JSA for Safe Operation of Tablet Sorting Machine
| JSA Number | JSA/OralDosage/042/2025 | 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 Sorting Machine. This equipment is used in pharmaceutical manufacturing to automatically sort tablets based on size, weight, or visual defects to ensure quality compliance. Proper handling and operation are essential to prevent contamination, mechanical hazards, and ensure accurate tablet sorting.
2. Scope
This JSA applies to all operators, supervisors, and maintenance personnel involved in using, cleaning, and maintaining the Tablet Sorting Machine in the Oral Dosage department. Ensuring compliance with safety measures minimizes risks associated with moving parts, tablet contamination, and improper sorting mechanisms.
3. Responsibilities
Operators:
- Follow the standard operating procedure (SOP) while operating the Tablet Sorting Machine.
- Ensure the machine is properly calibrated before use.
- Wear appropriate Personal Protective Equipment (PPE) to prevent contamination.
- Monitor tablet sorting accuracy and adjust settings as needed.
- Ensure proper cleaning and maintenance to prevent cross-contamination.
- Report any machine malfunction immediately to the supervisor.
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 Sorting Machine
and maintenance logs.
Safety Officers:
- Perform risk assessments and ensure compliance with occupational safety standards.
- Ensure that dust control and material handling procedures are followed.
- Verify that PPE, such as gloves, safety glasses, and protective clothing, are used correctly.
4. Definitions & Abbreviations
- PPE: Personal Protective Equipment (e.g., gloves, safety glasses, protective clothing).
- 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 hopper | Manual handling strain, tablet contamination | Medium | Use clean handling tools; wear gloves. |
| 3 | Adjusting sorting parameters | Misalignment, incorrect sorting | High | Follow SOP guidelines for setting sorting thresholds. |
| 4 | Sorting process | Moving parts hazards, tablet breakage | High | Ensure safety guards are in place; do not reach into moving parts. |
| 5 | Unloading and collecting sorted tablets | Cross-contamination, handling errors | Medium | Follow GMP cleaning procedures and use designated collection containers. |
| 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 tablet breakage | Low |
| Possible | Tablet misalignment leading to incorrect sorting | Medium |
| Likely | Entrapment due to moving parts | High |
7. Emergency Procedures
- In case of tablet contamination, stop the machine and notify the supervisor.
- If the system 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 from broken tablets.
- Safety glasses: Shields eyes from dust exposure.
- Protective gloves: Prevents direct contact with tablets.
- Machine guards: Ensures safety from moving parts.
- Designated sorting bins: Prevents cross-contamination.
9. References
- OSHA 1910.212 – Machine Guarding Standards.
- ISO 45001 – Occupational Health & Safety Management.
- GMP guidelines for tablet sorting and handling.
10. Approval Section
| Name | Designation | Signature | Date |
|---|---|---|---|
| [Name] | Prepared By | ||
| [Name] | Checked By | ||
| [Name] | Approved By |