Clean ROOM ISO 8

CLEANROOM - ISO 8

| Cleanroom requirements ISO Class 8 | ISO Cleanroom Class 8 | Cleanroom classification.
In order to achieve an ISO 8 air purity class in a Cleanroom, several levels of air filtration are usually used (e.g. G4 pre-filter, F9 filter, H13 final filter). Air movement in the room is non-unidirectional (there is a mixing of "clean" air supplied to the room with "dirty" air present in the room). Air vents in the ISO 8 room are placed on the walls. The required number of air exchanges per hour will depend on the nature of the activities conducted in the room and the number of personnel present, but the goal could be to provide 10-40 air exchanges/hr. In ISO Class 8, personnel are often present continuously. Employees may be dressed in standard work attire and visitors in a disposable apron. It is recommended to maintain a minimum overpressure of the room relative to the adjacent zone of 5-10 Pa.

Requirements for equipment and materials intended for Clean Room with ISO air cleanliness class 8 (maximum average amount of particles released when: number of samples taken = 100; measurement performed in accordance with ISO 14644-14 in a cleanliness class at least one better than the purpose of the device; number of particles/m3) Detailed description in photos.

Technical drawings attached to photos.

Guedpfeq H H Rusx Aa Eed

Description of ventilation
The purpose of the ventilation installation performed was to achieve the following air parameters in the Clean Room. The installation was made with the GBD PHARMA 2000 system, meeting all the requirements for 'clean rooms' in the highest classes of air purity.
Parameters for the installation: a. Air purity - ISO 8. b. Temperature 19-23 st C
c. Humidity max 38%.
a. To ensure the required purity of the supplied air, an air handling unit manufactured by DOSPEL with a maximum capacity of V= 3500 m3/h [up to 15 air changes per hour] was used. The air handling unit is equipped with pocket filters : pre-filters FK EU5/EC2 and fine filters FK-EU9/EC2. In addition, HEPA 11 filters made by EUFILTER were used in diffusers located in the ceiling. Data sheets in point H6.
As a result , with a measured flow rate of 3264 m3/h, an ISO 7 [class "C"] cleanliness class of the room was obtained in the resting state, and thus an ISO 8 [class "D" ] cleanliness class for the working state.
b. The temperature range of 19-23 deg C is for the enlarged cooler and chiller to be freely maintained with 25% fresh air.
c. In order to achieve in summer conditions with high temperatures of 30 deg C and humidity of 80%, a freon chiller of 31.4 kW and a chiller of 33.5 kW of cooling power were used. The chiller is made by FUJITSU supplied by Klimatherm Gdansk.
The room is automatically regulated overpressure in relation to the external pressure - the pressure difference at the door : 15 Pa
The automation of ventilation allows for "economical" mode , in which the installation works in a closed circuit and an overpressure of 15 Pa is maintained.

Technical data attached to the photos.

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