/06/2025	Grade B	Grade C	14	Deepika Nair

Annexure-3: Particulate Monitoring Report

Date	Area	≥0.5 µm Count	≥5.0 µm Count	Status
18/06/2025	LAF Bench	200	0	Pass

Annexure-4: Microbiological Monitoring Record

Date	Sample Type	Area	CFU Count	Remarks
18/06/2025	Settle Plate	Filling Area	0	Compliant

Annexure-5: Monthly Trend Report

Month	Parameter	No. of Excursions	Action Taken	Reviewed By
May 2025	RH	2	Adjusted dehumidifier settings	QA Manager

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP Release	New SOP	QA Head
18/06/2025	2.0	Added trend analysis and BMS integration reference	Annual Review	QA Head