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 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 and α β separation butterfly valves can be configured according to process requirements.

Ø A nitrogen system can be configured to respond to oxygen content detection according to process requirements.

Ø The whole machine can meet the explosion-proof requirements according to process requirements.