PYG系列不锈钢配液罐
本系列配液罐严格遵循《药品生产质量管理规范》GMP总则(1998年修订版)第三十一、三十二条要求,根据GB150-98《钢制压力容器》,JB/T4735-97《钢制焊接常压容器》要求进行设计,制造验收。
1、 容器保温材料采用耐高温、抗老化聚胺脂发泡或珍珠棉。
2、 接口采用通用标准ISO快装卡盘式,内胆选用进口不锈钢SUS316L或SUS304制造,内表面镜面抛光至Ra≤0.28um,外表面抛光、镜面、喷砂或冷轧原色亚光,符合GMP医药标准。
3、 搅拌器的密封采用进口卫生级机械搅拌密封或磁力全密封搅拌装置,搅拌转速可任选。
4、 管口设有液位计口(静压式、电容式、无触点式、超声波式、玻璃管式)、空气呼吸器、温度计(数显式或表盘式)、CIP清洗口、视镜、防爆视灯(视镜视灯一体化)、SIP灭菌口、进出液口及卫生人孔等。
5、 容积有100L-10000L等规格,也可根据客户实际需要进行设计、制造。
6、 随机附着有关GMP验证资料(含材质报告、外购件合格证、验证表格等)。
The liqukd arrangement tank strictly tallies with the 31st and 32nd clauses of 《Medicine Production Quality Management Norm》---GMP General Principles(1998Revised Edition),and is designed ,manuracturde and accepted according to the require-ments of GB150-98《Steel Welding Norma Vessel》.
1、 Heat preservation material of the vessel adopts high-temperature resistant and anti-aging polyurethane blister or pearl cotton.
2、 Joints adopt international general ISO package chuck,inner container adopts inported stainless steel SUS316l or SUS304,internal surface is polished to Ra≤0.28m,and external surface polishing mirror polish,sand blasting or cold-rolled nature-color surface polishing.All is in accordance with GMP medical standards.
3、 Sealing of mixer adopts imported sanitation-grade mechanical stirring enchosing or magnetic totally-enclosed stirring device.The mixing rotary speed is optional.
4、 Orifice is set with level gauge(static-pressure type,capacitance type,non-contact type,ultrasonic type and glass tube type),air respirator,thermometer(digital display type or dial plate type),CIP cleaning mouth ,viewing mirror,exlosion-proof viewing lamp(viewingmirror and viewing lamp integration),SIP sterilizing mouth,liquid entrance-exit gate and sanitary inlet.
5、 Volume Specification:100L-10000L orto be designed and manufactured at customers ,actual request.
6、 Relevant GMP testing data are attached in the machine.(including material report,external components cer-tificate of quality and verification form).
技术参数Technology Parameter:
公称容积 | 工作压力(Mpa) 工作温度(℃) 搅拌转速(转/分) H(mm) H1(mm) D(mm) D1(mm) h(mm) |
100 | 0.25 100 0-720 1750 450 Φ750 Φ550 300 |
200 | 0.25 100 0-720 1950 600 Φ850 Φ650 300 |
600 | 0.25 100 0-720 2500 1000 Φ1100 Φ900 350 |
1000 | 0.25 100 0-720 2850 1200 Φ1300 Φ1100 350 |
2000 | 0.25 100 0-720 3350 1500 Φ1500 Φ1300 350 |
3000 | 0.25 100 0-720 3700 1700 Φ1700 Φ1500 350 |
5000 | 0.25 100 0-720 4250 2000 Φ2000 Φ1800 400 |
10000 | 0.25 100 0-720 5000 2500 Φ2500 Φ2300 400 |