Clean rooms are one of the most valuable tools in limiting contamination of sensitive scientific research, including manufacturing pharmaceutical items, integrated circuits, LCD, OLED and micro-LED displays.
Cleanrooms generally maintain extremely low levels of particulates, such as dust, airborne organisms, or vaporized particles. In the cleanroom, the quantity and size of airborne particles are controlled to limit contamination.
Cleanrooms typically have a cleanliness level quantified by particles per cubic meter at a predetermined molecule measure.
Introduction generation and retention of contaminants inside the space filtered airflow is controlled by cleanroom construction and operation. It is executed through high-efficiency particulate air or HEPA filters.
Clean rooms are classified based on the amount of allowed airborne particles in the room at any given time; the fewer particles allowed, the more precautions have to be taken to prevent contamination.
There are two different types of cleanrooms hard wall cleanrooms have steadily constructed rigid walls. Soft wall cleanrooms have flexible walls such as plastic sheets or strips; hard wall cleanrooms are typically cleaner than soft walls, but the processes to avoid contamination are similar in both.
Clean rooms are classified under the ISO standard based upon the amount and size of airborne particles in a cleanroom at any given time. The ISO standard covers nine classes of clean rooms, with class one being the most pristine and class nine being the least clean. However, the direction of the air can also classify clean rooms
flow some clean rooms have horizontal airflow in which the filtered air enters at one wall in exits through an opposite wall.
Vertical flow cleanrooms provide filtered air from the ceiling, and the air flows downwards towards the floor.
Sources of contamination in a cleanroom
One must note that cleanrooms do not eliminate contamination; they control it to an acceptable level.
Our genuine concern is microbial contamination in most cases. Traditionally, the technology does not directly measure microbial contamination in real-time. So the “all airborne particulates” limits were used and extrapolated /assumed to represent possible airborne microbial contamination risk.
The GMP’s set out defining and controlling sources of particulates to prevent possible “microbial contamination”.
Personnel present in a cleanroom usually are the highest source of airborne particles and microbial contamination risk. There should be control over limiting the number of staff in a room within the cleanroom design.
How to enter in Clean-Room –
- A cleanroom is not an office or a general lab area.
- Sometimes certain items which are allowed in most areas get prohibited in cleanrooms.
- Therefore, We have to prepare properly before entering the clean area. First, remove any cardboard paper or other fibrous outer packaging from items paper. Because cleanrooms prohibit excessively shred cardboard particles and fibres
- The staff in a cleanroom should only use cleanroom notebooks and cleanroom paper.
- Only the regular paper that is sealed in plastic sheet protectors should be used. Only ballpoint pens without caps are used.
- Cleanrooms prohibit food and drinks.
- If there is any doubt about the item prohibition, consult the contamination control engineer or the manager in charge of your cleanroom. Next, wipe down the outer surfaces of any tools or hardware you plan to bring into the cleanroom. Consulting a professional will reduce the number of particles you introduce to the room.
- Cleanroom users should always count up in a top-down manner, starting at the head first place.
- The bouffant cap over your hair and ears to make sure the cap covers all of your hair.
- Above all, People with long hair should tie their hair back before putting on a bouffant kappa.
- Next, put on a facemask completely covering your nose and mouth.
- This will limit introducing the particles into the environment or hardware due to our breathing.
Three things keep a cleanroom “clean”:
- Cleaning the inner surfaces of the cleanroom and the equipment used within them.
- Controlling the quality of air through the cleanroom by maintaining, supply air and exhaust air.
- The cleanroom is getting operated, i.e. the number of staff is maintained through preventive measures.