Methodologies for Reduction of the Risks Associated with the Electrical System in the Pharmaceutical Industry.

1. Introduction

Electrical Safety Audit Service provided in a Pharmaceutical Industries Plant, which is one of the most renowned leading developers and manufacturers of Active Pharmaceutical Ingredients & High-Quality drugs making industries by unlocking the possibilities of science.

The client was facing multiple tripping issues and a blackout problem for the last 2 years. And they were unable to figure out the causes for the same. hence, they wanted to hire a subject matter expert and approached us.  

 2. Objective

 Elegrow Technology suggested a few ways to Identify the Risk & Hazards by

  1. Studying & Verifying Existing Documents,
  2. Monitoring Safety Policy & Operation, Maintenance and Condition Monitoring Process,
  3. Preparation of as-Built Documents (as they didn’t have them),
  4. Site visits & Visual Inspection
  5. Testing the condition of an asset

 3. Methodology

We executed the scope in 3 stages mentioned as follows –

 Step 1: Document Verification & Preparation of as-Built Documents

(Load List, Single Line Diagram, Lightning Protection System Layout, Earthing


Step 2: Electrical Safety Audit

  • Site Visit and Visual Inspection
  • Technical Discussion with the Operation and Maintenance Team
  • Identification of Risk and Hazardous

Step 3: Asset Condition Testing

Power Quality Audit

Earthing System Health Assessment

LV System

Soil Resistivity

Earth Pit Resistance

Loop Impedance

Prospective Fault Current


EHV System

Step and Touch Potential Testing

Lightning Protection System Adequacy Study (Analysis)

Partial Discharge Testing – Switchyard and Electrical Panels

Thermography – Switchyard and Electrical Panels

Electro Magnetic Induction Mapping – Overall Plant Area

Applicable Standards & Regulations

Indian Standards
Purpose Standard Number Standard Name
Design, O&M, Construction, Safety NBC – 2016 National Building Code of India – 2016
Safety IS 14489: 2018 Code of Practice on Occupational Safety and Health Audit
Safety IS 3043: 2018 Code of Practice for Earthing
Safety IEEE 80:2015 Guide for Safety in AC Substation Grounding
Testing IEEE 81:2012 Guide for Measuring Earthing Grounding System
Safety IEEE 142:2007 Recommended Practice for Grounding of Industrial and Commercial Power Systems
Design & Installation & Maintenance IEEE 519:2022 IEEE Standard for Harmonic Control in Electric Power Systems
Installation & Maintenance IS:1255-2016 Code of Practice For Installation and Maintenance of Power Cables Up to And Including 33 KV Rating
Safety & Testing IS-15652:2006 Insulating Mats for Electrical Purposes – Specifications
Safety IS 884:2015 First-Aid Hose Reel for Fire Fighting
Safety IS 8091:2018 Industrial Plant Layout – Code of Safe Practice
Safety IS 5572:2009 Classification of Hazardous Area – having flammable gases and vapours for Electrical Installation


Indian Regulation
Purpose Regulation Number Regulation Name
Safety CEA Regulations 2011 Central Electricity Authority Regulations – Safety · Requirements for Construction, Operation and Maintenance of Electrical Plants and Electric Lines
Safety CEA Regulations 2021 Central Electricity Authority Regulations – Measures relating to Safety and Electric Supply
Construction CEA Regulations 2015 Central Electricity Authority Regulations – Technical Standards for Construction of Electrical Plants and Electric Lines
Safety The Electricity Act – 2020 The Indian Electricity Act
Safety The Indian Electricity Rule – 2020 The Indian Electricity Rule


International Regulation
Purpose Regulation Number Regulation Name
Health and Safety OSHA Regulation Occupational Safety & Health Admin, Labor


International Standards
Purpose Standard Number Standard Name
Safety NFPA 70 E: 2021 Standard for Electrical Safety in Workplace
Maintenance NFPA 70 B: 2019 Recommended Practice for Electrical Equipment Maintenance
Safety NFPA 901: 2022 Standard Classifications for Fire and Emergency Services Incident Reporting
Safety NFPA 77: 2019 Recommended Practice on Static Electricity
Safety IEC 62305-1:2018 Protection against lightning – Part 1: General principles
Risk Assessment IEC 62305-2:2018 Protection against lightning – Part 2: Risk management
Safety IEC 62305-3:2022 Protection against lightning – Part 3: Physical damage to structures and life hazard
Safety IEC 62305-4:2018 Protection against lightning – Part 4: Electrical and electronic systems within structures
Health and Safety ISO 45001:2018 Health and safety management standard
Health and Safety IEC 61882:2016 Hazard and operability studies (HAZOP studies) – Application Guide
Installation & Maintenance IEC 60364:2022 Electrical installations of buildings
Installation & Maintenance IEC 61000:2022 Electromagnetic compatibility (EMC)
Safety IEC 61140:2016 Protection against electric shocks – common aspects of installation and equipment
Installation & Maintenance ISO 12944-5: 2019 Paints and Varnishes – Corrosion Protection of Steel Structures by Protective Paint Systems – Part-5-Protective Paint Systems.
Safety IEC 60079-10-1-2020 Electrical Apparatus for explosive gas atmospheres – Part 10: Classification of Hazardous Areas
Safety IEC 60270:2000 High-Voltage Test Techniques – Partial Discharge Measurements
Safety EN 61000-6-4:2019 Electromagnetic Compatibility – Generic Standards. Emission Standard for Industrial Environments
Safety EN 61000-6-2:2019 Electromagnetic Compatibility – Part 6-2: Generic Standards – Immunity Standard for Industrial Environments
Safety EN 61000-6-1:2019 Electromagnetic Compatibility – Part 6-1: Generic Standards – Immunity Standard for Residential, Commercial and Light-Industrial Environments
Safety EN / IEC 60947-1:2021 Low-Voltage Switchgear and Control Gear – General Rules
Safety IEC TS 61000-6-5:2015 Electromagnetic Compatibility – Part 6-5: Generic Standards – Immunity for Equipment Used in Power Station and Substation Environment
Safety EN/IEC 61326-1:2021 Electrical Equipment for Measurement, Control and Laboratory Use – EMC Requirements – Part 1: General Requirements
Safety IEC 60601-1-2: 2015 Electromagnetic Compatibility of Medical Devices

4. Results & Solutions

Step-1: Document Verification & Document Preparation:

Phase-1: Risk Assessment by Document Verification:

Total Documents List 30 Nos. We have found that 11 / 30 Nos. Documents require upgradation or new document preparation.

Phase-2: Risk Assessment by Document Verification – After Documents Preparation.

Total 1 / 30 Nos. The document needs to be prepared. (That’s Hazardous Area Classification Layout)


Step-2: Risk Assessment by Visual Inspection of Entire Plant:

As per our Visual Inspection Check List for Electrical Safety:

We have found that still there 39% Risk available with respect to Visual Inspection Audit (With Detail Risk Category: Low Risk = 5%, Moderate Risk = 10% & High Risk = 18%)

Step-3: Asset Condition Testing:

Phase-1: Risk Assessment by Asset Condition Testing:

A total of 12 Nos. of Testing needs to be done periodically inside any industry as per application. And their all-testing reports must be documented and submitted to authority or government authority as & when required. We have found that only 4 Nos. of Testing done & their reports documents are available with the client. So, there is risk = 67% (8 Testing Reports not Available with respect to testing never done.)

Phase-2: Risk Assessment by Asset Condition Testing:

We have done all 12 Nos. of Testing. So, now Clients have all the updated Testing Reports. But still, we have found some abnormal points during our all testing. So, Risk Decreases from 67% to 25% with respect to Asset Condition Testing. We have given our Observations & Recommendation to the client to implement & improve the Asset condition.


Overall Risk Assessment Summary

Before & after conducting the safety audit, the observations are shown in the following graph –


As we can see in the chart, the risk after implementation, document verification and asset condition monitoring has been reduced by implementing the required changes.


But the same has not happened in the case of the safety audit as incorporating the changes will take some time. And the results will be tracked once all the recommendations have been implemented. Hence there is not any change in the risk analysis for that factor.

Solutions: Major Observation for Improvement:

The following are a few recommendations Elegrow Technology suggested for long-term improvement and reliability.

  • Documents Upgradation (Timely Basis)
  • Lightning Protection System Upgradation & Implementation
  • Hazardous Area Classification Layout Preparation
  • Detail Cleaning & Maintenance of Electrical Panels
  • Electrically Safety Rubber Mat broken
  • Corrosion
  • Vegetation in the Switchyard Area

5. Conclusion

 Standard & Regulation Compliance: 100% Standard & Regulations Compliance done during the Electrical Safety Audit.

 Risk Reduction:

Document Risk:                  Reduced from 25% to 2%

Visual Inspection Risk:       56% Found which can be reduced to 0% by implementing Recommendations.

Asset Condition Risk:         Recued from 19% to 7%.

Employee Safety:   Employee Safety will increase by Reducing the Risk. Also, be aware of them by providing additional training which can reduce the risk of accidents and injuries.

Overall Performance: Overall Performance increases by Reducing Risk, Production will Increase, Loss will decrease, Reducing breakdowns & downtime.

The document verification and as-built document preparation helped their internal team with a reduced dependency on the respective person/department. Also helped them with accurate data and allowed them to invest more time in productivity.

The client is now incorporating the recommendations from the safety audit as it is a long time process and will be carrying out asset condition tests internally by applying relevant standards as shown by Elegrow Technology.

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