产品描述：

主要应用

The main application

本产品采用湿热灭菌的方法，对需要进行终端灭菌的样品进行充分灭菌，以保证产品无菌程度达到行业标准或要求。广泛应用于食品、日化、制药等行业。

This equipment uses the method of wet-heat sterilization to sterilize the samples which need terminal sterilization, so as to ensure that the sterility degree of the product meets the industry standards or requirements. It is widely used in food, daily chemical, pharmaceutical and other industries.

简介

Brief Introduction

本产品适用于已经制备好，且装入至特定规格容器内的需灭菌样品的灭菌。通过对灭菌用水加热，使其达到121℃（或更高），通过输送泵和喷淋球将加热好的过热水对样品进行加热灭菌，提高无菌保证水平，使SAL≤10-6，从而达到有效的灭菌效果。

This equipment is suitable for sterilizing samples that have been prepared and are loaded into specific specifications of containers. Heating the sterilized water to 121℃ (or higher) and then spray on the sample containers for sterilization. The superheated water is sprayed by conveying pump and spray ball. This can improve the sterility assurance level and make SAL less than 10-6, so as to achieve the perfect sterilization effect.

灭菌过程中盛装样品的容器固定于可旋转的灭菌夹具中，可保证样品的均匀受热，从而保证灭菌的均一性。灭菌系统中设置有特定的温度监控点，可对灭菌全过程的温度进行有效监控和修正，输出灭菌曲线，确保灭菌效果。

In the sterilization process, the container containing the sample is fixed in the rotating sterilization fixture, which can ensure the uniformity of the sample heating, thus ensuring the uniformity of the sterilization. There are specific temperature monitoring points in the sterilization system, which can effectively monitor and modify the temperature of the whole sterilization process, output sterilization curve and ensure the sterilization effect.

关于F0值

About F0 Value

F0值系指在灭菌过程中验证湿热灭菌可靠性的比较参数。规定湿热灭菌参比温度为121℃，以特别耐热的嗜热脂肪芽孢杆菌为微生物指示剂，将不同温度和时间折算到相同灭菌效力121℃湿热灭菌所相当的时间（分），此值即F0值。

F0 value refers to the comparative parameters used to verify the reliability of wet-heat sterilization in the sterilization process. The reference temperature of hygrothermal sterilization is 121℃, and Bacillus stearothermophilus with special heat resistance is used as microbial indicator. The different temperatures and times are converted to the equivalent time (minutes) of hygrothermal sterilization at 121℃ with the same sterilization efficacy, which is F0 value.

灭菌决策树

STERILIZATION DECISION TREE

技术特点

Technical Characteristics

• 灭菌方式：湿热灭菌

  Sterilization method: wet-heat sterilization

• 灭菌夹具：可旋转，确保各样品受热均匀

  Sterilization fixture: rotatable to ensure uniform heating of samples

• 温度仪表数量：＞3个

  Number of Temperature Instruments: ＞3

• 温度测量：0~150℃，±0.1℃

  Temperature measurement: 0~150℃, ±0.1℃

• 总功率：7.5kW

  Total power: 7.5kW

• 适用样品总容积：10ml~2000ml

  Total Volume of Applicable Samples: 10ml~2000ml

• 样品数量：1~10个

  Number of samples: 1~10

• **耐压：0.3Mpa

  Maximum pressure tolerance: 0.3Mpa

• 数据：监控并输出工艺参数数值及曲线（如温度、压力、F0值、时间、转速、流量等）

  Data: Monitor and output process parameter values and curves (such as temperature, pressure, F0 value, time, speed, flow rate, etc.)

• 法规符合性：符合GMP、FDA等卫生级、数据及验证要求

  Compliance of Regulations: Complying with GMP, FDA and other health level, data and validation requirements.

• 操作：全自动化操作

  Operation: Fully automatic operation.

modify the temperature of the whole sterilization process, output sterilization curve and ensure the sterilization effect.

数据输出界面

Data Output Interface