JSA for Safe Operation of Capsule Printing Machine
| JSA Number | JSA/OralDosage/047/2025 | 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 Capsule Printing Machine. This equipment is used in pharmaceutical manufacturing to imprint identification codes, logos, or brand names onto capsules. Proper handling and operation are essential to ensure accurate printing, prevent contamination, and maintain workplace safety.
2. Scope
This JSA applies to all operators, supervisors, and maintenance personnel involved in using, cleaning, and maintaining the Capsule Printing Machine in the Oral Dosage department. Ensuring compliance with safety measures minimizes risks associated with ink exposure, mechanical hazards, and misprinted capsules.
3. Responsibilities
Operators:
- Follow the standard operating procedure (SOP) while operating the Capsule Printing Machine.
- Ensure the machine is properly calibrated before use.
- Wear appropriate Personal Protective Equipment (PPE) to prevent exposure to printing inks and solvents.
- Monitor capsule alignment and printing quality.
- Ensure proper cleaning and avoid cross-contamination between batches.
- Report any machine malfunctions immediately to the supervisor.
Supervisors:
- Ensure compliance with GMP and workplace safety regulations.
- Monitor machine efficiency and ensure calibration is performed as scheduled.
- Conduct routine inspections of the Capsule Printing Machine and maintenance logs.
Safety Officers:
- Perform risk assessments and ensure compliance with occupational safety standards.
- Ensure that ventilation and solvent-handling procedures are followed.
- Verify that PPE, such as gloves, safety glasses, and protective clothing, are used correctly.
4. Definitions & Abbreviations
- PPE: Personal Protective Equipment (e.g., gloves, safety glasses, protective clothing).
- 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 capsules into the feeder | Manual handling strain, capsule contamination | Medium | Use clean handling tools; wear gloves. |
| 3 | Filling ink reservoirs | Solvent exposure, inhalation risk | High | Ensure proper ventilation; wear respirator if required. |
| 4 | Printing process | Ink smudging, capsule misalignment | Medium | Monitor capsule positioning and printing speed. |
| 5 | Unloading and sorting printed capsules | Cross-contamination, handling errors | Medium | Follow GMP cleaning procedures and use designated collection containers. |
| 6 | Cleaning and maintenance | Residual ink exposure, electrical shock | High | Follow LOTO procedures before servicing; wear PPE during cleaning. |
6. Risk Assessment
| Likelihood | Consequence | Risk Level |
|---|---|---|
| Rare | Minor capsule misalignment | Low |
| Possible | Capsule rejection due to ink smudging | Medium |
| Likely | Solvent inhalation causing respiratory discomfort | High |
7. Emergency Procedures
- In case of ink spillage, stop the machine and clean the affected area.
- If solvent inhalation occurs, move to fresh air and seek medical assistance.
- If the system 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 solvent fumes.
- Safety glasses: Shields eyes from ink splashes.
- Protective gloves: Prevents direct contact with ink and solvents.
- Machine guards: Ensures safety from moving parts.
- Designated ink handling area: Prevents accidental spills and exposure.
9. References
- OSHA 1910.212 – Machine Guarding Standards.
- OSHA 1910.1000 – Air Contaminants Standard for Solvent Handling.
- ISO 45001 – Occupational Health & Safety Management.
- GMP guidelines for capsule printing and handling.
10. Approval Section
| Name | Designation | Signature | Date |
|---|---|---|---|
| [Name] | Prepared By | ||
| [Name] | Checked By | ||
| [Name] | Approved By |