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SIP(sterilization in place)

Views:86     Author:Robin     Publish Time: 2021-06-22      Origin:Site

Overheated water method, hot water method, disinfectant method

Application objects: equipment and pipelines in contact with the product;

The purpose of application: to prevent the product from being polluted twice, to reduce the microbial load of disinfection and sterilization.


Overheated water method

I. Process conditions:

(1) Technical specification for disinfection: 20-30min at 121℃;

(2) Production and application: 125-130℃ for 20-30min.


II. Application principles:

(1) The system can withstand pressure (the pressure gauge at 121℃ shows 1.049bar;135℃ pressure gauge shows 2.131bar);

(2) The components and sealing materials in the system can withstand high temperature (the enthalpy of superheated water is less than that of steam at the same temperature);

(3) The system space is easily filled with liquid.


Ⅲ. Operation and quality control points:

(1) To ensure the accuracy and reliability of the process temperature detection device; Calibrate the temperature detection device regularly;

(2) Exhaust the air in the system to ensure that the liquid is filled with the entire system;

(3) Develop a reasonable sterilization formula of "heating - heat preservation - cooling";

(4) Reliable and accurate process parameter record.


IV. Verification method:

(1) Evaluate the disinfection and sterilization effect according to national standards;

(2) Common verification methods (temperature test paper method);

temperature test 1

V. Application cases:

Pre-sterilization operation of sterile UHT system.


Method of hot water

I. Process conditions:

(1) Pasteurization: above 85℃ sterilization for 30min;

(2) HTST: 93-95℃ for 30sec.


II. Application principles:

(1) The system cannot withstand the positive pressure;

(2) The system does not want to be exposed to chemicals;

(3) The system only wants to achieve disinfection function.


Ⅲ.Operation and quality control points:

(1) To ensure the accuracy and reliability of the process temperature inspection device, calibrate the temperature detection device regularly;

(2) Exhaust the air in the system to ensure that the liquid is filled with the entire system;

(3) Develop a reasonable sterilization formula of "heating - heat preservation - cooling";

(4) Reliable and accurate process parameter record.


IV. Verification method:

Common verification methods :(1) Temperature test paper method;

temperature test 2

(2) Microbial smear method:

Microbial smear

V. Application cases:

(1) Pre-deployment of system hot water method SIP;

85 ℃ ~ 93 ℃ for 10 ~ 15 min;

(2) Hot water method SIP of hot filling system;

Hot filling UHT;

Hot filling machine;

83 ℃ ~ 95 ℃ for 20 ~ 30 min.


Disinfectant method

I. Process conditions:

Determination of disinfectant varieties:

(1) Broad-spectrum and high efficiency;

(2) Little corrosion to equipment;

(3) Stability;

(4) Concentration of disinfectant;

(5) Temperature of disinfectant;

(6) Action time of disinfectant.


II. Application principles:

(1) The system cannot withstand the positive pressure;

(2) The system wants to achieve sterilization function;

Three, operation and quality control points:

(1) Before operation, the system must be guaranteed to go through a reliable CIP to remove the oil film on the surface;

(2) To ensure the accuracy and reliability of the process temperature detection device; Calibrate the temperature detection device regularly;

(3) Ensure that during the SIP process:

- The concentration of disinfectant should be controlled within the range required by the process;

- Temperature control within the range of process requirements;

- It is better to use "re-timing" or "cumulative timing" as appropriate;

(4) In the process of disinfectant washing, to avoid secondary pollution;

(5) Reliable and accurate process parameter record.


IV. Verification method:

Common verification methods:

(1) Stability test of disinfectant;

(2) Disinfectant disinfection intensity test; 

Hot filling machine;

83 ℃ ~ 95 ℃ for 20 ~ 30 min.


V. Application cases:

(1) Aseptic production line:

- Blowing cover sterile compressed air pipe disinfection method SIP;

- Flask (cover) sterile water pipe disinfection method SIP;

- POAA: 2000~25000ppm 60~65℃ for 15min.

(2) Medium temperature hot filling production line:

- Blowing cover sterilized compressed air pipe disinfectant method SIP;

- Flask (cover) sterile water pipe disinfection method SIP;

- UHT outlet and filling machine material channel;

- You jie: 0.2% at room temperature for 15min;

- Chlorine dioxide: 200ppm at room temperature for 15min.


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