| Customization: | Available |
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| Place of Origin: | Zhejiang, China (Mainland) |
| Brand Name: | Ltpm China |
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Audited Supplier Audited by an independent third-party inspection agency
Packaging Details: |
GMP Biological and Pharmaceutical Clean Room Materials and project packed by cases and wooden cases |
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| Delivery Detail: | within 25days after receive your previous payment. |
Service areas |
biological and pharmaceutical products (oral agents, immune reagents, trauma supplies), pharmaceutical production (injection, tablet, capsule and drugs for external use only, traditional Chinese medicine), etc. |
Purifying engineering imaging: |
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Biological pharmaceutical purification workshop |
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 |
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≥0.5um |
≥5um |
Plank tonic bacteria(cfu/m2) |
Settling microbe(cfu/DISH) |
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100 |
3500 |
0 |
5 |
1 |
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10000 |
350000 |
2000 |
100 |
3 |
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100000 |
3500000 |
20000 |
500 |
10 |
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Cleanliness level |
DUST count/ m2 |
Microbial number/ m2 |
Ventilation rate/h |
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≥0.5um |
≥5um |
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10 000 Class |
≤350 000 |
≤2 000 |
≤100 |
≥20 TIME |
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100 000Class |
≤3500 000 |
≤20 000 |
≤500 |
≥15 TIME |
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