JB/T 20007.3-2021Tunnel sterilizing dryers 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 3 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 20007.3-2009 "Glass Bottle Tunnel Sterilization Dryer for Oral Liquids", which is consistent with JB/T 20007.3-2009 In addition to comparisons, structural adjustments and editorial changes, the main technical changes are as follows:

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

--- Modified the appearance quality requirements and test methods (see 5.2, 4.2 and 5.2 of the 2009 edition);

--- Increased structural requirements and test methods (see 5.3.1);

--- Modified the temperature fluctuation range (see 5.3.3, 4.3.2 of the 2009 edition);

--- Increase the temperature difference requirements and test methods in the no-load high temperature section (see 5.3.4, 6.4);

--- Modified the sterilization quality requirements and test methods (see 5.3.11, 6.10, 4.3.9, 5.3.10 of the 2009 edition);

--- Added operation authority requirements and test methods (see 5.3.12);

--- Increased laminar wind requirements and test methods (see 5.3.13);

--- Increased the heating time requirements and test methods (see 5.3.14, 6.11).

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 consists of four 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 classification and model, requirements, test methods, inspection rules, signs, use of tunnel sterilizers for oral liquid glass bottles Instructions, packaging, transportation and storage.

This document applies to tunnel sterilization dryers (hereinafter referred to as dryers) for sterilizing and drying oral liquid glass bottles.

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/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 25915.3-2010 Cleanrooms and related controlled environments - Part 3: Testing methods

GB/T 36035-2018 General requirements for electrical safety of pharmaceutical machinery

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 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