JSA for Safe Operation of Tablet Dissolution Tester
| JSA Number | JSA/OralDosage/029/2025 | 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 Dissolution Tester. This equipment is used in pharmaceutical manufacturing to measure the rate at which tablets dissolve under simulated physiological conditions, ensuring compliance with pharmacopoeial standards. Proper handling and operation are essential to prevent contamination, equipment malfunctions, and operator hazards.
2. Scope
This JSA applies to all operators, supervisors, and maintenance personnel involved in using, cleaning, and maintaining the Tablet Dissolution Tester in the Oral Dosage department. Ensuring compliance with safety measures minimizes risks associated with electrical hazards, chemical exposure, and hot water spills.
3. Responsibilities
Operators:
- Follow the standard operating procedure (SOP) while operating the Tablet Dissolution Tester.
- Ensure the machine is properly calibrated before use.
- Wear appropriate Personal Protective Equipment (PPE) to prevent chemical exposure.
- Monitor the dissolution process and ensure water bath temperature is correctly set.
- Properly dispose of tested 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
dissolution 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 | Filling dissolution vessels with medium | Spillage, contamination | Medium | Use a clean pouring technique; avoid splashing. |
| 3 | Setting temperature and paddle rotation speed | Heat exposure, improper settings | High | Ensure hands are clear of heating elements; follow SOP for adjustments. |
| 4 | Tablet dissolution process | Chemical exposure, contamination risk | High | Ensure ventilation is active; monitor for leaks or spills. |
| 5 | Sampling of dissolution medium | Cross-contamination, ergonomic strain | Medium | Use a proper pipetting technique; avoid sample mix-ups. |
| 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 chemical spill | Low |
| Possible | Respiratory irritation due to chemical exposure | Medium |
| Likely | Electrical hazard due to water contact | High |
7. Emergency Procedures
- In case of chemical spills, clean immediately using appropriate absorbents.
- If an electrical issue arises, shut down the unit and report to maintenance.
- For accidental exposure to chemicals, rinse affected area with water and seek medical help.
- All incidents must be reported and logged for investigation.
8. Required PPE & Safety Controls
- Gloves: Prevents exposure to chemical solutions 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 1910.1200 – Hazard Communication Standard.
- ISO 45001 – Occupational Health & Safety Management.
- GMP guidelines for tablet dissolution testing.
10. Approval Section
| Name | Designation | Signature | Date |
|---|---|---|---|
| [Name] | Prepared By | ||
| [Name] | Checked By | ||
| [Name] | Approved By |