JSA for Safe Operation of Sugar Coating Machine
| JSA Number | JSA/OralDosage/016/2025 | 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 Sugar Coating Machine. This equipment is used in pharmaceutical manufacturing to apply a sugar-based protective coating to tablets, improving taste, appearance, and stability. Safe operation is essential to prevent injuries, chemical exposure, and mechanical hazards.
2. Scope
This JSA applies to all operators, maintenance personnel, and supervisors involved in using, cleaning, and maintaining the Sugar Coating Machine in the Oral Dosage department. Proper safety measures must be followed to minimize risks associated with high-speed rotation, hot air drying, handling of sugar solutions, and potential slip hazards.
3. Responsibilities
Operators:
- Operate the Sugar Coating Machine according to the standard operating procedure (SOP).
- Wear the appropriate Personal Protective Equipment (PPE) before handling coating materials.
- Ensure uniform loading of tablets into the machine.
- Monitor temperature, airflow, and sugar solution spray settings.
- Handle sugar solutions carefully to prevent spills and contamination.
- Conduct routine cleaning of the machine to prevent sugar build-up.
Supervisors:
- Ensure strict compliance with GMP and safety guidelines.
- Monitor operations for potential hazards and ensure corrective actions are taken.
- Conduct inspections
of machine components and ensure regular maintenance.
Safety Officers:
- Perform risk assessments and ensure compliance with safety regulations.
- Ensure the proper functioning of ventilation and exhaust systems.
- Verify that operators are trained in handling hot sugar solutions safely.
4. Definitions & Abbreviations
- PPE: Personal Protective Equipment (e.g., gloves, goggles, protective clothing).
- GMP: Good Manufacturing Practices – Guidelines ensuring product quality and safety.
- LOTO: Lockout/Tagout – A safety 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 hazard, improper calibration | Medium | Ensure the machine is grounded and properly calibrated before use. |
| 2 | Loading tablets into the coating pan | Manual handling strain, tablet breakage | Medium | Use proper lifting techniques and load tablets carefully. |
| 3 | Spraying sugar solution onto tablets | Inhalation of aerosols, sticky surfaces | High | Wear respiratory protection and ensure adequate ventilation. |
| 4 | Drying coated tablets | Heat exposure, risk of burns | Medium | Maintain a safe distance, use heat-resistant gloves if needed. |
| 5 | Unloading finished coated tablets | Cross-contamination, ergonomic strain | Medium | Follow cleaning procedures and use proper lifting aids. |
| 6 | Cleaning and maintenance | Hot sugar residue, chemical exposure | High | Use PPE, follow LOTO procedures before servicing. |
6. Risk Assessment
| Likelihood | Consequence | Risk Level |
|---|---|---|
| Rare | Minor burns from sugar solution | Low |
| Possible | Slip hazards from sugar solution spills | Medium |
| Likely | Respiratory irritation from aerosols | High |
7. Emergency Procedures
- In case of burns, immediately rinse the affected area with cool water and seek medical help.
- For respiratory exposure, move to fresh air and seek medical attention.
- If an equipment failure occurs, initiate an emergency shutdown and report to maintenance.
- All incidents must be recorded and reported to the safety officer for investigation.
8. Required PPE & Safety Controls
- Heat-resistant gloves: Protect hands from burns due to hot sugar solutions.
- Respiratory mask: Prevents inhalation of sugar aerosols.
- Goggles: Shields eyes from splashes and airborne particles.
- Protective clothing: Prevents contamination and exposure to sticky residues.
- Non-slip footwear: Reduces the risk of slips and falls.
9. References
- OSHA 1910.120 – Hazardous Materials Handling.
- ISO 45001 – Occupational Health & Safety Management.
- GMP guidelines for sugar 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] |