In order to produce sterile products or if the work requires a sterile environment, the environment must meet certain conditions. Entry and exit to these areas should be controlled. To maintain the existing sterile environment, the air-conditioning conditions must be specially designed and kept under constant pressure. Such areas are called "Clean Rooms".
Clean rooms are spaces designed to eliminate all kinds of factors such as evaporated particles, dust and microorganisms living on airborne particles. "Clean Room Class" is determined according to the work and product in the "Clean Room".
The most important criterion in determining the "Clean Room Class" is the amount of living and non-living particles in the Clean Room.
If the validation tests performed in the Clean Room are positive, the microbial load in the Clean Room must also be measured. Sampling points for particle and microorganism measurements in clean rooms are specified in "ISO 17141 standard", Table B2.
NL=27x(A/1000)/3 NL: Number of samples to be taken (If the output is decimal, it is rounded to the next integer).
The frequency of these tests performed in the Clean Room is determined according to the following situations.
If the room is newly built, before it is used for the first time.
After any maintenance operation in the room. Especially like replacing the ventilation filters in the Clean Room.
Changing the room plan in a size that will change the ventilation pattern within the room. After changing the cleaning procedure.
If a large amount of pollution source has somehow entered the room.
If a large amount of contamination is detected.
The Clean Room ventilation system (HVAC) has been turned off for an extended period of time. It is not correct to only look at the air quality when measuring the microbial load in the Clean Room.
It is also important to control all surfaces that can create pollution and personnel that can carry pollution.
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