JB/T 20007.1-2021Filling lines for oral liquid glass bottles (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 is part 1 of JB/T 20007, JB/T 20007 has issued the following parts.

---Oral liquid glass bottle filling line (JB/T 20007.1);

---Oral liquid glass bottle ultrasonic cleaning machine (JB/T 20007.2);

---Oral liquid glass bottle tunnel sterilization dryer (JB/T 20007.3);

---Oral liquid glass bottle filling and capping machine (JB/T 20007.4).

This document replaces JB/T 20007.1-2009 "Oral Liquid Glass Bottle Filling Line", compared with JB/T 20007.1-2009, except for the In addition to structural adjustments and editorial changes, the main technical changes are as follows:

--- Modified the model (see Chapter 4, Chapter 3 of the 2009 edition);

--- Deleted the requirements for the qualified rate of finished products (see 4.5.2 of the 2009 edition);

--- Modified the composition of linkage lines (see 5.1, 4.1 of the 2009 edition);

--- Modified the linkage control and test method of the linkage line (see 5.3.3, 6.3.3, 4.3.3, 5.3.3 of the 2009 edition);

--- Increased the production capacity requirements and test methods of the linkage line (see 5.3.7, 6.3.8).

Introduction

Oral liquid glass bottle filling process includes glass bottle unpacking, glass bottle cleaning, glass bottle disinfection and drying, and oral liquid sub-packaging Plugging and capping, labeling of oral liquid glass bottles, boxing and boxing of oral liquid glass bottles, etc. At present, most of the glass bottles at the front end are dismantled manually.

Completion, the back-end labeling, boxing and boxing belong to secondary packaging. Therefore, the front-end and back-end process equipment is not included in the primary packaging label of the oral liquid glass bottle. in the quasi-series. Considering that the equipment completed by each process is relatively independent but linked, if the requirements of the equipment for each process and the connection The overall requirements and test methods of the moving line are placed in one standard. The standard length is too long and it is not conducive to the detection of each equipment of the connecting line. It is intended to consist of 4 parts.

--- Part 1. Oral liquid glass bottle filling line. The purpose is to stipulate the inclusion of ultrasonic cleaners, tunnel sterilization dryers, Marking, requirements, test methods and inspection rules for the filling linkage line including each single machine of the filling and capping machine.

--- Part 2. Ultrasonic cleaning machine for oral liquid glass bottles. The purpose is to specify the ports included in the oral liquid glass bottle filling line.

Marking, requirements, test methods and inspection rules for a single machine of an ultrasonic cleaning machine for liquid glass bottles.

--- Part 3. Oral liquid glass bottle tunnel sterilization dryer. The purpose is to stipulate that the oral liquid glass bottle filling line contains The marking, requirements, test methods and inspection rules of the single machine of the oral liquid glass bottle tunnel sterilization dryer.

--- Part 4. Oral liquid glass bottle filling and capping machine. The purpose is to specify the oral liquid contained in the glass bottle filling line of oral liquid.

1 Scope

This document specifies the model, requirements, test methods and inspection rules of the oral liquid glass bottle filling line.

This document applies to the oral liquid glass bottle filling linkage line (hereinafter referred to as the linkage line).

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

GB 5749 Hygienic Standard for Drinking Water

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

JB/T 20007.2 Ultrasonic Cleaning Machine for Oral Liquid Glass Bottles

JB/T 20007.3 Oral Liquid Glass Bottle Tunnel Sterilizer Dryer

JB/T 20007.4 Oral liquid glass bottle filling and capping machine

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

YBB00022004 Borosilicate glass tube for oral liquid bottle

YBB00032004 Soda lime glass tube for oral liquid bottle

YY0131 Oral liquid bottle tear off aluminum cap 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 Models

Prepared in accordance with the provisions of JB/T 20188-2017 as follows:

Category code. preparation machinery and equipment Function code. Oral liquid agent machinery Feature code. Filling linkage line Specification code. Number of filling heads Example: ZYGX8 type. Represents an oral liquid glass bottle filling line with 8 filling heads.