Small evaluation on cleaning, disinfection and sterilization (I)

Small evaluation on cleaning, disinfection and sterilization (I)

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one

The crawling chemical indicator card (Class V card) in the pressure steam sterilization package must be printed with the sterilization temperature calibration value and time calibration value.

 

Analysis: gb18282 1 Chemical indicators for sterilization of medical and health products Part 1: General rules 5.4 each indicator shall be clearly marked with the process type applicable to the intended use, including the category of the indicator, and the calibration value for category III, IV, V and VI indicators. If the size and specification of the indicator do not allow these information to be marked in fonts of six characters per centimeter or larger, these information shall be provided on the label and / or in the instruction manual.

two

Low temperature steam formaldehyde sterilization refers to injecting steam formaldehyde at a temperature lower than 60 ℃ under positive pressure and maintaining it for a certain time under stable conditions to meet the sterilization requirements.

 

Analysis: WS / t651-2019 evaluation requirements for medical low-temperature steam formaldehyde sterilization indicators 3.1 when the temperature is lower than 85 ℃, after forcibly discharging the air, inject steam formaldehyde under negative pressure. After the sterilized articles are exposed to steam formaldehyde, maintain it for a certain time in a stable state to meet the sterilization requirements.

three

The spores of the biological indicator used in the medical low-temperature steam formaldehyde sterilizer are Bacillus stearothermophilus or microorganisms proved to have resistance and meet the requirements of is011138-5. The D60 value of Bacillus stearothermophilus spores should be ≥ 4.0min. Other microorganisms should have a D value that meets the service conditions.

Analysis: D60 value should be ≥ 6.0min. When reading the test report of biological indicator, pay attention to whether D60 meets the requirements.

four

The requirements for biological indication resistance of ethylene oxide sterilization are as follows: when exposed to ethylene oxide concentration of 400mg / L ± 30mg / L, temperature of 54 ℃ ± 1 ℃ and relative humidity of 60% ± 10%, the D value is greater than or equal to 1min, and the tested D value is within ± 10%.

 

Analysis: the concentration of ethylene oxide is 600mg / L ± 30mg / L, the D value is greater than or equal to 2.5min, and the tested D value is within ± 20%.

five

The parameter value of ethylene oxide sterilization refers to one (or several) specific values used to control the ethylene oxide sterilization process, in which time, temperature and ethylene oxide concentration are defined as key parameters, and others are non key parameters.

 

Analysis: the key parameters are time, temperature, ethylene oxide concentration and relative humidity.

six

In bag sterilization effect indicator: this kind of chemical indicator is used in the sterilization package to directly reflect the sterilization status of the monitored position (one or more) in the package.

 

seven

Process indicators can be printed on packaging materials or appear on self-adhesive labels, bags, packaging tapes (packaging tapes), tags, plug-in labels, etc.

 

eight

The crawling chemical indicator card (Class V card) in the pressure steam sterilization package must be printed with the sterilization temperature calibration value and time calibration value.

 

Analysis: these indicators are very important, but the test reports of many pressure steam sterilization five indicator cards are often incomplete. If there are missing items, it can be regarded as incomplete test reports, and the manufacturer needs to provide a complete report again.

nine

Additional requirements for the detection of integrated indicators of pressure steam sterilization (i.e. five types of indicators), including: the calibration value time at 121 ℃ shall be specified and shall not be less than 16.5min; The temperature coefficient of the integrated indicator shall not be less than 6 ℃ and not more than 14 ℃, and the curve correlation coefficient established through the data analysis of the least squares regression curve shall not be less than 0.9.

Analysis: it should be expressed as D value of 121 ℃, i.e. d121.

ten

For the identification of chemical indicator card, in addition to paying attention to its change into qualified color when reaching the required sterilization temperature and time, it must also observe whether it will not become qualified color when not reaching the required sterilization temperature and time. From the perspective of preventing unqualified sterilization, the latter is more important. Therefore, in the test, the temperature and time group lower than the sterilization requirements must not be omitted.

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Post time: Mar-23-2022