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Wind Resistant Medical Class 100000 Sterile Operating Room

Minimum Order Quantity : 1 set Price : discuss personally
Packaging Details : wooden box Delivery Time : 25days
Payment Terms : L/C, D/A, D/P, T/T, Western Union, MoneyGram Supply Ability : 25 days/month
Place of Origin : China Brand Name : LEADTOP
Certification : CE certification Model Number : LTPM China

Detail Information

Model: LTPM China Structure: Wall Panel, Ceiling Panel, Window, Profile, Floor, Etc.
Brand Name: LEADTOP Wind Resistance: Grade 11
Color: Blue Or Customized Driven Type: Electric
High Light:

Class 100000 Sterile Operating Room

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Grade 11 Medical Cleanroom

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Wind Resistant Pharmaceutical Cleanroom

Product Description

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

 

Wind Resistant Medical Class 100000 Sterile Operating Room 0

 

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
 

Wind Resistant Medical Class 100000 Sterile Operating Room 1

 

Wind Resistant Medical Class 100000 Sterile Operating Room 2

 

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