制藥網(wǎng)
詳細介紹
詳細介紹
主要應(yīng)用
The main application
本產(chǎn)品采用濕熱滅菌的方法，對需要進行終端滅菌的樣品進行充分滅菌，以保證產(chǎn)品無菌程度達到行業(yè)標準或要求。廣泛應(yīng)用于食品、日化、制藥等行業(yè)。
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.
簡介
Brief Introduction
本產(chǎn)品適用于已經(jīng)制備好，且裝入至特定規(guī)格容器內(nèi)的需滅菌樣品的滅菌。通過對滅菌用水加熱，使其達到121℃（或更高），通過輸送泵和噴淋球?qū)⒓訜岷玫倪^熱水對樣品進行加熱滅菌，提高無菌保證水平，使SAL≤10-6，從而達到有效的滅菌效果。
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.
滅菌過程中盛裝樣品的容器固定于可旋轉(zhuǎn)的滅菌夾具中，可保證樣品的均勻受熱，從而保證滅菌的均一性。滅菌系統(tǒng)中設(shè)置有特定的溫度監(jiān)控點，可對滅菌全過程的溫度進行有效監(jiān)控和修正，輸出滅菌曲線，確保滅菌效果。
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.
關(guān)于F0值
About F0 Value
F0值系指在滅菌過程中驗證濕熱滅菌可靠性的比較參數(shù)。規(guī)定濕熱滅菌參比溫度為121℃，以特別耐熱的嗜熱脂肪芽孢桿菌為微生物指示劑，將不同溫度和時間折算到相同滅菌效力121℃濕熱滅菌所相當(dāng)?shù)臅r間（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.
滅菌決策樹
STERILIZATION DECISION TREE
技術(shù)特點
Technical Characteristics
滅菌方式：濕熱滅菌
Sterilization method: wet-heat sterilization
滅菌夾具：可旋轉(zhuǎn)，確保各樣品受熱均勻
Sterilization fixture: rotatable to ensure uniform heating of samples
溫度儀表數(shù)量：＞3個
Number of Temperature Instruments: ＞3
溫度測量：0~150℃，±0.1℃
Temperature measurement: 0~150℃, ±0.1℃
總功率：7.5kW
Total power: 7.5kW
適用樣品總?cè)莘e：10ml~2000ml
Total Volume of Applicable Samples: 10ml~2000ml
樣品數(shù)量：1~10個
Number of samples: 1~10
gao耐壓：0.3Mpa
Maximum pressure tolerance: 0.3Mpa
數(shù)據(jù)：監(jiān)控并輸出工藝參數(shù)數(shù)值及曲線（如溫度、壓力、F0值、時間、轉(zhuǎn)速、流量等）
Data: Monitor and output process parameter values and curves (such as temperature, pressure, F0 value, time, speed, flow rate, etc.)
法規(guī)符合性：符合GMP、FDA等衛(wèi)生級、數(shù)據(jù)及驗證要求
Compliance of Regulations: Complying with GMP, FDA and other health level, data and validation requirements.
操作：全自動化操作
Operation: Fully automatic operation.
modify the temperature of the whole sterilization process, output sterilization curve and ensure the sterilization effect.
數(shù)據(jù)輸出界面
Data Output Interface
制藥網(wǎng)