Aseptic isolatorApplication field

　　

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 sterile 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).

　　

Characteristics of Aseptic Isolators

　　

The sterile isolator is made of an integral stainless steel plate as the material of the cabin, which is fully welded and polished, and then integrated with a ventilation and filtration system, glove operating accessories, control system, etc. to form an intelligent isolator.

　　

1. The cabin is made of 316L stainless steel plate with a thickness of 2-3mm, which is fully welded and polished as a whole. The interior of the cabin has rounded corners and transitions. The door is made of 15mm thick white tempered glass, which has good transparency and mechanical strength. It can be opened at a high angle using gas springs without affecting the cleaning operation inside the cabin.

　　

2. Air filtration and inlet/outlet mechanism: mainly composed of low-noise fan H14 level filter, uniform flow membrane and return air (exhaust) filter, electric butterfly valve and pipeline, ensuring that the interior of the isolator meets dynamic cleanliness standards, and that microorganisms and particles outside the cabin will not be brought into the isolator during the air exchange process inside and outside the cabin.

　　

3. By using a programmable logic controller (PLC) and a frequency converter to automatically control the inlet and outlet fans of the isolator, a certain pressure difference is ensured within the cabin to maintain a sterile state. Conventional product production uses a positive pressure of 10-40Pa to maintain the cabin. However, when producing high biological activity drugs (such as anti-tumor drugs and sex hormone drugs). Negative pressure operation of -40~-10Pa can be used, which not only maintains the sterile state inside the cabin, ensures that the product is not contaminated by microorganisms, but also ensures that the drug does not leak outside the cabin, causing harm to the operators. The air entering and exiting the cabin is filtered through H14 level filters, and there will be no contamination of the interior of the cabin due to pressure loss.

　　

4. Integrated vaporized hydrogen peroxide generator, realizing PLC integrated control of isolator host, automatic sterilization, and automatic pressure maintenance operation.

　　

5. Built 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 floating bacteria detection verification work.

　　

6. All units adopt modular design, which can be configured and specified according to customer process needs. For example, air lock chambers or RTP systems (laminar flow with hydrogen peroxide sterilization) can be installed on one or both sides, or multiple isolators can be connected according to process requirements, and pressure gradients can be set between them to achieve different operational functions.

　　

7. Complies with the relevant requirements of the 2010 version of GMP for isolators.