Some standard content:
JB | ||Rolling mode soft capsule machine
Capsule tablet printing machine
Released on 2004-02-05
Implemented on 2004-06-01
Released by the National Development and Reform Commission| |tt||ICS11.120.30
C92
JB
Pharmaceutical Machinery Industry Standard of the People's Republic of China JB20026—2004
Generation YY0255—1997
Automatic production line
Capsuleshell automatic productionline2004-02-05 release
2004-06-01 implementation
National Development and Reform Commission release
Foreword
1 Scope
Normative reference documents
2
3 Terms and definitions
4 Classification and labeling
Requirements
5
6 Test methods
Inspection rules
7
8 Marking, instructions for use, packaging and storage items
Times
JB20026—2004
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29
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JB20026—2004
Foreword
This standard is based on the "Good Manufacturing Practice for Drugs" and GB/T1.1-2000, GB/T1.2- In accordance with the requirements of the 2002 Standardization Work Guidelines, modifications were made to YY0255-1997 Hollow Capsule Automatic Production Line. This standard replaces YY0255-1997 from the date of implementation. Compared with YY0255-1997, the main technical content changes of this standard are as follows: a) The main technical content changes of Chapter 2 are as follows: - The introduction is modified according to GB/T1.1--2000; - The referenced standards are added in the supplement.
b) Chapter 3 adds the term "boot rate". e) Chapter 5:
Delete YY0255-1997 Table 1 and its content, and add appearance, materials and content related to "Good Manufacturing Practice for Drugs" (see 5.1.1~5.1.3);| |tt||—Tested and excepted 5.2 Appearance.5.3 material requirements in YY0255-1997: 1. Added requirements for buttons, indicators, displays, warning signs, etc.: 5.11 in YY0255-1997 was deleted. d) Change the noise test method from ZBJ50004 to GB/T16769. e) Other chapters:
Deleted Table 2, and changed the inspection items to narrative form: - Modified the terms in the judgment rules;
- Deleted "Storage (including transportation) validity period is 5 months" Month, short term (less than 7 days)" content; the new version deletes Appendix A (standard appendix) of the old version. 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: Beijing Aerospace Changfeng Co., Ltd. Honghua Pharmaceutical Machinery Branch. The main drafters of this standard: Feng Meijiang and Zuo Lihua. The previous versions of the standard replaced by this standard are: YY0255-1997. 24
1 Scope
Hollow Capsule Automatic Production Line
JB200262004
This standard specifies the hollow capsules Terms and definitions, classification and labeling, requirements, test methods, inspection rules and signs, instructions for use, packaging and storage of automatic production lines (hereinafter referred to as production lines). This standard is applicable to production lines that automatically produce hollow capsules from medicinal gelatin liquid. 2. Normative reference documents
The clauses in the following documents become the clauses of this standard through reference in this standard. For dated referenced documents, all subsequent amendments (excluding errata content) or revised versions do not apply to this standard. However, parties to an agreement based on this standard are encouraged to investigate whether the latest versions of these documents can be used. For undated referenced documents, the latest edition applies to this standard. GB/T191 Packaging, storage and transportation pictorial markings (eqVIS0780: 1997) GB5226.1-2002 Machinery safety mechanical and electrical equipment Part 1: General technical conditions (IEC60204-1: 2000, IDT)
CB/T6388|| tt||Transportation packaging receipt and delivery mark
GB/T 6576
GB/T7932
General technical conditions for machine tool lubrication system (eqvIS05170;1977) pneumatic system (neqIS04414:1982) GB /T9969.1 General instructions for industrial products GB/T10111
GB/T13306
GB/T13384
Method of random sampling using random numbers Signage
Electromechanical General technical conditions for product packaging
GB13731-1992 Medicinal gelatin hard glue change
CB/T 16769
YY/T0216
Measurement method for noise and sound pressure level of metal cutting machine tools (negISO/DIS230-5-2) Pharmaceutical Machinery Product Model Compilation Method
JB/T10051 General Technical Conditions for Hydraulic Systems of Metal Cutting Machine Tools "Pharmacopoeia of the People's Republic of China" (2000 Edition) Part 2 National Pharmacopoeia Commission 3 Terms and Definitions
3.1
Mouldband
The mold used to form capsules in the production line. 3.2 | | tt | proportion. 4 Classification and marking
4.1 Model
The production line model is in accordance with the provisions of YY/T0216. 4.2 Marking
EX port O
Improved design serial number: A, B, C..
Specification code: According to the maximum production capacity, 10,000-piece form and feature code: ZX-represents automatic line Function code: E-represents hollow capsule manufacturing machine marking example
EZX4.2A type: represents the hollow capsule production line with a maximum production capacity of 42,000 capsules/h after the first improved design. 5 Requirements
5.1 Basic requirements
5.1.1 The outer surface should be smooth and smooth, with no obvious scratches, no rust, and the coating should be consistent in color. The surface of gelatin liquid containers and parts such as boxes, shells, covers, etc. shall not have defects such as visible weld marks, unevenness, skewed appearance, and misalignment. 5.1.2 The surface coating should be smooth and beautiful, and there should be no defects such as paint peeling, paint leakage and uneven paint. 5.1.3 Parts that are in direct contact with the glue and capsules should be made of materials that are resistant to detachment and do not chemically react with the glue or absorb the glue. 5.2 Electrical system safety requirements
5.2.1 The continuity of the protective grounding circuit of the electrical system shall comply with the provisions of 19.2 in GB5226.1-2002. 5.2.2 The insulation resistance of the electrical system shall comply with the provisions of 19.3 in GB5226.1-2002. 5.2.3 The withstand voltage of the electrical system shall comply with the provisions of 19.4 in CB5226.1-2002. 5.2.4 The protective grounding circuit of the electrical system shall comply with the provisions of 8.2 in CB5226.1-20X02. 5.2.5 The buttons of the electrical system shall comply with the provisions of 10.2 of CB5226.1-2002. 5.2.6 The indicators and displays of the electrical system shall comply with the provisions of 10.3 in GB5226.1-2002. 5.2.7 The markings, warning signs and item codes of the electrical system shall comply with the provisions of Chapter 17 of GB5226.1-2002. 5.3 Mechanical operation requirements
5.3.1 The production line runs smoothly without abnormal noise. 5.3.2 The mold strips run smoothly in the production line, without any jamming or blockage, and all parts are coordinated. 5.3.3 The lubrication system should comply with the requirements of GB/T6576 and ensure reliable lubrication. When each bearing is in positive working condition, its temperature rise is less than 30℃.
5.3.4 The hydraulic system should comply with the requirements of JB/T10051, with reliable operation and easy maintenance. 5.4 Load operation requirements
5.4.1. The pneumatic system should comply with the requirements of CB/T7932, be reliable in action and easy to maintain. 26
5.4.2 The temperature and wind of the drying tunnel are adjustable within the range required for production, and the temperature control error is ±0.5°C. 5.4.3 The temperature of the glue tank is adjustable between 30℃~60℃, and the temperature control error is ±0.5℃. JB200262004 |
5.4.5 The viscosity control system should have the function of automatically adding water to adjust the viscosity of the glue, so that the viscosity of the glue for production is stable, with an error of ±4%.
5.4.6 The pass rate of capsules shall not be less than 85%.
5.4.7 The operating rate of the production line is not less than 98%. 5.5 Noise requirements
When the production line is operating at the highest speed without load, the noise sound pressure level is less than 85dB(A). 6 Test methods
6.1 Basic requirements inspection
6.1.1 Visually and tactile inspection of the outer surface of the production line, gelatin liquid containers and boxes, shells, covers and other parts. 6.1.2 Check the surface coating of the production line visually and by hand. 6.1.3 Check the materials of parts that are in direct contact with the glue and capsule by consulting the material list. 6.2 Inspection of electrical system safety requirements
Check the continuity of the protective grounding circuit of the electrical system according to the provisions of 19.2 in GB5226.1-2002. 6.2.1
6.2.2
Measure the insulation resistance of the electrical system according to the provisions of 19.3 in CB5226.1-2002. Measure the withstand voltage of the electrical system according to the provisions of 19.4 in GB5226.12002. 6.2.3
Check the protective grounding circuit of the electrical system according to the provisions of 8.2 in GB5226.1-2002. 6.2.4
Check the buttons of the electrical system according to the provisions of 10.2 in CB5226.1-2002. 6.2.5
6.2.6 Check the indicators and displays of the electrical system according to the provisions of 10.3 in GB5226.1-2002. 6.2.7 Check the markings, warning signs and project codes of the electrical system according to the provisions of Chapter 17 of GB5226.1-2002. 6.3 Mechanical operation test
6.3.1 Test conditions:
6.3.1.1 Fully lubricate the production line and check that the position of each part of the machine is normal. 6.3.1.2 The production line runs at the designed maximum speed. 6.3.1.3 The continuous operation time shall not be less than 24 hours. 6.3.2 Mechanical operation test method:
6.3.2.1 Start the production line without installing mold strips, and visually and listen to the operation status of the automatic line. 6.3.2.2 Manually or inchingly move the production line and install the mold strips so that the mold strips pass through each passing part; then the production line should run continuously. After 2 hours of continuous operation, check:
a) The operating status of the mold strips in the production line :b) Each lubrication point of the lubrication system, and use a thermometer to measure the temperature rise of each bearing; c) The coordination of each action of the hydraulic system. 6.4 Load operation test
27
JB20026—2004
6.4.1 Test conditions:
6.4.1.1 The load operation test is conducted at the user unit. 6.4.1.2 The load operation test can only be carried out after passing the mechanical operation test. 6.4.1.3 The test environment is:
a) altitude below 1000m;
b) temperature 20℃~22℃;
humidity 40%~70%.
6.4.1.4 Produce capsules according to specifications required by users. 6.4.1.5 The gelatin used in the test should comply with the provisions of Part 2 of the "Pharmacopoeia of the People's Republic of China" (2000 edition). 6.4.1.6 The glue configuration and technical indicators used in the test should meet production needs. 6.4.2 Load operation test method:
6.4.2.1 Before the load operation test, the glue liquid for the test should be injected into the glue tank. 6.4.2.2 Start the production line and let it run continuously for 2 hours. Then check: a) the working status and coordination of the pneumatic system; b) use a thermometer to measure the temperature of the drying tunnel; use a wind meter to measure the air volume of the drying tunnel: check the glue tank temperature adjustment function, and use a thermometer Measure the temperature of the glue tank: c)
d) Check the monitoring function of the viscosity control system and check the performance of the viscometer. 6.4.2.3 Take any 500 capsules produced within any one hour and inspect them according to Table 1, Table 4 and Table 5 of CB13731-1992. Class A unqualified blisters and Class B unqualified bubbles and black spots in Table 4 of GB13731-1992 are not included as inspection items. Calculate the capsule pass rate according to formula (1).
H,=n/500×100%.
In the formula:
H,—qualification rate, %;
The number of qualified capsules in 500 capsules, grain. (1)
6.4.2.4 Choose a time to start timing, and the continuous running time shall not be less than 24h. Within 24 hours, five downtimes are allowed for faults with a failure time of 3 minutes; seven downtimes for faults less than 2 minutes; the total downtime should not exceed 29 minutes, and the general downtime within 24 hours after the start of the timing is recorded, and the startup rate is calculated using equation (2).
K, = (24-A)/24×100%
Where:
K startup rate, %;
A--General fault shutdown within 24h Time, h
6.5 Noise test
When the production line is working at the highest speed in the no-load test, the noise is measured according to the method specified in GB/T16769. 7 Inspection Rules
7.1 Inspection Classification
28
: (2)
The production line is divided into factory inspection and type inspection. 7.2 Factory inspection
JB20026—2004
7.2.1 Each production line must undergo factory inspection by the quality department of the manufacturer before it can leave the factory. 7.2.2 Inspection items are subject to the requirements of 5.1.1, 5.1.2, 5.2.1~5.2.3, 5.3, and 5.5. If the indicators are met, the product is qualified. 7.3 Type inspection
7.3.1 Type inspection shall 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 materials of the product involve major When performance may be significantly improved; when production is resumed after 2 years of suspension;
c)
d) When the factory inspection results are significantly different from the last type inspection: e) National quality supervision agency When requesting type inspection. 7.3.2 Type inspection items shall be carried out in accordance with the requirements of Chapter 5. If all indicators are met, the product shall be considered qualified. 7.3.3 Judgment rules:
Type inspection shall select 10% of the products that have passed the factory inspection as test prototypes, and test one unit. The sampling method shall be implemented in accordance with the relevant provisions of GB/T10111. During the inspection, if one of the items in 5.2.1~5.2.3 fails, the type inspection will be judged as unqualified. If other items are unqualified, the unqualified items should be double re-inspected. If the items are still unqualified, the type inspection will be judged as unqualified. 8 Logo, instruction manual, packaging and storage
8.1 Logo
8.1.1 Each production line should be equipped with a nameplate according to the drawings. The size and technical requirements of the nameplate should comply with the regulations of CB/T13306. The nameplate should contain the following:
a) Name;
b) Model number;
e) Trademark;
d) Connection to power supply:
Power supply Frequency;
A connectable supply voltage or voltage range: a power supply category, such as the number of phases.
e) Manufacturer’s name or address;
f) Factory serial number;
g) Factory date;
h) Use standard numbers.
8.1.2 The production line transportation packaging mark should comply with the regulations of CB/T6388. The packaging mark includes the following: a) name;
b) model number;
c) overall dimensions;| |tt||d) Weight:
29
5. The viscosity control system should have the function of automatically adding water to adjust the viscosity of the glue, so that the viscosity of the glue for production is stable, with an error of ±4%.
5.4.6 The pass rate of capsules shall not be less than 85%.
5.4.7 The operating rate of the production line is not less than 98%. 5.5 Noise requirements
When the production line is operating at the highest speed without load, the noise sound pressure level is less than 85dB(A). 6 Test methods
6.1 Basic requirements inspection
6.1.1 Visually and tactile inspection of the outer surface of the production line, gelatin liquid containers and boxes, shells, covers and other parts. 6.1.2 Check the surface coating of the production line visually and by hand. 6.1.3 Check the materials of parts that are in direct contact with the glue and capsule by consulting the material list. 6.2 Inspection of electrical system safety requirements
Check the continuity of the protective grounding circuit of the electrical system according to the provisions of 19.2 in GB5226.1-2002. 6.2.1
6.2.2
Measure the insulation resistance of the electrical system according to the provisions of 19.3 in CB5226.1-2002. Measure the withstand voltage of the electrical system according to the provisions of 19.4 in GB5226.12002. 6.2.3
Check the protective grounding circuit of the electrical system according to the provisions of 8.2 in GB5226.1-2002. 6.2.4
Check the buttons of the electrical system according to the provisions of 10.2 in CB5226.1-2002. 6.2.5
6.2.6 Check the indicators and displays of the electrical system according to the provisions of 10.3 in GB5226.1-2002. 6.2.7 Check the markings, warning signs and project codes of the electrical system according to the provisions of Chapter 17 of GB5226.1-2002. 6.3 Mechanical operation test
6.3.1 Test conditions:
6.3.1.1 Fully lubricate the production line and check that the position of each part of the machine is normal. 6.3.1.2 The production line operates at the designed maximum speed. 6.3.1.3 The continuous operation time shall not be less than 24 hours. 6.3.2 Mechanical operation test method:
6.3.2.1 Start the production line without installing mold strips, and visually and listen to the operation status of the automatic line. 6.3.2.2 Manually or jog the production line, install the mold strips, so that the mold strips pass through each passing part; then the production line should run continuously, and after 2 hours of continuous operation, check:
a) The operating status of the mold strips in the production line :b) Each lubrication point of the lubrication system, and use a thermometer to measure the temperature rise of each bearing; c) The coordination of each action of the hydraulic system. 6.4 Load operation test
27
JB20026—2004
6.4.1 Test conditions:
6.4.1.1 The load operation test is conducted at the user unit. 6.4.1.2 The load operation test can only be carried out after passing the mechanical operation test. 6.4.1.3 The test environment is:
a) altitude below 1000m;
b) temperature 20℃~22℃;
humidity 40%~70%.
6.4.1.4 Produce capsules according to specifications required by users. 6.4.1.5 The gelatin used in the test should comply with the provisions of Part 2 of the "Pharmacopoeia of the People's Republic of China" (2000 edition). 6.4.1.6 The glue configuration and technical indicators used in the test should meet production needs. 6.4.2 Load operation test method:
6.4.2.1 Before the load operation test, the glue liquid for the test should be injected into the glue tank. 6.4.2.2 Start the production line and let it run continuously for 2 hours before checking: a) the working status and coordination of the pneumatic system; b) use a thermometer to measure the temperature of the drying tunnel; use a wind meter to measure the air volume of the drying tunnel: check the temperature adjustment function of the glue tank, and use a thermometer Measure the temperature of the glue tank: c)
d) Check the monitoring function of the viscosity control system and check the performance of the viscometer. 6.4.2.3 Take any 500 capsules produced within any one hour and inspect them according to Table 1, Table 4 and Table 5 of CB13731-1992. Class A unqualified blisters and Class B unqualified bubbles and black spots in Table 4 of GB13731-1992 are not included as inspection items. Calculate the capsule pass rate according to formula (1).
H,=n/500×100%.
In the formula:
H,—qualification rate, %;
The number of qualified capsules in 500 capsules, grain. (1)
6.4.2.4 Choose a time to start timing, and the continuous running time shall not be less than 24h. Within 24 hours, five downtimes are allowed for faults with a failure time of 3 minutes; seven downtimes for faults less than 2 minutes; the total downtime should not exceed 29 minutes, and the general downtime within 24 hours after the start of the timing is recorded, and the startup rate is calculated using equation (2).
K, = (24-A)/24×100%
Where:
K startup rate, %;
A--General fault shutdown within 24h Time, h
6.5 Noise test
When the production line is working at the highest speed in the no-load test, the noise is measured according to the method specified in GB/T16769. 7 Inspection Rules
7.1 Inspection Classification
28
: (2)
The production line is divided into factory inspection and type inspection. 7.2 Factory inspection
JB20026—2004
7.2.1 Each production line must undergo factory inspection by the quality department of the manufacturer before it can leave the factory. 7.2.2 Inspection items are subject to the requirements of 5.1.1, 5.1.2, 5.2.1~5.2.3, 5.3, and 5.5. If the indicators are met, it is qualified. 7.3 Type inspection
7.3.1 Type inspection shall 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 materials of the product involve major When performance may be significantly improved; when production is resumed after 2 years of suspension;
c)
d) When the factory inspection results are significantly different from the last type inspection: e) National quality supervision agency When requesting type inspection. 7.3.2 Type inspection items shall be carried out in accordance with the requirements of Chapter 5. If all the indicators are met, the product shall be considered qualified. 7.3.3 Judgment rules:
Type inspection shall select 10% of the products that have passed the factory inspection as test prototypes and test one unit. The sampling method shall be implemented in accordance with the relevant provisions of GB/T10111. During the inspection, if one of the items in 5.2.1~5.2.3 fails, the type inspection will be judged as unqualified. If other items are unqualified, the unqualified items should be double re-inspected. If the items are still unqualified, the type inspection will be judged as unqualified. 8 Logo, instruction manual, packaging and storage
8.1 Logo
8.1.1 Each production line should be equipped with a nameplate according to the drawings. The size and technical requirements of the nameplate should comply with the regulations of CB/T13306. The nameplate should contain the following:
a) Name;
b) Model number;
e) Trademark;
d) Connection to power supply:
Power supply Frequency;
A connectable supply voltage or voltage range: a power supply category, such as the number of phases.
e) Manufacturer's name or address;
f) Factory serial number;
g) Factory date;
h) Use standard numbers.
8.1.2 The production line transportation packaging mark should comply with the regulations of CB/T6388. The packaging mark includes the following: a) name;
b) model number;
c) overall dimensions;| |tt||d) Weight:
29
5. The viscosity control system should have the function of automatically adding water to adjust the viscosity of the glue, so that the viscosity of the glue for production is stable, with an error of ±4%.
5.4.6 The pass rate of capsules shall not be less than 85%.
5.4.7 The operating rate of the production line is not less than 98%. 5.5 Noise requirements
When the production line is operating at the highest speed without load, the noise sound pressure level is less than 85dB(A). 6 Test methods
6.1 Basic requirements inspection
6.1.1 Visually and tactile inspection of the outer surface of the production line, gelatin liquid containers and boxes, shells, covers and other parts. 6.1.2 Check the surface coating of the production line visually and by hand. 6.1.3 Check the materials of parts that are in direct contact with the glue and capsule by consulting the material list. 6.2 Inspection of electrical system safety requirements
Check the continuity of the protective grounding circuit of the electrical system according to the provisions of 19.2 in GB5226.1-2002. 6.2.1
6.2.2
Measure the insulation resistance of the electrical system according to the provisions of 19.3 in CB5226.1-2002. Measure the withstand voltage of the electrical system according to the provisions of 19.4 in GB5226.12002. 6.2.3
Check the protective grounding circuit of the electrical system according to the provisions of 8.2 in GB5226.1-2002. 6.2.4
Check the buttons of the electrical system according to the provisions of 10.2 in CB5226.1-2002. 6.2.5
6.2.6 Check the indicators and displays of the electrical system according to the provisions of 10.3 in GB5226.1-2002. 6.2.7 Check the markings, warning signs and project codes of the electrical system according to the provisions of Chapter 17 of GB5226.1-2002. 6.3 Mechanical operation test
6.3.1 Test conditions:
6.3.1.1 Fully lubricate the production line and check that the position of each part of the machine is normal. 6.3.1.2 The production line operates at the designed maximum speed. 6.3.1.3 The continuous operation time shall not be less than 24 hours. 6.3.2 Mechanical operation test method:
6.3.2.1 Start the production line without installing mold strips, and visually and listen to the operation status of the automatic line. 6.3.2.2 Manually or jog the production line, install the mold strips, so that the mold strips pass through each passing part; then the production line should run continuously, and after 2 hours of continuous operation, check:
a) The operating status of the mold strips in the production line :b) Each lubrication point of the lubrication system, and use a thermometer to measure the temperature rise of each bearing; c) The coordination of each action of the hydraulic system. 6.4 Load operation test
27
JB20026—2004
6.4.1 Test conditions:
6.4.1.1 The load operation test is conducted at the user unit. 6.4.1.2 The load operation test can only be carried out after passing the mechanical operation test. 6.4.1.3 The test environment is:
a) altitude below 1000m;
b) temperature 20℃~22℃;
humidity 40%~70%.
6.4.1.4 Produce capsules according to specifications required by users. 6.4.1.5 The gelatin used in the test should comply with the provisions of Part 2 of the "Pharmacopoeia of the People's Republic of China" (2000 edition). 6.4.1.6 The glue configuration and technical indicators used in the test should meet production needs. 6.4.2 Load operation test method:
6.4.2.1 Before the load operation test, the glue liquid for the test should be injected into the glue tank. 6.4.2.2 Start the production line and let it run continuously for 2 hours before checking: a) the working status and coordination of the pneumatic system; b) use a thermometer to measure the temperature of the drying tunnel; use a wind meter to measure the air volume of the drying tunnel: check the temperature adjustment function of the glue tank, and use a thermometer Measure the temperature of the glue tank: c)
d) Check the monitoring function of the viscosity control system and check the performance of the viscometer. 6.4.2.3 Take any 500 capsules produced within any one hour and inspect them according to Table 1, Table 4 and Table 5 of CB13731-1992. Class A unqualified blisters and Class B unqualified bubbles and black spots in Table 4 of GB13731-1992 are not included as inspection items. Calculate the capsule pass rate according to formula (1).
H,=n/500×100%.
In the formula:
H,—qualification rate, %;
The number of qualified capsules in 500 capsules, grain. (1)
6.4.2.4 Choose a time to start timing, and the continuous running time shall not be less than 24h. Within 24 hours, five downtimes are allowed for faults with a failure time of 3 minutes; seven downtimes for faults less than 2 minutes; the total downtime should not exceed 29 minutes, and the general downtime within 24 hours after the start of the timing is recorded, and the startup rate is calculated using equation (2).
K, = (24-A)/24×100%
Where:
K startup rate, %;
A--General fault shutdown within 24h Time, h
6.5 Noise test
When the production line is working at the highest speed in the no-load test, the noise is measured according to the method specified in GB/T16769. 7 Inspection Rules
7.1 Inspection Classification
28
: (2)
The production line is divided into factory inspection and type inspection. 7.2 Factory inspection
JB20026—2004
7.2.1 Each production line must undergo factory inspection by the quality department of the manufacturer before it can leave the factory. 7.2.2 Inspection items are subject to the requirements of 5.1.1, 5.1.2, 5.2.1~5.2.3, 5.3, and 5.5. If the indicators are met, it is qualified. 7.3 Type inspection
7.3.1 Type inspection shall 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 materials of the product involve major When performance may be significantly improved; when production is resumed after 2 years of suspension;
c)
d) When the factory inspection results are significantly different from the last type inspection: e) National quality supervision agency When requesting type inspection. 7.3.2 Type inspection items shall be carried out in accordance with the requirements of Chapter 5. If all the indicators are met, the product shall be considered qualified. 7.3.3 Judgment rules:
Type inspection shall select 10% of the products that have passed the factory inspection as test prototypes and test one unit. The sampling method shall be implemented in accordance with the relevant provisions of GB/T10111. During the inspection, if one of the items in 5.2.1~5.2.3 fails, the type inspection will be judged as unqualified. If other items are unqualified, the unqualified items should be re-inspected twice. If the unqualified items are still unqualified, the type inspection will be judged as unqualified. 8 Logo, instruction manual, packaging and storage
8.1 Logo
8.1.1 Each production line should be equipped with a nameplate according to the drawings. The size and technical requirements of the nameplate should comply with the regulations of CB/T13306. The nameplate should contain the following:
a) Name;
b) Model number;
e) Trademark;
d) Connection to power supply:
Power supply Frequency;
A connectable supply voltage or voltage range: a power supply category, such as the number of phases.
e) Manufacturer’s name or address;
f) Factory serial number;
g) Factory date;
h) Use standard numbers.
8.1.2 The production line transportation packaging mark should comply with the regulations of CB/T6388. The packaging mark includes the following: a) name;
b) model number;
c) overall dimensions;| |tt||d) Weight:
29
Check the buttons of the electrical system against the provisions of 2. 6.2.5
6.2.6 Check the indicators and displays of the electrical system according to the provisions of 10.3 in GB5226.1-2002. 6.2.7 Check the markings, warning signs and project codes of the electrical system according to the provisions of Chapter 17 of GB5226.1-2002. 6.3 Mechanical operation test
6.3.1 Test conditions:
6.3.1.1 Fully lubricate the production line and check that the position of each part of the machine is normal. 6.3.1.2 The production line operates at the designed maximum speed. 6.3.1.3 The continuous operation time shall not be less than 24 hours. 6.3.2 Mechanical operation test method:
6.3.2.1 Start the production line without installing mold strips, and visually and listen to the operation status of the automatic line. 6.3.2.2 Manually or jog the production line, install the mold strips, so that the mold strips pass through each passing part; then the production line should run continuously, and after 2 hours of continuous operation, check:
a) The operating status of the mold strips in the production line :b) Each lubrication point of the lubrication system, and use a thermometer to measure the temperature rise of each bearing; c) The coordination of each action of the hydraulic system. 6.4 Load operation test
27
JB20026—2004
6.4.1 Test conditions:
6.4.1.1 The load operation test is conducted at the user unit. 6.4.1.2 The load operation test can only be carried out after passing the mechanical operation test. 6.4.1.3 The test environment is:
a) altitude below 1000m;
b) temperature 20℃~22℃;
humidity 40%~70%.
6.4.1.4 Produce capsules according to specifications required by users. 6.4.1.5 The gelatin used in the test should comply with the provisions of Part 2 of the "Pharmacopoeia of the People's Republic of China" (2000 edition). 6.4.1.6 The glue configuration and technical indicators used in the test should meet production needs. 6.4.2 Load operation test method:
6.4.2.1 Before the load operation test, the glue liquid for the test should be injected into the glue tank. 6.4.2.2 Start the production line and let it run continuously for 2 hours before checking: a) the working status and coordination of the pneumatic system; b) use a thermometer to measure the temperature of the drying tunnel; use a wind meter to measure the air volume of the drying tunnel: check the temperature adjustment function of the glue tank, and use a thermometer Measure the temperature of the glue tank: c)
d) Check the monitoring function of the viscosity control system and check the performance of the viscometer. 6.4.2.3 Take any 500 capsules produced within any one hour and inspect them according to Table 1, Table 4 and Table 5 of CB13731-1992. Class A unqualified blisters and Class B unqualified bubbles and black spots in Table 4 of GB13731-1992 are not included as inspection items. Calculate the capsule pass rate according to formula (1).
H,=n/500×100%.
In the formula:
H,—qualification rate, %;
The number of qualified capsules in 500 capsules, grain. (1)
6.4.2.4 Choose a time to start timing, and the continuous running time shall not be less than 24h. Within 24 hours, five downtimes are allowed for faults with a failure time of 3 minutes; seven downtimes for faults less than 2 minutes; the total downtime should not exceed 29 minutes, and the general downtime within 24 hours after the start of the timing is recorded, and the startup rate is calculated using equation (2).
K, = (24-A)/24×100%
Where:
K startup rate, %;
A--General fault shutdown within 24h Time, h
6.5 Noise test
When the production line is working at the highest speed in the no-load test, the noise is measured according to the method specified in GB/T16769. 7 Inspection Rules
7.1 Inspection Classification
28
: (2)
The production line is divided into factory inspection and type inspection. 7.2 Factory inspection
JB20026—2004
7.2.1 Each production line must undergo factory inspection by the quality department of the manufacturer before it can leave the factory. 7.2.2 Inspection items are subject to the requirements of 5.1.1, 5.1.2, 5.2.1~5.2.3, 5.3, and 5.5. If the indicators are met, it is qualified. 7.3 Type inspection
7.3.1 Type inspection shall 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 materials of the product involve major When performance may be significantly improved; when production is resumed after 2 years of suspension;
c)
d) When the factory inspection results are significantly different from the last type inspection: e) National quality supervision agency When requesting type inspection. 7.3.2 Type inspection items shall be carried out in accordance with the requirements of Chapter 5. If all the indicators are met, the product shall be considered qualified. 7.3.3 Judgment rules:
Type inspection shall select 10% of the products that have passed the factory inspection as test prototypes and test one unit. The sampling method shall be implemented in accordance with the relevant provisions of GB/T10111. During the inspection, if one of the items in 5.2.1~5.2.3 fails, the type inspection will be judged as unqualified. If other items are unqualified, the unqualified items should be re-inspected twice. If the unqualified items are still unqualified, the type inspection will be judged as unqualified. 8 Logo, instruction manual, packaging and storage
8.1 Logo
8.1.1 Each production line should be equipped with a nameplate according to the drawings. The size and technical requirements of the nameplate should comply with the regulations of CB/T13306. The nameplate should contain the following:
a) Name;
b) Model number;
e) Trademark;
d) Connection to power supply:
Power supply Frequency;
A connectable supply voltage or voltage range: a power supply category, such as the number of phases.
e) Manufacturer’s name or address;
f) Factory serial number;
g) Factory date;
h) Use standard numbers.
8.1.2 The production line transportation packaging mark should comply with the regulations of CB/T6388. The packaging mark includes the following: a) name;
b) model number;
c) overall dimensions;| |tt||d) Weight:
29
Check the buttons of the electrical system against the provisions of 2. 6.2.5
6.2.6 Check the indicators and displays of the electrical system according to the provisions of 10.3 in GB5226.1-2002. 6.2.7 Check the markings, warning signs and project codes of the electrical system according to the provisions of Chapter 17 of GB5226.1-2002. 6.3 Mechanical operation test
6.3.1 Test conditions:
6.3.1.1 Fully lubricate the production line and check that the position of each part of the machine is normal. 6.3.1.2 The production line operates at the designed maximum speed. 6.3.1.3 The continuous operation time shall not be less than 24 hours. 6.3.2 Mechanical operation test method:
6.3.2.1 Start the production line without installing mold strips, and visually and listen to the operation status of the automatic line. 6.3.2.2 Manually or jog the production line, install the mold strips, so that the mold strips pass through each passing part; then the production line should run continuously, and after 2 hours of continuous operation, check:
a) The operating status of the mold strips in the production line :b) Each lubrication point of the lubrication system, and use a thermometer to measure the temperature rise of each bearing; c) The coordination of each action of the hydraulic system. 6.4 Load operation test
27
JB20026—2004
6.4.1 Test conditions:
6.4.1.1 The load operation test is conducted at the user unit. 6.4.1.2 The load operation test can only be carried out after passing the mechanical operation test. 6.4.1.3 The test environment is:
a) altitude below 1000m;
b) temperature 20℃~22℃;
humidity 40%~70%. bZxz.net
6.4.1.4 Produce capsules according to specifications required by users. 6.4.1.5 The gelatin used in the test should comply with the provisions of Part 2 of the "Pharmacopoeia of the People's Republic of China" (2000 edition). 6.4.1.6 The glue configuration and technical indicators used in the test should meet production needs. 6.4.2 Load operation test method:
6.4.2.1 Before the load operation test, the glue liquid for the test should be injected into the glue tank. 6.4.2.2 Start the production line and let it run continuously for 2 hours. Then check: a) the working status and coordination of the pneumatic system; b) use a thermometer to measure the temperature of the drying tunnel; use a wind meter to measure the air volume of the drying tunnel: check the glue tank temperature adjustment function, and use a thermometer Measure the temperature of the glue tank: c)
d) Check the monitoring function of the viscosity control system and check the performance of the viscometer. 6.4.2.3 Take any 500 capsules produced within any one hour and inspect them according to Table 1, Table 4 and Table 5 of CB13731-1992. Class A unqualified blisters and Class B unqualified bubbles and black spots in Table 4 of GB13731-1992 are not included as inspection items. Calculate the capsule pass rate according to formula (1).
H,=n/500×100%.
In the formula:
H,—qualification rate, %;
The number of qualified capsules in 500 capsules, grain. (1)
6.4.2.4 Choose a time to start timing, and the continuous running time shall not be less than 24h. Within 24 hours, five downtimes are allowed for faults with a failure time of 3 minutes; seven downtimes for faults less than 2 minutes; the total downtime should not exceed 29 minutes, and the general downtime within 24 hours after the start of the timing is recorded, and the startup rate is calculated using equation (2).
K, = (24-A)/24×100%
Where:
K startup rate, %;
A--General fault shutdown within 24h Time, h
6.5 Noise test
When the production line is working at the highest speed in the no-load test, the noise is measured according to the method specified in GB/T16769. 7 Inspection Rules
7.1 Inspection Classification
28
: (2)
The production line is divided into factory inspection and type inspection. 7.2 Factory inspection
JB20026—2004
7.2.1 Each production line must undergo factory inspection by the quality department of the manufacturer before it can leave the factory. 7.2.2 Inspection items are subject to the requirements of 5.1.1, 5.1.2, 5.2.1~5.2.3, 5.3, and 5.5. If the indicators are met, it is qualified. 7.3 Type inspection
7.3.1 Type inspection shall 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 materials of the product involve major When performance may be significantly improved; when production is resumed after 2 years of suspension;
c)
d) When the factory inspection results are significantly different from the last type inspection: e) National quality supervision agency When requesting type inspection. 7.3.2 Type inspection items shall be carried out in accordance with the requirements of Chapter 5. If all indicators are met, the product shall be considered qualified. 7.3.3 Judgment rules:
Type inspection shall select 10% of the products that have passed the factory inspection as test prototypes and test one unit. The sampling method shall be implemented in accordance with the relevant provisions of GB/T10111. During the inspection, if one of the items in 5.2.1~5.2.3 fails, the type inspection will be judged as unqualified. If other items are unqualified, the unqualified items should be double re-inspected. If the items are still unqualified, the type inspection will be judged as unqualified. 8 Logo, instruction manual, packaging and storage
8.1 Logo
8.1.1 Each production line should be equipped with a nameplate according to the drawings. The size and technical requirements of the nameplate should comply with the regulations of CB/T13306. The nameplate should contain the following:
a) Name;
b) Model number;
e) Trademark;
d) Connection to power supply:
Power supply Frequency;
A connectable supply voltage or voltage range: a power supply category, such as the number of phases.
e) Manufacturer’s name or address;
f) Factory serial number;
g) Factory date;
h) Use standard numbers.
8.1.2 The production line transportation packaging mark should comply with the regulations of CB/T6388. The packaging mark includes the following: a) name;
b) model number;
c) overall dimensions;| |tt||d) Weight:
29
3 Take any 500 capsules produced within any one hour and inspect them according to Table 1, Table 4 and Table 5 of CB13731-1992. Class A unqualified blisters and Class B unqualified bubbles and black spots in Table 4 of GB13731-1992 are not included as inspection items. Calculate the capsule pass rate according to formula (1).
H,=n/500×100%.
In the formula:
H,—qualification rate, %;
The number of qualified capsules in 500 capsules, grain. (1)
6.4.2.4 Choose a time to start timing, and the continuous running time shall not be less than 24h. Within 24 hours, five downtimes are allowed for faults with a failure time of 3 minutes; seven downtimes for faults less than 2 minutes; the total downtime should not exceed 29 minutes, and the general downtime within 24 hours after the start of the timing is recorded, and the startup rate is calculated using equation (2).
K, = (24-A)/24×100%
Where:
K startup rate, %;
A--General fault shutdown within 24h Time, h
6.5 Noise test
When the production line is working at the highest speed in the no-load test, the noise is measured according to the method specified in GB/T16769. 7 Inspection Rules
7.1 Inspection Classification
28
: (2)
The production line is divided into factory inspection and type inspection. 7.2 Factory inspection
JB20026—2004
7.2.1 Each production line must undergo factory inspection by the quality department of the manufacturer before it can leave the factory. 7.2.2 Inspection items are subject to the requirements of 5.1.1, 5.1.2, 5.2.1~5.2.3, 5.3, and 5.5. If the indicators are met, it is qualified. 7.3 Type inspection
7.3.1 Type inspection shall 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 materials of the product involve major When performance may be significantly improved; when production is resumed after 2 years of suspension;
c)
d) When the factory inspection results are significantly different from the last type inspection: e) National quality supervision agency When requesting type inspection. 7.3.2 Type inspection items shall be carried out in accordance with the requirements of Chapter 5. If all indicators are met, the product shall be considered qualified. 7.3.3 Judgment rules:
Type inspection shall select 10% of the products that have passed the factory inspection as test prototypes and test one unit. The sampling method shall be implemented in accordance with the relevant provisions of GB/T10111. During the inspection, if one of the items in 5.2.1~5.2.3 fails, the type inspection will be judged as unqualified. If other items are unqualified, the unqualified items should be double re-inspected. If the items are still unqualified, the type inspection will be judged as unqualified. 8 Logo, instruction manual, packaging and storage
8.1 Logo
8.1.1 Each production line should be equipped with a nameplate according to the drawings. The size and technical requirements of the nameplate should comply with the regulations of CB/T13306. The nameplate should contain the following:
a) Name;
b) Model number;
e) Trademark;
d) Connection to power supply:
Power supply Frequency;
A connectable supply voltage or voltage range: a power supply category, such as the number of phases.
e) Manufacturer’s name or address;
f) Factory serial number;
g) Factory date;
h) Use standard numbers.
8.1.2 The production line transportation packaging mark should comply with the regulations of CB/T6388. The packaging mark includes the following content: a) name;
b) model number;
c) overall dimensions;| |tt||d) Weight:
29
3 Take any 500 capsules produced within any one hour and inspect them according to Table 1, Table 4 and Table 5 of CB13731-1992. Class A unqualified blisters and Class B unqualified bubbles and black spots in Table 4 of GB13731-1992 are not included as inspection items. Calculate the capsule qualification rate according to formula (1).
H,=n/500×100%.
In the formula:
H,—qualification rate, %;
The number of qualified capsules in 500 capsules, grain. (1)
6.4.2.4 Choose a time to start timing, and the continuous running time shall not be less than 24h. Within 24 hours, five downtimes are allowed for faults with a failure time of 3 minutes; seven downtimes for faults less than 2 minutes; the total downtime should not exceed 29 minutes, and the general downtime within 24 hours after the start of the timing is recorded, and the startup rate is calculated using equation (2).
K, = (24-A)/24×100%
Where:
K startup rate, %;
A--General fault shutdown within 24h Time, h
6.5 Noise test
When the production line is working at the highest speed in the no-load test, the noise is measured according to the method specified in GB/T16769. 7 Inspection Rules
7.1 Inspection Classification
28
: (2)
The production line is divided into factory inspection and type inspection. 7.2 Factory inspection
JB20026—2004
7.2.1 Each production line must undergo factory inspection by the quality department of the manufacturer before it can leave the factory. 7.2.2 Inspection items are subject to the requirements of 5.1.1, 5.1.2, 5.2.1~5.2.3, 5.3, and 5.5. If the indicators are met, it is qualified. 7.3 Type inspection
7.3.1 Type inspection shall 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 materials of the product involve major When performance may be significantly improved; when production is resumed after 2 years of suspension;
c)
d) When the factory inspection results are significantly different from the last type inspection: e) National quality supervision agency When requesting type inspection. 7.3.2 Type inspection items shall be carried out in accordance with the requirements of Chapter 5. If all indicators are met, the product shall be considered qualified. 7.3.3 Judgment rules:
Type inspection shall select 10% of the products that have passed the factory inspection as test prototypes and test one unit. The sampling method shall be implemented in accordance with the relevant provisions of GB/T10111. During the inspection, if one of the items in 5.2.1~5.2.3 fails, the type inspection will be judged as unqualified. If other items are unqualified, the unqualified items should be re-inspected twice. If the unqualified items are still unqualified, the type inspection will be judged as unqualified. 8 Logo, instruction manual, packaging and storage
8.1 Logo
8.1.1 Each production line should be equipped with a nameplate according to the drawings. The size and technical requirements of the nameplate should comply with the regulations of CB/T13306. The nameplate should contain the following:
a) Name;
b) Model number;
e) Trademark;
d) Connection to power supply:
Power supply Frequency;
A connectable supply voltage or voltage range: a power supply category, such as the number of phases.
e) Manufacturer’s name or address;
f) Factory serial number;
g) Factory date;
h) Use standard numbers.
8.1.2 The production line transportation packaging mark should comply with the regulations of CB/T6388. The packaging mark includes the following: a) name;
b) model number;
c) overall dimensions;| |tt||d) Weight:
29
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