Radiation processing quality improvement and risk management and control method based on whole-process key parameters

Abstract

The invention discloses a radiation processing quality improvement and risk management and control method based on overall process key parameters, belongs to the technical field of radiation processing quality control, and aims to solve the problem that corresponding process evidences cannot be provided during high-risk and high-quality requirements or overall process tracing of foreign regulations. The method comprises the following steps: carrying out a PQ test, obtaining a reference processing parameter and a reference absorbed dose D0, determining the reference processing parameter according to the type of irradiation equipment, putting a batch of medical products on line, and deploying real-time monitoring equipment. The real-time monitoring equipment is used for capturing key parameter measured values in the machining process according to a preset sampling frequency; according to the invention, through the monitoring granularity leap from batch compliance to single box compliance, it is ensured that the dose received by each box of products is in a strictly controlled range, and the risk of abnormal intermediate product dose caused by process fluctuation in a traditional method is fundamentally avoided; and real-time recording and long-term tracing of whole-process parameters are realized.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of radiation processing quality control, and particularly relates to a radiation processing quality improvement and risk control method based on a whole-process key parameter. BACKGROUND

[0002] Currently, mainstream equipment for industrial irradiation processing is divided into two categories, namely gamma irradiation equipment and electron accelerator irradiation equipment. The radiation sterilization of medical care products needs to select an appropriate irradiation method according to the product characteristics, loading method, risk level and cost sensitivity. Regardless of which radiation sterilization method is used, the minimum dose uses a positive deviation and the maximum tolerance dose uses a negative deviation for processing during the irradiation sterilization process. That is, the measured absorbed dose of the product cannot be lower than the minimum dose required for sterilization, and cannot be higher than the tolerance dose. Under normal circumstances, the deviation value is selected to be 5%. In order to achieve the above quality control and risk control purposes, the irradiation station usually performs IQ, OQ and PQ (installation qualification, operation qualification and performance qualification) on the irradiation processing device, calibrates the equipment that affects the dose delivery, and places dosimeters before and after the online irradiation processing of goods to meet the customer's requirements for the dose during the radiation sterilization process. Among them, IQ represents installation qualification, which is a verification process that confirms that the irradiation equipment installation meets the design requirements and the environmental conditions are suitable; OQ represents operation qualification, which is a verification process that confirms that the irradiation equipment can stably operate within the rated parameter range; PQ represents performance qualification, which is a verification process that confirms that the parameters and dose delivery accuracy of the irradiation equipment match under actual processing conditions.

[0003] The prior art usually adopts a scheme of "periodic calibration + batch head and tail dose monitoring" during the irradiation processing process: 1. Equipment calibration: the key parameters (source strength, processing time for gamma irradiation; beam intensity, scanning width for electron accelerator) that affect the dose delivery are calibrated periodically, external calibration is performed once a year, internal calibration is performed once a month, and the parameter deviation is corrected through the calibration result; 2. Dose monitoring: before and after processing of each batch of goods, dosimeters are placed at the head and tail positions of the goods to verify the batch dose compliance through the measured values of the head and tail dosimeters; 3. Risk compensation: for medical products, the theoretical delivery dose is usually corrected by 5% positive deviation to try to reduce the sterilization failure risk.

[0004] However, the prior art has significant technical defects: the batch head and tail dosimeters can only indicate the compliance of the dose at the two time points by placing dosimeters at the head and tail, and cannot indicate the compliance of the theoretical delivery dose of the products during the period, because the key parameters fluctuate during the entire irradiation processing process. Once the non-head and tail dosimeter placement points fluctuate greatly, below the minimum dose or above the tolerance dose, the existing irradiation processing cannot identify such risks.

[0005] Therefore, a radiation processing quality improvement and risk control method based on whole-process key parameters is needed to solve the problem that the existing technology cannot provide corresponding process evidence when tracing the whole process according to foreign regulations, thereby failing to meet the requirements of quality improvement, risk identification and control. SUMMARY

[0006] The purpose of the present application is to provide a radiation processing quality improvement and risk control method based on whole-process key parameters to solve the problems raised in the background.

[0007] To achieve the above-mentioned purpose, the present application provides the following technical solution: a radiation processing quality improvement and risk control method based on whole-process key parameters, comprising:

[0008] Step S1, carry out a PQ test to obtain a reference processing parameter and a reference absorbed dose D0, wherein the reference processing parameter is determined according to the type of irradiation equipment;

[0009] Step S2, put a batch of medical products online and deploy real-time monitoring equipment, wherein the real-time monitoring equipment is used to capture key parameter measured values in the processing process at a preset sampling frequency;

[0010] Step S3, based on the real-time captured key parameter measured values, dynamically calculate the theoretical absorbed dose D t (z) of each time node through a theoretical dose calculation model, and integrate the single-box average theoretical dose Dbox according to the single-box product;

[0011] Step S4, compare the deviation of Dbox and D0, if the deviation is within an acceptable range, continue processing and store the box parameter-dose data; if the deviation exceeds the range, interrupt the processing, mark the abnormal box, fine-tune the parameters and perform a test irradiation verification, and resume the processing after meeting the requirements;

[0012] Step S5, store the whole-process data in a local and cloud backup mode, support encrypted query and traceability, and the data retention period is not less than the whole life cycle of the product.

[0013] It should be noted in the scheme that the type of irradiation equipment in step S1 includes electron accelerator irradiation equipment and gamma irradiation equipment, wherein the reference processing parameters of the electron accelerator irradiation equipment include accelerator beam intensity I0, electron beam scanning width L0, and beam speed V0, and the reference processing parameters of the gamma irradiation equipment include source intensity, monitoring dosimeter position, processing time, running speed, and station dwell time.

[0014] It is further worth mentioning that the real-time monitoring equipment in step S2 includes a high-precision beam transformer for capturing beam intensity, a digital oscilloscope for converting scanning width, and a photoelectric encoder for testing beam speed.

[0015] Further need to be explained is that the calculation formula of the theoretical dose calculation model in step S3 is as follows:

[0016] D t (z)=k(z)I t ·F i / l t ·v t

[0017] Wherein, D t (z) is the theoretical absorbed dose at the t time node, I t is the beam intensity at the t time node, l t is the scanning width at the t time node, v t is the beam speed at the t time node, k(z) is the material-height constant, which is calibrated in advance by the PQ test according to the product material and the loading height z, F i is the accelerator efficiency coefficient, which is calibrated once a quarter after the device is shipped.

[0018] As a preferred embodiment, the acceptable deviation range in step S4 is set according to the product risk level, and the deviation of the risk medical product is ≤±5%; if the initial parameter deviation exceeds the range, the beam speed on the track or the processing time is preferentially fine-tuned until the deviation meets the standard; in addition, the parameter fine-tuning amplitude is that the beam speed on the track of the electron accelerator is fine-tuned by 0.1-0.5 m / min, and the gamma irradiation processing time is fine-tuned by 5-10 s; the standard dosimeter is used for trial irradiation, only one small batch verification is needed, batch processing is restored after meeting the standard, and the device alarm is triggered if the standard is not met.

[0019] As a preferred embodiment, the stored data in step S5 includes the product batch number, the processing date, the real-time curve and the original value of the key parameters, the D t (z) dynamic curve, the Dbox, the measured values of the first and last dosimeters, the abnormal records and the intervention measures, and the stored data supports the customers and the regulatory authorities to query through the encrypted account.

[0020] Compared with the prior art, the radiation processing quality improvement and risk control method based on the whole-process key parameters provided by the present application at least has the following beneficial effects:

[0021] By leaping from batch compliance to single-box compliance in monitoring granularity, the system ensures that the dose received by each box of products is within a strictly controlled range, fundamentally avoiding the risk of abnormal doses in intermediate products due to process fluctuations, a risk inherent in traditional methods. It enables real-time recording and long-term traceability of parameters throughout the entire process, meeting international regulations for traceability of radiation sterilization of medical products and facilitating product entry into the international market. Furthermore, it represents a shift from post-event detection to in-process intervention. The system can identify dose drift trends in real time and automatically correct them before a large number of non-conforming products are generated, significantly reducing quality risks and economic losses. Attached Figure Description

[0022] Figure 1 This is a schematic diagram of the radiation processing quality improvement and risk control method based on key parameters throughout the entire process according to the present invention. Detailed Implementation

[0023] The present invention will be further described below with reference to embodiments.

[0024] Reference Figure 1 As shown, this invention provides a method for improving the quality and controlling the risks of radiation processing based on key parameters throughout the entire process, including the following steps:

[0025] Step S1: Conduct PQ tests to obtain baseline processing parameters and baseline absorbed dose D0. The baseline processing parameters are determined according to the type of irradiation equipment. The baseline processing parameters of electron accelerator irradiation equipment include accelerator beam intensity I0, electron beam scanning width L0, and beam track running speed V0. The baseline processing parameters of gamma irradiation equipment include source strength, monitoring dosimeter position, processing time, running speed, and station dwell time.

[0026] Step S2: Batch medical products are launched online, and real-time monitoring equipment is deployed. The real-time monitoring equipment is used to capture the measured values ​​of key parameters during the processing at a preset sampling frequency.

[0027] Step S3: Based on the real-time captured measured values ​​of key parameters, dynamically calculate the theoretical absorbed dose D at each time point using the theoretical dose calculation model. t (z), and the average theoretical dose D per box is obtained by integrating the products in each box, and the formula is:

[0028] D t (z)=k(z)I t ·F i / l t ·v t

[0029] Wherein, k(z) is the material-height constant, which is pre-calibrated by the product material and loading height z through PQ testing; F iThe accelerator efficiency coefficient is calibrated at the factory and calibrated once per quarter.

[0030] Step S4: Compare the deviation between box D and D0. If the deviation is within an acceptable range, continue processing and store the box parameters - dose data. If the deviation exceeds the range, interrupt processing, mark the abnormal box, fine-tune the parameters and perform a trial irradiation verification. Resume processing after the deviation meets the standard.

[0031] Step S5: Store all process data using local and cloud backup methods, support encrypted query and traceability, and retain data for a period no less than the entire product lifecycle.

[0032] It can be further understood that, in step S2, the real-time monitoring equipment includes: a high-precision beam transformer (accuracy ≥ 0.01mA, sampling frequency ≥ 1Hz) for capturing beam intensity, a digital oscilloscope (sampling rate ≥ 100Hz) for converting scan width, and an optical encoder (resolution ≥ 0.1m / min, sampling frequency ≥ 1Hz) for testing beam velocity.

[0033] Furthermore, it can be understood that in step S4, the acceptable deviation range is set according to the product risk level, with deviations of ≤±3% for high-risk medical products and ≤±5% for low-risk medical products; if the initial parameter deviation exceeds the range, the orbital speed under the beam (electron accelerator) or processing time (gamma irradiation) is finely adjusted first until the deviation meets the standard.

[0034] It can be further understood that in step S4, the parameter fine-tuning range is: the electron accelerator beam speed is fine-tuned by 0.1 to 0.5 m / min, and the gamma irradiation processing time is fine-tuned by 5 to 10 s; the test irradiation uses a standard dosimeter, and only one small batch verification is required. After the standard is met, batch processing is resumed. If the standard is not met, an equipment alarm is triggered.

[0035] Furthermore, it can be understood that in step S5, the stored data includes: product batch number, processing date, real-time curves and original values ​​of key parameters, and D. t (z) Dynamic curves, D-box, measured values ​​of the first and last dosimeters, abnormal records and intervention measures, data support customers and regulatory agencies to query through encrypted accounts.

[0036] The application process of the above-mentioned radiation processing quality improvement and risk control method based on key parameters throughout the entire process is as follows:

[0037] Step 1: Conduct PQ test: Under standard operating conditions during routine processing, deploy a monitoring dosimeter and record the current irradiation processing parameters (including accelerator beam intensity, electron beam scanning width, and under-beam trajectory speed); irradiate a standard dosimeter with the above parameters and test the measured absorbed dose D0 of the dosimeter; calculate the deviation between the measured dose D0 and the theoretical dose. If the deviation is ≤ ±3% (high-risk products) or ≤ ±5% (low-risk products), then determine this set of parameters as the "baseline processing parameters"; if the deviation exceeds the range, fine-tune the under-beam speed and repeat this step until the deviation meets the standard.

[0038] Step 2: Batch medical products are loaded online according to standard loading methods, and conventional dosimeters are placed at the beginning and end of the batch; then, real-time monitoring equipment is deployed: the current value is read in real time through an external high-precision beam transformer, the scanning signal is collected through a digital oscilloscope, and the actual scanning width is converted by combining the preset scanning frequency; the track running speed is tested in real time through a photoelectric encoder installed on the power motor branch line under the beam.

[0039] Step 3: After the product enters the irradiation area, the monitoring equipment captures the beam intensity I in real time at a frequency of 1Hz. t Scan width l t Beam velocity v t (where t is the real-time point); based on the formula

[0040] D t (z)=k(z)I t ·F i / l t ·v t

[0041] Calculate the theoretical absorbed dose D at each time point. t (z); Based on "single box product", integrate all D during the processing period of that box product. t (z), calculate the average theoretical dose D of the product in the box, which will be used as the basis for judging the quality of a single box;

[0042] Step 4: If the deviation between box D and the baseline dose D0 in Step 1 is within an acceptable range, continue processing the next box of products and automatically store the "parameter-dose" data for that box; if the deviation between box D and D0 exceeds the acceptable range: 1. The system immediately interrupts processing, completes the irradiation of the current box of products, and marks the box of products as "pending re-inspection"; 2. Suspends subsequent products from entering the irradiation area, and automatically fine-tunes the beam speed (reduces the speed if the dose is too low, and increases the speed if the dose is too high, with a fine-tuning range of 0.1~0.5m / min to avoid large fluctuations); 3. After fine-tuning, conduct a small-batch trial irradiation using a standard dosimeter to verify the dose deviation under the new parameters. Once the standard is met, resume batch processing; if the trial irradiation still fails to meet the standard, the system triggers an alarm, prompting manual inspection of the equipment;

[0043] Step 5: Store all data using a "local server + cloud backup" method. Stored content includes: basic information such as product batch number, product type, processing date, and operator; parameter data; and I / O records for the entire processing process. t l t v t Real-time curves and raw data; dose data, D t (z) Dynamic curve, D-box calculation results, and measured values ​​of the first and last dosimeters; abnormal records, including the time of occurrence of the abnormality, abnormal parameters, intervention measures, and re-inspection results.

[0044] In summary, the advantages of this invention are as follows: By leaping from "batch compliance" to "single-box compliance" in monitoring granularity, it ensures that the dose received by each box of products is within a strictly controlled range, fundamentally avoiding the risk of abnormal intermediate product doses due to process fluctuations in traditional methods; it enables real-time recording and long-term traceability of parameters throughout the entire process, meeting international regulations for traceability requirements of radiation sterilization of medical products, and facilitating product entry into the international market; and it achieves a shift from "post-event detection" to "in-process intervention." The system can identify dose drift trends in real time and automatically correct them before a large number of non-conforming products are generated, significantly reducing quality risks and economic losses.

[0045] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The embodiments and descriptions in the specification are merely principles of the invention. Various changes and modifications can be made to the invention without departing from its spirit and scope, and all such changes and modifications fall within the scope of the claimed invention. The scope of protection claimed by the appended claims and their equivalents is defined.

Claims

1. A method for improving the quality and controlling the risks of radiation processing based on key parameters throughout the entire process, characterized in that, include: Step S1: Conduct PQ tests to obtain baseline processing parameters and baseline absorbed dose D0. The baseline processing parameters are determined according to the type of irradiation equipment. Step S2: Batch medical products are launched online, and real-time monitoring equipment is deployed. The real-time monitoring equipment is used to capture the measured values ​​of key parameters during the processing at a preset sampling frequency. Step S3: Based on the real-time captured measured values ​​of key parameters, dynamically calculate the theoretical absorbed dose D at each time point using the theoretical dose calculation model. t (z), and integrate the products in each box to obtain the average theoretical dose D of each box; Step S4: Compare the deviation between box D and D0. If the deviation is within an acceptable range, continue processing and store the box parameters - dose data. If the deviation exceeds the range, interrupt processing, mark the abnormal box, fine-tune the parameters and perform a trial irradiation verification. Resume processing after the deviation meets the standard. Step S5: Store all process data using local and cloud backup methods, support encrypted query and traceability, and retain data for a period no less than the entire product lifecycle.

2. The method for improving radiation processing quality and controlling risks based on key parameters throughout the entire process, as described in claim 1, is characterized in that: The irradiation equipment types mentioned in step S1 include electron accelerator irradiation equipment and gamma irradiation equipment. The reference processing parameters of the electron accelerator irradiation equipment include accelerator beam intensity I0, electron beam scanning width L0, and beam track running speed V0. The reference processing parameters of the gamma irradiation equipment include source strength, monitoring dosimeter position, processing time, running speed, and station dwell time.

3. The method for improving radiation processing quality and controlling risks based on key parameters throughout the entire process, as described in claim 1, is characterized in that: The real-time monitoring equipment mentioned in step S2 includes: a high-precision beam transformer for capturing beam intensity, a digital oscilloscope for converting scan width, and an optical encoder for testing beam velocity.

4. The method for improving radiation processing quality and controlling risks based on key parameters throughout the entire process, as described in claim 1, is characterized in that: The calculation formula for the theoretical dose calculation model mentioned in step S3 is as follows: D t (z)=k(z)I t ·F i / l t ·v t Among them, D t (z) represents the theoretical absorbed dose at time t, I t Let l be the beam intensity at time t. t The scan width at time node t, v t Let be the velocity at time t, and k(z) be the material-height constant, pre-calibrated by PQ tests based on the product material and loading height z. i The accelerator efficiency coefficient is calibrated at the factory and calibrated once per quarter.

5. The method for improving radiation processing quality and controlling risks based on key parameters throughout the entire process, as described in claim 1, is characterized in that: The acceptable deviation range mentioned in step S4 is set according to the product risk level. For high-risk medical products, the deviation is ≤ ±5%. If the initial parameter deviation exceeds the range, the running speed of the track under the beam or the processing time is finely adjusted first until the deviation meets the standard.

6. The method for improving radiation processing quality and controlling risks based on key parameters throughout the entire process, as described in claim 1, is characterized in that: The stored data in step S5 includes product batch number, processing date, real-time curves and original values ​​of key parameters, and D. t (z) Dynamic curves, D-box, measured values ​​of the first and last dosimeters, abnormal records and intervention measures, and stored data that can be queried by customers and regulatory agencies through encrypted accounts.

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