SOP Guide for Pharma

Elixir Department: SOP for Environmental Monitoring of Dispensing Area – V 2.0

Auditor

Elixir Department: SOP for Environmental Monitoring of Dispensing Area – V 2.0

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.
See also  Elixir Department: SOP for Use of Material Transfer Hatches - V 2.0

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).
See also  Elixir Department: SOP for Environmental Conditions for Dispensing of Elixirs - V 2.0

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
See also  Elixir Department: SOP for Dispensing Excipients for Oral Liquid Formulations - V 2.0

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
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