Aseptic Isolation Technology
Download Product CatalogueThis technology is a fast-growing trend among first-class pharmaceutical and biotechnology companies around the world. Today, the use of isolators has become standard practice for sterility testing.
Aseptic isolator system is a set of integrated system which providing a controlled clean environment to ensure product safety or operator safety. Its performance characteristics are mainly reflected in the integrity of the sealing system, the effectiveness of the surface sterilization procedure, the ability to maintain the aseptic state and so on.
Application
Sterility Testing Isolator
Production Isolator
Application case
Microbial laboratory-Medicine QC research department
△ Sterility test for sterile preparation and sterile raw material. It is recommended product by ChP, USP, EP and JP, avoiding appearing false positive result in the test.
Aseptic production workshop-pharmaceutical industry
△ Aseptic subpackage, aseptic sampling, aseptic dosing, aseptic weight and other aseptic production process. Isolated operator from the product, effective protect the product when producing.
△ Toxicity and highly allergenic workshop-Pharmaceutical Industry
△ Special product have the risk of dangerous for operator during the production, such as Hormone products, penethamate.
Sterility test Isolator
Sterility test Isolator is a type of integrated containment system designed for large volume sterility testing. It can be customized for suitable working area to accommodate various batch sizes and process flows. It is normally composed of stainless steel and toughened glass matched with suitable glove port for person operation. And it can reach Class A inside when operation.
Integrated system is full automatic control by PLC system Complies with GMP, EP, USP, CP
According to GMP, the sterility test is allowed to be made in the sterility test isolator which is installed in the Class D background.
| Technical Parameter | Description |
|---|---|
| Cleanliness of working area | Class A |
| Wind speed | 0.36-0.54m/s, adjustable |
| Pressure difference during sterility test step | 20-50Pa |
| Sterilization method | H2O2 fogging technology |
| H2O2 sensor | Integrated with temperature and humidity |
| H2O2 concentration measuring range | 0-2000ppm, display as curve graph |
| Residual allowable limit | Less than 1ppm |
| Air flow direction | Uniflow |
| Air in and Air out | HEPA H14 (filtration efficiency: 99.995%) |
| Touch screen | Siemens 9 inches |
| Control system | Siemens PLC |
| Input & output | Siemens |
| Noise | ≤65dB(A) |
| Steritest pump | ≤270rpm |
| Air source | Clean compressed air |
| Glove holder | Available |
| Sample rack | Available |
| Illuminance | Available |
| Real time printer | Available |
| Alarm | Available |
| Emergency switch | Available |
| Reservation port for air sampler | Available |
| Reservation port for particle counter | Available |
| Data integrity and safety | 21CFR Part 11 compliance |