Contact: Mr. Hu
Tel: 137 3264 8199
Contact: Mr. Wang
Tel: 180 1357 4420
Website: www.rcclean.com
Add: No. 99, Tongcheng Road, Weitang Town, Xiangcheng District, Suzhou
Performance characteristics:
The chamber is made of SUS316L stainless steel, the thickness is 3mm, and the window is made of 15mm tempered glass.
The system meets the ergonomic design, the cleanliness is ISO 4.8, and provides a full set of 4Q verification services;
The isolator integrates temperature and humidity monitoring system, pressure difference monitoring system, wind speed monitoring system, hydrogen peroxide concentration monitoring system, particle and plankton monitoring system;
The isolator can detect the leakage rate online (pressure attenuation method) according to ISO 10648, ISO14644, PDA.
Data requirements for TR34:
System design conforms to GMP, ISO, ISPE, pharmacopoeia and other relevant requirements;
According to process requirements, sterility tester can be configured;
According to the process requirements, the WIP system can be configured to complete the cabin cleaning, pipe spraying and drying online;
According to process requirements, online weighing balance can be configured, data can be integrated with the system or independent;
According to the process requirements, it can be configured with RTP valve, garbage can, transfer car, storage rack, etc.
Technical parameters:
Cleanliness level: Class A (comply with GMP)
Sterility level: SAL≤10-6
Leakage rate: Q/V≤0.5%
Noise: ≤65dB
Illumination: ≥300LUX
Crack wind speed: ≥0.5m/s
Pressure difference range: 0-80Pa
Applications:
Sterility test
Aseptic filling
Aseptic dispensing
Aseptic cell culture
Product picture:
