JSA for Safe Operation of Hard Gelatine Capsule Filling Machine
| JSA Number | JSA/OralDosage/019/2025 | 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 Hard Gelatine Capsule Filling Machine. This equipment is used in pharmaceutical manufacturing to accurately fill hard gelatin capsules with powders, granules, or pellets, ensuring uniform dosage and high production efficiency. 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 Hard Gelatine Capsule Filling Machine in the Oral Dosage department. Ensuring compliance with safety measures is necessary to minimize risks associated with moving machine parts, powder dispersion, material handling, and electrical components.
3. Responsibilities
Operators:
- Follow the standard operating procedure (SOP) while operating the Hard Gelatine Capsule Filling Machine.
- Ensure proper calibration and machine setup before initiating operations.
- Wear appropriate Personal Protective Equipment (PPE) before handling raw materials.
- Monitor machine settings, filling accuracy, and reject capsule counts.
- Handle gelatin capsules and filling materials carefully to avoid contamination.
- Perform post-operation cleaning to maintain hygiene and prevent material buildup.
Supervisors:
- Ensure compliance
with GMP and safety regulations.
Monitor work areas for capsule integrity 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 are functioning correctly to minimize airborne contamination.
- Verify that machine guards and interlocks 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 raw materials and empty capsules | Manual handling strain, dust inhalation | Medium | Use lifting aids; wear a respirator and gloves. |
| 3 | Adjusting capsule filling parameters | Mechanical hazards, powder spillage | High | Keep hands clear of moving parts; ensure powder containment systems are active. |
| 4 | Capsule filling operation | Moving parts entrapment, powder contamination | High | Use interlocked machine guards; ensure proper dust extraction. |
| 5 | Capsule sealing and ejection | Jammed capsules, misalignment | Medium | Regularly check the sealing system and alignment guides. |
| 6 | Unloading filled capsules | Cross-contamination, ergonomic strain | Medium | Follow cleaning procedures and use proper lifting techniques. |
| 7 | Cleaning and maintenance | Powder inhalation, exposure to lubricants | High | Use PPE, follow LOTO procedures before servicing. |
6. Risk Assessment
| Likelihood | Consequence | Risk Level |
|---|---|---|
| Rare | Minor powder exposure | 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 powder exposure, move to fresh air and seek medical attention.
- All incidents must be reported and logged for investigation.
8. Required PPE & Safety Controls
- Gloves: Protect hands from powder contact and mechanical risks.
- Respiratory mask: Prevents inhalation of airborne powder particles.
- Goggles: Shields eyes from dust and particles.
- Protective clothing: Prevents contamination and powder adhesion.
- Machine guard: Ensures safety from moving parts.
9. References
- OSHA 1910.212 – Machine Guarding Standards.
- ISO 45001 – Occupational Health & Safety Management.
- GMP guidelines for capsule filling operations.
10. Approval Section
| Name | Designation | Signature | Date |
|---|---|---|---|
| [Name] | Prepared By | ||
| [Name] | Checked By | ||
| [Name] | Approved By |