CN-122016842-A - On-line detection system for production cleanliness of medical materials

CN122016842ACN 122016842 ACN122016842 ACN 122016842ACN-122016842-A

Abstract

The invention relates to the technical field of online detection, in particular to an online detection system for the production cleanliness of medical materials, which comprises a surface characteristic acquisition module, a cleanliness judging module, a thermodynamic characteristic acquisition module, a process stability judging module and a process correction module, wherein the surface characteristic acquisition module is used for acquiring surface characteristic parameters of target materials so as to analyze surface characteristic values, the cleanliness judging module is used for determining whether the cleanliness of the target materials subjected to cleaning and siliconizing and sterilizing treatment meets the standard or not, the thermodynamic characteristic acquisition module is used for acquiring thermodynamic characteristic parameters of the target materials so as to analyze thermodynamic characteristic values when the cleanliness of the target materials does not meet the standard, the process stability judging module is used for determining whether a temperature sensor of a pulsation vacuum sterilizing cabinet meets the standard or not, and the process correction module is used for determining the regulating range of the atomization pressure and the sterilizing temperature of silicone oil. The invention improves the accuracy of the on-line detection of the cleanliness of the medical material.

Inventors

ZHANG JIANMING
PAN MINGHUI
WANG QIANG
HU WU
LIU JUAN
HAN XUEJUAN
SHANG ERDONG
WU TONG

Assignees

宁波汉科医疗器械有限公司

Dates

Publication Date: 20260512
Application Date: 20260407

Claims (10)

1. An on-line detection system for the production cleanliness of medical materials, comprising: The surface characteristic acquisition module is used for acquiring surface characteristic parameters of the target material subjected to the cleaning, siliconizing and sterilizing treatment in a history period; The cleanliness judging module is used for analyzing the surface characteristic representation value based on the surface characteristic parameter, and determining whether the cleanliness standard of the target material after the cleaning, siliconizing and sterilizing treatment meets the standard or not based on the comparison result of the surface characteristic representation value and a preset surface characteristic representation threshold value; The thermodynamic characteristic acquisition module is used for acquiring thermodynamic characteristic parameters in a sterilization period of the target material in response to the cleanliness of the target material which is subjected to the cleaning, siliconizing and sterilization treatment is out of the standard; the process stability judging module is used for analyzing the thermodynamic characteristic characterization value based on the thermodynamic characteristic parameter, and determining whether a temperature sensor of the pulsation vacuum sterilization cabinet meets the standard or not based on a difference value result of the thermodynamic characteristic characterization value and a preset thermodynamic characteristic characterization threshold value; The process correction module is used for determining that the siliconizing is uneven and determining the adjustment amplitude of the atomization pressure of the silicone oil if the temperature sensor of the pulsation vacuum sterilization cabinet meets the standard; Determining that the sterilization temperature is insufficient if the temperature sensor of the pulsating vacuum sterilization cabinet does not meet the standard, and determining the adjustment amplitude of the sterilization temperature based on the difference result of the thermodynamic characteristic characterization value and the preset thermodynamic characteristic characterization threshold value; wherein the surface characteristic parameters comprise puncture chip quantity, surface insoluble particle quantity and yellowness index change value; The thermodynamic characteristic parameters comprise an F 0 value accumulated deviation value and extremely poor temperature uniformity.
2. The online detection system of medical material production cleanliness according to claim 1, wherein the cleanliness determination module analysis surface feature characterization value is determined based on a sum of a first feature definition characterization parameter, a second feature definition characterization parameter, and a third feature definition characterization parameter, wherein, The first characteristic limiting characterization parameter is the ratio of the puncture chip quantity to a preset puncture chip quantity threshold value; The second characteristic defining a characterization parameter that is a ratio of the amount of surface insoluble particulates to a predetermined surface insoluble particulate amount threshold; the third characteristic defines a characterization parameter as a ratio of a yellowness index variation value to a predetermined yellowness index variation threshold.
3. The system of claim 2, wherein the cleanliness determination module is configured to determine that the target material cleanliness compliance with the cleaning silicidation and sterilization process is standard-compliant, if the surface feature characterization value is less than a predetermined surface feature characterization threshold.
4. The system of claim 3, wherein the cleanliness determination module is configured to determine that the cleanliness of the target material after the cleaning, siliconizing and sterilizing process is not standard-compliant, and wherein the surface feature characterization value is greater than or equal to a predetermined surface feature characterization threshold.
5. The online detection system of medical material production cleanliness according to claim 4, wherein the process stability determination module is configured to analyze thermodynamic characteristic characterization values based on a sum of a first process definition characterization parameter and a second process definition characterization parameter, wherein, The first process limiting characterization parameter is the ratio of a preset F 0 value accumulated deviation threshold value to a F 0 value accumulated deviation value; The second process defines a characterization parameter as a ratio of a predetermined temperature uniformity margin threshold to a temperature uniformity margin value.
6. The on-line detection system of medical material production cleanliness according to claim 5, wherein the process stability determination module determines that the temperature sensor of the pulsating vacuum sterilization cabinet meets a standard condition that a difference between the thermodynamic characteristic characterization value and a predetermined thermodynamic characteristic characterization threshold is greater than a predetermined difference threshold.
7. The on-line detection system of medical material production cleanliness according to claim 6, wherein the process stability determination module determines that the condition that the temperature sensor of the pulsating vacuum sterilization cabinet does not meet the standard is that the difference between the thermodynamic characteristic characterization value and the predetermined thermodynamic characteristic characterization threshold is less than or equal to a predetermined difference threshold.
8. The on-line detection system of medical material production cleanliness according to claim 7, wherein the process modification module determines that the condition of the silicone oil atomization pressure adjustment amplitude is that the temperature sensor of the pulsating vacuum sterilization cabinet meets the standard.
9. The on-line detection system of medical material production cleanliness according to claim 8, wherein the process modification module determines that the condition for adjusting the sterilization temperature amplitude is that the temperature sensor of the pulsating vacuum sterilization cabinet does not meet the standard.
10. The on-line detection system of medical material production cleanliness according to claim 9, wherein the process modification module is configured to determine a sterilization temperature adjustment level based on a difference between the thermodynamic characteristic characterization value and a predetermined thermodynamic characteristic characterization threshold.

Description

On-line detection system for production cleanliness of medical materials Technical Field The invention relates to the technical field of online detection, in particular to an online detection system for the production cleanliness of medical materials. Background In the process of cleaning, siliconizing and sterilizing medical materials such as medical elastomer, the surface cleanliness of the medical materials directly influences the use safety and compliance of the medical materials. The existing medical material cleanliness detection mode is mainly used for carrying out single detection on parameters such as surface foreign matters, particles and the like, cannot comprehensively consider multiple key surface characteristics such as puncture falling scraps, insoluble particles, yellowness index change and the like, is difficult to comprehensively and accurately reflect the cleanliness standard-reaching state of the medical material, when the cleanliness is unqualified, the prior art cannot be generally combined with thermodynamic parameters in a sterilization process to carry out root analysis, whether unqualified reasons are caused by uneven siliconization process or caused by unstable process factors such as F 0 value deviation, abnormal temperature uniformity and the like in the sterilization process, so that the process regulation is lack of pertinence and strong blindness, and a comprehensive calculation, grading judgment and closed-loop correction mechanism is not formed based on historical period data, so that the cleanliness online detection is insufficient, the process correction response is lagged, and the high-efficiency, accurate and traceable online cleanliness management and control requirements of the medical material production process are difficult to meet. Chinese patent publication No. CN116934763A discloses a medical rubber plug defect detection method based on visual characteristics, which comprises the steps of obtaining a gray scale range of a defect area according to a rubber plug gray scale histogram, obtaining a defect connected domain, obtaining a plurality of iteration windows with different sizes, obtaining an objective function of the iteration windows, obtaining a brightness contrast parameter of the defect connected domain according to the objective function of the iteration window, obtaining a standard deviation of the optimal Gaussian filter core according to the brightness contrast parameter of the defect connected domain, obtaining an optimal Gaussian filter core of the defect connected domain, obtaining a burr defect rate of a rubber plug edge image according to a rubber plug edge image and a template edge image, and finishing defect detection according to the burr defect rate of the rubber plug edge image. According to the invention, under the condition of ensuring less distortion of the medical rubber plug image, noise of the medical rubber plug image is filtered, and the accuracy of detecting the rubber plug defects is improved. Chinese patent publication No. CN110694996A discloses a cleaning process of a high-cleanliness butyl rubber plug. The method comprises the steps of accurately weighing a butyl rubber plug, removing hair, fibers and other fine solid impurities attached to the surface of the butyl rubber plug due to electrostatic action through an electrostatic hair impurity removing machine, placing the rubber plug into a charging barrel of a full-automatic butyl rubber plug cleaning machine through an automatic feeding device, feeding water to a shuffling water level, adding cleaning agent, spraying high-cleanliness nitrogen gas into the bottom of the cleaning machine for shuffling, controlling water temperature, closing an air injection device after shuffling is finished, opening a water inlet valve, standing overflow, opening the air injection device, spraying high-cleanliness nitrogen gas, spraying air for overflow rinsing, closing the water inlet valve air injection device, opening the air injection device after water is discharged to a siliconizing water level, spraying high-cleanliness oxygen-enriched air, adding a proper amount of silicone oil for siliconizing, conveying the siliconizing rubber plug into a microwave oven through a conveying belt, and introducing the high-cleanliness nitrogen gas for drying. Disclosure of Invention Therefore, the invention provides an online detection system for the production cleanliness of medical materials, which is used for solving the problems that in the prior art, the online detection scene for the cleanliness of the medical elastomer rubber plug in the production process is low in accuracy because foreign matter residues on the surface of the rubber plug and material aging abnormality cannot be distinguished due to aging response deviation of a temperature sensor. To achieve the above object, the present invention provides an on-line detection system for production cleanliness of medical materials, comprising: T