JSA for Safe Operation of Tablet Disintegration Tester
| JSA Number | JSA/OralDosage/028/2025 | 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 Disintegration Tester. This equipment is used in pharmaceutical manufacturing to determine the time required for tablets to disintegrate under specified conditions, ensuring quality and compliance with regulatory standards. 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 Disintegration Tester in the Oral Dosage department. Ensuring compliance with safety measures minimizes risks associated with electrical hazards, water spills, and exposure to broken tablet fragments.
3. Responsibilities
Operators:
- Follow the standard operating procedure (SOP) while operating the Tablet Disintegration Tester.
- Ensure the machine is properly calibrated before use.
- Wear appropriate Personal Protective Equipment (PPE) to prevent exposure to chemicals and broken tablets.
- Monitor the test duration and ensure the water bath temperature is correctly set.
- Properly dispose of disintegrated tablet residues 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 the disintegration tester and maintenance logs.
Safety Officers:
- Perform risk assessments and ensure compliance with occupational safety standards.
- Ensure that water spillage is minimized to prevent electrical hazards.
- Verify that PPE, such as safety gloves and splash-resistant aprons, are used correctly.
4. Definitions & Abbreviations
- PPE: Personal Protective Equipment (e.g., gloves, safety glasses, lab coats).
- 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 basket | Manual handling strain, contamination | Medium | Use clean handling tools; wear gloves. |
| 3 | Adjusting water bath temperature and timer | Heat exposure, improper settings | High | Ensure hands are clear of heating elements; follow SOP for adjustments. |
| 4 | Tablet disintegration process | Water spills, contamination risk | High | Ensure water bath is stable; monitor for overflow. |
| 5 | Unloading tested tablets | Cross-contamination, ergonomic strain | Medium | Follow cleaning procedures and use proper lifting techniques. |
| 6 | Cleaning and maintenance | Electrical shock, water spillage | High | Follow LOTO procedures before servicing; wear PPE during cleaning. |
6. Risk Assessment
| Likelihood | Consequence | Risk Level |
|---|---|---|
| Rare | Minor water spill | Low |
| Possible | Respiratory irritation due to tablet dust | Medium |
| Likely | Electrical hazard due to water contact | High |
7. Emergency Procedures
- In case of water spillage near electrical components, power off the machine and report immediately.
- If an electrical issue arises, shut down the unit and report to maintenance.
- For broken tablet residues, follow disposal procedures to prevent contamination.
- All incidents must be reported and logged for investigation.
8. Required PPE & Safety Controls
- Gloves: Prevents exposure to tablet fragments and contamination.
- Safety glasses: Shields eyes from splashes during testing.
- Lab coat: Protects from minor spills and tablet dust.
- Grounding system: Ensures safe operation and prevents static buildup.
- Non-slip mat: Reduces risk of slipping due to water spills.
9. References
- OSHA 1910.95 – Occupational Safety Standards.
- ISO 45001 – Occupational Health & Safety Management.
- GMP guidelines for tablet disintegration testing.
10. Approval Section
| Name | Designation | Signature | Date |
|---|---|---|---|
| [Name] | Prepared By | ||
| [Name] | Checked By | ||
| [Name] | Approved By |