Čista soba ISO 8

CLEANROOM – ISO 8
Kodpfx Aeq H H Rusdkodi

| Requirements for Cleanroom ISO Class 8 | Cleanroom Room Classification ISO 8 |
To achieve ISO 8 air cleanliness class in a Cleanroom, a multi-stage air filtration system is typically applied (e.g., G4 pre-filter, F9 filter, H13 final HEPA filter). Airflow within the room is non-unidirectional (the supplied 'clean' air mixes with 'dirty' air present in the room). Air exhaust vents in an ISO 8 room are installed in the walls. The required number of air changes per hour depends on the activities carried out and the number of personnel present, but a target could be 10–40 air changes per hour. In ISO 8 class, personnel are often present continuously. Employees may wear standard work clothing, and visitors disposable gowns. It is recommended to maintain a minimum positive room pressure relative to adjacent zones at 5–10 Pa.

Requirements for equipment and materials intended for Cleanroom ISO 8 (maximum average amount of particles released, assuming 100 samples; measurement according to ISO 14644-14 in a class at least one better than required for device application; number of particles/m3). Detailed description available in photos.

Technical drawings included in the images.

Ventilation Description:
The aim of the ventilation installation was to achieve the following air parameters in the Cleanroom. The structure was built using the GBD PHARMA 2000 system, meeting all requirements for ‘cleanrooms’ in the highest air cleanliness classes.

Installation parameters:
a. Air cleanliness – ISO 8.
b. Temperature: 19–23°C
c. Maximum humidity: 38%.
a. To ensure the required cleanliness of supplied air, a DOSPEL ventilation unit with a maximum capacity of V = 3500 m3/h [up to 15 air changes per hour] was used. The ventilation unit is equipped with bag filters: pre-filter FK EU5/EC2 and secondary FK-EU9/EC2. Additionally, EUFILTER HEPA 11 filters were used in the ceiling-mounted supply diffusers. Technical data sheets are attached in section H6.
As a result, at a measured output of 3264 m3/h, ISO 7 [Class 'C'] room cleanliness was achieved at rest, and thus ISO 8 [Class 'D'] in operation.
b. The temperature range of 19–23°C can be easily maintained with an enlarged cooler and aggregate, even with 25% fresh air intake.
c. To achieve specified conditions during summer, at high ambient temperatures of around 30°C and humidity of around 80%, a 31.4 kW freon cooler and a 33.5 kW chiller were used. The chiller, made by FUJITSU, was supplied by Klimatherm Gdańsk.
The room features automated positive pressure regulation compared to external pressure—differential pressure at the doors: 15 Pa.
Ventilation automation allows for an 'economy' mode, where the system operates in a closed loop and maintains a pressure differential of 15 Pa.

Technical data attached in the images.

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