JSA for Safe Operation of Capsule Polishing Machine
| JSA Number | JSA/OralDosage/044/2025 | 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 Capsule Polishing Machine. This equipment is used in pharmaceutical manufacturing to remove excess powder and polish hard gelatin or HPMC capsules, ensuring a smooth, clean surface before packaging. Proper handling and operation are essential to prevent contamination, mechanical hazards, and exposure to airborne particles.
2. Scope
This JSA applies to all operators, supervisors, and maintenance personnel involved in using, cleaning, and maintaining the Capsule Polishing Machine in the Oral Dosage department. Ensuring compliance with safety measures minimizes risks associated with capsule damage, dust exposure, and improper handling of polished capsules.
3. Responsibilities
Operators:
- Follow the standard operating procedure (SOP) while operating the Capsule Polishing Machine.
- Ensure the machine is properly calibrated before use.
- Wear appropriate Personal Protective Equipment (PPE) to prevent exposure to airborne particles.
- Monitor capsule flow, polishing efficiency, and dust collection.
- Ensure proper cleaning and avoid cross-contamination between batches.
- Perform post-operation maintenance as required.
Supervisors:
- Ensure compliance with GMP and workplace safety regulations.
- Monitor machine efficiency and ensure calibration is performed as scheduled.
- Conduct routine inspections of
the Capsule Polishing Machine and maintenance logs.
Safety Officers:
- Perform risk assessments and ensure compliance with occupational safety standards.
- Ensure that dust extraction and ventilation systems are functioning correctly.
- Verify that PPE, such as respiratory masks and protective gloves, 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 capsules into the hopper | Manual handling strain, capsule contamination | Medium | Use clean handling tools; wear gloves. |
| 3 | Adjusting polishing settings | Machine misalignment, improper polishing | High | Follow SOP guidelines for setting polishing speed and airflow. |
| 4 | Polishing process | Dust exposure, capsule breakage | High | Ensure dust extraction is functional; avoid overloading capsules. |
| 5 | Unloading and collecting polished 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 breakage due to excessive polishing force | 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 polishing.
- Safety glasses: Shields eyes from dust exposure.
- Protective gloves: Prevents direct contact with capsules.
- Machine guards: Ensures safety from moving parts.
- Designated collection bins: Prevents cross-contamination.
9. References
- OSHA 1910.212 – Machine Guarding Standards.
- ISO 45001 – Occupational Health & Safety Management.
- GMP guidelines for capsule polishing and handling.
10. Approval Section
| Name | Designation | Signature | Date |
|---|---|---|---|
| [Name] | Prepared By | ||
| [Name] | Checked By | ||
| [Name] | Approved By |