JSA for Safe Operation of Tablet Coating Machine
| JSA Number | JSA/OralDosage/014/2025 | 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 Tablet Coating Machine. The coating process enhances the stability, appearance, and controlled release of pharmaceutical tablets. Proper operation and adherence to safety protocols are necessary to prevent contamination, exposure to chemicals, and mechanical hazards.
2. Scope
This JSA applies to all operators, maintenance personnel, and supervisors involved in using, cleaning, and maintaining the Tablet Coating Machine in the Oral Dosage department. Ensuring compliance with safety measures is necessary to minimize risks associated with coating solutions, mechanical components, and high-temperature operations.
3. Responsibilities
Operators:
- Ensure the machine is operated according to the standard operating procedure (SOP).
- Wear appropriate Personal Protective Equipment (PPE) before handling coating solutions.
- Monitor machine settings, airflow, and coating parameters.
- Follow safe handling practices for solvents and other coating materials.
- Conduct routine cleaning to prevent cross-contamination.
Supervisors:
- Ensure compliance with GMP and safety guidelines.
- Monitor the work environment for solvent exposure and ventilation efficiency.
- Conduct routine inspections of the machine and safety features.
Safety Officers:
- Perform risk assessments and ensure compliance with occupational safety regulations.
- Ensure that solvent exposure
limits are within permissible levels.
Verify that PPE and fume extraction systems are functioning properly.
4. Definitions & Abbreviations
- PPE: Personal Protective Equipment (e.g., gloves, goggles, respirators).
- GMP: Good Manufacturing Practices – Regulations ensuring consistent product quality.
- 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 the machine is grounded and calibrated before use. |
| 2 | Loading tablets into the drum | Manual handling strain, tablet breakage | Medium | Use proper lifting techniques and load tablets carefully. |
| 3 | Coating process | Exposure to solvents, fire hazard | High | Ensure proper ventilation, wear a respirator, and avoid open flames. |
| 4 | Unloading coated tablets | Cross-contamination, ergonomic strain | Medium | Follow cleaning procedures and use proper lifting aids. |
| 5 | Cleaning and maintenance | Solvent exposure, chemical burns | High | Use 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 from 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 solvent exposure.
- Respiratory mask: Prevents inhalation of solvent fumes.
- Goggles: Shields eyes from splashes.
- Protective clothing: Prevents contamination and chemical exposure.
- Ventilation system: Essential to remove 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] |