Revolutionizing the Major Threat Challenges in Pharmaceutical Industries by Monitoring Heating, Ventilation and Air Conditioning Systems

Authors

  • Natarajan Tamilselvan
  • Appavoo Umamaheswari
  • Sakthivel Lakshmana Prabu

DOI:

https://doi.org/10.7251/EORU2309203T

Keywords:

HVAC system, environmental protection, pharmaceutical industry, validation, qualification, FMEA, automation

Abstract

The environmental as well as personal individuals are mainly influenced by the air ventilation. In pharmaceutical industry the efficacy of substances including raw materials, in-process ingredients, finished products and machineries in the pharmaceutical manufacturing industry is mainly influenced by the air ventilation quality in interior area of the industry. Heating, ventilation and airconditioning system plays a vital role in ensuring the quality pharmaceutical drug substances as well as drug products. It also protects the pharmaceutical products from contamination and cross contamination from various contaminants like dust or dirt particles and environmental other microorganisms. HVAC system design impacts the architectural design layout of the building as these sequentially have an influence on the room pressure, pressure cascades, pressure differentials, contamination and cross-contamination control. So, the design of the system must be considered carefully at the primary design period of the pharmaceutical industrial plant.It also controls a variety of operating functions which are involved in regulating the acceptance criteria, quality assurance, validation and qualification of the building facility, operational documents and the documentation for maintenance. These protocols are mainly followed and performed for new equipment’s, utilities, premises and systems, at periodic intermissions, as soon as major variations have been completed. This chapter provides insight into the superlative necessities of HVAC system on the environmental protection in pharmaceutical industries and also about the role of it in manufacturing of drug substances and products in the production unit of the industrial plant. In addition, it summarizes existing information about the validation, qualification, maintenance, risk assessment and also highlights about the automation of HVAC system in the pharmaceutical industries.

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Published

2024-03-27

Issue

Section

Articles