Audited Supplier
NO
0-10℃
Freon
Large
Assembled
Production
Factory
Medicine
1-2 Years
ISO, CE
New
120-5000
Sun world
Carton
CE
China
94060000
Product Description
Clean room Manufacture for pharmaceutical, laboratory, foodstuffs industry. Size can be customised.
1. Operator purification
a) Operator purification: biological medicine clean room (area) personnel purification program is as follows:
b) Medicine clean zone shall be set up to the entrance of the gas chamber; The introduction of the gas chamber should be set interlock device.
c) Air clean level the same sterile clean room and the sterile clean its personnel with room shall be installed separately purification.
2. material purification
a) Medicine clean room raw and auxiliary materials, packaging material inward and outward, shall set up with material purification room.
b) Into the sterile clean room raw materials, packaging material in addition to meeting the requirements above there should be set up in the entrance material room and the sterilization facilities.
c) Material clean room or sterilization room and medicine clean room between shall set up gas chamber or pass ark.
3. 100,000 grade and above area should be in clean indoor wash clothes, dry, whole shall, when necessary, according to requirements sterilization.
1. Operator purification
a) Operator purification: biological medicine clean room (area) personnel purification program is as follows:
b) Medicine clean zone shall be set up to the entrance of the gas chamber; The introduction of the gas chamber should be set interlock device.
c) Air clean level the same sterile clean room and the sterile clean its personnel with room shall be installed separately purification.
2. material purification
a) Medicine clean room raw and auxiliary materials, packaging material inward and outward, shall set up with material purification room.
b) Into the sterile clean room raw materials, packaging material in addition to meeting the requirements above there should be set up in the entrance material room and the sterilization facilities.
c) Material clean room or sterilization room and medicine clean room between shall set up gas chamber or pass ark.
3. 100,000 grade and above area should be in clean indoor wash clothes, dry, whole shall, when necessary, according to requirements sterilization.
Air cleanliness class | The maximum allowable number of suspended particles(pcs/ m2 ) | The maximum allowable number of suspended microorganisms | ||||
≥0.5um | ≥5um | Plank tonic bacteria(cfu/m2) | Settling microbe(cfu/DISH) | |||
100 | 3500 | 0 | 5 | 1 | ||
10000 | 350000 | 2000 | 100 | 3 | ||
100000 | 3500000 | 20000 | 500 | 10 | ||
Cleanliness level | DUST count/ m2 | Microbial number/ m2 | Ventilation rate/h | |||
≥0.5um | ≥5um | |||||
10 000 Class | ≤350 000 | ≤2 000 | ≤100 | ≥20 TIME | ||
100 000Class | ≤3500 000 | ≤20 000 | ≤500 | ≥15 TIME | ||
