Eventos Anais de eventos
COBEM 2023
27th International Congress of Mechanical Engineering
Performance Verification of Cleanrooms in an INCA Pharmacy
Submission Author:
Oseas Carlos da Silva , RJ , Brazil
Co-Authors:
Oseas Carlos da Silva, Manoel Antônio da Fonseca Costa Filho
Presenter: Oseas Carlos da Silva
doi://10.26678/ABCM.COBEM2023.COB2023-0051
Abstract
Clean rooms are controlled environments with low levels of particles and contaminants, designed to support critical processes such as pharmaceutical and food manufacturing, and medical surgeries. These ambients should comply with the international and national cleaning and contamination control standards such as ISO 14644 and ABNT NBR 7256. The National Cancer Institute (INCA) located in Rio de Janeiro has various hospital and research environments that require strict contamination control. In this context, clean rooms with non-directional air flow class ISO 8 and biological safety cabinets class ISO 5 were chosen for the study and verification of their design parameters. These environments characterize a pharmacy, where there is strict control over the production of a diet for immunosuppressed patients, achieved using a special air conditioning system. Additionally, in the design, construction materials and finishes were chosen to minimize the particle dispersion and facilitate frequent cleaning. Through acting on the filter replacement schedule and periodically measuring the critical parameters, it is possible to verify if the clean room in question meets the requirements imposed by the standard and the design concept. This paper encompasses some areas of the above pharmacy, air conditioned by two fan-coil-type air handling units. One has the following design characteristics: 12.5 TR, filtration G4 + F7 + H13, inflow flow rate of 5,800 m3/h, return air flow rate of 4,000 m3/h, with two cold water coils and one 12.0 kW reheating coil. The other has the following characteristics: 52 TR, filtration G4 + F7, inflow flow rate of 100% outdoor air of 10,000 m3/h, with two cold water coils and one 24.0 kW reheating coil. Performing the certification and validation of the room by experimental appraisal, it was verified, over a six-month period, that the particle count for the clean areas met the criteria from the standard: ISO 8 (0.5 µm: 3,520,000 particles; 5 µm: 29,300 particles) and ISO 5 (0.5 µm: 3520 particles; 5 µm: 29 particles). The temperature range established by the standard, within 21 - 24°C, was also reached, as well as the required pressure level. However, the measured air relative humidity, up to 80%, exceeded the allowed range (40%-60%).
Keywords
Cleanroom, Indoor air quality, environmental control
