JSA for Safe Operation of Capsule Weight Variation Tester
| JSA Number | JSA/OralDosage/030/2025 | 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 Weight Variation Tester. This equipment is used in pharmaceutical manufacturing to ensure that capsules meet specified weight uniformity requirements, preventing underdosing or overdosing. Proper handling and operation are essential to prevent contamination, measurement errors, and operator hazards.
2. Scope
This JSA applies to all operators, supervisors, and maintenance personnel involved in using, cleaning, and maintaining the Capsule Weight Variation Tester in the Oral Dosage department. Ensuring compliance with safety measures minimizes risks associated with capsule dust exposure, improper handling, and calibration errors.
3. Responsibilities
Operators:
- Follow the standard operating procedure (SOP) while operating the Capsule Weight Variation Tester.
- Ensure the machine is properly calibrated before use.
- Wear appropriate Personal Protective Equipment (PPE) to prevent exposure to capsule dust.
- Monitor weight variation readings and ensure capsules are handled correctly.
- Properly dispose of capsules that fail weight variation requirements.
- Perform post-operation cleaning to prevent cross-contamination.
Supervisors:
- Ensure compliance with GMP and workplace safety regulations.
- Monitor machine efficiency and ensure calibration is performed as scheduled.
- Conduct routine inspections of the weight variation tester and maintenance logs.
Safety Officers:
- Perform risk assessments and ensure compliance with occupational safety standards.
- Ensure that dust collection systems are functioning correctly to minimize airborne particles.
- Verify that PPE, such as respiratory masks and safety 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 capsules onto the balance | Manual handling strain, contamination | Medium | Use clean handling tools; wear gloves. |
| 3 | Adjusting weight tolerance settings | Measurement errors, improper settings | High | Follow SOP to ensure accurate weight measurements. |
| 4 | Weight variation measurement | Capsule dust exposure, contamination risk | High | Ensure ventilation is active; monitor for capsule dust buildup. |
| 5 | Recording test results | Data entry errors, cross-contamination | Medium | Use dedicated tools and follow documentation SOP. |
| 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 capsule dust exposure | Low |
| Possible | Respiratory irritation due to capsule dust | Medium |
| Likely | Measurement errors leading to out-of-spec results | High |
7. Emergency Procedures
- In case of excessive capsule dust exposure, move to fresh air and seek medical help.
- If the machine malfunctions, shut it down and report to maintenance.
- For capsule rejection issues, verify calibration settings before retesting.
- All incidents must be reported and logged for investigation.
8. Required PPE & Safety Controls
- Respiratory mask: Prevents inhalation of airborne capsule dust.
- Safety glasses: Shields eyes from small particles.
- Protective clothing: Prevents dust adherence to skin and garments.
- Calibration weights: Ensures machine accuracy before use.
- HEPA filters: Ensures high-efficiency dust extraction.
9. References
- OSHA 1910.94 – Ventilation Standards.
- ISO 45001 – Occupational Health & Safety Management.
- GMP guidelines for capsule weight variation testing.
10. Approval Section
| Name | Designation | Signature | Date |
|---|---|---|---|
| [Name] | Prepared By | ||
| [Name] | Checked By | ||
| [Name] | Approved By |