GB/T 36756-2018General requirements for activity detection of reagent enzymes (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

Introduction

The tool enzyme is a system for cleavage, ligation, synthesis (amplification), modification, and the like of biological molecules such as nucleic acids, proteins, sugars, and lipids.

It is used in biomedical and life science related fields such as genetic engineering, enzyme engineering, protein engineering, and cell engineering. Formulating tool enzyme activity The determination of national standards for general requirements to promote the industrialization of tool enzymes is of great significance for the production and application of tool enzymes.

1 Scope

This standard specifies the general requirements for laboratory enzyme activity determination, general requirements for material reagents and reference materials, general sampling requirements, General requirements for sample preparation, general requirements for enzyme activity determination methods, test quality assurance, test reports and sample retention.

This standard applies to the determination of the enzyme activity of the tool in the process of scientific research, production and application.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB/T 6682 Analytical laboratory water specifications and test methods

General requirements for GB/T 27025 testing and calibration laboratory capabilities

3 General requirements for laboratories

3.1 The laboratory shall comply with the provisions of GB/T 27025.

3.2 The design of the laboratory should be compatible with the testing requirements. There should be sufficient space to avoid confusion and cross-contamination, and there should be sufficient areas. The field is used for sample disposal, storage of samples, and record keeping.

3.3 If necessary, a special instrument room should be set up to protect the instrument with high sensitivity from static electricity, vibration, electromagnetic waves, moisture and other factors.

4 General requirements for materials, reagents and reference materials

4.1 The experimental consumables, reagents and reference materials should be purchased from the manufacturer or supplier approved by the qualification agency, and if necessary, the supplier Evaluation; key reagents, if necessary, should be quality checked before use.

4.2 Chemical reagents should meet at least analytical purity requirements; biochemical reagents should be free of hybrid enzyme contamination; primers used should be PCR grade and/or HPLC Level; probe should be HPLC grade.

Note: PCR is an abbreviation of Polymerase Chain Reaction (PCR). HPLC is high performance liquid chromatography (HighPer- Abbreviation for formanceLiquidChromatography, HPLC).

4.3 The test water should meet at least the requirements of GB/T 6682 secondary water.

4.4 When preparing the solvent, the name, concentration, preparation time, storage conditions, expiration date and formulator's name should be indicated on the container.

5 General sampling requirements

5.1 The sampling process should ensure that the products and products are not contaminated.

5.2 Sampling equipment should be clean and disinfected if necessary.

5.3 Sampling should be representative. When multi-packaging, the sampling rules of Table 1 should be used.