Bioburden

Sterilization of medical devices -Microbiological methods-Part1: Determination of a population of microorganisms on products GB/T 19973.1-2015;

Sterilization of health care products- Microbiological methods-Part:1 Determination of a population of microorganisms on products ISO 11737-1: 2018 EN ISO 11737-1 2018;

CP 2020 PART IV Nonsterile pharmaceutical microbial limit inspection: microbial counting method General 1105;

USP, MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: MICROBIAL ENUMERATION TESTS USP43-NF38 87;

Removal of microorganisms from product and transfer of

removed microorganisms to culture medium followed by

incubation and enumeration.

Sterility Test

Sterilization of medical devices-Microbiological methods-Part 2:Test of sterility performed in the definition, andmaintenance of a sterilization process GB/T 19973.2-2018;

Test methods for infusion, transfusion, injection equipment for medical use. Part2: Biological test methods GB/T 14233.2-2005;

Sterilization of health care products-Microbiological methods-Part2: Test of sterility performed in the definition,validation and maintenance of a sterilization process ISO 11737-2:2019 EN IOS 11737-2:2020; 

CP 2020 PART IV sterility test General 1101;

USP,STERILITY TESTS USP43-NF38 71;

1. Direct immersion of product in culture medium or addition of culture  medium to product, followed by incubation. The product shall be immersed in the culture media for the duration of the incubation time where possible.

2. Removal of microorganisms from product and transfer of

removed microorganisms to culture medium followed by

incubation.

3.Filtration of liquid products by immersion of the filter in

culture medium followed by incubation.

 Determination of a population of microorganisms on products

Sterilization of medical devices -Microbiological methods-Part:1 Determination of a population of microorganisms on products GB/T 19973.1-2015;

Sterilization of health care products- Microbiological methods-Part:1 Determination of a population of microorganisms on products ISO 11737-1: 2018 EN ISO 11737-1: 2018;

CP 2020 PART IV Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests General 1105;

CP 2020 PART IV Microbiological Examination of Nonsterile Products: control bacteria inspection method General 1106;

USP. MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: MICROBIAL ENUMERATION TESTS USP43-NF38 61;

USP. MICROBIOLOGICAL EXAMINATION NONSTERILE PRODUCTS: TESTS FOR SPECIFIED MICROORGANISMS USP43-NF38 62;

Removal of microorganisms from product and transfer of

removed microorganisms to culture medium followed by

incubation, characterization, enumeration.

Bacterial endotoxins test

Medical gloves for single use: Requirements and testing for biological evaluation YY/T 0616.1-2016 5.1;

Test methods for infusion, transfusion, injection equipment for medical use. Part 2: Biological test methods GB/T 14233.2-2005 4;

CP 2020 PART IV Bacterial endotoxins test General 1143;

Medical gloves for single use- Part 3: Requirements and testing for biological evaluation EN 455-3: 2015;

USP, BACTERIAL ENDOTOXINS TEST USP43-NF38 85;

1. Gel method:

The gel-clot technique is used for detecting or quantifying endotoxins based on clotting of the lysate reagent in the presence

of endotoxin. The minimum concentration of endotoxin required to cause the lysate to clot under standard conditions is the

labeled sensitivity of the lysate reagent.

2. Dynamic chromogenic method: 

The kinetic-chromogenic assay is a method to measure either the time (onset time) needed to reach a predetermined absorbance

of the reaction mixture, or the rate of color development.

Bioburden

12

Sterility Test

Direct Inoculation

22 for CP,  11 for ISO

Membrane Filtration

22

 Determination of a population of microorganisms on products

12

Bacterial endotoxins test

Gel method

4

Dynamic chromogenic method

4