JSA for Safe Operation of Fluidized Bed Granulator

JSA Number	JSA/OralDosage/004/2025	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 Fluidized Bed Granulator used in the production of solid oral dosage forms.

2. Scope

This JSA applies to all operators, maintenance personnel, and supervisors involved in using, cleaning, and maintaining the Fluidized Bed Granulator in the Oral Dosage department.

3. Responsibilities

Operators:

• Ensure the machine is operated per SOPs.
• Wear appropriate Personal Protective Equipment (PPE).
• Report any malfunctions or safety concerns immediately.

Supervisors:

• Ensure compliance with safety guidelines.
• Monitor risk control measures and address safety violations.

Safety Officers:

• Conduct regular safety audits.
• Provide training on hazard mitigation and emergency response.

4. Definitions & Abbreviations

• PPE: Personal Protective Equipment (e.g., gloves, goggles, ear protection).
• LOTO: Lockout/Tagout – Procedure to isolate hazardous energy.
• Risk Assessment: A process to evaluate and control hazards.

5. Procedure

Step	Task Description	Potential Hazard	Risk Level (L/M/H)	Control Measures
1	Machine setup and calibration	Pinching, crushing injuries	High	Use guards, follow SOP
2	Loading raw materials	Dust exposure, inhalation	Medium	Wear dust mask and gloves
3	Granulation process	Mechanical failure, noise exposure	High	Regular maintenance, use ear protection
4	Unloading granules	Repetitive strain injury	Medium	Use ergonomic posture, take frequent breaks

6. Risk Assessment

Likelihood	Consequence	Risk Level
Rare	Minor injury	Low
Possible	Noise-induced hearing loss	Medium
Likely	Severe injury from machine failure	High

7. Emergency Procedures

1. In case of injury, seek medical assistance immediately.
2. If a mechanical failure occurs, stop operation and inform maintenance.
3. For dust exposure incidents, move to fresh air and use eyewash if needed.
4. All incidents must be reported and logged.

8. Required PPE & Safety Controls

• Safety gloves: Protect hands from crushing and sharp edges.
• Ear protection: Prevents hearing damage due to noise exposure.
• Face mask: Reduces inhalation of dust particles.
• Safety goggles: Protects against dust and debris.
• Machine guard: Must always be in place during operation.

9. References

• OSHA 1910.212 – Machine Guarding Standards.
• ISO 45001 – Occupational Health & Safety Standards.
• Manufacturer’s Operation Manual for Fluidized Bed Granulator.

10. Approval Section

Name	Designation	Signature	Date
[Name]	Prepared By
[Name]	Checked By
[Name]	Approved By

11. Revision History

Version	Date	Description of Changes	Approved By
V 1.0	01/02/2025	Initial Release	[Name]