JSA for Safe Operation of Wet Granulator
| JSA Number | JSA/OralDosage/034/2025 | 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 Wet Granulator. This equipment is used in pharmaceutical manufacturing to convert fine powders into larger, uniform granules using liquid binders, which enhances the tablet compression process. Proper handling and operation are essential to prevent mechanical hazards, exposure to liquid binders, and cross-contamination.
2. Scope
This JSA applies to all operators, supervisors, and maintenance personnel involved in using, cleaning, and maintaining the Wet Granulator in the Oral Dosage department. Ensuring compliance with safety measures minimizes risks associated with mechanical moving parts, liquid binder handling, and electrical hazards.
3. Responsibilities
Operators:
- Follow the standard operating procedure (SOP) while operating the Wet Granulator.
- Ensure the machine is properly calibrated before use.
- Wear appropriate Personal Protective Equipment (PPE) to prevent exposure to liquid binders and airborne particles.
- Monitor granulation parameters, including liquid addition and impeller speed.
- Ensure proper drainage and cleaning after every batch.
- Perform post-operation cleaning to prevent cross-contamination.
Supervisors:
- Ensure compliance with GMP and workplace safety regulations.
- Monitor machine efficiency and ensure calibration is performed as scheduled.
- Conduct routine inspections of the Wet
Granulator and maintenance logs.
Safety Officers:
- Perform risk assessments and ensure compliance with occupational safety standards.
- Ensure that ventilation and dust control systems are functioning correctly to minimize airborne particles.
- Verify that PPE, such as gloves and protective aprons, are used correctly.
4. Definitions & Abbreviations
- PPE: Personal Protective Equipment (e.g., gloves, safety glasses, protective aprons).
- 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 powder and liquid binder | Manual handling strain, exposure to airborne dust | Medium | Use lifting aids; wear a respirator and gloves. |
| 3 | Starting the granulation process | Moving parts entrapment, excessive binder addition | High | Ensure hands are clear of moving parts; follow SOP for binder dosing. |
| 4 | Monitoring granulation | Clumping, batch inconsistency | High | Adjust liquid addition and impeller speed to maintain uniformity. |
| 5 | Unloading and transferring granules | Cross-contamination, ergonomic strain | Medium | Follow cleaning procedures and use proper lifting techniques. |
| 6 | Cleaning and maintenance | Electrical shock, liquid residue | High | Follow LOTO procedures before servicing; wear PPE during cleaning. |
6. Risk Assessment
| Likelihood | Consequence | Risk Level |
|---|---|---|
| Rare | Minor liquid spillage | Low |
| Possible | Respiratory irritation due to airborne powders | Medium |
| Likely | Entrapment due to moving parts | High |
7. Emergency Procedures
- In case of excessive powder exposure, move to fresh air and seek medical help.
- If the machine 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.
- Safety glasses: Shields eyes from fine dust exposure.
- Protective clothing: Prevents dust adherence to skin and garments.
- Machine guards: Ensures safety from moving parts.
- HEPA filters: Ensures high-efficiency dust extraction.
9. References
- OSHA 1910.94 – Ventilation Standards.
- ISO 45001 – Occupational Health & Safety Management.
- GMP guidelines for wet granulation in pharmaceutical production.
10. Approval Section
| Name | Designation | Signature | Date |
|---|---|---|---|
| [Name] | Prepared By | ||
| [Name] | Checked By | ||
| [Name] | Approved By |