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对于药品冻干机隔板要求

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药机的冻干设备搁板材质均为AISI 316L 不锈钢,搁板的中空结构提供导热硅油循环通道。

The shelves are manufactured from AISI 316L stainless steel as a hollow construction that provides channels through which a silicone oil heat exchange fluid passes.

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XY-SGY系列冻干机采用新型设计的搁板,与传统设计的冻干机搁板相比有许多先进性

• 在制造时材料均匀加热,避免了D立焊接之间所产生的应力,因此在使用中搁板表现出了非常好的平整度

• 在搁板加热和制冷时,通常可以减少20%的能量消耗

• 在SIP 过程中减少了蒸汽的消耗并缩短了SIP 后的冷却时间

• 采用中空的隔条增加了搁板与硅油之间的热交换区域,这样搁板达到温度均匀状态更加快速

•搁板的制造过程是高度自动化的,重要的组装步骤是在一个受控的环境中完成的,这样可以显著地降低采用人工制造方式可能出现质量不一致的可能性

搁板采用D立的压力测试达到4barg 并使用氦质谱仪检测泄漏率达到10-7mbarl/s,搁板的平面度为0.5 mm/m。搁板采用特殊的机械抛光避免产生局部的内部应力,粗糙度达到0.4 - 0.6mmRa 并进行钝化,这个粗糙度可以既满足cGMP 所要求的洁净程度,又可以实现Z佳的热量传导,同时还将压塞后搁板粘胶塞的可能性降至Z低。

提供一块顶部补偿板,以确保上部搁板上的物料与下部搁板的物料受热条件相同。

The XY-SGY series freeze-dryer has a new design shelf, which is advanced compared to the traditional design of the freeze-dryer shelf:

 

When the material is uniformly heated in manufacture, the stress between independent welding is avoided, so the shelf shows a very good smoothness in use.

When the shelf is heated and refrigerated, the energy consumption can usually be reduced by 20%.

 

In the process of SIP, the consumption of steam is reduced and the cooling time after SIP is shortened.

 

The heat exchange area between the shelf and silicone oil is increased by using a hollow partition, so that the shelf reaches a uniform temperature state more quickly.

 

The manufacturing process of the shelf is highly automated, and the important assembly steps are completed in a controlled environment, which can significantly reduce the likelihood of a quality inconsistency that may occur in a man-made manufacturing approach

 

The shelf uses an independent pressure test to reach 4 barg and uses a helium mass spectrometer to detect a leak rate of 10-7 mbil/ s and the shelf has a flatness of 0.5 mm/ m. the shelf adopts special mechanical polishing to avoid the local internal stress, the roughness reaches 0.4-0.6mmRa and is passivated, the roughness can meet the cleanliness of the cGMP, and the optimal heat conduction can be realized, At the same time the possibility of pressing the post-plug shelf adhesive plug is minimized.

 

Provide a top compensation board to ensure that the material on the upper shelf is the same as the material on the lower shelf.

导热流体通过不锈钢软管进入到板层,软管外配有不锈钢加强编织网,软管与板层为焊接连接,并通过焊接方式与箱体后部汇流管相连,所有焊点均平整、抛光。汇流管直接焊接在箱体上,Z大限度地减少泄漏的危险。 通过采用机械支撑,

带编织网的软管比不带编织网的软管有更长的使用寿命,同时也减少了软管在加热过程中的扩张。

The heat exchange fluid is supplied to the shelves via braided stainless steel hoses that are welded to the shelves and, in turn, welded to a distribution manifold. All welds are ground smooth and polished. The manifold is in turn welded into the chamber to minimise the risk of fluid leakage. Braided hoses have a considerably longer life expectancy than non-braided hoses by providing mechanical support and eliminating hose extension during thermal cycling.

板层的侧面和后部安装护杆以防止托盘偏离,护杆材质为AISI 316L 不锈钢,与板层为焊接连接,护杆经机械抛光至小于0.6μmRa,所有焊点均抛光及钝化。

The sides and rear of each shelf are fitted with guard rails, fabricated from circular section AISI 316L stainless steel that are welded to the shelves, to ensure trays and vials are correctly positioned on the shelf. The guardrails are mechanically polished to less than 0.6mmRa. Welds are polished and passivated.

在板层组件的上部和下部装有压力板,由AISI304L 不锈钢制成。镜面抛光至小于0.6μmRa,所有焊缝都经平整。压力板采用开放式网状结构以减少重量,这样在SIP之后就缩短了降温时间并提高了清洗过程中的排水性。

Pressure plates are supplied above and below the shelf stack when the stoppering option is selected. These are fabricated in AISI 304L stainless steel and mirror finished to at least 0.6mmRa and all welds ground smooth.  The pressure plates employ an open web construction to minimise weight, thereby reducing cooldown time after SIP (if supplied) and improved drainage during cleaning.


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