JSA for Safe Operation of Automatic Tablet Packager
| JSA Number | JSA/OralDosage/050/2025 | 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 Automatic Tablet Packager. This equipment is used in pharmaceutical manufacturing to automate the packaging of tablets into blister packs, bottles, or pouches. Proper handling and operation are essential to ensure packaging accuracy, 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 Automatic Tablet Packager in the Oral Dosage department. Ensuring compliance with safety measures minimizes risks associated with moving parts, packaging material handling, and improper machine settings.
3. Responsibilities
Operators:
- Follow the standard operating procedure (SOP) while operating the Automatic Tablet Packager.
- Ensure the machine is properly calibrated before use.
- Wear appropriate Personal Protective Equipment (PPE) to prevent contamination.
- Monitor tablet feeding and ensure correct packaging alignment.
- 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 Automatic Tablet Packager and maintenance logs.
Safety
Officers:
- Perform risk assessments and ensure compliance with occupational safety standards.
- Ensure that proper ventilation and packaging waste disposal 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 tablets into the feeding system | Manual handling strain, tablet contamination | Medium | Use clean handling tools; wear gloves. |
| 3 | Adjusting packaging material feed | Misalignment, incorrect sealing | High | Follow SOP guidelines for setting film or bottle alignment. |
| 4 | Tablet packaging process | Moving parts hazards, tablet breakage | High | Ensure safety guards are in place; do not reach into moving parts. |
| 5 | Unloading and inspecting packaged tablets | Cross-contamination, packaging errors | Medium | Follow GMP cleaning procedures and use designated collection containers. |
| 6 | Cleaning and maintenance | Residual packaging material exposure, electrical shock | High | Follow LOTO procedures before servicing; wear PPE during cleaning. |
6. Risk Assessment
| Likelihood | Consequence | Risk Level |
|---|---|---|
| Rare | Minor tablet misalignment | Low |
| Possible | Tablet rejection due to incorrect packaging | Medium |
| Likely | Entrapment due to moving parts | High |
7. Emergency Procedures
- In case of packaging material jam, stop the machine and notify the supervisor.
- 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 airborne dust from packaging materials.
- Safety glasses: Shields eyes from packaging debris.
- Protective gloves: Prevents direct contact with tablets.
- Machine guards: Ensures safety from moving parts.
- Packaging waste disposal bins: Ensures proper handling of defective packaging.
9. References
- OSHA 1910.212 – Machine Guarding Standards.
- ISO 45001 – Occupational Health & Safety Management.
- GMP guidelines for tablet packaging and handling.
10. Approval Section
| Name | Designation | Signature | Date |
|---|---|---|---|
| [Name] | Prepared By | ||
| [Name] | Checked By | ||
| [Name] | Approved By |