Bersihkan KAMAR ISO 8

CLEANROOM - ISO 8

| Requirements for Cleanroom ISO Class 8 | ISO 8 Cleanroom Classification |
To achieve ISO 8 air cleanliness in Cleanroom environments, a multi-stage air filtration system is typically implemented (e.g. pre-filter G4, filter F9, final filter H13). Airflow within the room is non-unidirectional (there is mixing of "clean" supply air with "dirty" air already present in the room). Air exhausts in ISO 8 rooms are located on the walls. The required number of air changes per hour depends on the operations performed in the room and the number of personnel present, but a target range is 10–40 air changes per hour. In ISO 8 class, personnel may remain in the room continuously. Workers may wear standard workwear, and guests should wear disposable gowns. It is recommended to maintain a minimum positive room pressure relative to adjacent areas at 5–10 Pa.

Requirements for equipment and materials intended for ISO 8 air cleanliness class Cleanrooms (maximum average number of particles released, when: number of samples taken = 100; measurement performed according to ISO 14644-14 in a cleanliness class at least one better than device usage class; particles/m³). Detailed description in photos.

Technical drawings attached in photos.

Ventilation Description
The goal of the installed ventilation system was to achieve the following air parameters in the Cleanroom. Construction was carried out using the GBD PHARMA 2000 system, compliant with all requirements for ‘cleanrooms’ in the highest air cleanliness classes.
Parameters for the installation: a. Air cleanliness - ISO 8. b. Temperature 19–23°C c. humidity max 38%.
a. To ensure the required supply air cleanliness, a DOSPEL air handling unit with a maximum capacity of V = 3500 m³/h [up to 15 air changes per hour] was used. The unit is equipped with bag filters: pre-filter FK EU5/EC2 and fine filter FK-EU9/EC2. Additionally, HEPA 11 filters by EUFILTER were fitted in ceiling diffusers. Catalog sheets in section H6. As a result, with a measured capacity of 3264 m³/h, ISO 7 cleanroom class [class “C”] was achieved at rest and ISO 8 class [class “D”] during operation.
b. The temperature range of 19–23°C is easily maintained by the oversized cooler and unit at 25% fresh air share.
c. To achieve the required conditions during summer with outside temperatures up to 30°C and humidity around 80%, a 31.4 kW freon cooler and a 33.5 kW refrigeration unit were used. The refrigeration unit is manufactured by FUJITSU and supplied by Klimatherm Gdańsk.
The room maintains automatically regulated overpressure relative to external pressure – pressure difference at doors: 15 Pa. The ventilation automation allows for an “economy” mode, in which the system works in a closed loop, maintaining 15 Pa overpressure.

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Technical data attached in the photos.

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