通过美国FDA的标准

fanganq

制药工程中，项目要通过美国FDA的标准。纯化水、注射水系统中什么材料需要通过美国的认可，我知道的包括密封垫，其他的还有吗？

APHI

敢问一下：你见过哪本FDA指南具体到材质？我怎么没见过。  通常状况下都是采用316L抛光的管道储罐材质。   FDA提到北美的案例用PVDF材质的管道也是可以接受的。 FDA很活泛。只要能证明你的材料在预期的极端条件下运行对水的稳定性和质量不产生影响都可以。

凯博思咨询

添加的絮凝剂、消毒剂、ph调节剂之类的，要求无毒、无后续难清除残留，最好符合FDA安全卫生要求。最好不附加任何额外的东西进去。
还有就是所有的过滤滤材（石英砂、活性炭、离子交换树脂……）也要符合要求。
工艺管道、阀门管件、仪器仪表、密封材料……安装、焊接、抛光、酸洗钝化、1D-3D要求、各种工程规范……

zhengxiaorong

向楼上学习

石头968

有些材质是要符合FDA安全卫生认证的

一沙一叶

水系统的书很多找找看

bell_yong

添加的絮凝剂、消毒剂、ph调节剂之类的，要求无毒、无后续难清除残留，最好符合FDA安全卫生要求。最好不附加任何额外的东西进去。
还有就是所有的过滤滤材（石英砂、活性炭、离子交换树脂……）也要符合要求。
工艺管道、阀门管件、仪器仪表、密封材料……安装、焊接、抛光、酸洗钝化、1D-3D要求、各种工程规范……
学习！！！还有制水设备上仪表的校准。

pine

原则前面的说了。

前处理：PVC、不锈钢；
后面：不锈钢；
垫圈：EPDM， PTFE，PTFE/EPDM
其它虽然有推荐，或可以用，但一般用的少。

Piping to the pretreatment system may be copper, galvanized steel, or a suitable thermoplastic. Piping in the
pretreatment system, where high temperatures are not encountered, is usually plastic (PVC, CPVC, polypropylene,
or other material) based upon cost and corrosion resistance. Leaching from some plastics such as PVC and CPVC
may make these materials undesirable. Vessels may be Fiberglass Reinforced Plastic (FRP), lined carbon steel, or
stainless steel.
The piping and equipment in a portion of the pretreatment system may encounter high temperature (periodic heat
sanitization) or high pressure (RO plus degasification). In these portions, piping typically is stainless steel or a plastic
that can be heat sanitized, such as PVDF. Equipment designed for high pressure may be carbon steel, lined carbon
steel, stainless steel, or a high-strength plastic. Mill finish is satisfactory for these materials; electropolishing is
unnecessary.


The recommended material for contact with WFI and pure steam is 316L Stainless Steel (SS). Legacy systems
continue to operate successfully using other construction materials, such as 304 Stainless Steel (SS) or titanium;
however, these materials are relatively uncommon and rarely used for new installations.
Gasket materials in contact with WFI or pure steam normally are required to be in compliance with the Class VI
of the classification of plastics as determined in USP <88> Biological Reactivity Tests, (Reference 4, Appendix 1)
in vivo. This requirement should be assessed based on the use of the WFI product. Common sanitary gasket and
sealing materials include; blended PTFE/316LSS, PTFE, PTFE/EPDM Envelope, EPDM, and Viton. The use of solid
PTFE gaskets is not recommended for high temperature and pressure applications, as it does not have elastomeric
properties.