JSA for Safe Operation of Tablet Hardness Tester
| JSA Number | JSA/OralDosage/026/2025 | 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 Hardness Tester. This equipment is used in pharmaceutical manufacturing to measure the mechanical strength of tablets, ensuring they can withstand handling and transportation. Proper handling and operation are essential to prevent contamination, equipment malfunctions, and operator injuries.
2. Scope
This JSA applies to all operators, supervisors, and maintenance personnel involved in using, cleaning, and maintaining the Tablet Hardness Tester in the Oral Dosage department. Ensuring compliance with safety measures minimizes risks associated with mechanical movements, tablet breakage, and exposure to tablet dust.
3. Responsibilities
Operators:
- Follow the standard operating procedure (SOP) while operating the Tablet Hardness Tester.
- Ensure the machine is properly calibrated before use.
- Wear appropriate Personal Protective Equipment (PPE) to prevent dust inhalation.
- Monitor the machine operation and ensure tablets are placed correctly.
- Properly dispose of broken or tested tablets after the test.
- 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 hardness testing equipment and
maintenance logs.
Safety Officers:
- Perform risk assessments and ensure compliance with occupational safety standards.
- Ensure that dust collection systems are functioning correctly to minimize airborne particles.
- Verify that PPE, such as respiratory masks and safety glasses, 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 tablets into the machine | Manual handling strain, contamination | Medium | Use clean handling tools; wear gloves. |
| 3 | Adjusting pressure settings | Mechanical hazards, improper settings | High | Ensure hands are clear of moving parts; follow SOP for adjustments. |
| 4 | Tablet testing process | Tablet breakage, dust exposure | High | Ensure dust collection is active; monitor for tablet displacement. |
| 5 | Unloading tested 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 dust exposure | Low |
| Possible | Respiratory irritation due to dust | Medium |
| Likely | Tablet breakage leading to test errors | High |
7. Emergency Procedures
- In case of excessive dust exposure, move to fresh air and seek medical help.
- If the machine malfunctions, shut it down and report to maintenance.
- For broken tablets, follow the disposal procedure to prevent contamination.
- All incidents must be reported and logged for investigation.
8. Required PPE & Safety Controls
- Respiratory mask: Prevents inhalation of airborne tablet dust.
- Safety glasses: Shields eyes from tablet particles.
- Protective clothing: Prevents dust adherence to skin and garments.
- Calibration weights: Ensures machine accuracy before use.
- HEPA filters: Ensures high-efficiency dust extraction.
9. References
- OSHA 1910.94 – Ventilation Standards.
- ISO 45001 – Occupational Health & Safety Management.
- GMP guidelines for tablet quality testing.
10. Approval Section
| Name | Designation | Signature | Date |
|---|---|---|---|
| [Name] | Prepared By | ||
| [Name] | Checked By | ||
| [Name] | Approved By |