JSA for Safe Operation of Film Coating Pan
| JSA Number | JSA/OralDosage/015/2025 | 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 Film Coating Pan. This equipment is essential in pharmaceutical manufacturing to apply a uniform film coating to tablets, enhancing their appearance, stability, and controlled release. Proper operation and adherence to safety protocols are critical to preventing exposure to coating solutions, mechanical hazards, and contamination risks.
2. Scope
This JSA applies to all operators, supervisors, and maintenance personnel involved in the operation, cleaning, and maintenance of the Film Coating Pan in the Oral Dosage department. Ensuring compliance with safety measures is essential to minimize risks associated with coating solvents, moving mechanical parts, and high-temperature drying systems.
3. Responsibilities
Operators:
- Operate the Film Coating Pan as per the standard operating procedure (SOP).
- Wear appropriate Personal Protective Equipment (PPE) before handling coating solutions.
- Ensure the proper loading of tablets into the coating pan.
- Monitor machine parameters, airflow, and spray system during operation.
- Follow safety measures for handling and disposing of solvents.
- Thoroughly clean the coating pan after each batch to prevent cross-contamination.
Supervisors:
- Ensure compliance with safety protocols and GMP guidelines.
- Monitor the work environment for solvent exposure and adequate ventilation.
- Conduct routine inspections of the machine, safety features, and operational practices.
Safety Officers:
- Perform risk assessments and ensure compliance with occupational safety regulations.
- Verify solvent exposure levels remain within permissible limits.
- Ensure proper functioning of fume extraction and ventilation systems.
4. Definitions & Abbreviations
- PPE: Personal Protective Equipment (e.g., gloves, goggles, respirators).
- GMP: Good Manufacturing Practices – Guidelines ensuring quality and safety in pharmaceutical production.
- LOTO: Lockout/Tagout – A procedure for isolating hazardous energy sources.
5. Procedure
| Step | Task Description | Potential Hazard | Risk Level (L/M/H) | Control Measures |
|---|---|---|---|---|
| 1 | Machine setup and calibration | Electrical hazard, improper calibration | Medium | Ensure proper grounding and calibration before operation. |
| 2 | Loading tablets into the pan | Manual handling strain, tablet breakage | Medium | Use proper lifting techniques and load tablets gently. |
| 3 | Coating process | Solvent exposure, fire hazard | High | Ensure proper ventilation, wear a respirator, and avoid open flames. |
| 4 | Drying phase | Heat exposure, risk of burns | Medium | Maintain a safe distance, use heat-resistant gloves if necessary. |
| 5 | Unloading coated tablets | Cross-contamination, ergonomic strain | Medium | Follow cleaning procedures and use proper lifting aids. |
| 6 | Cleaning and maintenance | Solvent exposure, chemical burns | High | Wear PPE, follow LOTO procedures before servicing. |
6. Risk Assessment
| Likelihood | Consequence | Risk Level |
|---|---|---|
| Rare | Minor equipment failure | Low |
| Possible | Solvent inhalation or skin irritation | 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 further investigation.
8. Required PPE & Safety Controls
- Gloves: Protect hands from solvent exposure.
- Respiratory mask: Prevents inhalation of solvent fumes.
- Goggles: Shields eyes from splashes.
- Protective clothing: Prevents contamination and chemical exposure.
- Ventilation system: Ensures safe removal of solvent vapors.
9. References
- OSHA 1910.106 – Flammable and Combustible Liquids Standards.
- ISO 45001 – Occupational Health & Safety Management.
- GMP guidelines for pharmaceutical tablet coating.
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] |