JSA for Safe Operation of Soft Gelatine Capsule Encapsulation Machine
| JSA Number | JSA/OralDosage/020/2025 | 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 Soft Gelatine Capsule Encapsulation Machine. This equipment is used in pharmaceutical manufacturing to produce soft gelatin capsules by encapsulating liquids, suspensions, or pastes. Proper handling and operation are critical to preventing safety risks, contamination, and mechanical hazards.
2. Scope
This JSA applies to all operators, supervisors, and maintenance personnel involved in using, cleaning, and maintaining the Soft Gelatine Capsule Encapsulation Machine in the Oral Dosage department. Ensuring compliance with safety measures is necessary to minimize risks associated with gelatin handling, temperature control, moving machine parts, and lubrication systems.
3. Responsibilities
Operators:
- Follow the standard operating procedure (SOP) while operating the Soft Gelatine Capsule Encapsulation Machine.
- Ensure proper calibration and temperature settings before initiating operations.
- Wear appropriate Personal Protective Equipment (PPE) before handling gelatin and fill materials.
- Monitor machine settings, capsule integrity, and reject capsule counts.
- Handle gelatin sheets and fill materials carefully to avoid contamination.
- Perform post-operation cleaning to maintain hygiene and prevent gelatin residue buildup.
Supervisors:
- Ensure compliance with GMP and safety
regulations.
Monitor work areas for gelatin handling and reject rates.
Conduct routine inspections of the machine and its safety features.
Safety Officers:
- Perform risk assessments and ensure compliance with workplace safety guidelines.
- Ensure that dust collection systems and ventilation are functioning correctly.
- Verify that machine guards and lubrication systems are in place and operational.
4. Definitions & Abbreviations
- PPE: Personal Protective Equipment (e.g., gloves, respirators, goggles).
- 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 | Pinching, electrical hazards, improper settings | Medium | Ensure the machine is grounded, settings are verified, and guards are in place. |
| 2 | Loading gelatin sheets and fill materials | Manual handling strain, contamination | Medium | Use lifting aids; wear gloves and protective clothing. |
| 3 | Adjusting encapsulation parameters | Mechanical hazards, gelatin leakage | High | Keep hands clear of moving parts; ensure proper gelatin sheet tension. |
| 4 | Capsule filling and sealing operation | Moving parts entrapment, temperature hazards | High | Use interlocked machine guards; ensure proper lubrication. |
| 5 | Capsule drying process | Heat exposure, gelatin shrinkage | Medium | Monitor drying temperature; use protective gloves when necessary. |
| 6 | Unloading filled capsules | Cross-contamination, ergonomic strain | Medium | Follow cleaning procedures and use proper lifting techniques. |
| 7 | Cleaning and maintenance | Lubricant exposure, gelatin residue buildup | High | Use PPE, follow LOTO procedures before servicing. |
6. Risk Assessment
| Likelihood | Consequence | Risk Level |
|---|---|---|
| Rare | Minor gelatin spills | Low |
| Possible | Hand injuries from moving machine parts | Medium |
| Likely | Capsule misfeeds causing machine jams | High |
7. Emergency Procedures
- In case of hand entrapment, immediately activate the emergency stop and seek medical help.
- If an electrical issue arises, shut down the machine and report to maintenance.
- For gelatin spills, clean the area immediately to prevent slip hazards.
- All incidents must be reported and logged for investigation.
8. Required PPE & Safety Controls
- Gloves: Protect hands from contamination and mechanical risks.
- Respiratory mask: Prevents inhalation of airborne particles.
- Goggles: Shields eyes from gelatin splashes.
- Protective clothing: Prevents contamination and lubricant exposure.
- Machine guard: Ensures safety from moving parts.
9. References
- OSHA 1910.212 – Machine Guarding Standards.
- ISO 45001 – Occupational Health & Safety Management.
- GMP guidelines for soft gelatin capsule manufacturing.
10. Approval Section
| Name | Designation | Signature | Date |
|---|---|---|---|
| [Name] | Prepared By | ||
| [Name] | Checked By | ||
| [Name] | Approved By |