Standard Operating Procedure for Environmental Monitoring in Dispensing Rooms
| Department | Sterile Injectable Manufacturing |
|---|---|
| SOP No. | SOP/SIM/106/2025 |
| Supersedes | SOP/SIM/106/2022 |
| Page No. | Page 1 of 12 |
| Issue Date | 18/06/2025 |
| Effective Date | 20/06/2025 |
| Review Date | 18/06/2026 |
1. Purpose
To establish a procedure for environmental monitoring of dispensing rooms used in sterile injectable manufacturing to ensure compliance with GMP requirements and maintenance of cleanroom standards.
2. Scope
This SOP applies to all dispensing rooms classified as controlled environments (Grade C/D) in sterile injectable production
3. Responsibilities
- Microbiology Analyst: Responsible for conducting environmental monitoring and recording results.
- QA Executive: Reviews reports and assesses compliance with limits.
- Production Supervisor: Ensures area readiness and supports monitoring schedule.
4. Accountability
The Head of Quality Assurance is accountable for implementation and compliance.
5. Procedure
5.1 Parameters to Monitor
- Non-viable particle count
- Viable microbial count (air and surface)
- Temperature and relative humidity
- Differential pressure
5.2 Frequency of Monitoring
- Non-viable particles: Daily (before start of dispensing)
- Viable monitoring: Weekly (air settle plates and contact plates)
- Temperature & RH: Continuous digital logging
- Differential Pressure: Daily and continuous with alarms
5.3 Sampling Locations
Defined as per Dispensing Area Layout (Annexure-1). Minimum of 3 locations per dispensing room, including near balance, entrance, and material transfer area.
5.4 Limits and Alerts
Acceptable limits shall be as per ISO 14644 and EU GMP Annex 1 (Annexure-2). Any deviation must be investigated and documented.
5.5 Action on Deviations
- Immediately inform QA and stop dispensing operations.
- Initiate deviation report (Annexure-3).
- Perform additional cleaning and repeat monitoring.
- Resume activity only after QA approval.
6. Abbreviations
- RH: Relative Humidity
- GMP: Good Manufacturing Practice
- SOP: Standard Operating Procedure
7. Documents
- Dispensing Area Layout – Annexure-1
- Environmental Limits Reference Table – Annexure-2
- Deviation Report Format – Annexure-3
- Environmental Monitoring Logbook – Annexure-4
8. References
- EU GMP Annex 1
- ISO 14644 Cleanroom Standards
- Internal Microbiology SOPs
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | Microbiologist | QA Executive | Head QA |
| Department | Quality Control | Quality Assurance | Quality Assurance |
11. Annexures
Annexure-1: Dispensing Area Layout
(Attach certified layout with sampling points marked)
Annexure-2: Environmental Limits Reference Table
| Parameter | Grade C | Grade D |
|---|---|---|
| Particles ≥0.5 µm | 352,000 | 3,520,000 |
| Viable Airborne Microbes | 100 CFU/m³ | 200 CFU/m³ |
| Surface Microbes | 5 CFU/plate | 50 CFU/plate |
Annexure-3: Deviation Report Format
Include fields for date, monitoring parameter, observed deviation, root cause analysis, corrective actions, and approvals.
Annexure-4: Environmental Monitoring Logbook
Used for recording daily and weekly monitoring data including location, instrument ID, date, and analyst signature.
Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 15/02/2022 | 1.0 | Initial release | New SOP | Head QA |
| 18/06/2025 | 2.0 | Updated with alarm integration and deviation form | System Upgrade | Head QA |