This standard specifies the classification and labeling, requirements, test methods, inspection rules and signs, instructions for use, packaging, transportation and storage of ampoule filling and sealing machines. JB 20002.4-2004 Ampoule filling and sealing machine JB20002.4-2004 Standard download and decompression password: www.bzxz.net

JB | Machine
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||2004 No. 8
The National Development and Reform Commission approved 47 pharmaceutical equipment industry standards including the "Ancyan 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: 47 pharmaceutical equipment industry standard numbers and names National Development and Reform Commission of the People's Republic of China February 5, 2004
Attachment:
Serial number
47 pharmaceutical equipment Industry standard number and name Standard number
JB20002.1~20002.5—2004
2
3
4
5
6| |tt||7
8
9
10
11
12
13
14||tt ||15
16
17
18
JB20003.1~20003.52004
JB 20004—2004
JB 20005.1—2004| |tt||JB 20005.22004
JB 20005.3—2004
JB 20005.4—2004
JB 20006—2004
JB20007.1~20007.5—2004
JB 20008.1 — 2004 ||tt | ||JB20012—2004
JB20013—2004
JB20014—2004
Standard name
Anyan washing, drying, filling and sealing linkage line
Eye drops linkage Line
Suppository production line
Glass infusion bottle cleaning machine
Glass infusion bottle filling machine
Glass infusion bottle turning machine
Glass infusion bottle rolling machine Capping machine
An injection light inspection machine
Oral liquid bottle filling linkage line
Antibiotic glass bottle powder dispensing linkage line
Antibiotic glass bottle powder dispensing machine| |tt||Antibiotic glass bottle capping machine
Linear plunger filling machine
Three-dimensional mixer
Turnover hopper mixer
Pick-type mixer|| tt||Double-dimensional rotary vacuum dryer
Medicinal boiling granulator
Replaced standard number
YY0259.1~0259.5—1997
YY 0235.1— 1995
YY 0235.21995
YY 0235.3--1995
YY 0235.4--1995
|YY0234.2—1995
YY 0234.3—1995
YY0225—1995
YY0219—1995
YY/T 0134—1993
Serial number
19
20|| tt||21
22
23
24
25
26
27
28||tt| |29
30
31
32
33
34
35
36
37
38||t t||39
40
41
Standard No.
JB20015—2004
JB200162004
JB20017—2004
JB20018-2004
JB200192004
JB20020—2004
JB20021—2004
JB20022—2004
JB 20023—2004
JB 20024—2004
JB 20025—2004
JB 20026—2004
JB 20027—2004
JB 20028—2004||tt ||JB200292004
JB 20030—2004
JB20031—2004
JB20032—2004
JB20033—2004
JB 20034—2004
JB20035—2004
JB 20036—2004
JB 20037—2004
Standard Name
Wet Mixing Granulator
High Efficiency Coating Machine
Taro Coating Machine
Oscillating granulator
Electronic medicine counting and bottling machine
Rotary tablet press
High-speed rotary tablet press
Tablet press tablet punching die
Aluminum-plastic blister packaging machine
Chinese medicine automatic pill making machine
Fully automatic hard capsule filling machine
Hollow capsule automatic production line
Rolling mode soft Rubber-fired engine
Capsule and tablet printer
Hot-pressed distilled water machine
Multi-effect distilled water machine| |tt||Pharmaceutical machinery pure steam generator
Medicinal vacuum freeze dryer
Hot air circulation oven
Medicinal vortex vibration sieving machine
Powder removal sieve| |tt||Extraction concentration tank
Vacuum concentration tank
Replaced standard number
YY0256—1997
YY0253—1997
YY0222—1995|| tt||YY0220—1995
YY0221—1995
YY0020—1990
YY/T0139—1993
YY 0023—1990
YY0254—1997
YY0255—1997
YY0224—1995
YY/T0135—1993
YY0230—1995
YY0229—1995
YY0026—1990
YY0098——1992
YY0258—1997
YY 0024—1990
YY0025—1990
Serial number
42
43
44
45
46||tt ||47
Standard No.
JB20038—2004
'B 20039—2004
JB20040—2004
JB/T20041—2004||tt| |JB/T20042—2004
JB/T 20043—2004
Extraction tank
Standard name
Hammer mill
Knife type granulating mill
Reciprocating medicine cutting machine|| tt||Medicine washing machine
Rotary medicine cutting machine
Replaced standard number
ZB C91 001—1988
YY0227—1995
YY0228— 1995
YY0022-1990
YY/T 0137—1993
YY/T 0140-1993
ICS11.120.30
C92
JB
Pharmaceutical Machinery Industry Standard of the People's Republic of China JB20002.4—2004
Replaces YY0259.4— 1997
Ampoule filling and sealing machine
sealingmachine2004-02-05issuedwwW.bzxz.Net
2004-06-01implemented
National Development and Reform Commissionissued
Foreword
Scope
Normative references| |tt||2
Classification and marking
3
4 Requirements
5
Test methods
Inspection rules||tt| |6
Marking, instruction manual, packaging, transportation and storage list
Time
JB 20002.42004
32
33
33
33
34
35
36
36| |tt||31
JB20002.4—2004
Foreword
This standard is based on GB/T1.1-2000 "Guidelines for Standardization Work Part 1: Structure and The revision of YY0259.4-1997 "Safety Filling and Sealing Machine" was based on the "Compilation Rules for Standardization" and CB/T1.2-2002 "Guidelines for Standardization Work Part 2: Methods for Determining the Contents of Normative Technical Elements in Standards". This standard shall apply from the date of implementation YY0259.4-1997. Compared with YY0259.4-1997, the content of this standard has changed as follows: a) The referenced standards have been modified and the latest standards have been adopted. b) With the development of the market economy, the product specifications of the sealing machine are also expanding. In order to leave room for product development, this standard does not restrict the basic parameters of the product. e) For the inspection of the qualified rate of sealing, this standard stipulates that the factory inspection uses an aqueous solution, and the type inspection uses a 10% glucose solution. The inspection is done on a machine-by-machine basis. It is more economical to use aqueous solution for inspection. Glucose solution is used for type inspection. It can check quality defects such as the focus during injection, and puts forward certain requirements for product applicability. This standard is proposed by the China Pharmaceutical Equipment Industry Association. This standard is under the jurisdiction of the Pharmaceutical Equipment Industry Standardization Technical Committee. The drafting unit of this standard: Shanghai Yuandong Pharmaceutical Machinery Factory. The main drafters of this standard: Lin Xiaohua and Hu Qihao. The standards replaced by this standard are: GB11754.3-1989, YY0259.4-1997. 32
1 Scope
Anyi filling and sealing machine
JB20002.4-2004
This standard specifies the classification and marking, requirements, test methods, inspection rules and signs, operating instructions, packaging, transportation and storage of ampoule filling and sealing machines.
This standard applies to ampoules Filling and sealing machine (hereinafter referred to as filling and sealing machine). 2 Normative references
The clauses in the following documents become the clauses of this standard through reference in this standard. For all references with a date, all subsequent Amendments (excluding errata) or revisions are not applicable to this standard. However, parties to agreements based on this standard are encouraged to study whether the latest versions of these documents can be used. The version applies to this standard. GB/T191 Packaging, storage and transportation pictorial symbols
GB5226.12002 Mechanical safety Mechanical electrical equipment Part 1: General technical requirements GB/T9969.1 General instructions for use of industrial products GB/T10111 Method of random sampling using random numbers GB/T13306 Labeling
GB/T13384 General technical conditions for packaging of mechanical and electrical products GB/T16769| |tt||Pharmaceutical Machinery Product Model Compilation Method
YY/T0216
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 Labeling
3.1 type
The potting machine has a step-by-step transmission system, a balcony structure, multiple potting branches, and stepless speed regulation. It can be used with tunnel dry blasting machines and ultrasonic cleaning machines. It can also be used with tunnel dry blasting machines and ultrasonic cleaning machines. Can be used stand-alone.
3.2 Model and marking examples
The filling machine model should comply with the relevant regulations of YYT0216. 33
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