This standard specifies the classification and marking, requirements, test methods and inspection rules for antibiotic glass bottle powder dispensing lines. This standard applies to antibiotic glass bottle powder dispensing lines. JB 20008.1-2004 Antibiotic glass bottle powder dispensing line JB20008.1-2004 Standard download and decompression password: www.bzxz.net

JB | Linkage line
Antibiotic glass bottle powder dispensing linkage line
Linear plunger filling machine
Released on 2004-02-05
Implemented on 2004-06-01| |tt||National Development and Reform Commission released
ICS11.120.30
C92
JB
Pharmaceutical Machinery Industry Standard of the People's Republic of China JB20008.1—2004||tt ||Replacing YY0234.1—1995
Antibiotic glass bottle powder filling linkage line
Antibioticsvial powderfillingproduction2004-02-05 release
2004-06-01 implementation
National Development and Reform Commission
Release
Foreword
1 Scope
2 Normative Reference Documents
3 Classification and Labeling
Requirements|| tt||4
5
Test method
Inspection rules
6
Item
Times
JB 20008.1- 2004
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53| | tt | According to the requirements of the regulations, the revision of YY0234.1--1995 "Antibiotic Glass Bottle Powder Distribution Linkage Line". This standard replaces YY0234.11995 from the date of implementation. Compared with YY0234.1-1995, the main technical content changes of this standard are as follows: a) The filling error is less than or equal to ±5% and is changed to comply with the "Pharmacopoeia of the People's Republic of China": b) The error rate of rubber stopper capping is changed to qualified rubber stopper capping. rate; e) the capping pass rate is changed to greater than or equal to 99.5%; d) the height of the conveyor track is cancelled.
This standard is proposed by China Pharmaceutical Equipment Industry Association. This standard is under the jurisdiction of the Pharmaceutical Equipment Industry Standardization Technical Committee. This standard was drafted by: Harbin Aircraft Industry Group Pharmaceutical Machinery Factory. The main drafters of this standard: Xu Mingtang and Liu Hongmei. 54
1Scope
Antibiotic glass bottle powder dispensing linkage
JB20008.12004
This standard specifies the classification and classification of antibiotic glass bottle powder dispensing linkage line Markings, requirements, test methods and inspection rules. This standard applies to the antibiotic glass bottle powder dispensing linkage line (hereinafter referred to as the powder line). 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 to an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. . For undated referenced documents, the latest edition applies to this standard. GB2640 molded antibiotic cord glass bottle
GB2641 regulated antibiotic glass bottle
GB5198.1 Antibiotic cord glass bottle cap Part 1: Aluminum cap GB5198.2 Antibiotic glass bottle cap Part 2: Aluminum-plastic combination Cover CB5226.1-2002 Mechanical safety mechanical and electrical equipment Part 1: General technical conditions CB/T16769 Metal cutting machine tool noise sound pressure level measurement method JB20007.2 Oral liquid bottle filling linkage line ultrasonic cleaning machine tunnel sterilization dryer | |tt||JB20007.3 Liquid bottle filling linkage line
YY0169.2 Butyl rubber antibiotic bottle stopper
YY/T0216 Pharmaceutical machinery product model compilation method HC4-559 Antibiotic rubber bottle stopper| |tt||Pharmacopoeia of the People's Republic of China (2000 Edition) National Pharmacopoeia Commission Good Manufacturing Practice for Drugs (1998 Revised Edition) State Food and Drug Administration 3 Classification and Labeling
3.1 Composition
Powder line consists of the following Each single machine is composed of: a) ultrasonic cleaning machine;
b) tunnel sterilization dryer;
c) antibiotic cord glass bottle powder dispensing machine (referred to as dispensing machine): d) antibiotic glass Bottle capping machine (tube capping machine): e) Use a buffer turntable to adjust the output of each unit. 3.2 Parameters
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JB 20008.1—2004
Powder line parameters are shown in Table 1. | |tt | |tt||Purified air layer inner layer air wind speed, m/s charging amount, nag/bottle
Corrugated glass bottle damage rate, %
Filling error,||tt ||Capping rubber plug qualification rate, %
Capping qualification rate, %
3.3 mark
Model preparation should comply with the regulations of YY/T0216. 3.3.1 Model preparation
K
Table 1
Powder line parameters
Parameters
5,7,10,25,30||tt| |350 ±7
100
0.2~0.5
250~2000
50.18
Complies with (Chinese and Kunming Pharmacopoeia (2000 edition) 99.8
≥99.5
Improved design sequence number (A, B-))
Specification code: production capacity, bottles/min
Single machine feature code: All lines are optional: Single machine code: Wash one Type: Indicates an antibiotic glass bottle powder dispensing line with a production capacity of 300 bottles/min. 4 Requirements
4.1 Each single machine forming the powder line should comply with the corresponding standards. a) The ultrasonic cleaning machine should comply with the regulations of JB200X07.2: b) The tunnel sterilization and drying machine should comply with the regulations of JB20007.3: c) The packaging machine and capping machine should comply with the regulations of JB20008.2 and JB20008.3. 4.2 Control requirements for linkage lines
The buffer turntable between single machines should be equipped with a synchronization device. When bottles accumulate, the front-end machine should display and automatically stop. 4.3 Load operation requirements
The damage rate of qualified glass bottles from input to output on the linkage line is not greater than 0.2%. 4.4 Noise requirements
The operating sound of the powder line is the average operating noise of each single machine, which should not be greater than the sound pressure level 82dB (A). 56
5 Test methods
5.1 Carry out stand-alone tests according to the methods specified in each stand-alone standard. 5.2 Buffer turntable synchronization device test
After the powder line is in normal operation, set up a stack of bottles under the buffer turntable sensor for simulation testing. 5.3 Load operation test
The test is allowed to be conducted at the product use site. 5.3.1 Test conditions:
a) The filling material for the test is medicinal starch.
JB 20008.12004
b) Antibiotic cord glass bottles for testing, molded bottles should comply with the regulations of CB2640, and controlled bottles should comply with the regulations of GB2641. c) Test speed and running time: According to the maximum speed, the test time shall not be less than 5 minutes. 5.3.2 Test results:
The glass bottle breakage rate is calculated according to formula (1):
Glass bottle breakage rate (%) = 4-B
×100||tt| |A
In the formula:
A——Total number of bottles entered, bottles:
B——Total number of bottles produced, bottles.
6 Inspection Rules
6.1 Inspection Categories
Product inspection is divided into factory inspection and type inspection. 6.2 Factory inspection
6.2.1 Factory inspection shall be carried out one by one according to the requirements in Table 2. Only qualified products shall be allowed to leave the factory and shall be accompanied by a product certificate. Table 2 Factory Inspection Items
Item Category
Second General Performance
Main Performance
6.3 Type inspection
When one of the following situations occurs, type inspection shall be carried out: a) Trial type identification of new products or old products transferred to factory production: Inspection items
4.1
4.2 , 4.3, 4.4
When the design, process or materials used of the product involve major performance or significant improvements; b)
When production is resumed after 3 years of suspension;
Factory inspection When the results are significantly different from the last type inspection: d)
e) When the national quality supervision agency makes a request for type inspection. (1)
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6.4 Judgment Rules
Type inspection shall randomly inspect one linkage from the products that have passed the factory inspection according to the method specified in CB/T10111 If any of the electrical safety performance is unqualified, the type inspection will be deemed to have failed. If two other items are unqualified, the unqualified items can be re-tested twice. If the unqualified items are still unqualified, the product will be judged to have failed the type inspection. 58
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