Study on dose of irradiation sterilization
Writer: Sterilization Time: 2020-09-02 Browse: 861 ℃
Research ideas of radiation sterilization dose
Research on the product itself and packaging
-
Confirm sterilization dose
-
Validation of sterilization process
-
Verification of sterilization dose
Radiation dose setting
At present, there are three ways to determine it
Method 1
When BB > 0.1: the sterilization dose is determined by the initial contaminating bacteria, and then the selected dose meets the microbial resistance distribution after verification
According to the sterilization dose of sal10 - 2, 100 samples were sterilized, and the microbial content on the products was detected
If less than 2 samples have bacteria, accept
If 3 and 4 samples have bacteria, remove the operating factors and repeat. If confirmed, increase the dose
If more than 5, it is better to stop sterilization and reconsider other methods
If the dose fluctuation is within plus or minus 10%, the verification will fail.
Method 2:
three batches of samples, 280 samples in each batch, 840 samples in total
The first sterile sample was defined as FFP
The dose of the first sample with all sterile appearance was defined as D*
There are FFP and D * push d *, 100 samples are sterilized at this dose, and the number of positive samples is used to calculate the final sterilization dose.
Method 3
VDMAX25
When the bioburden is less than 1000.
The average bioburden of three batches of samples was calculated. Refer to table 9 to get the sterilization dose of 10-1
10 samples were sterilized, and the fluctuation of dose was acceptable within plus or minus 10%, otherwise it failed.
There must be no bacteria, and the validation must be repeated. Asepsis received 25 kGy irradiation dose.
VDMAX15
The same three batches of samples were sterilized, the average load was calculated, and the verification dose was obtained by referring to table 10
10 samples were sterilized under the verification dose, and no bacteria were found, otherwise the validation failed. Sterile received 15kgy irradiation dose.
Confirmation process of irradiation sterilization
IQ(installationqulitification)
Objective to confirm the installation of the equipment and record it.
Source introduction, building introduction, transmission structure and transmission situation, irradiation container, isolation and dose distribution
OQ(operationalqulitification)
Objective: to prove that the installed irradiation device can operate and grant appropriate dose within the standard allowable range, which can be completed by dose distribution test and determining the process related to dose distribution.
For the dose distribution test of the product container, the samples with the same properties and contaminating bacteria can be used to verify the dose.
PQ(performancequalification)
Objective: to determine the maximum and minimum distribution points of dose in the box of loading products according to the normal sterilization method. The density of the loaded product and the way of discharge are described. Confirm the performance of the product after irradiation.
Microbiological validation (ensure sterility of sterilized products)
Product performance qualification (physical, chemical and biological properties)
Confirmation of dose distribution
Confirm the product performance and dose
The frequency of sterilization dose audit shall be carried out according to Article 12.1 of iso11137-1:2006. The initial frequency is high. When the product and manufacturing experience is obtained, the sterilization dose audit time can be increased: the initial interval is 3 months, and then it can be 6 months, but the longest is no more than 12 months.
