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對(duì)于藥品凍干機(jī)隔板要求

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藥機(jī)的凍干設(shè)備擱板材質(zhì)均為AISI 316L 不銹鋼,擱板的中空結(jié)構(gòu)提供導(dǎo)熱硅油循環(huán)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.

隔板.jpg 

XY-SGY系列凍干機(jī)采用新型設(shè)計(jì)的擱板,與傳統(tǒng)設(shè)計(jì)的凍干機(jī)擱板相比有許多先進(jìn)性

? 在制造時(shí)材料均勻加熱,避免了D立焊接之間所產(chǎn)生的應(yīng)力,因此在使用中擱板表現(xiàn)出了非常好的平整度

? 在擱板加熱和制冷時(shí),通??梢詼p少20%的能量消耗

? 在SIP 過程中減少了蒸汽的消耗并縮短了SIP 后的冷卻時(shí)間

? 采用中空的隔條增加了擱板與硅油之間的熱交換區(qū)域,這樣擱板達(dá)到溫度均勻狀態(tài)更加快速

?擱板的制造過程是高度自動(dòng)化的,重要的組裝步驟是在一個(gè)受控的環(huán)境中完成的,這樣可以顯著地降低采用人工制造方式可能出現(xiàn)質(zhì)量不一致的可能性

擱板采用D立的壓力測(cè)試達(dá)到4barg 并使用氦質(zhì)譜儀檢測(cè)泄漏率達(dá)到10-7mbarl/s,擱板的平面度為0.5 mm/m。擱板采用特殊的機(jī)械拋光避免產(chǎn)生局部的內(nèi)部應(yīng)力,粗糙度達(dá)到0.4 - 0.6mmRa 并進(jìn)行鈍化,這個(gè)粗糙度可以既滿足cGMP 所要求的潔凈程度,又可以實(shí)現(xiàn)Z佳的熱量傳導(dǎo),同時(shí)還將壓塞后擱板粘膠塞的可能性降至Z低。

提供一塊頂部補(bǔ)償板,以確保上部擱板上的物料與下部擱板的物料受熱條件相同。

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.

導(dǎo)熱流體通過不銹鋼軟管進(jìn)入到板層,軟管外配有不銹鋼加強(qiáng)編織網(wǎng),軟管與板層為焊接連接,并通過焊接方式與箱體后部匯流管相連,所有焊點(diǎn)均平整、拋光。匯流管直接焊接在箱體上,Z大限度地減少泄漏的危險(xiǎn)。 通過采用機(jī)械支撐,

帶編織網(wǎng)的軟管比不帶編織網(wǎng)的軟管有更長(zhǎng)的使用壽命,同時(shí)也減少了軟管在加熱過程中的擴(kuò)張。

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.

板層的側(cè)面和后部安裝護(hù)桿以防止托盤偏離,護(hù)桿材質(zhì)為AISI 316L 不銹鋼,與板層為焊接連接,護(hù)桿經(jīng)機(jī)械拋光至小于0.6μmRa,所有焊點(diǎn)均拋光及鈍化。

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.

在板層組件的上部和下部裝有壓力板,由AISI304L 不銹鋼制成。鏡面拋光至小于0.6μmRa,所有焊縫都經(jīng)平整。壓力板采用開放式網(wǎng)狀結(jié)構(gòu)以減少重量,這樣在SIP之后就縮短了降溫時(shí)間并提高了清洗過程中的排水性。

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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