JB/T 20106-2022Pharmaceutical V-type mixers (English PDF)

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules for Standardization Documents" drafting.

This document replaces JB/T 20106-2007 "Pharmaceutical V-type Mixer". Compared with JB/T 20106-2007, except for structural adjustment and editing The main technical changes other than sexual changes are as follows.

--- Deleted the term charging coefficient (see 3.2 of the 2007 edition);

--- Deleted the term mixing uniformity (see 3.1 of the 2007 edition);

--- Changed the surface roughness requirements (see 5.2.2, 5.2.2 of the 2007 edition);

--- Changed the requirements for the feed volume of the mixer (see 5.3.1, 5.3.1 of the 2007 edition);

--- Increased speed control requirements (see 5.3.3);

--- Changed the requirements and test methods for content uniformity after mixing (see 5.3.8, Appendix B, 5.3.6, Appendix B of the 2007 edition);

--- Added the requirements for the position of the outlet when the mixer is shut down (see 5.3.4);

--- Added the requirement for the output residue of the mixer (see 5.3.9).

1 Scope

This document specifies the terms and definitions, marks, requirements, test methods, inspection rules, signs, packaging, instructions for use of pharmaceutical V-type mixers. Instructions, transportation and storage.

This document applies to pharmaceutical V-type mixers (hereinafter referred to as mixers) for mixing dry powder and granular materials.

2 Normative references

The contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document.

GB/T 191 Packaging, storage and transportation icon marks

GB/T 3768 Acoustic sound pressure method Determination of sound power level of noise source Simple method using envelope measurement surface above the reflecting surface

GB/T 6388 Transport packaging receipt and delivery marks

GB/T 9969 General Rules for Instructions for Use of Industrial Products

GB/T 10111 Generation of Random Numbers and Its Application in Product Quality Sampling Inspection

GB/T 12309 Industrial Corn Starch

GB/T 13306 Signage

GB/T 13384 General Technical Specifications for Packaging of Mechanical and Electrical Products

GB/T 36035 General Requirements for Electrical Safety of Pharmaceutical Machinery

JB/T 20188-2017 Pharmaceutical machinery product model compilation method Pharmacopoeia of the People's Republic of China (2020 Edition)

3 Terms and Definitions

This document does not have terms and definitions that need to be defined.

4 Models

The model of the mixer should be compiled as follows according to the provisions of JB/T 20188-2017.

Category code. preparation machinery and equipment Function code. hybrid machinery Feature code. V type Specification code. nominal volume of mixing cylinder (L)

Example: Model ZHV1000 means a V-type mixer with a mixing cylinder with a nominal volume of 1000L.