It is used for sterile testing , weighing, dispensing and transferring for the sterile substance with toxicity to ensure the reliable sterile environment.
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Main description
It is used for sterile testing , weighing, dispensing and transferring for the sterile substance with toxicity to ensure the reliable sterile environment.
Main features
1. Sterile test isolator is a sealing system, through fan filter unit (high efficiency filter , HEPA)to realize the air safe exchange and achieve the online monitoring of particles and microorganisms in the inner environment. Use quickly transfer channels or air brakes to aseptic transfer of materials and ensure the protection between the operator and the drug, and can handle 1-6 operators at the same time.
2. Equipped with Millipore sterility tester, it saves a lot of time for checking. It has H2O2 pass box, which is suitable for multiple batch sample testing.
3. Fully meet the requirements of USP/EP/CHP sterility testing regulations, stable performance, ensure the quality of drug testing.
Parameters of samples are monitored and recorded, they can be either directly sent to a printer(option) or stored on a remote PC.
| Item | Isolator (soft) | Isolator(stainless steel) | API sampling isolator |
| Production capacity | 8-10batches/day | 8-10batches/day | 8hours*7days |
| Motor power | 5-7kw | 5-7kw | 4-0.8kw |
| Total power | 0.4-0.8kw/h | 4-0.8kw/h | 5-15kw/h |
| Power supply | 380V±38V/50±1Hz/60Hz | ||
| Dimension | 3019×1000×2390 | 2508×1100×2500 | 2800×855×2800 |
| Material | PVC,SS316L, cover ss304 | SS316L/304 | SS316L/304 |
| Weight | 400kg | 600kg | 700kg |
| Noise | ≤70db(A) | ||
| OEL | OEB5 | ||
| Air speed | 0.36-0.54m/s | ||
| Laminar flow | Vertical unidirectional flow/Turbulent flow | ||
| Tem/humidity online monitoring | Yes | ||
| Working pressure | ＋45~－150Pa | ||
| Cleanliness level | A class environment | ||
| Structure mode | Modular + Expansion port | ||
| Leakage rate | ≤0.25%Vol/h | ||
| Illumination | ≥500Lux | ||
| Inner cavity material | PVC | AISI316L | AISI316L |
| Outside material | PVC | AISI304 | AISI304 |
| H2O2 sterilizing time | ≤90min | ||
| Sterilization effect | 6LOG | ||
| Sterilization method | Hydrogen peroxide vapor | ||
| Sterilization concentration | ＞300PPM | ||
| Standard for residual VHP concentration after sterilization | ≤1PPM | ||
| Classification during equipment operation | A LEVEL | ||
1. Technical service: provide free consultation and suggestion, technical support and service by email/fax/telephone and lifetime technical support.
2. Customized service: product development and design according to different customer's different requirements.
3. After-sale service team: technical engineers available to service overseas if needed.
4. Installation: we can arrange engineers to install machines in customer's factory.
5. Maintenance: reply will be given within 48 hours once customer inform us any malfunction happened, we can also arrange engineers to customer's factory to main machines.
6. Training: normal machine is properly adjusted before delivery, you will be able to use the machines immediately and you will be able to get free training advice towards our machine in our factory.
7. Warranty: one year since the date of delivery.
There are multiple models of one type machine , we need to know more details about your products in order that we can recommend the most suitable machine for you. Our questions as below:
1. What's your product ? please send one picture to us
2. What's the dimension or specification of your product ?
3. What's the filling volume of your product ?
4. What's the production capacity of your required machines?
5. If possible , please tell us your production process, we can select the approximate machine according to your requirements.
