SOP Guide for Pharma

Job Safety Analysis for Weighing and Dispensing Station

Job Safety Analysis for Weighing and Dispensing Station

JSA for Safe Operation of Weighing and Dispensing Station

JSA Number JSA/OralDosage/013/2025 Department Oral Dosage
Revision Number V 1.0 Issue Date 01/02/2025
Effective Date 05/02/2025 Review Date 05/02/2026

1. Purpose

The purpose of this JSA is to identify and mitigate potential hazards associated with the operation of the Weighing and Dispensing Station. This station is critical in pharmaceutical manufacturing, ensuring precise measurement and dispensing of raw materials. Strict adherence to safety protocols is necessary to prevent contamination, exposure risks, and manual handling injuries.

2. Scope

This JSA applies to all operators, supervisors, and maintenance personnel involved in using, cleaning, and maintaining the Weighing and Dispensing Station in the Oral Dosage department. Implementing safety measures minimizes risks associated with handling hazardous materials, cross-contamination, and ergonomic strain.

3. Responsibilities

Operators:

  • Ensure compliance with the weighing and dispensing SOP.
  • Wear the necessary Personal Protective Equipment (PPE) before handling raw materials.
  • Calibrate the weighing scale before each batch operation.
  • Handle materials carefully to prevent spills and contamination.
  • Maintain proper documentation of weighed and dispensed materials.

Supervisors:

  • Ensure adherence to safety guidelines and good manufacturing practices (GMP).
  • Monitor material handling practices to prevent measurement errors.
  • Provide necessary training to operators on handling hazardous materials.

Safety Officers:

  • Conduct regular safety inspections and ensure compliance with regulatory requirements.
  • Verify that PPE is used correctly
by all personnel.
  • Ensure ventilation and dust extraction systems are functioning correctly.
  • 4. Definitions & Abbreviations

    • PPE: Personal Protective Equipment (e.g., gloves, goggles, respirators).
    • GMP: Good Manufacturing Practices – Guidelines ensuring quality control.
    • Risk Assessment: A systematic process for identifying and controlling hazards.

    5. Procedure

    Step Task Description Potential Hazard Risk Level (L/M/H) Control Measures
    1 Machine setup and scale calibration Electrical hazard, inaccurate measurements Medium Ensure scale calibration before operation; inspect power connections.
    2 Weighing raw materials Dust inhalation, manual handling strain High Wear dust masks; use proper lifting techniques.
    3 Dispensing materials Cross-contamination, spills High Follow GMP guidelines; clean spills immediately.
    4 Recording weight and batch details Human errors, documentation mistakes Medium Double-check entries; follow standard documentation practices.
    5 Cleaning and maintenance Exposure to cleaning chemicals, equipment malfunction High Use PPE; follow LOTO procedures before maintenance.

    6. Risk Assessment

    Likelihood Consequence Risk Level
    Rare Minor equipment failure Low
    Possible Inhalation of hazardous powders Medium
    Likely Spillage leading to cross-contamination High

    7. Emergency Procedures

    1. In case of exposure to hazardous materials, move to fresh air and seek medical assistance.
    2. If an electrical fault occurs, shut down the station and report to maintenance.
    3. For accidental spills, follow proper cleaning and decontamination protocols.
    4. All incidents must be recorded and reported to the safety officer.

    8. Required PPE & Safety Controls

    • Gloves: Prevent contamination and skin contact with hazardous materials.
    • Face mask: Reduces exposure to airborne powders.
    • Goggles: Protects eyes from dust and chemical exposure.
    • Protective clothing: Prevents material contamination.
    • Weighing hood: Ensures controlled dispensing of powders.

    9. References

    • OSHA 1910.1200 – Hazard Communication Standards.
    • ISO 45001 – Occupational Health & Safety Management.
    • Good Manufacturing Practice (GMP) guidelines for pharmaceutical weighing.

    10. Approval Section

    Name Designation Signature Date
    [Name] Prepared By
    [Name] Checked By
    [Name] Approved By

    11. Revision History

    Version Date Description of Changes Approved By
    V 1.0 01/02/2025 Initial Release [Name]
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