JSA for Safe Operation of Effervescent Tablet Compression Machine
| JSA Number | JSA/OralDosage/041/2025 | 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 Effervescent Tablet Compression Machine. This equipment is used in pharmaceutical manufacturing to compress effervescent powder formulations into tablets that dissolve quickly in liquid. Proper handling and operation are essential to prevent contamination, exposure to hygroscopic materials, mechanical hazards, and ensuring precise moisture control.
2. Scope
This JSA applies to all operators, supervisors, and maintenance personnel involved in using, cleaning, and maintaining the Effervescent Tablet Compression Machine in the Oral Dosage department. Ensuring compliance with safety measures minimizes risks associated with powder handling, moisture sensitivity, and improper calibration.
3. Responsibilities
Operators:
- Follow the standard operating procedure (SOP) while operating the Effervescent Tablet Compression Machine.
- Ensure the machine is properly calibrated before use.
- Wear appropriate Personal Protective Equipment (PPE) to prevent exposure to airborne powders.
- Monitor compression force, punch alignment, and weight variation to ensure uniformity.
- Ensure proper cleaning and avoid moisture contamination.
- Perform post-operation maintenance as required.
Supervisors:
- Ensure compliance with GMP and workplace safety regulations.
- Monitor machine efficiency and ensure calibration is performed as scheduled.
- Conduct routine
inspections of the Effervescent Tablet Compression Machine and maintenance logs.
Safety Officers:
- Perform risk assessments and ensure compliance with occupational safety standards.
- Ensure that humidity control and ventilation systems are functioning correctly.
- Verify that PPE, such as respiratory masks and protective gloves, are used correctly.
4. Definitions & Abbreviations
- PPE: Personal Protective Equipment (e.g., gloves, safety glasses, respirators).
- 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, incorrect calibration | Medium | Ensure proper grounding and calibration before operation. |
| 2 | Loading powder blend into the hopper | Manual handling strain, dust exposure | Medium | Use lifting aids; wear a respirator and gloves. |
| 3 | Adjusting compression force | Mechanical hazards, misalignment | High | Ensure hands are clear of moving parts; follow SOP for force adjustment. |
| 4 | Compression process | Tablet breakage, weight variation | High | Ensure uniform feed and monitor weight variation. |
| 5 | Unloading and packaging of tablets | Moisture contamination, handling errors | Medium | Ensure packaging area is humidity-controlled. |
| 6 | Cleaning and maintenance | Electrical shock, residual powder exposure | High | Follow LOTO procedures before servicing; wear PPE during cleaning. |
6. Risk Assessment
| Likelihood | Consequence | Risk Level |
|---|---|---|
| Rare | Minor powder spillage | Low |
| Possible | Respiratory irritation due to airborne powders | Medium |
| Likely | Tablet breakage due to excessive moisture exposure | High |
7. Emergency Procedures
- In case of excessive powder exposure, move to fresh air and seek medical help.
- If the machine malfunctions, shut it down and report to maintenance.
- For equipment failure, activate the emergency stop and seek immediate assistance.
- All incidents must be reported and logged for investigation.
8. Required PPE & Safety Controls
- Respiratory mask: Prevents inhalation of airborne powder.
- Safety glasses: Shields eyes from fine dust exposure.
- Protective clothing: Prevents dust adherence to skin and garments.
- Humidity control system: Ensures moisture-free tablet production.
- Dehumidified storage: Prevents premature effervescence.
9. References
- OSHA 1910.94 – Ventilation Standards.
- ISO 45001 – Occupational Health & Safety Management.
- GMP guidelines for effervescent tablet manufacturing.
10. Approval Section
| Name | Designation | Signature | Date |
|---|---|---|---|
| [Name] | Prepared By | ||
| [Name] | Checked By | ||
| [Name] | Approved By |