"Clean ROOM" ISO 8

CLEANROOM – ISO 8

| Requirements for Cleanroom ISO Class 8 | ISO 8 Cleanroom Classification |
To achieve ISO 8 air cleanliness class in a cleanroom, a multi-stage air filtration system is typically used (e.g., pre-filter G4, F9 filter, final H13 filter). Airflow in the room is non-unidirectional, with "clean" air supplied to the room mixing with the "dirty" air already present. Exhaust grilles in ISO 8 rooms are placed on the walls. The required number of air changes per hour depends on the type of activity conducted and the number of personnel present; typically, the goal is to ensure 10–40 air changes per hour. In ISO 8 class, personnel often remain in the room continuously. Staff may wear standard workwear, while visitors wear disposable lab coats. It is recommended to maintain a minimum positive room pressure relative to the adjacent zone at 5–10 Pa.

Requirements for devices and materials intended for use in ISO 8 air cleanliness class cleanrooms (maximum average number of particles released, assuming: 100 samples taken; measurement performed in accordance with ISO 14644-14 in at least one class cleaner than the intended class; particles/m3). Detailed descriptions are provided in the photos.

Technical drawings are attached in the photos.

Ventilation Description
The purpose of the installed ventilation system was to achieve the following air parameters in the cleanroom. The enclosure was built using the GBD PHARMA 2000 system, complying with all requirements for "clean rooms" in the highest air cleanliness classes.

Installation parameters:
a) Air cleanliness – ISO 8.
b) Temperature: 19–23°C.
c) Humidity: max 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/hour] was used. The unit is equipped with pocket filters: pre-filter FK EU5/EC2 and fine filter FK-EU9/EC2. In addition, EUFILTER HEPA 11 filters were installed in the ceiling diffusers. Specifications are in item H6.

As a result, at a measured throughput of 3264 m3/h, ISO 7 [Class “C”] cleanliness was achieved at rest, and ISO 8 [Class “D”] during operation.
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b. The temperature range 19–23°C is easily maintained by the upgraded cooling coil and chiller, even with a 25% share of fresh air.

c. To achieve proper cooling in summer conditions (ambient temperature approx. 30°C and humidity approx. 80%), a freon cooler with 31.4 kW capacity and a refrigerating unit of 33.5 kW cooling capacity were used. The chiller is manufactured by FUJITSU and supplied by Klimatherm Gdańsk.

Room overpressure relative to external pressure is automatically controlled; pressure differential at the door: 15 Pa.

The ventilation system automation allows an “economy” mode, where the installation operates in a closed loop and maintains 15 Pa overpressure.

Technical data is attached in the photos.

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