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SIP (sterilization in place) - Steam Method

Views:107     Author:Robin     Publish Time: 2021-04-23      Origin:Site

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.

The main methods of SIP:

(1) physical method: steam method - superheated water method - hot water method

At the same temperature, the effect of wet heat sterilization is better than dry heat sterilization, high temperature water vapor has a high penetration of protein, accelerate protein denaturation;

(2) chemical method: disinfectant method;

Steam process conditions: disinfection process -121℃ for 20-30min;

Production and application of steam method: maintain 20-30min at 125-130℃.

Ⅰ. Application principles:

(1) Positive pressure that the system can withstand: 121℃-1.049bar

135 ℃ to 2.131 bar 145 ℃ - 3.155 bar;

(2) The components and sealing materials in the system can withstand high temperature;

(3) The components in the system cannot withstand chemicals or superheated water (such as gas sterilizing filters);

(4) the system space is large, the use of hot water can’t guarantee to cover all corners (such as aseptic tank).

Ⅱ. The choice of steam source:

1.Ordinary industrial steam

(1) The saturated steam has higher heat content, greater heat penetration and better sterilization effect;

(2) wet saturated steam with moisture, low heat content, poor penetration, sterilization effect is not good;

(3) the temperature of superheated steam is higher than that of saturated steam, but the penetration is poor and the sterilization efficiency is low;

(4) Impurities in the pipeline will cause pollution to the system.

2.Clean steam

The steam obtained after the industrial steam is filtered by precision filter;

(1) Choose a reasonable filter material;

(2) Choose a reasonable filter matching level and final precision;

(3) effectively remove the condensate in the industrial steam.

3. Food-grade steam

The steam prepared by heating the purified water with industrial steam;

Steam output pressure: 0.3Mpa;

Pure steam temperature: 140℃;

Heating steam pressure: 0.6Mpa.



III. System design and installation

(1) In the design and installation of the system, the dead Angle of condensed water should be reduced or avoided;

(2) The system must be designed and installed with a reliable sterilization temperature detection and recording device;

(3) The temperature detection device must be installed at the lowest point of the process temperature of the system;

(4) The program should be designed reasonably, with air discharge in the system as the core point; Because the heat conduction of air is lower than that of steam, the cold air will hinder the contact and heat exchange between steam and surface.

IV. Key points of operation and quality control

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

(2) Develop a reasonable sterilization method of "exhaust - heating - heat preservation - cooling";

Exhaust: to ensure the effective discharge of air;

Temperature rise and heat preservation: to ensure the effective discharge of steam condensate water;

Insulation: ensure to kill microorganisms;

Cooling: ensure the positive pressure of the system, to ensure that the outside air containing bacteria is not inhaled into the system during the cooling process, causing secondary pollution;

(3) Reliable and accurate process parameter record.

5. Application cases

(1) Sterile compressed air sterilization filter steam method;


(2) Sterile tank steam method;


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