THE RISK MANAGEMENT APPROACH BY APPLYING HAZARDOUS AREA CLASSIFICATION, WHICH HELPS IN IDENTIFYING THE CRITICAL ZONES IN A PHARMACEUTICAL INDUSTRY

Yudhistra Kumar A.; Linga Murthy

doi:10.29121/ijoest.v7.i5.2023.533

Authors

Yudhistra Kumar A. Porus Labs Pvt Ltd, Unit 6, Atchutapuram, Visakhapatnam, Andhra Pradesh, India https://orcid.org/0000-0002-3250-169X
Linga Murthy Aragen Life Science Pvt Ltd (GVK BIO), Mallapur, Hyderabad, India

DOI:

https://doi.org/10.29121/ijoest.v7.i5.2023.533

Keywords:

Hazard Area Classification, Critical Zone, ATEX Standard

Abstract

Identifying the various critical zones in the pharmaceutical industry, various protection to the electrical instruments / equipment’s and the ingress protection enclosures class based on the international standards are presented. Collecting the flammability data based on the MSDS. Classifying the various location in the form of various zones by using different international standards. Application of various ATEX standards, Temperature class and ingress protection for the different equipment’s. In the pharmaceutical industry the zone 1, zone 2, zone 21 and zone 22 were classified as four, two, three, and two locations. The VOC concentration were highest in the clean room was 8 ppm during the monitoring. The ATEX standard Ex d, Ex e, Ex I, Ex n and Ex p were used in various zones for different instruments or electrical equipment’s. Temperature class 400 o C, T2 was highest inside the boiler. Ingress protection class of IP65, IP66 and IP67 enclosures are used for the various equipment’s.

Downloads

Download data is not yet available.

References

Abbasi, T., & Abbasi, S. A. (2007). Dust Explosions-Cases, Causes, Consequences, and Control. Journal of Hazardous Materials, 140(1-2), 7-44. https://doi.org/10.1016/j.jhazmat.2006.11.007.

Abraham, S. J. (2021). New Knowledge Management Framework for Manufacturing SMEs Working in Strictly Regulated Sectors. Procedia Manufacturing, 54, 290-295. https://doi.org/10.1016/j.promfg.2021.09.001.

Ayman, D., & Allian, R. C. Flanagan, Ray Mentzer, Jeffrey B. (2021). Precompetitive Collaborations in the Pharmaceutical Industry: Process Safety Groups Work Together to Reduce Hazards, from R&D Laboratories to Manufacturing Facilities. ACS. Sperry, Han Xia and Ralph Zhao. Chemical Health and Safety, 28(5), 297-302. https://doi.org/10.1021/acs.chas.1c00049.

Bhagirath, A., Singh, A. K., & Vishwakarma, R. K. (2015). Area Classification and Types of Protection for Explosive Atmospheres: A Review. Telkomnika Indonesian Journal of Electrical Engineering, 16(2), 238-243. https://doi.org/10.11591/tijee.v16i2.1608.

Bloch, H. P. (2009). Ingress Protection Code Explained. World Pumps, 2009(11), 26. https://doi.org/10.1016/S0262-1762(09)70418-3.

Boeck, L. R., Bauwens, C. R. L., & Dorofeev, S. B. (2023). Large-Scale Dust Explosions in Vessel-Pipe Systems. Journal of Loss Prevention in the Process Industries, 82. https://doi.org/10.1016/j.jlp.2023.104980.

Boltic, Z., Ruzic, N., Jovanovic, M., Savic, M., Jovanovic, J., & Petrovic, S. (2013). Cleaner Production Aspects of Tablet Coating Process in Pharmaceutical Industry : Problem of Vocs Emission. Journal of Cleaner Production, 44, 123-132. https://doi.org/10.1016/j.jclepro.2013.01.004.

Bozek, A., Gordon, C., & Phillips, N. (2014). Electrical Hazardous Area Classification Design as a Basis for Safer Operations. Record of Conference Papers - Annual Petroleum and Chemical Industry Conference, 459-464. https://doi.org/10.1109/PCICon.2014.6961911.

Cashdollar, K. L. (2000). Overview of Dust Explosibility Characteristics. Journal of Loss Prevention in the Process Industries, 13(3-5), 183-199. https://doi.org/10.1016/S0950-4230(99)00039-X.

Chen, X., Mao, Y., Fan, C., Wu, Y., Ge, S., & Ren, Y. (2022). Experimental Investigation on Filtration Characteristic with Different Filter Material of Bag Dust Collector for Dust Removal. International Journal of Coal Preparation and Utilization, 42(12), 3554-3569. https://doi.org/10.1080/19392699.2021.1975686.

EPCS. (2014). 2014/34/EU the Harmonisation of the Laws of the Member States Relating to Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres (recast) ; European Parliament and of the Council : Bruxelles, Belgium. European Parliament and of the Council. Directive, 2014.

Eckhoff, R. K. (2006). Differences and Similarities of Gas and Dust Explosions : A Critical Evaluation of the European "ATEX"Directives in Relation to Dusts. Journal of Loss Prevention in the Process Industries, 19(6), 553-560. https://doi.org/10.1016/j.jlp.2006.01.001.

Gaurav, A., & Chaudhari, S. H. (2015). Sarje. Clean Room Classification for Pharmaceutical Industry. International Journal of Engineering and Technical Research (IJETR), 3(4), 241-244.

Glor, M. (2006). Transfer of Powders into Flammable Solvents Overview of Explosion Hazards and Preventive Measures. Journal of Loss Prevention in the Process Industries, 19(6), 656-663. https://doi.org/10.1016/j.jlp.2005.12.005.

Han, D. H. (2021). Selection Guide to Wearing Respirators According to Work Situations and On-Site Applicability. Safety and Health at Work, 12(4), 424-431. https://doi.org/10.1016/j.shaw.2021.07.011.

Han, D., Xu, L., Wu, Q., Wang, S., Duan, L., Wen, M., Li, Z., Tang, Y., Li, G., & Liu, K. (2021). Potential Environmental Risk of Trace Elements in Fly Ash and Gypsum from Ultra-Low Emission Coal-Fired Power Plants in China. Science of the Total Environment, 798. https://doi.org/10.1016/j.scitotenv.2021.149116.

Hirak, D. (2021). Asset and Mechanical Integrity Management, Process Safety Management and Human Factors (A Practitioner's Experiential Approach) Chapter 8. Elsevier Publications. https://doi.org/10.1016/B978-0-12-818109-6.00008-3.

Hoffmann, R., & Kögl, T. (2017). An ATEX-Proof Gamma Tomography Setup for Measuring Liquid Distribution in Process Equipment. Flow Measurement and Instrumentation, 53(A), 147-153. https://doi.org/10.1016/j.flowmeasinst.2016.05.009.

James, M., Khan, W. S., Nannaparaju, M. R., Bhamra, J. S., & Morgan-Jones, R. J. (2015). Current Evidence for the Use of Laminar Flow in Reducing Infection Rates in Total Joint Arthroplasty. Open Orthopaedics Journal, 9, 495-498. https://doi.org/10.2174/1874325001509010495.

Ji, W., Wang, Y., Yang, J., He, J., Lu, C., Wen, X., & Wang, Y. (2023). Explosion Overpressure Behavior and Flame Propagation Characteristics in Hybrid Explosions of Hydrogen and Magnesium Dust. Fuel, 332(1). https://doi.org/10.1016/j.fuel.2022.125801.

Kuseva, C., Marinov, V., Pavlov, T., Petkov, T., Chapkanov, A., Dimitrova, D., Wombacher, T., Mullen-Hinkle, S., Zhu, W., Siebold, M., & Mekenyan, O. (2022). Predicting Explosive Properties of Chemicals Accounting for Thermodynamic and Kinetic Factors. Computational Toxicology, 23. https://doi.org/10.1016/j.comtox.2022.100230.

Lele, D. V. (2012). Risk Assessment: A Neglected Tool for Health, Safety, and Environment Management. Indian Journal of Occupational and Environmental Medicine, 16(2), 57-58. https://doi.org/10.4103/0019-5278.107064.

Li, X., Zhang, M., Jiang, Y., Zhao, X., Wang, L., Zhu, J., Xu, X., Li, Z., Jia, J., & Zhu, D. (2022). Air Curtain Dust-Collecting Technology : An Experimental Study on the Performance of a Large-Scale Dust-Collecting System. Journal of Wind Engineering and Industrial Aerodynamics, 220, 104875. https://doi.org/10.1016/j.jweia.2021.104875.

Lin, Q., Gao, Z., Zhu, W., Chen, J., & An, T. (2023). Underestimated Contribution of Fugitive Emission to VOCs in Pharmaceutical Industry Based on Pollution Characteristics, Odorous Activity and Health Risk Assessment. Journal of Environmental Sciences, 126, 722-733. https://doi.org/10.1016/j.jes.2022.03.005.

Luo, Y., Wu, Y., Ma, S., Zheng, S., Zhang, Y., & Chu, P. K. (2021). Utilization of Coal Fly Ash in China : A Mini Review on Challenges and Future Directions. Environmental Science and Pollution Research International, 28(15), 18727-18740. https://doi.org/10.1007/s11356-020-08864-4.

Paloma, L. Barros., Aurélio M. Luiz., Claudemi A. Nascimento., Antônio T.P. Neto., & José J.N. Alves. (2020). "On the Non-Monotonic Wind Influence on Flammable Gas Cloud from CFD Simulations for Hazardous Area Classification". Journal of Loss Prevention in the Process Industries, 68. https://doi.org/10.1016/j.jlp.2020.104278.

Pang, Y., Fuentes, M., & Rieger, P. (2014). Trends in the Emissions of Volatile Organic Compounds (VOCs) from Light-Duty Gasoline Vehicles Tested on Chassis Dynamometers in Southern California. Atmospheric Environment, 83, 127-135. https://doi.org/10.1016/j.atmosenv.2013.11.002.

Paul, C., Richard, W. P., & Vahid, E. (2021). Compared : A Solvent Vapor Explosion in Germany and a Combustible Dust Explosion in the United States. AIChE, Process Safety Progress Journal, 40(4), 191-194. https://doi.org/10.1002/prs.12317.

Pietraccini, M., Delon, E., Santandrea, A., Pacault, S., Glaude, P. A., Dufour, A., & Dufaud, O. (2021). Determination of Heterogeneous Reaction Mechanisms : A Key Milestone in Dust Explosion Modelling. Journal of Loss Prevention in the Process Industries, 73. https://doi.org/10.1016/j.jlp.2021.104589.

Rogala, I. (2015). Hazardous Area Classification - Dust Atmospheres New Plant Design and Operation and Re-Evaluate Changes to Existing Plant. International Electrotechnical Commission System for Certification to Standards Relating to Equipment for Use in Explosive Atmospheres, 1-23.

Song, Y., Zhang, Q., Wang, B., & Li, J. (2019). Numerical Study on the Internal and External Flow Field of Dust Explosion Venting. International Journal of Thermal Sciences, 145. https://doi.org/10.1016/j.ijthermalsci.2019.106008.

Sophie, S. (2013). Laminar Flow Hood System Design. Senior Project Engineering Department California Polytechnic State University, 1-46.

Sun, H., Pan, Y., Guan, J., Jiang, Y., Yao, J., Jiang, J., & Wang, Q. (2019). Thermal Decomposition Behaviours and Dust Explosion Characteristics of Nanopolystyrene. Journal of Thermal Analysis and Calorimetry, 135(4), 2359-2366. https://doi.org/10.1007/s10973-018-7329-1.

Tommasini, R. (2013). The Classification of Hazardous Areas Where Explosive Gas Atmospheres May Be Present. Safety Science, 58, 53-58. https://doi.org/10.1016/j.ssci.2013.03.010.

Tsai, Y.-T., Huang, G.-T., Zhao, J.-Q., & Shu, C.-M. (2021). Dust Cloud Explosion Characteristics and Mechanisms in MgH2-Based Hydrogen Storage Materials. AIChE Journal, 67(8). https://doi.org/10.1002/aic.17302.

Tzanakopoulou, V. E., Castro-Rodriguez, D., & Gerogiorgis, D. I. (2021). Process Modelling and Simulation of Volatile Organic Compound (Voc) Recovery from Pharmaceutical Gas Emission Streams. Computer Aided Chemical Engineering, 50, 717-723. https://doi.org/10.1016/B978-0-323-88506-5.50113-3 .

Wan Sulaiman, W. Z., Mohd Idris, M. F., Gimbun, J., & Sulaiman, S. Z. (2020). Assessment of Explosibility and Explosion Severity of Rice Flour at Different Concentration and Ignition Time. Process Safety Progress, 39(S1). https://doi.org/10.1002/prs.12107.

Wang, Y., Lin, C., Qi, Y., Pei, B., Wang, L., & Ji, W. (2020). Suppression of Polyethylene Dust Explosion by Sodium Bicarbonate. Powder Technology, 367, 206-212. https://doi.org/10.1016/j.powtec.2020.03.049.

Wei, M. C., Cheng, Y. C., Lin, Y. Y., Kuo, W. K., & Shu, C. M. (2020). Applications of Dust Explosion Hazard and Disaster Prevention Technology. Journal of Loss Prevention in the Process Industries, 68. https://doi.org/10.1016/j.jlp.2020.104304.

Wu, X., Liu, W., Gao, H., Alfaro, D., Sun, S., Lei, R., Jia, T., & Zheng, M. (2021). Coordinated Effects of Air Pollution Control Devices on Pah Emissions in Coal-Fired Power Plants and Industrial Boilers. Science of the Total Environment, 756. https://doi.org/10.1016/j.scitotenv.2020.144063.

Zhang, G., Fei, B., & Xiu, G. (2021). Characteristics of Volatile Organic Compound Leaks from Equipment Components : A Study of the Pharmaceutical Industry in China. Sustainability, 13(11). https://doi.org/10.3390/su13116274.

Zhao, J., & Chen, M. (2018). Leak Detection and Repair (LDAR) Standard Review for Self-Inspection and Management for VOC Emission in China's Traditional Energy Chemical Industry. Journal of Environmental Protection, 09(11), 1155-1170. https://doi.org/10.4236/jep.2018.911072.

Zohdirad, H., Ebadi, T., Givehchi, S., & Meysami, H. (2016). Grid-Based Individual Risk Calculation in the Classification of Hazardous Area with a Risk-Based Approach. Journal of Loss Prevention in the Process Industries, 43, 98-105. https://doi.org/10.1016/j.jlp.2016.05.007.