JSA for Safe Operation of Spray Coating System
| JSA Number | JSA/OralDosage/017/2025 | 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 Spray Coating System. This equipment is used in pharmaceutical manufacturing to apply a uniform film coating onto tablets or capsules, improving their stability, taste, and controlled release. Proper handling and operation are essential to prevent safety risks, contamination, and equipment malfunctions.
2. Scope
This JSA applies to all operators, supervisors, and maintenance personnel involved in using, cleaning, and maintaining the Spray Coating System in the Oral Dosage department. Ensuring compliance with safety measures is necessary to minimize risks associated with solvent exposure, airborne particles, high-pressure spray nozzles, and potential fire hazards.
3. Responsibilities
Operators:
- Follow the standard operating procedure (SOP) while operating the Spray Coating System.
- Ensure proper calibration and settings before starting the spray coating process.
- Wear the appropriate Personal Protective Equipment (PPE) before handling coating solutions.
- Monitor machine settings, spray pressure, airflow, and solvent flow rates.
- Handle coating solutions carefully to avoid spillage and contamination.
- Perform post-operation cleaning to maintain hygiene and prevent nozzle blockages.
Supervisors:
- Ensure strict compliance with GMP and safety regulations.
- Monitor work
areas for potential solvent exposure and ensure proper ventilation.
Conduct routine inspections of the machine and its safety features.
Safety Officers:
- Perform risk assessments and ensure compliance with workplace safety guidelines.
- Ensure that solvent vapor exposure remains within permissible limits.
- Verify that fume extraction and ventilation systems are functioning correctly.
4. Definitions & Abbreviations
- PPE: Personal Protective Equipment (e.g., gloves, respirators, goggles).
- GMP: Good Manufacturing Practices – Guidelines ensuring product quality and worker safety.
- LOTO: Lockout/Tagout – A procedure to isolate hazardous energy sources.
5. Procedure
| Step | Task Description | Potential Hazard | Risk Level (L/M/H) | Control Measures |
|---|---|---|---|---|
| 1 | Machine setup and calibration | Electrical hazards, improper settings | Medium | Ensure the machine is grounded and settings are verified before use. |
| 2 | Loading coating solution | Chemical exposure, inhalation risks | High | Wear gloves and a respirator; ensure ventilation is functional. |
| 3 | Adjusting spray nozzles | High-pressure spray hazard | High | Ensure the system is deactivated before making adjustments. |
| 4 | Coating application | Fire hazard, solvent exposure | High | Keep ignition sources away; monitor solvent levels and exhaust systems. |
| 5 | Unloading coated tablets | Cross-contamination, ergonomic strain | Medium | Follow cleaning procedures and use proper lifting techniques. |
| 6 | Cleaning and maintenance | Solvent exposure, clogged nozzles | High | Use PPE, follow LOTO procedures before servicing. |
6. Risk Assessment
| Likelihood | Consequence | Risk Level |
|---|---|---|
| Rare | Minor chemical exposure | Low |
| Possible | Skin and eye irritation due to solvent splashes | Medium |
| Likely | Fire hazard due to solvent vapors | High |
7. Emergency Procedures
- In case of chemical exposure, rinse affected areas immediately and seek medical help.
- For fires, use a Class B fire extinguisher and evacuate if necessary.
- In the event of an equipment failure, follow emergency shutdown procedures.
- All incidents must be reported and logged for investigation.
8. Required PPE & Safety Controls
- Gloves: Protects hands from chemical exposure.
- Respiratory mask: Prevents inhalation of solvent fumes.
- Goggles: Shields eyes from splashes and airborne particles.
- Protective clothing: Prevents contamination and chemical exposure.
- Ventilation system: Ensures the safe removal of solvent vapors.
9. References
- OSHA 1910.106 – Flammable and Combustible Liquids Standards.
- ISO 45001 – Occupational Health & Safety Management.
- GMP guidelines for spray coating in pharmaceutical production.
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] |