SOP Guide for Pharma

SOP for Indoor Air Quality Monitoring in Manufacturing Areas

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SOP for Indoor Air Quality Monitoring in Manufacturing Areas

Standard Operating Procedure for Indoor Air Quality Monitoring in Manufacturing Areas

1) Purpose

The purpose of this SOP is to establish a standardized procedure for monitoring and maintaining indoor air quality (IAQ) in manufacturing areas to ensure a safe and healthy environment for employees and compliance with regulatory requirements.

2) Scope

This SOP applies to all manufacturing areas, including production floors, storage rooms, and utility areas, where indoor air quality must be monitored and maintained.

3) Responsibilities

  • EHS Manager: Oversee the implementation of IAQ monitoring and ensure compliance with air quality standards.
  • Monitoring Team: Conduct air quality assessments, document findings, and recommend corrective actions.
  • Maintenance Team: Ensure proper functioning of ventilation systems and air quality equipment.
  • Employees: Report air quality concerns and adhere to safety protocols in the workplace.

4) Procedure

4.1 Planning Air Quality Monitoring

  1. Identify Monitoring Areas:
    • Focus on areas with high potential for air contamination, such as production lines, chemical storage, and HVAC systems.

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  2. Define Monitoring Parameters:
    • Measure key parameters such as particulate matter (PM10, PM2.5), volatile organic compounds (VOCs), carbon dioxide (CO2), temperature, and humidity.
  3. Establish Frequency:
    • Conduct monitoring monthly, quarterly, or as required by regulations or operational needs.
See also  SOP for Incineration of Pharmaceutical Waste

4.2 Conducting Air Quality Monitoring

  1. Use Approved Instruments:
    • Utilize calibrated air quality monitors or sensors
to collect accurate data.

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  • Measure Air Quality:
    • Record readings for all parameters at designated locations and times during regular operations.
  • Document Observations:
    • Log air quality data, including date, time, location, and parameter readings, in the Air Quality Monitoring Log (Annexure 1).
  • Analyze Results:
    • Compare recorded values with permissible limits defined by local regulations or internal standards.

    • 4.3 Addressing Non-Compliance

    1. Identify Sources of Contamination:
      • Trace elevated levels of pollutants to specific processes, equipment, or materials.

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    2. Implement Corrective Actions:
      • Enhance ventilation, repair faulty equipment, or adjust processes to reduce air contamination.
    3. Monitor Post-Implementation:
      • Conduct follow-up monitoring to confirm the effectiveness of corrective measures.

    4.4 Maintenance of Air Quality Systems

    1. Inspect Ventilation Systems:
      • Perform regular inspections and maintenance of HVAC systems, filters, and exhausts to ensure optimal performance.

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    2. Clean Air Filters:
      • Replace or clean air filters periodically to maintain air circulation and quality.
    3. Calibrate Monitoring Equipment:
      • Ensure all air quality monitoring devices are calibrated as per manufacturer guidelines.

    4.5 Training and Awareness

    1. Provide Employee Training:
      • Educate employees on the importance of indoor air quality and their role in maintaining it.

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    2. Promote Reporting:
      • Encourage employees to report unusual odors, visible emissions, or discomfort in the workplace.
    3. Display IAQ Information:
      • Share air quality results and corrective actions through dashboards or internal communications.

    4.6 Documentation and Reporting

    1. Maintain Records:
      • Keep monitoring logs, maintenance records, and corrective action reports for audits and compliance purposes.

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    2. Prepare IAQ Reports:
      • Compile monthly or quarterly IAQ reports summarizing data trends and non-compliance resolutions (Annexure 2).
    3. Submit Reports to Authorities:
      • Provide reports to regulatory agencies during inspections or as required by permits.

    5) Abbreviations, if any

    • IAQ: Indoor Air Quality
    • HVAC: Heating, Ventilation, and Air Conditioning
    • PM: Particulate Matter
    • VOC: Volatile Organic Compounds

    6) Documents, if any

    • Air Quality Monitoring Log
    • Corrective Action Reports
    • Monthly/Quarterly IAQ Reports

    7) Reference, if any

    • ASHRAE Standards for Indoor Air Quality
    • ISO 14644-1 Cleanroom Standards
    • Local Air Quality Regulations

    8) SOP Version

    Version: 1.0

    Annexure

    Template 1: Air Quality Monitoring Log
    Date Location Parameter Reading Permissible Limit Comments
    DD/MM/YYYY Production Area PM2.5 35 µg/m³ 50 µg/m³ Within limit

    Template 2: IAQ Report
    Month Average PM2.5 Average VOC Non-Compliance Areas Corrective Actions
    January 2024 40 µg/m³ 0.1 ppm Storage Area Improved Ventilation
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