对于一台制药型冻干机的前舱有哪些组成和要求

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对于一台制药型冻干机的前舱有哪些组成和要求

CHAMBER箱体                                    

对于SIP、CIP 设备标准的箱体材料为AISI 316L。优化设计使箱体内不仅易于接近同时尽量减少死角。

The freeze dryer chamber is a rectangular section, wetted surfaces are made from AISI 316L stainless steel.  The construction is optimised to provide adequate access to components within the chamber whilst minimising dead volumes.

箱体内部圆角半径>20mm,箱体底部略有倾斜以利于排水。排水口装有可拆卸的保护网,可以防止较大的异物进入排水口。

The internal corners of rectangular chambers have a radius >20mm and the floor of the chamber is pitched in two planes to ensure drainage. The drain connection is fitted with a removable screen, to prevent large objects entering the drain.

 

所有内部焊接均被处理与周围材料平滑。箱体内表面机械抛光至<0.4μmRa。

All internal welds are ground smooth and flush with the surrounding material. The internal surfaces of the chamber are mechanically polished to <0.4mmRa.

 

 所所有接管的焊接均被处理与周围材料平滑并抛光。

接口略有倾斜以保证液体排空完全,长径比小于等于6:1,完全符合行业的标准要求。

Nozzle welds are ground smooth and flush with the surrounding material, radiused and polished.

Nozzles are pitched to ensure drainage of liquids and have an aspect ratio equal to or less than 6:1, in accordance with typical industry practice.

与箱体直接连接的法兰使用填丝焊焊接并使用与箱体相同的材料,焊缝经过平整、抛光。

Flanges mounted directly to the chamber are fillet welded using the same material as the chamber. The fillet is ground smooth, polished to the same finish as surrounding material.

提供一个直径150mm (6") 可照明的观察镜,安装在箱体侧面。

One illuminated sight glass of 150mm (6”) diameter is supplied being fitted to the side of the chamber.

在箱体的开口处四周安装有一个304L 板,以确保密封在洁净间的墙上。箱门的开门在洁净间内。穿墙板抛光<0.75μmRa 。

箱体的外表面采用聚合发泡材料保温。箱体外覆金属板以保护保温材料。

The periphery of the chamber opening has a 304L bezel to enable the equipment to be sealed into the wall of a clean room, such that the chamber opens into the clean room. The bezel is mirror polished to <0.75mmRa.

The external surfaces of the chamber are insulated with a polymer foam. All chambers are clad with sheet metal to protect t he insulation material.

箱体.jpg

CHAMBER DOOR 箱门

箱门为方形,对于SIP、CIP 设备标准的箱门材料为AISI 316L。 箱门的铰链位于面向箱门的左侧(根据要求也可以安装在右侧),箱门可以开启90 度。箱门内表面机械抛光镜面<0.4μmRa。

箱门四周装有硬硅胶垫,适合真空和压力密封。

箱门的保温采用聚合发泡材料,外覆AISI304L 不锈钢拉丝板,外罩板光洁度小于0.75μmRa。

箱门通过手柄关闭,用于真空状态。

箱门上安装一个直径 150mm (6") 带照明的视镜。

The door of the chamber is rectangular and fabricated from stainless steel AISI 316L grade. The door is hinged according to layout and may be opened 90°. The interior surface of the door is mechanically polished to a mirror finish of  <0.4mmRa.

The chamber door has a solid silicone seal located around the periphery of the door, suitable for vacuum and pressure applications.

The door is insulated externally with a polymer foam insulation and clad with a satin finish, AISI 304L stainless steel cover of <0.75mmRa.

The door is closed by use of a manual latch (or latches as required) for vacuum applications.

A 150mm (6") diameter, remotely illuminated sight glass is installed on the door.


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