Sterile Injectable Manufacturing: SOP for Environmental Monitoring in Dispensing Rooms – V 2.0

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Sterile Injectable Manufacturing: SOP for Environmental Monitoring in Dispensing Rooms – V 2.0

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

facilities.

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.
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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.

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5.5 Action on Deviations

  1. Immediately inform QA and stop dispensing operations.
  2. Initiate deviation report (Annexure-3).
  3. Perform additional cleaning and repeat monitoring.
  4. Resume activity only after QA approval.

6. Abbreviations

  • RH: Relative Humidity
  • GMP: Good Manufacturing Practice
  • SOP: Standard Operating Procedure

7. Documents

  1. Dispensing Area Layout – Annexure-1
  2. Environmental Limits Reference Table – Annexure-2
  3. Deviation Report Format – Annexure-3
  4. 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
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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
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