June 29, 2021
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);
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;
(2) Microbial smear method:
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.
Author: Robin