JSA for Safe Operation of High-Speed Capsule Sorter
| JSA Number | JSA/OralDosage/048/2025 | 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 Capsule Sorter. This equipment is used in pharmaceutical manufacturing to rapidly separate acceptable capsules from defective ones based on size, shape, weight, or visual defects. Proper handling and operation are essential to ensure product quality, prevent contamination, and maintain workplace safety.
2. Scope
This JSA applies to all operators, supervisors, and maintenance personnel involved in using, cleaning, and maintaining the High-Speed Capsule Sorter in the Oral Dosage department. Ensuring compliance with safety measures minimizes risks associated with capsule misalignment, moving parts, and dust exposure.
3. Responsibilities
Operators:
- Follow the standard operating procedure (SOP) while operating the High-Speed Capsule Sorter.
- Ensure the machine is properly calibrated before use.
- Wear appropriate Personal Protective Equipment (PPE) to prevent contamination and exposure to airborne particles.
- Monitor capsule sorting accuracy and adjust settings as required.
- Ensure proper cleaning and maintenance to prevent cross-contamination.
- Report any machine malfunctions 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 High-Speed Capsule Sorter 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 capsules into the feeder | Manual handling strain, capsule 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, capsule breakage | High | Ensure safety guards are in place; do not reach into moving parts. |
| 5 | Unloading and collecting sorted capsules | 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 capsule misalignment | Low |
| Possible | Capsule rejection due to incorrect sorting parameters | Medium |
| Likely | Entrapment due to moving parts | High |
7. Emergency Procedures
- In case of capsule 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 capsule handling.
- Safety glasses: Shields eyes from dust exposure.
- Protective gloves: Prevents direct contact with capsules.
- 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 capsule sorting and handling.
10. Approval Section
| Name | Designation | Signature | Date |
|---|---|---|---|
| [Name] | Prepared By | ||
| [Name] | Checked By | ||
| [Name] | Approved By |