該快速冷卻滅菌柜嚴(yán)格按照GMP標(biāo)準(zhǔn)設(shè)計(jì)制作，主要用于制藥行業(yè)對(duì)玻璃瓶裝大輸液、口服液產(chǎn)品進(jìn)行高溫蒸汽滅菌操作和冷卻、清洗處理。
對(duì)于輸液類產(chǎn)品，需要高溫狀態(tài)來(lái)殺滅細(xì)菌的芽孢，同時(shí)又要盡量減少高溫滅菌對(duì)產(chǎn)品本身的影響，特別是對(duì)溫度較為敏感的產(chǎn)品尤甚。因此，快速升溫滅菌及滅菌后快速冷卻是程序控制出現(xiàn)后最早提出的概念。而“快速冷卻滅菌柜”很好地解決了這個(gè)問(wèn)題。
輸液產(chǎn)品是溫度與壓力比較滯后性較大的品種，初期產(chǎn)品測(cè)溫點(diǎn)采樣并不精確。該快速冷卻滅菌柜采取實(shí)測(cè)輸液溫度來(lái)達(dá)到精確控溫，確保滅菌當(dāng)量值（F0值）達(dá)到工藝要求，同時(shí)保證冷卻階段真正達(dá)到安全的冷卻溫度。在整個(gè)工作過(guò)程中，確保所有參數(shù)在設(shè)定的工藝下運(yùn)行。
該設(shè)備采用微機(jī)觸摸屏人機(jī)界面操作設(shè)定系統(tǒng)，西門(mén)子PLC全程檢測(cè)控制。F0值與溫度時(shí)間雙重測(cè)控確保滅菌效果，滅菌報(bào)表由打印機(jī)輸出以存檔備案。
該設(shè)備工作過(guò)程中采用循環(huán)水與蒸汽混合加熱的工作方式，確保溫度的均勻性。滅菌后通過(guò)逐步冷卻循環(huán)水對(duì)輸液降溫，安全可靠。整個(gè)工作過(guò)程控制在90分鐘左右，最終產(chǎn)品冷卻溫度控制在60℃以下。（冷卻溫度可以根據(jù)環(huán)境溫度作適當(dāng)調(diào)整）
The rapid cooling sterilization cabinet is designed and manufactured in strict accordance with GMP standards, and is mainly used for high temperature steam sterilization, cooling and cleaning of glass bottled infusion and oral liquid products in the pharmaceutical industry.
For infusion products, high temperature is required to kill bacterial spores, while minimizing the impact of high temperature sterilization on the product itself, especially for products sensitive to temperature.Therefore, rapid heating sterilization and rapid cooling after sterilization were the earliest concepts proposed after the emergence of program control.And the "rapid cooling sterilization cabinet" solved this problem well.
Infusion product is a kind of product with lag between temperature and pressure, and the sampling of temperature measuring point of initial product is not accurate.The rapid cooling sterilization cabinet adopts the measured infusion temperature to achieve accurate temperature control, to ensure that the sterilization equivalent value (F0 value) meets the process requirements, and to ensure that the cooling stage truly achieves a safe cooling temperature.During the whole working process, ensure that all parameters operate under the set process.
The equipment adopts the computer touch screen human-machine interface operation setting system, Siemens PLC full-range detection and control.Dual measurement and control of F0 value and temperature and time ensure sterilization effect, and sterilization report is output by printer for archiving.
The equipment adopts the working mode of mixing heating of circulating ** and steam to ensure the uniformity of temperature.After sterilization, cooling the infusion by gradually cooling the circulating ** is safe and reliable.The whole working process is controlled in about 90 minutes, and the final product cooling temperature is controlled below 60 C.(Cooling temperature can be adjusted appropriately according to ambient temperature)
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