This standard specifies the classification and labeling, requirements, test methods, inspection rules and markings, packaging, and storage of antibiotic glass bottle capping machines. This standard applies to antibiotic glass bottle capping machines. JB 20008.3-2004 Antibiotic glass bottle capping machine JB20008.3-2004 Standard download and decompression password: www.bzxz.net

ICS11.120.30
C92
JB
People's Republic of China pharmaceutical machinery industry standard JB20008.3-2004www.bzxz.net
replaces YY0234.3-1995
antibiotic glass Bottle capping machine
Antibioticsvialcappingmachine2004-02-05 release
2004-06-01 implementation
National Development and Reform Commission release
Foreword·
1 Scope
Normative reference documents
2
3 Classification and labeling
4 Requirements
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5 Test methods||tt ||6 Inspection Rules
Marking, Packaging and Storage
7
Item
Times
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Foreword
This standard is based on the "Good Manufacturing Practice for Drugs" and the CB/T1.1-2000, GB/T1.2-2002 standardization work guidelines. YY0234.3—1995 Revision of "Antibiotic Glass Bottle Capping Machine". This standard replaces YY0234.3-1995 from the date of implementation. Compared with YY0234.3-1995, the main technical content changes of this standard are as follows: a) The chapters and clauses in YY0234.3-1995 are deleted: Composition (3.3);
—Basic Parameter Table 1 (3.4. 1):
Determination of cleanliness of working environment (5.1).
b) Revised the chapters and articles in YY0234.3-1995: Vial breakage rate (Table 2);
Capping pass rate (4.14);
Load operation noise ( 4.9).
c) Added instructions for use requirements (see 7.2). 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: Liu Hongmei and Xu Mingtang. 72
1 Scope
Antibiotic glass bottle capping machine
JB20008.3--2004
This standard specifies the classification and marking of antibiotic glass bottle capping machines, Requirements, test methods, inspection rules and markings, packaging, and storage.
This standard applies to antibiotic glass bottle capping machines (hereinafter referred to as capping machines). 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 investigate whether to use the latest versions of these documents. . For undated referenced documents, the latest edition applies to this standard. GB/T191 Packaging, storage and transportation pictorial mark
GB2640 Molded antibiotic glass bottle
CB2641 Controlled antibiotic glass bottle
GB5198.1 Antibiotic glass bottle cap Part 1: Aluminum cap GB5198. 2 Antibiotic glass bottle caps Part 2: Aluminum-plastic combination caps GB5226.1-2002 Mechanical Safety Mechanical and Electrical Equipment Part 1: General Technical Conditions GB/T6388 Transport Packaging Receipt and Delivery Marks
GB/T9969.1 Industrial General provisions of product instructions GB/T13306 Labeling
GB/T13384 General technical conditions for mechanical and electrical product packaging GB/T16769 Measuring method of noise and sound pressure level of metal cutting machine tools YY0076 Technical conditions for coating classification of metal parts YY0169.2 Engineering-based rubber antibiotics Bottle stopper
YY/T0216 Pharmaceutical machinery product model compilation method HG4-559 Antibiotic rubber bottle stopper
Pharmacopoeia of the People's Republic of China (2000 edition) National Pharmacopoeia Commission Good Manufacturing Practice for Drugs (1998 revised edition) National Drug Administration 3 Classification and Marking
3.1 Classification
The capping machine is of the rolling type.
3.2 model
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The capping machine model compilation should comply with the regulations of YY/T0216. KL
Improved design sequence number (A, B-)
Specification code; production capacity, bottles/min
Single machine feature code: G-rolling type
Type Code: Linkage line
Product function code: Antibiotic glass bottle powder packaging machinery 3.3 marking example
KLG320 type: Indicates an antibiotic glass bottle capping machine with a production capacity of 320 bottles/min. 3.4 Specifications
The specifications and parameters of the capping machine are shown in Table 1.
Table 1 specification parameters
item
applicable glass bottle specifications, mL
glass bottle breakage rate, %
4 requirements
parameters
5,7,10,25,30
0.08
4.1 All parts in contact with glass bottles and aluminum caps should be made of stainless and chemically stable materials. No smudges, flat and smooth.
4.2 The outer surface of the capping machine is smooth and smooth, without scratches or rust. The coating on the surface treated parts has the same color and luster, without falling off or burrs. 4.3 The conveying device of the capping machine must not pass through areas with different cleanliness levels. 4.4 Safety requirements
4.4.1 The continuity of the protective grounding circuit of the electrical system shall comply with the provisions of 19.2 of CB5226.1-2002. 4.4.2 The insulation resistance of the electrical system should comply with the provisions of 19.3 in GB5226.1-2002. 4.4.3 The withstand voltage of the electrical system shall comply with the provisions of 19.4 in GB5226.1-2002. 4.4.4 Safety signs and warning signs should be clear, eye-catching and durable. 4.5 Dry running requirements
The transmission part should run smoothly, all moving parts should move in place, and the temperature rise of the reducer and motor should not exceed 35°C. 4.6 Load requirements
When using bottles that comply with GB2640, GB2641 and aluminum caps of GB5198.1, GB5198.2 for capping, the breakage rate of the glass bottle should not be greater than 0.08%, and the capping pass rate should be greater than 99.5%. 4.7 Capping quality requirements
After capping, the crimp should be smooth and wrinkle-free, 4.8 Self-control requirements
When bottles are stuck at the bottle inlet or bottle outlet, bottles are missing or inverted at the bottle inlet. . The machine should be able to shut down automatically when the supply of aluminum caps is insufficient. 4.9 Noise requirements
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When the capping machine is operating normally, there should be no abnormal noise and the noise sound pressure level should not be greater than 80dB(A). 5 Test methods
5.1 Visual inspection requirements of 4.1~4.3.
5.2 Safety performance test
JB20008.3-2004
5.2.1 The continuity, insulation resistance and withstand voltage test of the protective grounding circuit of the electrical system is in accordance with CB5226.1-2002 The provisions of 19.2~19.4.
5.2.2 Visual inspection of safety signs and warning signs. 5.3 Dry running test
5.3.1 Test conditions;
a) Each capping machine should be run dry for no less than 2 hours (without adding glass bottles or aluminum caps); b) Test speed and Running time:
The test time for common speed is 1h;
The test time for the highest speed is 1h.
5.3.2 The maximum speed works continuously for 1 hour. The machine runs smoothly and all moving parts move in place. Use a thermometer to measure the temperature rise of the motor and reducer and calculate according to formula (1):
Att||tt| |In the formula:
At temperature rise.C:
t——--actually measured temperature of the component, ℃;
to actual measured ambient temperature.℃.
5.4 Load operation test
a) The test bottle and aluminum cap meet the corresponding standards b) Test speed and running time:
Test machine with operating speed (85% of the maximum speed) The time shall not be less than 5min; the maximum speed test time shall not be less than 5min. 5.4.1 Test results:
5.4.1.1 Randomly sample no less than 100 bottles and inspect them using the three-finger method. (1)
5.4.1.2 Three-finger inspection method: Hold the bottle with one hand, and use the thumb, index finger, and middle finger of the other hand to clamp the edge of the bottle cap, stand upright in a triangle, and turn to one side. If it cannot turn, it indicates that the crimp is firm. 5.4.1.3 The qualified rate of capping shall be calculated according to formula (2): qualified rate of capping (%) =
Wherein:
A—tested bottles, bottles
B—total number of tested bottles, bottles.
5.4.1.4 The breakage rate of glass bottles shall be calculated according to formula (3): x100
(2)
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Wherein:
N—total number of bottles entering, bottles;
M—total number of qualified bottles leaving, bottles.
5.5 Automatic control test
Glass bottle breakage rate (%) =
NM
x100
(2)
By simulating fault inspection on the capping machine, set the bottle inversion at the bottle inlet, and set the bottle jamming on the capping and bottle turning discs. The aluminum cap jamming on the aluminum cap track should be displayed and the machine should stop. 5.6 Noise test
Use a sound pressure meter to measure the noise during high-speed operation according to the method specified in GB/T3768. 6 Inspection rules
6.1 Inspection classification
Product inspection is divided into factory inspection and type inspection. 6.2 Factory inspection
6.2.1 Factory inspection should be carried out according to the requirements of Table 2. Only qualified ones are allowed to leave the factory and are accompanied by a product certificate. Table 2 Factory Inspection Items
Item Category
General Performance
Main Performance
Inspection Items
4.1,4.2
4.4, 4.5, 4.6, 4.7, 4.8
6.2.2 If a product is found to be unqualified during the inspection process, it is allowed to be returned for repair and re-inspection. If it is still unqualified, it shall be judged as a non-conforming product.
6.3 Type Inspection
Type inspection shall be carried out when one of the following situations occurs: a) Trial production and identification of new products or old products transferred to the factory for production; b) When the design, process or materials used of the product involve major performance or have major improvements; c) When production is resumed after suspension for 3 years: d) When the factory inspection results are significantly different from the last type inspection: e) When the national quality supervision agency puts forward the requirement of type inspection. 6.3.1 Sampling:
The type inspection sample shall be sampled from the qualified products in the factory inspection according to the method specified in CB/T10111. 6.4 Judgment rules
During the type inspection, if one item of electrical safety performance fails, the product shall be judged to have failed the type inspection. If other items fail, the unqualified items shall be doubled and retested. If they still fail, the product shall be judged to have failed the type inspection. 7 Marking, packaging and storage
7.1 Marking
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7.1.1 The product label shall comply with the provisions of GB/T13306. The label shall include the following contents: a) Product name and model;
b) Manufacturer name;
ce) Factory number and date:
d) Main technical parameters;
e) This standard number.
JB20008.3—2004
7.1.2 The busy transport sign shall comply with the provisions of CB/T191, including storage and transportation graphic signs such as "upward", "lift from here", "afraid of rain", and "no rolling".
The delivery and receiving signs shall comply with the provisions of GB/T6388. 7.1.3
7.2 Product instruction manual
The abbreviation of the instruction manual shall comply with the requirements of CB/T9969.1. The instruction manual shall include the following contents: a) Product name, manufacturer name, address, zip code and contact number; b) Implementation of product standards;
c) The main structure, performance, specifications, product use, applicable scope, precautions, warnings and prompts, safety measures to protect the user and the product, and installation and use instructions; d)
Explanation of the graphic symbols, abbreviations, etc. of labels and logos; e) Product maintenance and care methods;
f) Installation and use instructions.
The random documents shall be packed in plastic bags and placed in the packaging box. 7.3 The packaging of the product shall be carried out in accordance with the provisions of GB/T13384. 7.4 The packaging box shall be accompanied by the following random documents: a) Product certificate;
b) Packing list.
7.5 Storage
After packing, the capping machine shall be placed in a dry and ventilated room or under a shed without corrosive gas. It is prohibited to pile up and store it in the open air.
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