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Medium detection method

Medium detection method

2022-07-13

For a long time, the road of domestic medium testing has been bumpy. As some domestic media suppliers have invested more and more energy in the R&D and production of media, many excellent products have gradually surpassed imported brands and become the mainstream, which also allows us to see the hope of domestic brands.

What are the environmental control factors and techniques for cleanroom testing in bioburden testing?

What are the environmental control factors and techniques for cleanroom testing in bioburden testing?

2022-07-25

What are the environmental controls and techniques for cleanroom testing in bioburden testing? With the continuous advancement of science and technology, the production environment of the clean room, including indoor environment and outdoor environment, is particularly important. The following editor will explain the specific content of bioburden testing clean room testing.

What are the standards and tests for cleanroom inspections for bioburden testing?

What are the standards and tests for cleanroom inspections for bioburden testing?

2022-08-02

What are the standards and tests for bioburden testing in clean rooms? 1. Bioburden testing Whether the clean room test complies with the specified standards should meet the following standards: 1. The air supply volume of the clean room is sufficient to dilute or eliminate indoor pollution. 2. The air in the clean room flows from the clean area to the area with poor cleanliness, the flow of polluted air reaches a low level, and the air flow at the door and indoor buildings is correct. 3. The air supply in the clean room will not significantly increase indoor pollution. 4. The movement state of the indoor air can ensure that there is no high-concentration gathering area in the secret room. If the cleanroom meets the requirements of the above guidelines, its particle concentration or microbial concentration (if necessary) can be measured to ensure that it meets the specified cleanroom standards. 2. Testing of clean room standards for bioburden detection 1. Air supply and exhaust air volume: If it is a turbulent flow clean room, its air supply and exhaust air volume must be measured. If it is a one-way clean room, measure its wind speed. 2. Interval airflow control: To prove that the direction of the airflow in the interval is correct, that is, from the clean area to the poor clean area, you should check: (1) The pressure difference in the interval is correct; (2) The airflow at the door or openings on walls and floors. Move in the right direction, i.e. from a clean area to an area with poor cleanliness.

How to ensure the accuracy of microbial test results in bioburden testing? How to do?

How to ensure the accuracy of microbial test results in bioburden testing? How to do?

2022-08-12

How to ensure the accuracy of microbial test results in bioburden testing? How to do? In the process of bioburden detection and microbial inspection, it is necessary to ensure the cleanliness of the testing environment (such as ultra-clean platform, testing room) and the instruments used, and at the same time ensure the standardization of personnel's operations, try to ensure its sterility, and prevent human errors If the result is wrong, it should be cultivated at a suitable temperature to provide a basis for reasonable decision-making and production guidance. In order to ensure the accuracy of the test results, we should do the following. 1. Every time you prepare, pay attention to whether the production date is within the shelf life, check the date of opening the bottle and the sealing of the bottle mouth to ensure that there is no deterioration or moisture absorption. 2. When preparing the culture medium, the weighing must be accurate, including the packaging of the saline. 3. Make sure that the prepared medium is sterilized now, and the unsterilized prepared medium cannot be stored for a long time, let alone overnight. 4. When sterilizing, it is necessary to ensure constant temperature and pressure, and at the same time ensure effective sterilization time. 5. The sterilized culture medium should be stored in the refrigerator for one week, generally no more than 3 days. Moreover, the principle of "first in, first out" must be followed, and the first to be prepared is used first. 6. When using, the root

Bioburden testing Key criteria related to bioburden

Bioburden testing Key criteria related to bioburden

2022-08-25

Bioburden Detection The effectiveness of irradiation sterilization depends on the amount and type of bioburden on the product. Therefore, the bioburden must be measured when determining the sterilization dose, periodically on a daily basis, and at dose audits. Once the development of bioburden or type of enterprise changes, it may lead to the failure of the sterilization dose audit and affect the effectiveness of the original sterilization dose that can be set.

Bioburden testing Key criteria related to bioburden

Bioburden testing Key criteria related to bioburden

2022-08-25

Irradiation Sterilization of Medical Devices (6) Bioburden Detection Bioburden Detection The effectiveness of radiation sterilization depends on the amount and type of bioburden on the product. Therefore, it is necessary to measure the bioburden when determining the sterilization dose, and measure it regularly every day Bioburden, and measure the bioburden during dose audit. Once the development of bioburden or type of enterprise changes, it may cause the failure of sterilization dose audit and affect the effectiveness of the original sterilization dose. Therefore, in daily operation management In the process, various social factors that may affect bioburden need to be controlled, such as materials, production and living environment, production process, product market structure, composition, etc. When these factors change, their impact on bioburden needs to be carefully evaluated. Bioburden detection The main standards related to bioburden are as follows: GB/T 19973.1-2015 ISO 11737-1: Microbiological methods for sterilization of medical devices 2006 Part 1: Determination of total microbial load on products GB/T 19973.2-2018 idt ISO 11737 -2:2009 Sterilization of medical service devices - Microbiological research methods - Part 1: Definition, validation and maintenance of sterilization processes

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