This standard specifies the classification and labeling, requirements, test methods, inspection rules and signs, instructions for use, packaging, transportation and storage of ampoule tunnel sterilization dryers. JB 20002.3-2004 Ampoule tunnel sterilization dryer JB20002.3-2004 Standard download and decompression password: www.bzxz.net

JB | Inspection
Released on 2004-02-05
Implemented on 2004-06-01
Released by the National Development and Reform Commission
Announcement of the National Development and Reform Commission of the People's Republic of China| |tt||No. 8 of 2004
The National Development and Reform Commission approved 47 pharmaceutical equipment industry standards including the "Anshu Washing, Drying, Filling and Sealing Linkage Line", which are now announced and will be implemented from June 1, 2004 . The above standards are published by China Planning Press. Attachment: Numbers and names of 47 pharmaceutical equipment industry standards National Development and Reform Commission of the People's Republic of China February 5, 2004
Attachment:
Serial number
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3
4
5
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8
9
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47 items Pharmaceutical equipment industry standard number and name Standard number
JB 20002.1 ~ 20002.5—2004
JB20003.1~20003.5—2004
JB20004—2004
JB 20005.1—2004| |tt||JB20005.2-2004
JB 20005.3—2004
JB 20005.4—2004
JB 20006—2004
JB20007.1~20007.5—2004|| tt | |tt||JB20012—2004
JB20013—2004
JB20014—2004
standard name
ampoule washing, drying, filling and sealing linkage line
eye drops Agent linkage line
Suppository production line
Glass infusion bottle cleaning machine
Glass infusion bottle filling machine
Glass infusion bottle re-corking machine
Glass infusion bottle Capping machine
Anyan injection light inspection machine
oral liquid bottle filling linkage line
antibiotic glass bottle powder sub-packaging linkage
antibiotic glass bottle powder sub-package line Installation
Antibiotic glass bottle capping machine
Linear plunger discharge filling machine
Three-dimensional mixer
Turnover hopper mixer
Trough mixer| |tt||Double cone rotary vacuum dryer
Medicinal boiling granulator
Replaced standard number
YY0259.10259.5—1997
YY 0235.1—1995
YY0235,2-1995
YY 0235.3—1995
YY 0235.4—1995
YY0217.1~0217.5—1995
YY 0234.11995||tt ||YY 0234.2—1995
YY 0234.3—1995
YY 0225—1995
YY0219—1995
YY/T 0134—1993
Serial number
19
20| |tt||21
22
23bZxz.net
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25
26
27
28||tt ||29
30
31
32
33
34
35
36
37
38
39
40
41
Standard number
JB20015—2004
JB20016—2004|| tt | ||JB20023—2004
JB 20024—2004
JB20025—2004
JB20026—2004
JB 20027—2004
JB20028—2004||tt ||JB 20029—2004
JB 20030—2004
JB20031-2004
JB20032—2004
JB20033—2004
JB20034—2004||tt ||JB 20035—2004
JB 20036—2004
JB 20037—2004
Standard name
Wet mixing granulator
High efficiency coating Machine
Taro type coating machine
Pendant granulator
Pharmaceutical electronic counting bottle filling machine
Rotary tablet press
High speed rotary Tablet press
Tablet press tablet punching die
Aluminum plastic blister packaging machine
Automatic pill making machine for traditional Chinese medicine
Fully automatic hard capsule filling machine
Automatic production line for hollow capsules
Rolling mode soft glue machine
Jiaoxiang tablet printing machine
Hot-pressed distilled water machine
Multi-effect steaming and stuffing water machine||tt| |Pure steam generator for pharmaceutical machinery
Pharmaceutical vacuum freeze dryer
Hot air circulation oven
Pharmaceutical vortex vibration screening machine
Powder removal sieve||tt| |Extraction and concentration tank
Vacuum concentration tank
Replaced standard number
YY0256—1997
YY0253—1997
YY0222—1995
YY0220—1995
YY0221—1995
YY0020—1990
YY/T0139—1993
YY0023—1990
YY0254—1997
YY0255—1997
YY 02241995
YY/T0135—1993
YY0230—1995
YY 0229—1995
YY 0026—1990||tt| |YY 00981992
YY0258—1997
YY0024—1990
YY0025—1990
Serial number
42
43
44
45
46
47
Standard number
JB20038—2004
'B 20039—2004
JB20040 —2004
JB/T 20041—2004
JB/T20042—2004
JB/T20043—2004
Extraction tank
Standard name||tt ||Hammer crusher
Knife type particle crusher
Reciprocating medicine cutting machine
Pharmaceutical washing machine
Rotary medicine cutting machine||tt| |Replaced standard number
ZB C91 001—1988
YY0227—1995
YY0228—1995
YY 0022-1990
YY/T 0137— 1993
YY/T 0140-1993
ICS11.120.30
C92
JB
Pharmaceutical Machinery Industry Standard of the People's Republic of China JB20002.3—2004| |tt||Replacing YY0259.3—1997
Anyan tunnel sterilizing dryer
Ampouletunnelsterilizingdryer2004-02-05 release
2004-06-01 implementation
Released by the National Development and Reform Commission
Foreword
1
Scope
2 Normative reference documents
3 Classification and labeling
4| |tt||5
6
7
Requirements
Test methods
Inspection rules
Logo, instructions for use, packaging, transportation Auxiliary and storage from
times
JB20002.32004
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JB20002.3—2004
Foreword
This standard is based on GB/T1 .1-2000 "Standardization Work Guidelines Part 1: Structure and Writing Rules of Standards" and GB/T1.2-2002 "Standardization Work Guidelines Part 2: Methods for Determining the Content of Normative Technical Requirements in Standards", Revision of YY0259.3-1997 "Ampoule Tunnel Sterilization Dryer". This standard replaces YY0259.3-1997 from the date of implementation. Compared with YY0259.31997, the content of this standard has changed as follows: the quoted standard terms and content are according to the latest standards. a)
b) In order to leave more room for development of the product, this standard does not impose restrictions on its specifications and parameters. c) Added the sterilization temperature and time test in the tunnel, which includes heat distribution test and heat penetration test. d) The electrical safety performance requirements implement the mandatory provisions in CB5226.1-2002. This standard is proposed by China Pharmaceutical Equipment Industry Association. This standard is under the jurisdiction of the Pharmaceutical Equipment Industry Technical Committee. This standard is originated from Shanghai Far East Pharmaceutical Machinery Factory. The main drafters of this standard: Lin Xiaohua and Hu Shengsheng. Previous releases of the standards replaced by this standard: CB11754.2-1989, YY0259.3-1997. 22
1 Scope
Ann Tunnel Sterilization Dryer
JB20002.3 —2004
This standard specifies the classification and labeling, requirements, test methods, inspection rules and signs, instructions for use, packaging, transportation and storage of Anyan tunnel-type sterilizing dry media machines.
This standard applies to tunnel-type sterilization dryers (hereinafter referred to as dryers). 2 Normative reference documents
The provisions in the following documents become provisions of this standard through reference in this standard. For dated reference documents, all subsequent amendments (excluding corrigenda) or revisions do not apply to this standard. However, parties that reach an agreement based on this standard are encouraged to study whether they can use these documents. The latest version of. For undated referenced documents, the latest edition applies to this standard. GB/T191 Packaging, storage and transportation pictorial markings
GB5226.1-2002 Machinery Safety Machinery and Electrical Equipment Part 1: General Technical Conditions CB/T9969.1 General instructions for use of industrial products GB/T10111 Method of random sampling using random numbers GB/T13306 Label
CB/T13384 General technical conditions for mechanical and electrical product packaging 9 Method for measuring noise and sound pressure level of metal cutting machine tools CB/T16769
YY/T0216 Pharmaceutical Machinery Product Model Compilation Method JG/T19-1999 Laminar Flow Clean Workbench Inspection Standard Pharmacopoeia of the People's Republic of China (2000 Edition) National Pharmacopoeia Commission 3 Classification and Marking
3.1 Type|| tt||The dryer has an overall tunnel structure and uses the principle of hot air laminar flow sterilization to sterilize. This product can be produced in conjunction with an ultrasonic cleaning machine and a filling and sealing machine, or can be used alone. 3.2 Model and marking examples
The dryer model should comply with the relevant regulations of YYT0216. 23
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