1, in-place cleaning (CIP) refers to the equipment (tank, pipe, etc.) or the entire production line in the premise of no manual disassembly, under a certain time, temperature, pressure spray equipment surface to achieve the purpose of cleaning.

The pretreatment before steam disinfection is to remove soluble dust and dirt from the inner wall and shelf surface of the lyophilized box.
 

The cleaning of lyophilizer is an important means to ensure the quality of products.
 

WFI of water for injection must comply with Chinese pharmacopoeia.
 

The cleaning effect increases with the increase of the temperature of the cleaning agent. Generally, the temperature of the cleaning water is 65 ℃, the highest is 80 ℃, and the pressure is 0.3 ~ 0.5 MPa.

The flow of cleaning water is determined according to the system nozzle layout, nozzle type, spray sequence and so on.

The drainage after cleaning shall not be reused to avoid cross-contamination.

 

 

 

 

(1) Wall cleaning nozzle + four vertical nozzle tubes are arranged at the four corners of the box, as shown in Figure 1.

 

(2) wall cleaning nozzle + horizontal nozzle tube arranged at the back of the box shelf.

 

 

 

(3) Domestic has not seen with high temperature steam cleaning ".

Steam-cip is the high temperature Steam cleaning method, which not only ensures the cleaning effect of the system, but also greatly saves the water consumption for injection.

 

Its method: 1) the shelf cooling to -40 ℃, and then with pure steam for a certain temperature pressure jet, high temperature steam quickly formed water impact surface.

2) Clean the second time with normal temperature WFI water

 

 

 

(1) The comparison between the traditional cleaning method and the currently developing cleaning method is shown in Table 1.

 

(2) Close the tank internal cleaning nozzle

 

(3) Movable flat surface cleaning nozzle.

 

1) Solid cone nozzle

 

The covering area is circular and can be completely filled with spray droplets.

Similarly, solid conical cover can be obtained by using the collector arrangement of atomizing nozzles or micro-atomizing nozzles.

 

 

 

 

The liquid spray is flat fan or thin slice, and the spray section formed by fan nozzle is uniform.

This fan-shaped spray nozzle, which produces a flat edge rather than a tapering edge, is commonly used in cleaning applications where the entire section is impinged uniformly without the need for overlapping spray.

 

 

 

 

The impact force is very important under the conditions of temperature, flow rate, pressure and coverage.

 

 

 

(1) The actual cleaning impact force decreases with the increase of injection Angle, as shown in Table 2.

 

(2) Performance comparison of the two nozzles is shown in Table 3.

The application of solid fan nozzle can be considered according to the above data analysis.

 

 

 

(1) CAD aided design (including dynamic simulation), and consider the impact of the problem.

 

(2) Dynamic cleaning verification of the lyophilized box to verify the feasibility of the design scheme.