澳门新葡萄新京威尼斯(987·中国)官方网站-2024App Store

Ø The isolation system guarantees the aseptic production of drugs and prevents harm to the production personnel by toxic products.

Ø The isolation system can be configured with water injection, powder injection, pre-filled syringe, sterile powder and other production lines and grade-A unidirectional air flow to ensure the products in the core area, and the gasified hydrogen peroxide sterilization system is integrated to achieve the sterility assurance level of SAL not greater than 10-6.

Ø The equipment cavity is made of SUS316L stainless steel with a thickness of 3 mm, and the visual window is made of 15 mm tempered glass.

Ø The system conforms to the ergonomic design, cleanliness is ISO 4.8, and a full set of 4q verification services is available.

Ø The isolator is integrated with the temperature and humidity monitoring system, differential pressure monitoring system, air speed monitoring system, hydrogen peroxide concentration monitoring system, glove grating monitoring system, and the particle and plankton monitoring system.

Ø The isolator can detect the leak rate online (the pressure attenuation method), which meets the data requirements of ISO 10648, ISO 14644 and PDA TR34.

Ø The system design meets the GMP, ISO, ISPE, pharmacopoeia and other relevant requirements and complies with 21CFR Part11, and the product has passed the EU CE certification.

Ø A WIP system can be configured according to process requirements to complete cabin cleaning, pipeline spraying and drying online.

Ø RTP valves can be configured according to process requirements.

Ø A vertical rubber stopper cleaning machine can be configured according to process requirements to ensure aseptic transportation of rubber stoppers during industrial production.