JSA for Safe Operation of Peristaltic Pump for Liquid Encapsulation
| JSA Number | JSA/OralDosage/038/2025 | 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 Peristaltic Pump for Liquid Encapsulation. This equipment is used in pharmaceutical manufacturing to precisely dispense liquid formulations into capsules or containers, ensuring accuracy and sterility. Proper handling and operation are essential to prevent contamination, mechanical hazards, and exposure to liquid formulations.
2. Scope
This JSA applies to all operators, supervisors, and maintenance personnel involved in using, cleaning, and maintaining the Peristaltic Pump for Liquid Encapsulation in the Oral Dosage department. Ensuring compliance with safety measures minimizes risks associated with liquid spillage, exposure to active pharmaceutical ingredients (APIs), and improper handling.
3. Responsibilities
Operators:
- Follow the standard operating procedure (SOP) while operating the Peristaltic Pump.
- Ensure the machine is properly calibrated before use.
- Wear appropriate Personal Protective Equipment (PPE) to prevent exposure to liquid formulations.
- Monitor liquid flow rate, tubing integrity, and dispensing accuracy.
- 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 Peristaltic Pump 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 formulations.
- 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 liquid formulation into the reservoir | Chemical exposure, spillage | Medium | Use proper handling techniques; wear gloves and safety glasses. |
| 3 | Checking tubing connections | Leaks, contamination | High | Ensure all connections are secure and properly fitted. |
| 4 | Starting the dispensing process | Overfilling, flow rate inconsistencies | High | Monitor flow settings and adjust as necessary. |
| 5 | Monitoring encapsulation | Clogging, improper filling | Medium | Check for air bubbles and consistent filling levels. |
| 6 | Cleaning and maintenance | Residual liquid exposure, electrical shock | High | Follow LOTO procedures before servicing; wear PPE during cleaning. |
6. Risk Assessment
| Likelihood | Consequence | Risk Level |
|---|---|---|
| Rare | Minor liquid spillage | Low |
| Possible | Respiratory irritation due to vapor exposure | Medium |
| Likely | Contamination due to tubing leaks | 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 vaporized liquids.
- Safety glasses: Shields eyes from liquid splashes.
- Protective clothing: Prevents liquid 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 liquid encapsulation in pharmaceutical production.
10. Approval Section
| Name | Designation | Signature | Date |
|---|---|---|---|
| [Name] | Prepared By | ||
| [Name] | Checked By | ||
| [Name] | Approved By |