This standard specifies the classification and marking, requirements, test methods and inspection rules of ampoule washing, drying, filling and sealing linkage lines. This standard applies to ampoule washing, drying, filling and sealing linkage lines. JB 20002.1-2004 Ampoule washing, drying, filling and sealing linkage line JB20002.1-2004 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||No. 8 of 2004
The National Development and Reform Commission approved 47 pharmaceutical equipment industry standards including the "Anshao Washing, Drying, Filling and Sealing Linkage Line", which are now announced and will be implemented from June 1, 2004. The above standards were published by China Plan 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
JB20003.1~20003.5—2004
JB20004—2004
JB 20005.1—2004
JB 20005.2~2004
JB 20005.3—2004
JB 20005.4—2004
JB 20006—2004
JB 20007.1~20007.5—2004||tt ||JB 20008.1—2004
JB 20008.2-2004
JB 20008.3—2004
JB 20009-—2004
JB20010—2004
JB 20011— 2004
JB20012—2004
JB20013—2004
JB 20014—2004
Standard name
Anyan washing, drying, potting and sealing linkage line||tt| |Eye drops linkage line
Suppository production line
Glass infusion bottle cleaning machine
Glass infusion bottle filling machine
Glass infusion bottle capping machine
Glass infusion bottle capping machine
Anzhen injection light inspection machine
oral liquid bottle filling linkage line
antibiotic glass bottle powder sub-packaging line
antibiotic glass Bottle powder filling machine
Antibiotic glass bottle capping machine
Linear plunger filling machine
Three-dimensional mixer
Turnover hopper mixer
Sugar Type mixer
Double cone rotary vacuum dryer
Medicinal boiling granulator
Replaced standard numberbzxz.net
YY 0259.1~0259.5—1997||tt| |YY 0235.1—1995
YY 0235.2—1995
YY 0235.3—1995
YY 0235.4—1995
YY0217.1~0217.5—1995
YY 0234.1—1995
YY 0234.2—1995
YY 0234.3—1995
YY0225—1995
YY0219—1995
YY/T 0134—1993
Serial number
19
20
21
22
23
24
25
26
27
29
30
31
32
33
34
35
36
37
38
39
40
41
Standard number
JB20015—2004
JB200162004
JB 20017—2004
JB20018-2004
JB 200192004
JB20020—2004
JB20021—2004
JB 20022—2004
JB20023—2004
JB 20024—2004
JB20025—2004
JB20026—2004
JB 20027—2004
JB20028—2004
JB20029—2004
JB 20030—2004
JB 20031—2004
JB 20032-
—2004
JB 20033—2004
JB 20034—2004
JB 20035—2004
JB 20036—2004
JB 20037—2004
Standard Name
Wet Mixing Granulator
High Efficiency Coating Machine
Taro Coating Machine
Swinging Granulator
Drug Electronic Counting Bottle Filling Machine
Rotary Tablet Press
High Speed ??Rotary Tablet Press
Tablet Press Tablet 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 Capsule Machine
Capsule Tablet Printing Machine
Hot Press Distilled water machine
Multi-effect evaporation and water increasing machine
Pharmaceutical machinery pure steam generator
Medicinal vacuum freeze dryer
Hot air circulation oven
Medicinal vortex vibration screening machine
Powder removal screen
Extraction concentration tank
Vacuum concentration tank
Replaced standard number
YY0256—1997
YY0253—1997
YY0222—1995
YY0220—1995
YY0221—1995
YY 0020—1990
YY/T 0139—1993
YY0023—1990
YY0254—1997
YY0255—1997
YY 02241995
YY/T 0135—1993
YY0230—1995
YY0229—1995
YY 0026—1990
YY 0098-1992
YY0258—1997
YY 0024—1990
YY0025—1990
Serial number
42
43
44
45
46
47
Standard number
JB20038—2004
'B 20039—2004
JB20040—2004
JB/T20041—2004
JB/T20042—2004
JB/T 20043—2004
Extraction tank
Standard name
Hammer crusher
Knife-type granulating crusher
Reciprocating medicine cutter
Medicine washing machine
Rotary medicine cutter
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 JB20002.1—2004
Replace YY0259.1-1997
Ampoule cleaning-drying and filling-sealing production line2004-02-05 issued
2004-06-01 implemented
National Development and Reform Commission issued
Foreword
1Scope
2Normative references
3Classification and marking
4Requirements
5Test methods
6
Inspection rules
Catalog
Sub-items
JB20002. 1—2004
JB20002.12004
Foreword
This standard is a revision of YY0259.1—1997 “Integrated line of washing, drying, filling and sealing” based on GB/T1.1—2000 “Guidelines for standardization work Part 1: Structure and writing rules of standards” and GB/T1.2—2002 “Guidelines for standardization work Part 2: Determination method of the content of normative technical requirements in standards”. This standard replaces YY0259.1—1997 from the date of implementation. Compared with YY0259.1—1997, the main changes in this standard are as follows: a) The referenced standards have been modified and the latest standards have been adopted. b) In order to further improve the coordination reliability of the operation of the integrated line, this standard adds a test method for the matching of the units after the connection of each single machine.
The qualified rate of clarity after filling and sealing has been changed from the original 96% to 98%. c)
The clarity qualification rate shall be inspected according to the judgment standard in YY/T0188.11.
d)
The electrical safety performance index shall be in accordance with the provisions of GB5226.1-2002 to ensure the normal operation of the linkage line and the personal safety of the operators.
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 drafter of this standard: Lin Beihua.
4
1 Scope
Ampoule washing, drying, filling and sealing linkage line
JB 20002.1—2004
This standard specifies the classification and marking, requirements, test methods and inspection rules of the ampoule washing, drying, filling and sealing linkage line. This standard applies to the ampoule washing, drying, filling and sealing linkage line (hereinafter referred to as linkage line). 2 Normative references
The clauses in the following documents become the clauses of this standard through reference in this standard. For all dated references, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, parties to an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. For all undated references, the latest versions are applicable to this standard. GB5226.1-2002 Mechanical safety Mechanical electrical equipment Part 1: General technical conditions CB/T10111 Random sampling method using random number setting GB/T16769 Metal cutting machine noise sound pressure level measurement method CB50073 Clean room design specification
JB20002.2 Anshao ultrasonic decontamination machine
JB20002.3 Anyan tunnel sterilization dryer JB20002.4 An filling and sealing machine
YYT0188.11 Pharmaceutical Crystal Inspection Operating Procedures Part 11: Clarity Inspection Method YY/T0216 Pharmaceutical Machinery Product Model Preparation Method Pharmacopoeia of the People's Republic of China (2000 Edition) National Pharmacopoeia Commission 3 Classification and Labeling
3.1 Type
A linkage line consisting of Anshu ultrasonic cleaning machine, tunnel sterilization dryer, Anshu filling and sealing machine and Anshu printing machine, and is equipped with a connecting mechanism between single machines.
3.2 Model and marking examples
The model of the linkage line should comply with the relevant regulations of YY/T0216. ALX 1~20A
First improved design sequence number
Anzhen specification (lmL~20mL)
Feature code: (LX-linkage line)
Product function Code (A-Water Injection Machinery)
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