Customization: | Available |
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Application: | Chemical Industry, Clinical Diagnosis, Cosmetic Industry, Food Industry, Pharmaceutical Industry |
Certification: | CE, GMP |
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Introduction:
As a decontamination equipment separating operators and machines and complying with the requirements of Class A environment, the sterile isolator is mainly used for the protection of sterile testing, sterile product dispensing and other key process. It can reduce the background or environment requirements, improve the reliability of inspection results, meet the requirements of China GMP and Pharmacopoeia, EU GMP/FDA and cGMP/USP-NF, and can carry out "continuous" or "batch" operation.
Key Features:
Customization and Integration:
Cleanliness | ISO4.8 |
Temperature and humidity | Conventional 18-26ºC/45%-65%, can be customized according to the pharmaceutical process |
Differential pressure | Regular 20-50pa |
Air flow rate | 0.36m/s-0.54m/s |
Air flow type | Vertical one-way flow |
Sterilazation effect | log6 and above |
Leakage rate | 0.5% |