JB/T 20099-2022Pharmaceutical filter-washer-dryers (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 20099-2007 "Drug Filtration Washing and Drying Machine". Compared with JB/T 20099-2007, this standard except for the structure In addition to adjustments and editorial changes, the main technical changes are as follows.

--- Changed the terms and definitions (see 3.1, 3.1 of the 2007 edition);

--- Changed the model number (see 4.2, 4.2 of the 2007 edition);

--- Changed the design and manufacturing requirements (see 5.1, 5.1 of the 2007 edition);

--- Changed the material requirements (see 5.2, 5.2 of the 2007 edition);

--- Increased safety interlock (see 5.4.8, 5.4.9);

--- Increase the safety clearance between the stirring paddle and the mesh surface and cylinder wall (see 5.4.10);

--- Changed the quality of the filter washing and drying machine (see 5.6, 5.6 of the 2007 edition);

--- Changed the performance test (see 6.1, 6.4 of the 2007 edition);

---Deleted the remaining powder cake thickness (5.4.9 of the 2007 edition);

--- Deleted Appendix B (see Appendix B of the 2007 edition).

1 Scope

This document specifies the classification and model, requirements, test methods, inspection rules, signs, and instructions for use of pharmaceutical filter washing and drying machines. Books, packaging, transport and storage.

This document applies to pharmaceutical filter washing and drying machines (hereinafter referred to as three-in-one).

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 150.1~150.4 Pressure vessels

GB/T 191 Packaging, storage and transportation icon marks

GB/T 3768 Acoustic sound pressure method for measuring sound power level and sound energy level of noise sources adopts the simple method of enveloping the measuring surface above the reflecting surface. easy method

GB/T 4272 General Rules for Equipment and Pipeline Insulation Technology

GB/T 6388 Transport packaging receipt and delivery marks

GB 8599 Technical Requirements for Large Steam Sterilizer Automatic Control Type

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 13306 Signage

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

GB/T 36030 General Technical Requirements for Cleaning in Place and Sterilization of Pharmaceutical Machinery (Equipment)

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

JB/T 20188-2017 Pharmaceutical machinery product model compilation method

NB/T 10558 Pressure vessel coating and transport packaging

TSG21 Safety Technical Supervision Regulations for Stationary Pressure Vessels Pharmacopoeia of the People's Republic of China (2020 Edition)

3 Terms and Definitions

The following terms and definitions apply to this document.