Responsibilities

• Production Operator: Ensure proper grounding, monitor for static buildup, and follow safety practices.
• Production Supervisor: Verify electrostatic control measures before operation and approve startup.
• Engineering Department: Maintain earthing systems and check conductivity of static-dissipative components.
• QA Department: Ensure compliance with SOP and review static hazard assessments during audits.

4. Accountability

The Production Head is accountable for implementation and monitoring of electrostatic safety practices. Engineering and QA are jointly responsible for preventive controls and compliance oversight.

5. Procedure

5.1 Risk Identification

1. Identify materials prone to static charge (e.g., low-conductivity APIs, fine powders, dry atmospheres).
2. Refer to Safety Data Sheet (SDS) and prior static discharge incidents, if any.
3. Classify area for electrostatic control requirements.

5.2 Equipment and Area Preparation

1. Ensure the milling equipment is grounded with certified grounding cable (resistance < 1 MΩ).
2. Verify continuity of earthing using multimeter and record in “Electrostatic Safety Checklist” (Annexure-1).
3. Use static-dissipative materials for hoppers, gloves, shoes, and flexible ducts where applicable.
4. Maintain relative humidity between 45%–65% in the milling area to minimize static generation.

5.3 Operational Controls

1. Start air-handling system before operation to ensure humidity control.
2. Avoid fast transfer of dry powders which may induce static buildup.
3. Use anti-static PPE (conductive gloves, ESD shoes, grounded clothing).
4. Ensure operators touch grounded surfaces before and after handling the equipment.
5. Never use plastic or non-conductive scoops or liners unless validated as static-safe.

5.4 Handling Static Events

1. If spark or electrostatic shock is observed:
   • Stop the milling operation immediately.
   • Inform Production Supervisor and Engineering.
   • Investigate grounding failure, low humidity, or dry material friction as cause.
   • Do not resume operation until corrective actions are implemented and documented.

5.5 Maintenance and Records

1. Inspect earthing terminals monthly and after any maintenance activity.
2. Keep records of all earthing checks, static incidents, and corrective actions taken.
3. Incorporate electrostatic risk in HIRA (Hazard Identification and Risk Assessment).

6. Abbreviations

• SOP: Standard Operating Procedure
• ESD: Electrostatic Discharge
• QA: Quality Assurance
• API: Active Pharmaceutical Ingredient
• SDS: Safety Data Sheet
• HIRA: Hazard Identification and Risk Assessment

7. Documents

1. Electrostatic Safety Checklist (Annexure-1)
2. Grounding Verification Log
3. Incident Report (in case of spark or ESD)

8. References

• ICH Q9 – Quality Risk Management
• NFPA 77 – Recommended Practice on Static Electricity
• OSHA Guidelines on Static Control

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Electrostatic Safety Checklist

Date	Equipment ID	Earthing Verified	Humidity (%RH)	Anti-static PPE Used	Remarks	Checked By
13/04/2025	MILL-005	Yes	53%	Yes	All OK

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP Release	New Electrostatic Safety Practice	QA Head
13/04/2025	2.0	Added Humidity Control and PPE Protocol	Regulatory Compliance	QA Head