Job Safety Analysis for Tablet Coating Machine

JSA for Safe Operation of Tablet Coating Machine

JSA Number	JSA/OralDosage/014/2025	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 Tablet Coating Machine. The coating process enhances the stability, appearance, and controlled release of pharmaceutical tablets. Proper operation and adherence to safety protocols are necessary to prevent contamination, exposure to chemicals, and mechanical hazards.

2. Scope

This JSA applies to all operators, maintenance personnel, and supervisors involved in using, cleaning, and maintaining the Tablet Coating Machine in the Oral Dosage department. Ensuring compliance with safety measures is necessary to minimize risks associated with coating solutions, mechanical components, and high-temperature operations.

3. Responsibilities

Operators:

Ensure the machine is operated according to the standard operating procedure (SOP).
Wear appropriate Personal Protective Equipment (PPE) before handling coating solutions.
Monitor machine settings, airflow, and coating parameters.
Follow safe handling practices for solvents and other coating materials.
Conduct routine cleaning to prevent cross-contamination.

Supervisors:

Ensure compliance with GMP and safety guidelines.
Monitor the work environment for solvent exposure and ventilation efficiency.
Conduct routine inspections of the machine and safety features.

Safety Officers:

Perform risk assessments and ensure compliance with occupational safety regulations.
Ensure that solvent exposure

limits are within permissible levels.

Verify that PPE and fume extraction systems are functioning properly.

4. Definitions & Abbreviations

PPE: Personal Protective Equipment (e.g., gloves, goggles, respirators).
GMP: Good Manufacturing Practices – Regulations ensuring consistent product quality.
LOTO: Lockout/Tagout – A procedure for isolating hazardous energy sources.

5. Procedure

Step	Task Description	Potential Hazard	Risk Level (L/M/H)	Control Measures
1	Machine setup and calibration	Electrical hazard, improper calibration	Medium	Ensure the machine is grounded and calibrated before use.
2	Loading tablets into the drum	Manual handling strain, tablet breakage	Medium	Use proper lifting techniques and load tablets carefully.
3	Coating process	Exposure to solvents, fire hazard	High	Ensure proper ventilation, wear a respirator, and avoid open flames.
4	Unloading coated tablets	Cross-contamination, ergonomic strain	Medium	Follow cleaning procedures and use proper lifting aids.
5	Cleaning and maintenance	Solvent exposure, chemical burns	High	Use PPE, follow LOTO procedures before servicing.

6. Risk Assessment

Likelihood	Consequence	Risk Level
Rare	Minor equipment failure	Low
Possible	Solvent inhalation or skin irritation	Medium
Likely	Fire hazard from solvent vapors	High

7. Emergency Procedures

In case of chemical exposure, rinse affected areas immediately and seek medical help.
For fires, use a Class B fire extinguisher and evacuate if necessary.
In the event of an equipment failure, follow emergency shutdown procedures.
All incidents must be reported and logged for investigation.

8. Required PPE & Safety Controls

Gloves: Protects hands from solvent exposure.
Respiratory mask: Prevents inhalation of solvent fumes.
Goggles: Shields eyes from splashes.
Protective clothing: Prevents contamination and chemical exposure.
Ventilation system: Essential to remove solvent vapors.

9. References

OSHA 1910.106 – Flammable and Combustible Liquids Standards.
ISO 45001 – Occupational Health & Safety Management.
GMP guidelines for pharmaceutical tablet coating.

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]