Sanqiang PH-Mixer
Mixing System
Efficient mixing and hygienic design are of paramount concern in the manufacture of pharmaceuticals and bio-pharma products. Sanqiang PH Mixer is manufactured to comply with national and international pharmaceutical standards and constantly exceed these stringent standards. Thanks to experienced staff and comprehensive quality management as per DIN ISO 9001:2008, Sanqiang is able to fulfill the specific requirements of the industry with regard to technical workmanship and standards of appearance.
The surfaces of Sanqiang’s vessels are ground and polished, and as required, electro-polished. All welds are smoothed to the current GMP/FDA standards and exclude even the smallest cleaning dead spaces. Sanqiang guarantees the traceability of all material used including the provision of certificates.
Application
Pharmaceutical, Bio-Pharma.
Design Features
· Sterile design, non-dead-angle activity area
· cGMP/FDA
· ASME U stamp
· D1 & D2 Pressure Vessels License (PRC)
· Skid-mounted
· Material of product contact surfaces: AISI 316L
· Orbital welded pipework
· Integrated CIP / SIP
· Touch-screen operating concept, with process shown in the active flow diagram
· Continuous monitoring of the production and recording function
· Customized solutions
Technical Specifications
· Capacity: 30 litres – 50,000 litres
· Internal surface: Ra ≤ 0,4 µm electro-polished
· External surface: Ra ≤ 0,6 µm mechanical-polished
· Tank Pressure: -1/+3 bar
· Jacket Pressure: 0/+3.5 bar
· Temperature: -20 / +150 °C
· Cleaning Options: CIP, SIP
· Agitator Type: Top mechanical agitator, bottom magnetic agitator
· Impeller Type: propeller, spiral, anchor
· Jacket: Half-pipe limpet jacket, full jacket, dimple jacket
· Insulation: Rock wool, polyurethane, pearl cotton
· Sampling Valve
· Pneumatic bottom valve: to solve the problem of the residual liquid
Automation
A programmable logic control (PLC) controls and regulates the process. The system offers the following functions during operation:
· Stirring with adjustable speed: 0 to 600 rpm
· Data Storage
· Data Print
· Temperature control
· Filter integrity test
· Automatic weighing system with density ratio control of volume
· Automatic air tightness & pressure tests for SIP
· 3 levels authority for system management
Quality Assurance
· Quality plan and materials tracing
· First-Class manufacturing facility
· Orbital welding
· Temperature controlled & dust-free welding room
· Weld seam documentation
· Piping inspection by endoscope
· Own radiographic testing (RT)
· Qualification (IQ/OQ)
Cleaning
· Riboflavin test
· 360° spray ball in the dome top tank
· Cleanliness effect monitoring by conductivity or TOC analysis
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