JB/T 20079-2021Liquid filling and stoppering machines for antibiotic vials (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 of Standardization Documents" drafted.

This document replaces JB/T 20079-2006 "Antibiotic bottle liquid filling and corking machine", compared with JB/T 20079-2006, except for structural adjustment In addition to the adjustment and editorial changes, the main technical changes are as follows:

--- Modified the model (see 4.2, 3.2 of the 2006 edition);

--- Deleted working conditions (see 4.3 of the 2006 edition);

--- Deleted the requirements for the certification of instruments and meters (see 4.4.5 of the 2006 edition);

--- Deleted the fault alarm shutdown (see 4.4.10.4 of the 2006 edition);

--- Deleted the requirement for adjusting the handle (see 4.4.10.3 of the 2006 edition);

--- Modify the filling volume error requirements and test methods (see 5.3.1.3, 6.1.2.3, 4.4.1.3, 5.4.1.3 of the 2006 edition);

--- Modified the requirements for the pass rate of tampons (see 5.3.2.3, 4.4.2.3 of the 2006 edition);

--- Revised the requirements for the breakage rate of bottles (see 5.3.3, 4.4.3 of the 2006 edition);

--- Added jog function requirements and test methods (see 5.3.7, 6.1.6);

--- Modify the level 3 login authority requirements and test methods (see 5.3.9, 6.1.8, 4.4.9, 5.4.9 of the 2006 edition);

--- Modified the interlocking control requirements and test methods (see 5.3.10.1, 6.1.10.1, 4.4.10.1, 5.4.10.1 of the 2006 edition);

--- Added automatic sampling requirements and test methods (see 5.3.10.3, 6.1.10.3);

--- Added automatic rejection requirements and test methods (see 5.3.10.4, 6.1.10.4);

--- Increased the requirements and test methods for counting and production capacity (see 5.3.10.5, 6.1.10.5);

--- Increased the requirements and test methods for residual oxygen (see 5.3.10.6, 6.1.10.6);

--- Increased the requirements and test methods for operation in isolators (see 5.3.10.7);

--- Increased the requirements and test methods for operation under the air shower device (see 5.3.10.8);

--- Increased the requirements and test methods for unobstructed objects (see 5.3.10.9).

1 Scope

This document specifies the classification and model, requirements, test methods, inspection rules and signs, and instructions for use of antibiotic bottle liquid filling and corking machines Books, packaging, transportation and storage.

This document is applicable to the antibiotic bottle liquid filling and corking machine (hereinafter referred to as the filling and corking machine) for antibiotic liquid injection or freeze-dried powder injection.

2 Normative references

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

GB/T 191 Graphical signs of packaging, storage and transportation

GB/Z 2640 Molded injection bottle

GB/T 3768 Acoustic sound pressure method to determine the sound power level and sound energy level of noise sources easy law

GB/T 6388 Receipt and Delivery Marks for Transport Packaging

GB/T 9969 General Principles of Instruction Manual for Industrial Products

GB/T 10111 Generation of random numbers and its application in product quality sampling inspection

GB/T 13306 Signs

GB/T 13384 General technical conditions for packaging of mechanical and electrical products

GB/T 16292-2010 Test method for suspended particles in clean room (area) of pharmaceutical industry

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

JB/T 20175-2017 Aseptic isolator

JB/T 20188-2017 Preparation method of pharmaceutical machinery product model

YY0169.2 Butyl rubber antibiotic stopper Pharmacopoeia of the People's Republic of China (No. 78 [2020] of the National Health Commission of the State Food and Drug Administration)

3 Terms and Definitions

There are no terms and definitions that need to be defined in this document.

4 Classification and model