Class 100~100,000 Sterile Operating Room Clean Room Cleanroom
Medical Production Workshop
Important Considerations for Operating a Sterile Cleanroom
The use of sterile cleanrooms in the manufacture of food and
beverage products follows the same principles that are laid out in
the GMP (Good Manufacturing Practice) for pharmaceutical
manufacturing. The goal is to minimize potential contaminants in
the form of dust particles and microorganisms in order to increase
product safety and quality.
(1) For personal safety reasons, all personnel entering the
cleanroom should first turn off all UV lights.
(2) Sterile cleanrooms and buffer areas should be designed to meet
FS209E level 10,000 (ISO 7). Cleanroom temperature should be
maintained between 20-24℃ with a humidity level between 45-60%. All
workstations should meet FS209E level 100 (ISO 5).
(3) In order to maintain a sterile environment, strict precautions
must be taken to avoid contamination of the cleanroom and any
cleaning equipment. Operator should immediately discontinue use of
any contaminated equipment or item.
(5) The cleanroom should be cleaned regularly with a disinfecting
agent.
(6) Any machinery, device, lab equipment, etc. should be thoroughly
disinfected and sealed before it is taken into the sterile
cleanroom.
(7) All personnel must disinfect their hands with soap and/or
disinfectant before entering the buffer area. In the buffer area,
they should then change put on shoes and clothing approved for use
in the clean area, and also put on approved hats/hairnets, masks,
and gloves (or wash their hands again with hand disinfectant.)
(8) Before using the sterile cleanroom, the UV lights should be
turned on for at least 30 minutes. At the same time, the fans on
the clean benches should be turned on. After turning out the UV
lights, cleanroom surfaces should be thoroughly cleaned with
disinfectant, and then the UV lights should be turned on for
another 20 minutes.
(9) When inspecting test samples make sure that the packaging is
completely sealed, and do not open the packaging in order to avoid
contamination. Before inspection, wipe down the outer surface of
the test sample container with a cotton ball dipped in 70%
isopropyl alcohol.
(10) Any items containing living organisms or bacteria must be
disinfected before being washed in the sink to avoid contamination
of the pipes.
Sterile Cleanrooms and Air Showers
Air showers are an essential part of any modern cleanroom solution.
The purpose of an air shower is to clean away surface contaminants
from any human or object that will enter a clean area. Air showers
also serve as a buffer zone between clean and non-clean areas and
areas of varying cleanliness levels. Air showers are frequently
seen facilities that manufacture food and beverage products,
pharmaceutics, medical instruments, and electronics.
Air showers are generally classified as either “general" or
"interlocking", where general air showers are manually operated and
interlocking air showers are fully automatic. Interlocking air
showers eliminate the risk of personnel skipping the air shower
when entering the cleanroom, and are thus the recommended choice
for nearly all operations. The biggest risk of contamination is
generally cleanroom personnel themselves. Therefore, air showers
are a vital component for any cleanroom system design
cleanroom standards
| Class | Maximum particles/m3 a | FED STD 209E |
| ≥0.1 μm | ≥0.2 μm | ≥0.3 μm | ≥0.5 μm | ≥1 μm | ≥5 μm | equivalent |
| ISO 1 | 10b | d | d | d | d | e | |
| ISO 2 | 100 | 24b | 10b | d | d | e | |
| ISO 3 | 1,000 | 237 | 102 | 35b | d | e | Class 1 |
| ISO 4 | 10,000 | 2,370 | 1,020 | 352 | 83b | e | Class 10 |
| ISO 5 | 100,000 | 23,700 | 10,200 | 3,520 | 832 | d,e,f | Class 100 |
| ISO 6 | 1,000,000 | 237,000 | 102,000 | 35,200 | 8,320 | 293 | Class 1,000 |
| ISO 7 | c | c | c | 352,000 | 83,200 | 2,930 | Class 10,000 |
| ISO 8 | c | c | c | 3,520,000 | 832,000 | 29,300 | Class 100,000 |
| ISO 9 | c | c | c | 35,200,000 | 8,320,000 | 293,000 | Room air |
