阿法拉伐 Pharma-line 是一种高质量的双管板壳管式换热器,专用于制药和生物行业。它有多种标准尺寸,并符合管理机构和行业实行的严格卫生标准。
应用
Pharma-line 用于制药用水系统;注射水 (WFI) 和净化水 (PW) 以及加热或冷却制药产品。
工作原理
Pharma-line 根据 FDA 准则设计。在 Pharma-line 中,双管板设计消除了产品与加热或冷却(服务)介质之间的混合风险。产品流入管件,同时服务介质在管件周围、外壳内部进行错流。服务介质通过第一个管板密封在外壳中,而第二个管板密封产品。如果发生泄漏,将很容易观察到泄漏的液体。
端板
双管板可防止产品与加热/冷却介质之间交叉污染。
Hygenic design
The Pharma-line has no dead legs and is fully drainable on the product side. All product wetted parts in the Pharma-line are either electropolished to Ra<0.5 µm, Ra<0.4 µm, Ra<0.3 µm or mechanically polished to Ra<0.8 µm. The Pharma-line tubes are seamless and U-tubes are bent to a larger radius than required in ASME BPE. The Pharma-line is easy to clean and can be steam sterilized. Gaskets come with a USP class VI certificate and are in compliance with FDA.
Documentation
The Pharma-line is delivered along with a complete documentation package including:
- Approved drawings and calculations signed by Notified body
- List of welders, welding procedure and welder qualification
- 3.1 Material certificates, pressure and product wetted steel parts
- FDA compliance and USP class VI certificates, gaskets
- Liquid penetrant test report and procedure
- Surface roughness certificate
- Dimension control report
- Pressure test certificate, signed by Notified body
- Identification (technical sign)
- Quality system certificate
- CE-Documents
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