JSA for Safe Operation of High-Speed Rotary Tablet Press
| JSA Number | JSA/OralDosage/032/2025 | 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 High-Speed Rotary Tablet Press. This equipment is used in pharmaceutical manufacturing to compress powder formulations into uniform tablets at high speeds. Proper handling and operation are essential to prevent contamination, mechanical hazards, and exposure to airborne powders.
2. Scope
This JSA applies to all operators, supervisors, and maintenance personnel involved in using, cleaning, and maintaining the High-Speed Rotary Tablet Press in the Oral Dosage department. Ensuring compliance with safety measures minimizes risks associated with powder handling, high-speed rotating parts, and mechanical failures.
3. Responsibilities
Operators:
- Follow the standard operating procedure (SOP) while operating the High-Speed Rotary Tablet Press.
- 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.
- Ensure proper lubrication and avoid contamination of tooling.
- Perform post-operation cleaning to prevent cross-contamination.
Supervisors:
- Ensure compliance with GMP and workplace safety regulations.
- Monitor machine efficiency and ensure calibration is performed as scheduled.
- Conduct routine inspections of the tablet press and maintenance logs.
Safety Officers:
- Perform risk assessments and ensure compliance with occupational safety standards.
- Ensure that dust extraction systems are functioning correctly to minimize airborne particles.
- 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 into the hopper | Manual handling strain, dust exposure | Medium | Use lifting aids; wear a respirator and gloves. |
| 3 | Starting the compression process | Moving parts entrapment, mechanical failure | High | Ensure safety guards are in place; do not reach into moving parts. |
| 4 | Monitoring tablet output | Weight variation, punch misalignment | High | Ensure tablets meet specifications; stop the machine if variation exceeds limits. |
| 5 | Unloading and storing finished tablets | Cross-contamination, ergonomic strain | Medium | Follow cleaning procedures and use proper lifting techniques. |
| 6 | Cleaning and maintenance | Electrical shock, dust 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 | Entrapment due to moving parts | 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 entrapment, 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.
- Machine guards: Ensures safety from moving parts.
- HEPA filters: Ensures high-efficiency dust extraction.
9. References
- OSHA 1910.94 – Ventilation Standards.
- ISO 45001 – Occupational Health & Safety Management.
- GMP guidelines for tablet compression in pharmaceutical production.
10. Approval Section
| Name | Designation | Signature | Date |
|---|---|---|---|
| [Name] | Prepared By | ||
| [Name] | Checked By | ||
| [Name] | Approved By |