该快速冷却灭菌柜严格按照GMP标准设计制作,主要用于制药行业对玻璃瓶装大输液、口服液产品进行高温蒸汽灭菌操作和冷却、清洗处理。
对于输液类产品,需要高温状态来杀灭细菌的芽孢,同时又要尽量减少高温灭菌对产品本身的影响,特别是对温度较为敏感的产品尤甚。因此,快速升温灭菌及灭菌后快速冷却是程序控制出现后最早提出的概念。而“快速冷却灭菌柜”很好地解决了这个问题。
输液产品是温度与压力比较滞后性较大的品种,初期产品测温点采样并不精确。该快速冷却灭菌柜采取实测输液温度来达到精确控温,确保灭菌当量值(F0值)达到工艺要求,同时保证冷却阶段真正达到安全的冷却温度。在整个工作过程中,确保所有参数在设定的工艺下运行。
该设备采用微机触摸屏人机界面操作设定系统,西门子PLC全程检测控制。F0值与温度时间双重测控确保灭菌效果,灭菌报表由打印机输出以存档备案。
该设备工作过程中采用循环水与蒸汽混合加热的工作方式,确保温度的均匀性。灭菌后通过逐步冷却循环水对输液降温,安全可靠。整个工作过程控制在90分钟左右,最终产品冷却温度控制在60℃以下。(冷却温度可以根据环境温度作适当调整)
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)