JSA for Safe Operation of Dry Powder Compacting Machine
| JSA Number | JSA/OralDosage/035/2025 | 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 Dry Powder Compacting Machine. This equipment is used in pharmaceutical manufacturing to compress dry powders into dense, uniform granules for further processing. Proper handling and operation are essential to prevent mechanical hazards, exposure to fine powders, and cross-contamination.
2. Scope
This JSA applies to all operators, supervisors, and maintenance personnel involved in using, cleaning, and maintaining the Dry Powder Compacting Machine in the Oral Dosage department. Ensuring compliance with safety measures minimizes risks associated with airborne powder, moving parts, and improper calibration.
3. Responsibilities
Operators:
- Follow the standard operating procedure (SOP) while operating the Dry Powder Compacting Machine.
- Ensure the machine is properly calibrated before use.
- Wear appropriate Personal Protective Equipment (PPE) to prevent exposure to airborne powders.
- Monitor compaction force and ensure uniformity of granules.
- Ensure proper cleaning and avoid cross-contamination between batches.
- Perform post-operation maintenance as required.
Supervisors:
- Ensure compliance with GMP and workplace safety regulations.
- Monitor machine efficiency and ensure calibration is performed as scheduled.
- Conduct routine inspections of the Dry Powder Compacting Machine and maintenance logs.
Safety Officers:
- Perform risk assessments and ensure compliance with occupational safety standards.
- Ensure that dust extraction systems are functioning correctly to minimize airborne particles.
- Verify that PPE, such as respiratory masks and protective gloves, are used correctly.
4. Definitions & Abbreviations
- PPE: Personal Protective Equipment (e.g., gloves, safety glasses, respirators).
- 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 dry powder into the hopper | Manual handling strain, dust exposure | Medium | Use lifting aids; wear a respirator and gloves. |
| 3 | Adjusting compaction pressure | Mechanical hazards, excessive pressure | High | Follow SOP for pressure settings; ensure hands are clear of moving parts. |
| 4 | Compaction process | Entrapment hazards, dust emissions | High | Ensure safety guards are in place; operate dust extraction systems. |
| 5 | Unloading compacted granules | Cross-contamination, ergonomic strain | Medium | Follow cleaning procedures and use proper lifting techniques. |
| 6 | Cleaning and maintenance | Electrical shock, dust exposure | High | Follow LOTO procedures before servicing; wear PPE during cleaning. |
6. Risk Assessment
| Likelihood | Consequence | Risk Level |
|---|---|---|
| Rare | Minor powder 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 dry powder compaction in pharmaceutical production.
10. Approval Section
| Name | Designation | Signature | Date |
|---|---|---|---|
| [Name] | Prepared By | ||
| [Name] | Checked By | ||
| [Name] | Approved By |