JSA for Safe Operation of Capsule Banding Machine
| JSA Number | JSA/OralDosage/036/2025 | 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 Banding Machine. This equipment is used in pharmaceutical manufacturing to apply a sealing band around the joint of hard gelatin or HPMC capsules, preventing leakage and ensuring product integrity. Proper handling and operation are essential to prevent contamination, mechanical hazards, and exposure to sealing solutions.
2. Scope
This JSA applies to all operators, supervisors, and maintenance personnel involved in using, cleaning, and maintaining the Capsule Banding Machine in the Oral Dosage department. Ensuring compliance with safety measures minimizes risks associated with moving parts, sealing solution exposure, and improper handling of capsules.
3. Responsibilities
Operators:
- Follow the standard operating procedure (SOP) while operating the Capsule Banding Machine.
- Ensure the machine is properly calibrated before use.
- Wear appropriate Personal Protective Equipment (PPE) to prevent exposure to sealing solutions.
- Monitor capsule alignment, banding application, and drying processes.
- 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 Capsule Banding Machine and maintenance logs.
Safety Officers:
- Perform risk assessments and ensure compliance with occupational safety standards.
- Ensure that ventilation systems are functioning correctly to minimize exposure to volatile components of sealing solutions.
- Verify that PPE, such as gloves, safety glasses, and protective aprons, 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 capsules into the feeder | Manual handling strain, contamination | Medium | Use clean handling tools; wear gloves. |
| 3 | Preparing sealing solution | Chemical exposure, inhalation risk | High | Wear respirators and gloves; ensure ventilation is operational. |
| 4 | Banding process | Entrapment hazards, improper alignment | High | Ensure safety guards are in place; follow alignment SOP. |
| 5 | Drying and curing of capsules | Overheating risk, contamination | Medium | Monitor temperature; follow drying SOP. |
| 6 | Cleaning and maintenance | Electrical shock, chemical residue | High | Follow LOTO procedures before servicing; wear PPE during cleaning. |
6. Risk Assessment
| Likelihood | Consequence | Risk Level |
|---|---|---|
| Rare | Minor chemical spillage | Low |
| Possible | Respiratory irritation due to sealing solution vapors | Medium |
| Likely | Entrapment due to moving parts | High |
7. Emergency Procedures
- In case of excessive chemical 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 sealing solution vapors.
- Safety glasses: Shields eyes from liquid splashes.
- Protective clothing: Prevents chemical exposure.
- Machine guards: Ensures safety from moving parts.
- Ventilation system: Reduces airborne chemical exposure.
9. References
- OSHA 1910.94 – Ventilation Standards.
- ISO 45001 – Occupational Health & Safety Management.
- GMP guidelines for capsule banding in pharmaceutical production.
10. Approval Section
| Name | Designation | Signature | Date |
|---|---|---|---|
| [Name] | Prepared By | ||
| [Name] | Checked By | ||
| [Name] | Approved By |