Maintaining a Sterile Environment: Validation and Qualification Strategies for Heating, Ventilation, and Air Conditioning Systems Adhering to Current Good Manufacturing Practices in Pharmaceutical Facilities.

Autor:	Dhandapani K; Department of Pharmaceutical Quality Assurance, SRM College of Pharmacy, SRM Institute of Science and Technology, Chengalpattu, IND., Kella A; Department of Pharmaceutical Quality Assurance, SRM College of Pharmacy, SRM Institute of Science and Technology, Chengalpattu, IND., Narayanasamy D; Department of Pharmaceutical Quality Assurance, SRM College of Pharmacy, SRM Institute of Science and Technology, Chengalpattu, IND.
Jazyk:	angličtina
Zdroj:	Cureus [Cureus] 2024 Sep 01; Vol. 16 (9), pp. e68410. Date of Electronic Publication: 2024 Sep 01 (Print Publication: 2024).
DOI:	10.7759/cureus.68410
Abstrakt:	This article presents a validation and qualification on heating, ventilation, and air conditioning (HVAC) systems. An HVAC system is required for suitable temperature maintenance, continuous air flow, and also keeping the air fresh, which ultimately helps in the prevention of cross-contamination and air accumulation and also ensures the availability of cool air on the premises. The quality of air ventilation in the pharmaceutical business has a considerable impact on worker safety, material efficacy, including raw materials, in-process items, and final products, and machinery. It ensures the optimal quality of air, as directed by the regulatory guidelines. Three degrees of validation are important for HVAC systems: installation qualification (IQ), performance qualification (PQ), and operational qualification (OQ). Air variations per hour, air circulation velocity, and air circulation pattern, pressure differential, recovery test for temperature and humidity, temperature and humidity uniformity, filter leak test, particle count, loss of utility test, compliance test, filter integrity test, and fresh air determination are some of the parameters to be assessed for the HVAC system validation. The validation tests that are mentioned in this article have acceptance criteria and procedures for conducting the tests that are provided by the current good manufacturing practices (cGMP) guidelines. Competing Interests: Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work. (Copyright © 2024, Dhandapani et al.)
Databáze:	MEDLINE
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