GB/T 38499-2020Evaluation method for stability of disinfectant (English PDF)

3.1 Valid period

Under the specified storage conditions, the stability of the disinfectant can be guaranteed to meet the required period.

3.2 stability

The ability of disinfectant to continue to be used effectively after being stored under prescribed conditions.

Note. The storage stability is often determined by measuring the content of the effective ingredient that kills microorganisms or the change of the ability to kill microorganisms.

3.3 Stereotyped packaging disinfectant

Packaging products whose materials and packaging conditions are consistent with those of the marketed products.

3.4 Accelerated test

Through supernormal conditions such as heating, humidification, and light, the chemical and physical changes of the disinfectant are accelerated, and the observation time of the test is shortened to speculate its

Methods of stability results.

3.5 Long-term test

Disinfectant under the specified conditions [temperature 25°C±2°C, relative humidity (60±10)% or temperature 30°C±2°C, relative humidity (65±5)%]

Or the method of determining its stability after storage under the storage conditions indicated in the instructions.

3.6 Strong light exposure test

For the new active ingredient products, the disinfectant is irradiated with the prescribed light conditions, and the method is used to determine its stability.

3.7 Illuminance

The luminous flux irradiated on a surface element at a point divided by the area of the element.

Note. The unit is Lux (lx) (1lx=1lm/m2).

3.8 Active ingredients

In disinfectant formulations, substances that have a killing effect on pathogenic microorganisms.

4.1 Requirements for samples to be tested

4.1.1

The samples to be tested should be 3 batches of the same product with complete packaging.

4.1.2

The sample to be tested should be a batch-produced stereotyped packaging disinfectant product. If the product is packaged in a large barrel with restricted test conditions, it should be used instead

To simulate a small package, its packaging material and packaging conditions should be consistent with the inner packaging of the large barrel package.

4.2 Requirements for equipment

4.2.1 Constant temperature and humidity box

temperature fluctuations should be controlled within the set temperature ± 2 °C, relative humidity fluctuations should be controlled within the set relative humidity

Within ±5%.

4.2.2 Light test chamber

Temperature fluctuations should be controlled within ±2°C of the set temperature, and relative humidity fluctuations should be controlled within ±5%.

The degree should be able to reach 4500lx±500lx.

5.1

The stability test is divided into accelerated test, long-term test and strong light irradiation test according to storage conditions.

5.2

Accelerated testing can be used to initially determine the validity period of the product as a basis for marketing.

5.3

The result of the long-term test is used as the final basis for the actual validity period of the disinfectant. For example, the product has passed the accelerated test but failed the corresponding long-term

For the test, the validity period should be determined according to the results of the actual long-term test; if the product fails the accelerated test, but has passed the corresponding long-term test, the

The test results determine the validity period.

5.4

If new raw materials are sampled as the effective ingredients of the disinfectant, a strong light irradiation test should be carried out, and the test proves that the disinfectant is unstable to light

Light-proof packaging should be used.

6.1

The stability test is divided into chemical method and microbiological method according to the determination method.

6.2

When determining the stability of disinfectants, chemical methods are preferred to determine changes in the content of active ingredients, and microbiological methods can also be used.

6.3

In the application of chemical methods, unstable disinfectants such as peracetic acid, hydrogen peroxide, chlorine dioxide, sodium hypochlorite, etc.

The drop rate should be <=15%, and the drop rate of the effective ingredient content of other disinfectants should be <=10%, and the effective ingredient content after storage should not be lower than the product manufacturer.

The industry standard specifies the lower limit of the content.

6.4

When applying the microbiological method, there should be no significant change in the microbial killing effect before and after storage. There is no obvious change in the effect of killing microorganisms

Refers to the disinfectant that only uses the original solution, the killing effect of the microorganisms after storage can maintain the disinfection qualified level or more; for the use after dilution

The shortest time required to kill microorganisms to reach disinfection qualification after storage is less than or equal to kill the same microorganisms before storage to achieve disinfection.

The shortest time required to pass the poison.

6.5

In addition to determining the content of active ingredients or the effect of killing microorganisms, the color change of the disinfectant should also be observed and recorded; and the liquid should be disinfected.

The drug should be observed and recorded for precipitation or suspension, and the appearance of the tablet should be observed and recorded whether it is intact. Records of changes in traits should be written in

Test Report. Changes in physical properties should meet the requirements of product enterprise standards.

7.1 Accelerated test

7.1.1 Storage method

See Table 1 for the prediction of the validity period of disinfectants under different storage conditions.

Solid disinfectants require a relative humidity of 75%±5%, and liquid disinfectants do not require relative humidity.

7.1.2 Testing method

Determine the effective ingredient content of the disinfectant before and after storage according to the chemical method, or determine the disinfectant kill before and after storage according to the microbiological method

Microbial capacity.

7.1.3 Evaluation method

7.1.3.1

When the content of active ingredients or the ability to kill microorganisms meets the requirements of 6.3 or 6.4, the validity period of the product shall be initially determined according to Table 1.

7.1.3.2

Under the accelerated test conditions, the content of the effective ingredients of the disinfectant does not meet the requirements of 6.3 or the ability to kill microorganisms does not meet the requirements of 6.4

When requested, the validity period of the disinfectant will not be determined temporarily, and the long-term test method should be tested to determine the validity period.

7.2 Long-term test

7.2.1 Storage method

Place the sample to be tested at a temperature of 25°C±2°C, relative humidity (60±10)% or a temperature of 30°C±2°C, relative humidity 65%±5% constant

Store for 12 months in the temperature and humidity box or under the storage conditions marked in the instructions (for liquid disinfectants such as solutions or suspensions, relative humidity is not required.

degree). Those who still need to observe after 12 months can be stored until the end of the observation. Adopt storage conditions of 25°C±2°C or 30°C±2°C,

It is up to the company to decide. If storage conditions of 25°C±2°C are used, the product label and manual should be marked with "Avoid high temperature" or "In a cool place

Descriptive text such as "Save".

7.2.2 Detection method

Before storage and at the 3rd, 6th, 9th and 12th months after storage, the content of the effective ingredients of the disinfectant before and after storage was determined according to the chemical method.

Or according to the microbiological method to determine the disinfectant's ability to kill microorganisms before and after storage. If you still need to observe after 12 months,

Put it in the 18th and 24th months and thereafter every 12 months to sample for testing, until the active ingredient content or the ability to kill microorganisms is lower than the relevant standard requirement.

7.2.3 Evaluation method

The validity period of the disinfectant is determined by the maximum storage time that the content of the active ingredient meets 6.3 or the ability to kill microorganisms meets the requirements of 6.4.

7.3 Strong light exposure test

7.3.1 Storage method

Place 3 batches of solid samples to be tested or their raw materials in an open petri dish with a thickness of <=5mm, and place the liquid samples to be tested

In a 250mL colorless transparent ground bottle, the filling volume should be 80% of the volume of the ground bottle, close the lid tightly, and then place it in a strong light test box.

Store for 10 days under the conditions of illuminance of 4500lx±500lx, temperature of 25°C±2°C, and relative humidity of (60±10)%.

7.3.2 Detection method

Determine the effective ingredient content of the disinfectant before and after storage according to the chemical method, or determine the disinfectant kill before and after storage according to the microbiological method

Microbial capacity.

7.3.3 Evaluation method

After being irradiated with strong light, when the content of active ingredients does not meet the requirements of 6.3 or the ability to kill microorganisms does not meet the requirements of 6.4, it is light unstable

Set disinfectant.

7.4 Chemical method

7.4.1

The content of effective ingredients of various disinfectants can be determined in accordance with methods such as 2.2 in the "Disinfection Technical Specifications" (2002 Edition).

7.4.2

For each batch of samples to be tested, one sample is tested, and each sample is tested twice, and the average value is taken as the effective ingredient content of the batch of samples.

the amount. According to formula (1), calculate the relative average deviation of 3 batches of samples to be tested. If the relative average deviation between batches is <=5%, take the average of 3 batches

The average value is used as the judgment basis; if the relative average deviation between batches is >5%, the largest average deviation is used as the judgment basis.

7.4.3

If there is no national and industry inspection method for the effective ingredient content, it can be implemented according to the enterprise standard.

7.5 Microbiological method

7.5.1

Mix the 3 batches of samples to be tested stored in accordance with the prescribed method and sample them according to 2.1 in the "Disinfection Technical Specification" (2002 Edition)

The method detects the ability of various disinfectants to kill microorganisms.

7.5.2

In the microbial killing test, the indicator microorganisms used should be the most resistant of the microorganisms to be killed in the instruction manual.

7.5.3

For disinfectants that only use the original solution for disinfection, after storage, still use the original solution of the disinfectant to conduct a microbial killing test; perform the test after dilution

The disinfectant disinfectant is tested for killing microorganisms, and the dilution factor before and after storage should be the same.

7.5.4

The action time and other test conditions of the microbial killing test after storage shall be the same as the microbial killing test before storage.