YY/T 0929.2-2018Liquid filters for medical infusion equipments - Part 2: Test method for determining candida albicans retention of 1.2µm filter (English PDF)

Foreword

YY/T 0929 "Liquid filter for infusion" is divided into two parts.

---Part 1. Decontamination filter integrity test method 1);

--- Part 2. Test method for the retention of Candida albicans with a nominal pore size of 1.2 µm. This part is the second part of YY/T 0929.

This part is drafted in accordance with the rules given in GB/T 1.1-2009.

Introduction

At present, the infusion set with the nominal pore size 1.2µm liquid filter is mainly used for the whole nutrient mixture containing fat milk, lansoprazole and other drugs.

Intravenous infusion of the substance. For fat emulsion drugs, the main function of the liquid filter is to filter out particles and bubbles. For Lansola The main function of the azole drug, the liquid filter is to filter out the sediment which may be generated during the infusion process.

The whole nutrient mixture contains carbohydrates, amino acids, lipids, vitamins, minerals and trace elements, which is a good growth ring for microorganisms. territory. Although care is taken to maintain sterility during production, formulation, and infusion, microbial contamination occasionally occurs. Among them, Candida It is the most typical contaminating microorganism. It is generally believed that the nominal pore size 1.2µm liquid filter used for infusion of the whole nutrient mixture is filtered.

In addition to particles and bubbles, it can effectively filter out Candida which may be contaminated.

The latex particle suspension filtration rate test is given in YY 0286.1 as the pass filter performance of the nominal pore size 1.2µm liquid chemical filter.

Requirements; at the same time, it should be able to pass the Candida albicans strain for the nominal pore size 1.2µm liquid filter that claims to be able to filter out Candida albicans Leave the test.

This part of YY/T 0929 gives a test method for the Candida albicans interception of a 1.2 µm nominal liquid pore filter. Because of this method It is complicated and not suitable for routine inspection. For routine inspection, refer to the liquid filter integrity test specified in YY/T 0929.1, provided that It is the prescribed bubble point depression limit that has been associated with the Candida albicans interception test.

1 Scope

This part of YY/T 0929 specifies the Candida albicans interception test method for a nominal pore size 1.2 µm liquid chemical filter.

This section applies to the microbial retention capacity of a liquid filter that claims to be able to filter out Candida albicans with a nominal pore size of 1.2 µm. Evaluation.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document. Pharmacopoeia of the People's Republic of China (2015 edition four)

3 Terms and definitions

The following terms and definitions apply to this document.

4 Method Overview

Simulate clinical use conditions to enable the specified challenge level of Candida albicans challenge suspension to be supplied under specified challenge flow and challenge time The test solution filter is challenged, and the filtrate is collected and subjected to microbiological analysis to evaluate the microbial retention capacity of the test solution filter.

5 Instruments and equipment

5.1 Peristaltic pump (or infusion pump) and associated pump tube.

5.5 Microbial filter device and matching filter bowl.

6 Reagents and materials

6.1 Whole nutrient mixture, commercially available or prepared by yourself, see 7.1.