Some standard content:
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 JB20008.2—2004||tt ||Replacing YY0234.2—1995
Antibiotic glass bottle powder filling machine
Antibioticsvialpowder-Fillingmachine2004-02-05 release
2004-06-01 implementation
National Development and Reform Committee Release
Foreword
1 Scope
2 Normative Reference Documents
3 Classification and Labeling
4 Requirements
5 Test Methods
6 Inspection Rules
7 Marking, Packaging and Storage
Item
Times
JB20008.22004
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63
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61||tt| |JB20008.2--2004
Foreword
This standard is based on the "Good Manufacturing Practice for Drugs" and the GB/T1.1-2000, CB/T1.22002 standardization work guidelines. For YY0234 .2—Revision of the 1995 "Antibiotics Glass Bottle Powder Dispensing Machine". This standard replaces YY0234.2-1995 from the date of implementation. Compared with YY0234.2-1995, the main technical content changes of this standard are as follows: a) The chapters and clauses in YY0234.2-1995 are deleted: Composition (3.2);
Basic Parameter Table 1 (3.4.1 );
The function of inorganic speed regulation of the dispensing machine (4.9);
—cleanliness measurement (5.1, 5.1.1);
Use a wrench to adjust the machine feet (5.3).
b) Revised the chapters and clauses in YY0234.21995: loading error; conveying device of dispensing machine; pass rate of rubber stoppers (Table 2); the operating noise of the whole machine under load is not greater than 80dB(A) (4.12 ). c) Added requirements for instructions for use (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: Xu Mingtang and Liu Hongmei. 62
1 Scope
Antibiotic glass bottle powder dispensing machine
JB20008.22004
This standard specifies the classification, marking, requirements, and testing of antibiotic glass bottle powder dispensing machines Methods, inspection rules and markings, packaging, storage.
This standard applies to the antibacterial glass bottle powder dispensing machine (hereinafter referred to as the dispensing machine). 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 to use the latest versions of these documents. For undated referenced documents, the latest edition applies to this standard. CB/T191 Packaging, storage and transportation pictorial mark
GB2640 molded antibiotic glass bottles
GB2641 controlled antibiotic glass bottles
GB5226.1-2002 Mechanical Safety Mechanical and Electrical Equipment Part 1: General Technical Conditions GB/T6388 Transportation Packaging Receipt and Delivery Marks
GB/T9969.1 Industrial Product Instructions General Signs
GB/T13306
GB/T13384
Mechanical and Electrical Products General technical conditions for packaging
Measurement method of machine tool noise sound pressure level before metal cutting GB/T16769
YY0076 Technical conditions for coating classification of metal parts YY0169.2 Butyl rubber antibiotic bottle stoppersbzxz.net
YY/T0216 Pharmaceutical Machinery Product Model Compilation Method HG4-559 Antimicrobial Rubber Bottle Stopper
Pharmacopoeia of the People's Republic of China (2000 Edition) National Pharmacopoeia Commission Good Manufacturing Practice for Pharmaceutical Crystals (1998 Revised Edition) National Medical Products Administration 3 Classifications and mark
3.1 Classification
The dispensing machine is divided into two types according to its working principle: air flow dispensing machine and screw dispensing machine. 3.2 Model
The model preparation of the dispensing machine should comply with the regulations of YY/T0216. 63
JB 20008.22004
K card product
3.3 marking example
Improved design sequence number (A, B-)
Specification code: production Capacity, bottles/min
Single machine feature code: FQ—air flow dispensing; FL-screw dispensing type code: linkage line
Product function code: Antibiotic glass bottle powder dispensing machine KLF0320 : Indicates an airflow powder dispensing machine for antibiotic glass bottles with a production capacity of 320 bottles per minute. 3.4 Basic parameters
The basic parameters of the dispensing machine are shown in Table 1.
Table 1 basic parameters
item
applicable glass bottle specifications, mL
applicable rubber stopper specifications
month
purified air laminar flow Cleanliness inside the hood, level
Purified air laminar flow hood inner air wind speed, m/charge, mg/bottle
Loading error, nig
Cap rubber stopper qualified Rate, %
4 requirements
parameters
5,710,25,30
conform to HC4-599 or YY0169.2
100
0.2~0.5
2502000
Comply with "Pharmacopoeia of the People's Republic of China" (2000 edition) 99.8
4.1 All parts on the dispensing machine that come into contact with the powder should be stainless, non-toxic, and non-toxic. It is made of materials with stable chemical properties and medicated powders that are adsorbed. The contact surface is stain-free and smooth. 4.2. The outer surface of the dispensing machine is smooth and clean, 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 dispensing machine shall not pass through areas with different cleanliness levels. 4.4 The compressed air used in the dispensing machine should be free of oil and water, with a sterile filtration cleanliness level of 100 and a pressure of not less than 0.6MPa. 4.5 Safety requirements
4.5.1 The continuity of the protective grounding circuit of the electrical system shall comply with the provisions of 19.2 in GB5226.12002. 4.5.2 The insulation resistance of the electrical system should comply with the provisions of 19.3 in GB5226.1-2002. 4.5.3 The withstand voltage of the electrical system shall comply with the provisions of 19.4 in CB5226.1-2002. 4.5.4 Safety signs and warning signs should be clear, eye-catching and durable. 4.6 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. 4.7 Load operation requirements
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Use bottles that comply with GB2640, GB2641 and rubber stoppers of HG4-559. When filling medicinal starch, the pass rate of the rubber stopper should be Greater than 99.8%, the filling error meets the requirements of the "Pharmacopoeia of the People's Republic of China" (2000 edition). 4.8 Self-control requirements
When problems such as bottle inversion, bottle jam, repeated powder filling, lack of rubber plugs, etc. occur at the bottle inlet of the dispensing machine, the dispensing and sealing glue cold station, and the plug supply track, it should be able to automatically alarm and downtime.
4.9 Noise requirements
When the sub-assembly machine is operating at high speed, there should be no abnormal sound, and the noise sound pressure level should not be greater than 80dB (A), 5 Test Methods
5.1 Visual Inspection 4.1 ~4.4 requirements,
5.2 The cleanliness and wind speed test in the laminar flow hood of the sub-assembly machine uses a dust particle counter and a hot ball anemometer to measure the number of dust particles and wind speed in the air in the laminar flow hood of the sub-assembly machine. 5.3 Compressed air test
Use a dust particle counter and a pressure gauge on the machine to measure the compressed air quality and pressure. 5.4 Safety requirements inspection
5.4.1 The protective grounding circuit, insulation resistance, and withstand voltage test of the electrical system shall be in accordance with the provisions of 19.2~19.4 in GB5226.1-2002. 5.4.2 Visually inspect safety signs and warning signs. 5.5 Dry running test
5.5.1 Test conditions:
a) Each dispensing machine should be idle for no less than 2 hours (without adding glass bottles, glue, or powder): 6) Test Speed ??and running time:
The test time for a common speed is 1h;
The test time for the highest speed is 1h.
5.5.2 The maximum speed should be operated continuously for not less than 1 hour. The machine should run smoothly and all moving parts should be in place. Use a thermometer to measure the temperature rise of the motor and reducer. Calculate according to formula (1):
At=t- to
where:
A—temperature rise, C;
—measured component temperature, ℃;
to—measured ambient temperature, C.
5.5.3 Load operation test:
5.5.3.1 test is allowed to be conducted at the user's site. 5.5.3.2 Test conditions:
a) The test powder is medicinal starch;
b) The test bottle and rubber stopper must meet the corresponding standards: test speed and running time:
e
Common speed test time is not less than 5min; (1)
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The highest speed test time is not less than 5min. 5.5.3.3 Test results:
The pass rate of the rubber stopper is calculated according to formula (2), and the filling error is calculated according to formula (3): The pass rate of the rubber stopper (%)
Where: | |tt||A-
The total number of bottles produced, bottles;
B——The total number of qualified products with rubber stoppers, bottles.
Loading capacity error (%) =
Where:
C—actual measured loading capacity, mg:
D—standard loading capacity, mg
5.6 Self-control test
B
A
x ??100
CD
1×100
D
(2)
·(3)
....
By conducting simulated fault inspection on the dispensing machine, place inverted bottles at the bottle inlet and dispensing and capping parts, so that When there is a missing plug in the plug supply track, it should be able to display and shut down the machine.
5.7 Noise test
Use a sound pressure meter to measure the noise during high-speed operation according to the method specified in CB/T16769. 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 those that pass the standard shall be allowed to leave the factory and shall be 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 When 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, the product will be determined to be unqualified.
6.3 Type inspection
Type inspection should be carried out when one of the following situations occurs: a) Trial type identification of new products or old products transferred to factory production: b) When the design, process or When the materials used involve major properties or have major improvements; when production is resumed after 3 years of suspension:
c
When the factory inspection results are significantly different from the last type inspection: d)|| tt||When the national quality supervision agency proposes type inspection requirements. e) | |tt | Check one unit randomly. 6.3.2 Judgment rules:
During the type inspection, if any electrical safety performance fails, the product will be judged to have failed the type inspection. If other items are unqualified, double the retest for the unqualified items. If the items are still unqualified, the product will be deemed to have failed the type inspection. 7 Marking, packaging and storage
7.1 Marking
7.1.1 Product labels should comply with the regulations of CB/T13306. The label should include the following contents: a) product name and model;
b) manufacturer name;
c) factory serial number and harvest period;
d) main technical parameters: || tt||e) This standard number.
7.1.2 Storage and transportation signs should comply with the regulations of GB/T191, including "upward", "lift here", "afraid of rain", "no rolling\" and other storage and transportation pictorial signs, and comply with the standards stipulations.
7.1.3 The receipt and delivery mark shall comply with the provisions of GB/T6338. 7.2 The product instructions for use
shall be prepared in accordance with the provisions of CB/T9969.1, and the instructions for use shall include: a) Product name, manufacturer name, address, postal address and contact number: b) Implemented product standards;
The main structure, performance, specifications, product use, scope of application, precautions, warnings and tips of the product Safety instructions, protective operations c)
Safety measures for operators and products, installation and use instructions; explanations of labels, logo graphic symbols, abbreviations, etc.: d)
e) Product maintenance and care methods :
Illustrations of installation and usage instructions.
The accompanying documents should be sealed in plastic bags and placed in the packaging box. 7.3 The packaging of the product should be in accordance with GB/T13384. The packaging box should be accompanied by the following. Random documents: a) Product qualification certificate:
b) Packing list.
7.5 Busy storage
After packing, the sub-packaging machine should be placed in a dry and ventilated room without corrosive gas or Under sheds, stacking and open storage are prohibited 67
1. Factory inspection should be carried out one by one according to the requirements in Table 2. Only those that pass the test will be allowed to leave the factory and be 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 When 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, the product will be determined to be unqualified.
6.3 Type inspection
Type inspection should be carried out when one of the following situations occurs: a) Trial type identification of new products or old products transferred to factory production: b) When the design, process or When the materials used involve major properties or have major improvements; when production is resumed after 3 years of suspension:
c
When the factory inspection results are significantly different from the last type inspection: d)|| tt||When the national quality supervision agency proposes type inspection requirements. e) | |tt | Check one unit randomly. 6.3.2 Judgment rules:
During the type inspection, if any electrical safety performance fails, the product will be judged to have failed the type inspection. If other items are unqualified, double the retest for the unqualified items. If the items are still unqualified, the product will be deemed to have failed the type inspection. 7 Marking, packaging and storage
7.1 Marking
7.1.1 Product labels should comply with the regulations of CB/T13306. The label should include the following contents: a) product name and model;
b) manufacturer name;
c) factory serial number and harvest period;
d) main technical parameters: || tt||e) This standard number.
7.1.2 Storage and transportation signs should comply with the regulations of GB/T191, including "upward", "lift here", "afraid of rain", "no rolling\" and other storage and transportation pictorial signs, and comply with the standards stipulations.
7.1.3 The receipt and delivery mark shall comply with the provisions of GB/T6338. 7.2 The product instructions for use
shall be prepared in accordance with the provisions of CB/T9969.1, and the instructions for use shall include: a) Product name, manufacturer name, address, postal address and contact number: b) Implemented product standards;
The main structure, performance, specifications, product use, scope of application, precautions, warnings and tips of the product Safety instructions, protective operations c)
Safety measures for operators and products, installation and use instructions; explanations of labels, logo graphic symbols, abbreviations, etc.: d)
e) Product maintenance and care methods :
Illustration of installation and usage instructions.
The accompanying documents should be sealed in a plastic bag and placed in the packaging box. 7.3 The packaging of the product should be in accordance with the requirements of GB/T13384. Random documents: a) Product qualification certificate:
b) Packing list.
7.5 Busy storage
After packing, the sub-packaging machine should be placed in a dry and ventilated room without corrosive gas or Under sheds, stacking and open storage are prohibited 67
1. Factory inspection should be carried out one by one according to the requirements in Table 2. Only those that pass the test will be allowed to leave the factory and be 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 When 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, the product will be determined to be unqualified.
6.3 Type inspection
Type inspection should be carried out when one of the following situations occurs: a) Trial type identification of new products or old products transferred to factory production: b) When the design, process or When the materials used involve major properties or have major improvements; when production is resumed after 3 years of suspension:
c
When the factory inspection results are significantly different from the last type inspection: d)|| tt||When the national quality supervision agency proposes type inspection requirements. e) | |tt | Check one unit randomly. 6.3.2 Judgment rules:
During the type inspection, if any electrical safety performance fails, the product will be judged to have failed the type inspection. If other items are unqualified, double the retest for the unqualified items. If the items are still unqualified, the product will be deemed to have failed the type inspection. 7 Marking, packaging and storage
7.1 Marking
7.1.1 Product labels should comply with the regulations of CB/T13306. The label should include the following contents: a) product name and model;
b) manufacturer name;
c) factory serial number and harvest period;
d) main technical parameters: || tt||e) This standard number.
7.1.2 Storage and transportation signs should comply with the regulations of GB/T191, including "upward", "lift here", "afraid of rain", "no rolling\" and other storage and transportation pictorial signs, and comply with the standards stipulations.
7.1.3 The delivery and receipt marks shall comply with the provisions of GB/T6338. 7.2 The product instructions for use
shall be prepared in accordance with the provisions of CB/T9969.1, and the instructions for use shall include: a) Product name, manufacturer name, address, postal address and contact number: b) Implemented product standards;
The main structure, performance, specifications, product use, scope of application, precautions, warnings and tips of the product safety instructions, protective operations c)
safety measures for operators and products, installation and use instructions; explanations of labels, logo graphic symbols, abbreviations, etc.: d)
e) product maintenance and care methods :
Illustration of installation and usage instructions.
The accompanying documents should be sealed in a plastic bag and placed in the packaging box. 7.3 The packaging of the product should be in accordance with the requirements of GB/T13384. Random documents: a) Product qualification certificate:
b) Packing list.
7.5 Busy storage
After packing, the sub-packaging machine should be placed in a dry and ventilated room without corrosive gas or Under sheds, stacking and open storage are prohibited 67
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