B cleanroom environments used for sterile injectable product filling operations at [Company Name].

3. Responsibilities

• Production Officer: Ensures adherence to aseptic behavior and filling process practices.
• IPQA Officer: Monitors environmental conditions and documents aseptic compliance.
• Microbiologist: Conducts viable/non-viable environmental monitoring and evaluates results.

4. Accountability

The Head – Quality Assurance is accountable for compliance with aseptic monitoring practices and documentation.

5. Procedure

5.1 Preparation for Filling

1. Verify HVAC performance, HEPA airflow velocity, and pressure differentials.
2. Ensure viable and non-viable monitoring instruments are calibrated and ready.
3. Ensure personnel perform aseptic gowning as per SOP/SIM/022/2025.

5.2 Monitoring of Aseptic Conditions

1. Monitor differential pressure between classified areas every hour and record (Annexure-1).
2. Use a particle counter to record non-viable particle counts during filling at critical locations (e.g., near open vials, syringe tips).
3. Perform settle plate and active air sampling at start, mid, and end of each batch at designated sampling points.
4. Conduct surface sampling of gloves, gowns, and filling machine parts using RODAC plates.

5.3 Monitoring Personnel Practices

1. Observe aseptic behavior, including:
   • No rapid movements or excessive talking
   • Proper use of hand disinfection
   • Minimal personnel intervention inside Grade A zone
2. Document non-compliance or observations in the Personnel Monitoring Log (Annexure-2).

5.4 Alert and Action Limits

1. Refer to validated alert/action limits for:
   • Non-viable particles (≥0.5 µm and ≥5 µm)
   • CFU limits for settle/RODAC plates
2. In case of excursions:
   • Immediately inform QA
   • Initiate deviation and investigation

5.5 Documentation

1. Record all monitoring results in Environmental Monitoring Log (Annexure-3).
2. Attach all results and logs in the Batch Manufacturing Record (BMR).

6. Abbreviations

• SOP: Standard Operating Procedure
• IPQA: In-Process Quality Assurance
• CFU: Colony Forming Units
• BMR: Batch Manufacturing Record

7. Documents

1. Pressure Monitoring Log – Annexure-1
2. Personnel Monitoring Log – Annexure-2
3. Environmental Monitoring Log – Annexure-3

8. References

• WHO TRS 961 Annex 6: GMP for Sterile Pharmaceutical Products
• EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
• 21 CFR Part 211

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: Pressure Monitoring Log

Date	Room	Expected Pressure (mm WC)	Observed	Status
18/06/2025	Grade B	15–20	18	Acceptable

Annexure-2: Personnel Monitoring Log

Date	Name	Glove CFU	Gown CFU	Comments
18/06/2025	Sunita Reddy	0	0	Compliant

Annexure-3: Environmental Monitoring Log

Date	Location	Settle Plate CFU	RODAC CFU	Particle Count ≥0.5µm	Remarks
18/06/2025	Filling Zone	0	0	320	Within Limit

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Version	New SOP	QA Head
18/06/2025	2.0	Included new monitoring log formats and clarified gowning roles	Annual Review	QA Head