Performance verification of drying equipment and facilities

project

1）Filter leak detection

2）Suspended particle counting

3）Comparison and arrangement of temperature probes

4）No load heat distribution test

5）Full load thermal penetration test

Introduction to Testing Methods

quoteGB/T25915.3-2010/ISO14644-3:2005Cleanroom related controlled environment3Part: Detection Methods

1）Efficient filter leak detection

Before conducting the inspection, the wind speed qualification test should have been completed.

First, measure the upwind aerosol using a photometer or counter method to verify its concentration and uniformity.

If the aerosols in the downwind direction of the filter are evenly mixed, there should be no less than one aerosol concentration measurement point in the downwind direction of each filter. If the mixing is uneven, the measurement method should be changed by setting several equidistant measuring points on the downwind section of the filter inside the air duct, with intervals between the measuring points30cm~100cm, approximately from the pipe wall3cm.

To confirm the stability of aerosol dust sources, the particle concentration in the upwind direction of the filter should be repeatedly measured at appropriate time intervals.

By measuring the concentration, calculate the total particle transmittance of each measuring point in the downwind direction and the particle size adjusted by the corresponding measuring instrument.

The transmittance of all points should not exceed the rated transmittance of the particle size that is most easily transmitted through the filter5Twice. However, if a photometer is used, the transmittance should not exceed10-4（0.01%）. The supply and demand parties can negotiate to determine other acceptance limits for filtering efficiency testing.

quoteGB/T16292-2010Method for detecting suspended particles in clean rooms (areas) of the pharmaceutical industry

2）Suspended particle counting

1. Minimum number of sampling points. The minimum number of sampling points for suspended particle testing can be selected from one of the following two methods:

A) NL=in the formulaNLMinimum sampling points,AThe area of a clean room or controlled clean area, measured in square meters (㎡).

B)The minimum number of sampling points can be obtained from the table1Found in the middle.

table1

2. Location of sampling points

The location of sampling points should meet the following requirements:

A）Sampling points are generally located above the ground0.8mUniformly arranged on a high horizontal plane.

B）More than sampling points5At the moment, it can also be done above the ground0.8m～1.5mArrange in layers within a high area, but each layer should not be less than5Point.

3. Sampling frequency limit

For any small clean room or local air purification area, the number of sampling points shall not be less than2The total number of sampling times shall not be less than5Next time. The number of sampling times for each sampling point can be more than1Moreover, the number of sampling times for different sampling points can vary.

3）Comparison and arrangement of temperature probes

a.Probe calibration

――Before the experiment begins, place the dry heat probe for testing in the calibration furnace for temperature calibration, and set the low temperature probe as the low point, high point, and measurement point.

――After the experiment is completed, the dry heat probe used will be tested“low point”and“high point”Temperature review, confirm that the error of the temperature instrument after the test is not greater than0.5℃.

b.Probe arrangement

Cut the cavity into three directions respectively4Place the remaining temperature probes evenly throughout the cavity on a flat surface. Please refer to the temperature probe distribution diagram for details. All temperature probes are suspended and not in contact with the metal surface.

4）No load heat distribution test

a.Purpose: To verify the temperature of each point inside the cavity under no-load conditions, and to identify the difference between the average temperature of cold and hot spots and the average temperature inside the cavity, in order to find the no-load cold point.

b.Verification steps: Verify the10Number the temperature probe and place it in the dry heat sterilization cabinet through the device's verification interface. Cut the cavity into three directions respectively4Place the temperature probe evenly throughout the cavity on a flat surface. All temperature probes are suspended and not in contact with the metal surface.

c.According to the operating procedures of the dry heat validation system, the sampling time shall not be less than the working cycle of the dry heat sterilization cabinet, including the heating, sterilization, and cooling processes. The dry heat sterilization cabinet shall be started, and the heat distribution measurement shall be carried out under the no-load operation state of the equipment, running continuously for 3 times to confirm the reproducibility of the sterilization process.

e.result evaluation

In the experiment, the temperature area obtained by the standard probe, that is, inside the sterilizer“cold spot”The location. Specially marked as a key monitoring location for loading heat distribution and heat penetration testing.

5）Full load thermal penetration test

a.Purpose: To verify the temperature of each point inside the chamber, the difference between the average temperature of cold and hot spots and the average temperature inside the chamber under loading conditions, and to find the sterilization or heat removal effect of loading cold and hot spots.

b.Verification steps: Verify the10Number the temperature probe and place it in the dry heat sterilization cabinet through the device's verification interface. Cut the cavity into three directions respectively4Place the temperature probe evenly throughout the cavity on a flat surface. All temperature probes are suspended and not in contact with the metal surface.

c.According to the operating procedures of the dry heat validation system, the sampling time shall not be less than the working cycle of the dry heat sterilization cabinet, including the heating, sterilization, and cooling processes. The dry heat sterilization cabinet shall be started, and the heat distribution measurement shall be carried out under the no-load operation state of the equipment, running continuously for 3 times to confirm the reproducibility of the sterilization process.

e.If it is found during the experiment that the temperature distribution does not meet the standard, the sterilizer should be adjusted or repaired. Usually, the air flow condition can be improved by adjusting the inlet air, return air, and circulating windshield. When the test meets the standard, it should run continuously3To demonstrate the reproducibility of the process.

f.result evaluation

◆The evaluation of cold spots and temperature uniformity in the loading heat distribution is the same as that of the unloaded heat distribution. But the location of the cold spot may be different and should be marked for key monitoring in future use.

◆Under each loading method, the experimental results reached the coldest point for sterilizing the itemsFhThe value shall not be less than the set value of the sterilization program.