Aseptic isolator manufacturermodel

Aseptic isolator manufacturerTechnical Parameter

Power Supply:AC 380±38/50HzThree-phase power supply

Power: Approximately4000W

Compressed air source: clean compressed air or nitrogen, source pressure 0.3~0.6MPa

Touch screen: Siemens7Inch color touch screen

Efficient filter:H14Grade, filtration efficiency99.95%

Cabin pressure control range:-80~80Pa

Temperature display resolution:0.1℃

Humidity display resolution:0.1%

Pressure display resolution:0.1Pa

Purification level:Alevel

Hull airtightness: hourly leakage rate≤0.5%

Airflow mode: vertical laminar flow, wind speed0.36~0.54m/s

Exhaust duct diameter: Φ150mm

Basic dimensions: Unit: mm

characteristic

A smart isolator is composed of a whole stainless steel plate as the material for the cabin, which is fully welded and polished, and integrated with a ventilation and filtration system, glove operating accessories, control system, etc.

1The cabin material is thick2~3mm316LThe stainless steel plate is fully welded and polished as a whole, with rounded corners inside the cabin. The door is15mmThick white tempered glass, with good transparency and mechanical strength, can be opened at a high angle using gas springs, without affecting the cleaning operation inside the cabin.

2Air filtration and inlet/outlet mechanism: mainly composed of low-noise fansH14The high-efficiency filter, flow equalization membrane and return air (exhaust) high-efficiency filter, electric butterfly valve and pipeline are composed to ensure dynamic performance inside the isolatorAThe level of cleanliness standard is maintained, and during the air exchange process inside and outside the cabin, microorganisms and particles outside the cabin will not be introduced into the isolator.

3Through programmable controllers（PLC）Automatically control the inlet and outlet fans of the isolator with a frequency converter to ensure a certain pressure difference in the environment inside the cabin. Conventional product production uses10~40PaPositive pressure is used to maintain the sterile state inside the cabin, especially when producing high biological activity drugs such as anti-tumor drugs and sex hormone drugs. Can be used-40~-10PaThe negative pressure operation not only maintains the sterile state inside the cabin, ensuring that the products are not contaminated by microorganisms, but also ensures that the drugs do not leak outside the cabin, causing harm to the operators. The air entering and exiting the cabin passes throughH14The high-efficiency filter ensures that there will be no contamination of the interior of the cabin due to pressure loss.

4Integrated vaporized hydrogen peroxide generator to achieve isolator hostPLCIntegrated control, automatic sterilization, and automatic pressure maintenance operation.

5Built in cleaning water and compressed air spray gun interfaces are used for cabin cleaning. Multi functional real-time monitoring interfaces and verification interfaces are reserved for real-time wind speed, dust particle monitoring, and planktonic bacteria detection verification work.

6All units adopt modular design, which can be combined into different configurations and specifications according to customer process needs. For example, air lock chambers can be installed on one or both sidesRTPThe system (laminar flow with hydrogen peroxide sterilization) can also be connected by multiple isolators according to process requirements, and pressure gradients can be set between them to achieve different operational functions.

7Compliant with2010editionGMPRegarding the requirements for isolators.

application area

Processes that require aseptic operations such as packaging, sampling, and weighing of high biological activity products and sterile products; Installing a built-in bacterial collection device can also be used for product sterility testing and positive bacterial control testing Compliant with the requirements of the Aseptic Inspection Method in the Appendix of the 2015 edition of the Chinese Pharmacopoeia, it is suitable for sterile testing of various sterile products such as sterile preparations, sterile raw materials, and sterile medical devices (including direct inoculation method and membrane filtration method).