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 | Hard capsule filling machine
Fully automatic hard gelatin capsule filling machine released on 2004-02-05
Implemented on 2004-06-01
Released by the National Development and Reform Commission
Foreword| |tt||1 Scope
2 Normative references
3 Terms and definitions
4 Classification and labeling
5 Requirements
6 Test methods| |tt||7 Inspection rules
8 Marks, instructions for use, packaging and storage items
times
JB20025—2004
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13||tt| | JB20025-2004 | Revision of YY0254-1997 "Fully Automatic Hard Capsule Filling Machine". This standard replaces YY0254-1997 from the date of implementation. Compared with YY0254-1997, the main technical content changes of this standard are as follows: a) The cited documents are modified according to the currently effective standards. b) Added the term "probability of getting on the machine".
The basic requirements and content related to the "Good Manufacturing Practice for Drugs" have been added to the requirements; the electrical system safety requirements have added buttons, indicators, displays, warning signs, etc. Content; The mechanical operation requirements have added the content of dry operation and the temperature rise of the motor, vacuum pump, and reducer; the test method has been modified to correspond to the requirements one by one. The inspection of the working area, materials and lubricants has been added. Methods; Electrical system d)
Safety Added inspection methods for buttons, indicators, displays, warning signs, etc.; Modified the test times for dry operation, common speed, and maximum speed in the mechanical operation test: The test time for the chance of loading was increased The requirements for the test material "medicinal starch\" were changed; the charge difference test was changed to the provisions of "Appendix IE in Part II of the Pharmacopoeia of the People's Republic of China (2000 Edition)": the noise test was changed to follow the provisions of GB/T16769.
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: Liu Rongshan, Zuo Lihua, Sun Yafang. The previous versions of the standard replaced by this standard are: YY0254-1997. 14
1 Scope
Fully automatic hard capsule filling machine
JB 200252004
This standard stipulates The terms and definitions, classification and labeling, requirements, test methods, inspection rules and signs, instructions for use, packaging and storage of fully automatic hard plastic filling machines (hereinafter referred to as filling machines) are provided. This standard applies to filling machines for filling powders, pellets and other drugs into hollow femoral sacs of different specifications. 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. GB/T191 Packaging, storage and transportation pictorial markings (eVIS0780: 1997) GB5226.1-2002 Machinery safety mechanical and electrical equipment Part 1: General technical conditions (IEC602041:2000, IDT) CB/T6388 Transportation, packaging, receipt and delivery markings ||tt ||GB/T9969.1 General principles of industrial product instructions GB/T10111
Random sampling method using random numbers GB/T16769
Measurement method of noise and sound pressure level of metal cutting machine tools (negISO/ DIS230-5-2) GB/T13306 label
General technical conditions for mechanical and electrical product packaging
GB/T 13384
CB13731 Medicinal gelatin hard glue decay
YY/T0216 Pharmaceutical Machinery Product Model Compilation Method Pharmacopoeia of the People's Republic of China (2000 Edition) Part 2 National Pharmacopoeia Commission 3 Terms and Definitions
3.1
Capsulesuitabilityratio Within a certain period of time, the quantity of qualified capsules that are filled and output is equal to Enter the ratio of the total amount of capsules. 4 Classification and Marking
4.1 Classification
Filling machines are divided into intermittent style and continuous type according to the filling mode. According to the filling mode, they are divided into orifice plate filling and insertion tube filling. 4.2 Mark
The filling machine model is compiled according to the regulations of YY/T0216. 15
JB20025—2004
Marking example:
N
Improved design serial number: A, B, C..
Specification code: according to maximum production Capacity, granule min Characteristic code: P Hole plate filling: A - Broadcast tube filling type code: J - Intermittent: L - Continuous Function code: N - Fully automatic hard capsule filling machine NJP800A type: Indicates the first improved design , maximum production capacity of 800 capsules/min, hole plate filling, intermittent fully automatic hard capsule filling machine.
5 requirements
5.1 Basic requirements
5.1.1 The outer surface of the filling machine is flat, smooth, no obvious scratches, no rust: the coating has the same color, no blistering, no fall off. 5.1.2 The studio should be isolated from the outside world, pollution-free, easy to disassemble and clean. 5.1.3 The surface of the parts in direct contact with drugs and capsules should be smooth, non-falling, and easy to clean or disinfect. 5.1.4 Parts in direct contact with drugs and capsules should be made of materials that are corrosion-resistant, do not chemically react with drugs, and do not absorb drugs.
5.1.5 Lubricant shall not come into contact with medicines or containers. 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 of CB5226.1-2002. 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 should comply with the provisions of 8.2 in GB5226.1-2002. 5.2.5 The buttons of the electrical system should comply with the provisions of 10.2 in GB5226.1-2002. 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 project codes of the electrical system shall comply with the provisions of Chapter 17 of CB5226.12002. 5.3 Mechanical operation requirements
5.3.1 The transmission part runs smoothly without abnormal noise. 5.3.2 The temperature rise of the motor, vacuum pump and reducer shall not exceed 40℃. 5.4 Requirements for loading rate
Use medicinal gelatin hard capsules specified in GB13731, and the probability of loading the capsules shall not be less than 99%. 5.5 Filling difference requirements
Use medicinal gelatin hard capsules specified in GB13731 to be filled with medicinal starch, and the difference limit of the filling amount is ±5%. 5.6 Noise requirements
When operating at the highest speed without load, the noise should be less than 85dB(A). 16
6 Test Methods
6.1 Basic Requirements Inspection
6.1.1 Visually inspect the quality, coating color and structure of the outer surface of the filling machine. 6.1.2 Visual inspection The working room of the filling machine should be airtight, pollution-free, easy to disassemble and clean. 6.1.3 Visually inspect the quality of parts in direct contact with drugs and capsules. 6.1.4. Check the material certification documents of parts and materials that are in direct contact with drugs and capsules. 6.1.5 Check the lubricant instruction manual and perform chemical testing on the lubricant if necessary. 6.2 Inspection of electrical system safety requirements
6.2.1 Connect with 19.2 of GB5226.1-2002 to inspect the continuity of the electrical system protective grounding circuit. 6.2.2 Measure the insulation resistance of the electrical system according to the method in 19.3 of GB5226.12002. 6.2.3 Measure the withstand voltage of the electrical system according to the method of 19.4 in GB5226.1-2002. 6.2.4 Check the protective grounding circuit of the electrical system according to the provisions of 8.2 in GB5226.1-2002. 6.2.5 Check the buttons of the electrical system according to the provisions of 10.2 in GB5226.1-2002. 6.2.6 Check the indicators and displays of the electrical system according to the provisions of 10.3 in GB5226.1-2002. JB20025-2004
6.2.7 Check the markings, warning signs and project codes of the electrical system according to the provisions of Chapter 17 of CB5226.1-2002. 6.3 Mechanical operation test
6.3.1 Test conditions:
a) Each filling machine should be mechanically operated for no less than 4 hours (without adding capsules and powder); b) Test speed and operation Time:
1) Run at 70% of the maximum speed for 2 hours;
2) Run at the maximum speed for 2 hours.
6.3.2 The continuous working time of the maximum speed is not less than 2 hours, and the machine runs smoothly. Use a thermometer to measure the temperature of the motor, vacuum and reducer, and calculate the temperature rise according to formula (1).
At=t- to
In the formula:
At—temperature rise.℃;
tactually measured component temperature,℃;
to— —Actual ambient temperature, °C.
6.4 Loading probability test
6.4.1 Each filling machine shall undergo a loading probability test after the mechanical operation test. 6.4.2 Test conditions:
8) The test should be conducted indoors with a temperature of 18°C ??~ 24 and a relative intensity of 45% ~ 65%: b) The test capsule should comply with the regulations of GB13731; (1)
c) The filling used for the drug-loading test is medicinal starch, and the requirements for starch should be in accordance with the provisions of Part 2 of the "Pharmacopoeia of the People's Republic of China" (2000 edition);
d) For testing without drug-filling The rotation speed and running time are: 17
JB20025-2004
1) Run at 70% of the maximum speed for 5 minutes: 2) Run at the maximum speed for 5 minutes.
e) The rotation speed and operating time for the charge test are: 1) Run at 70% of the maximum speed for 10 minutes; 2) Run at the maximum speed for 10 minutes.
6.4.3 No-loading test: Calculate the capsule loading probability according to the test results of the two rotation speeds according to formula (2), and then calculate the average of the capsule loading probability as the loading probability. || tt | The number of glue for side, neck concave, deformation and other defects, in grains; the number of capsules put into the test, in grains.
·(2)
6.4.4 Charging test: Calculate the capsule loading probability according to the test results of the two rotation speeds according to Equation (2), and then calculate the average value of the capsule loading rate as the loading probability .
6.5 Charge difference test
6.5.1 test is allowed to be performed by the user.
6.5.2 The test conditions shall be as specified in a), b), c) and e) of 6.4.2. 6.5.3 The filling difference limit shall be based on the provisions of the capsule filling difference inspection method in Appendix E of the Pharmacopoeia of the People's Republic of China (2000 Edition).
6.6 Noise test
When the filling machine is at its maximum no-load speed, use a sound level meter to measure the noise according to the method specified in GB/T16769. 7 Inspection rules
7.1 Inspection classification
Filling machines are divided into factory inspection and type inspection. 7.2 Factory inspection
7.2.1 Each filling machine shall undergo factory inspection by the quality department of the manufacturer. It must pass the inspection and be accompanied by a certificate of conformity before it can leave the factory. 7.2.2 The inspection items shall be in accordance with the requirements of 5.1.1, 5.1.3.5.2.1~5.2.3, 5.3, and 5.4, and shall be considered 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 the performance may be significantly improved; when production is resumed after two years of suspension;
When the factory inspection results are significantly different from the last type inspection; d)
e) The national quality supervision agency proposes a type When inspection is required. 7.3.2 Type inspection shall be carried out in accordance with the requirements of Chapter 5, and all inspections shall be considered qualified. 7.3.3 Judgment rules:
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JB20025—2004
Type inspection prototypes should be selected from 10% of the products that pass factory inspection. If there are less than three prototypes (including three), random testing One unit. If the prototype is larger than three units, two units shall be randomly tested. The sampling method shall be implemented in accordance with the relevant provisions in GB/T10111. During the inspection, if any one of 5.2.1~5.2.3 fails, the type inspection will be deemed unqualified. If one of the other items is unqualified, the unqualified item should be added for re-inspection. If the item is still unqualified, the product will be deemed to have failed the type inspection. 8 Logo, instruction manual, packaging and purchase and inventory 8.1 Logo
8.1.1 Each filling machine should be equipped with a nameplate according to the drawings. The size and technical requirements of the nameplate should comply with the provisions of GB/T13306. The nameplate emergency contains the following content:
a) name;
b) model number;
e) trademark;
d) power connection content includes: ||tt| |1) Power frequency:
2) Connectable power supply voltage or voltage range; 3) Power supply category, such as number of phases.
e) Input power;
f) Manufacturer’s name or address;
g
Factory number;
h)
Factory date:
adopts standard number.
8.1.2
The transportation packaging mark should comply with the provisions of GB/T6388. The packaging mark content contains the name:
a)
b)
c )
d)
e)
Model number;
Dimensions:
Weight:
Receiving location and unit:|| tt||f
Shipping location and unit.
Packaging, storage and transportation pictorial signs should comply with the provisions of CB/T191. The pictorial signs include: 8.1.3
a) center of gravity;
b) fear of rain; ||tt| |e) upward.
8.2 Instructions for use
8.2.1
The preparation of instructions for use shall comply with the requirements of GB/T9969.1. The content of the instruction manual should include:
8.2.2
a) product name, manufacturer name, address, postal code and contact number: b) implemented product standards;
19| |tt||2. The continuous working time of the maximum speed is not less than 2 hours, and the machine runs smoothly. Use a thermometer to measure the temperature of the motor, vacuum and reducer, and calculate the temperature rise according to formula (1).
At=t- to
In the formula:
At—temperature rise.℃;
tactually measured component temperature,℃;
to— —Actual ambient temperature, °C.
6.4 Loading probability test
6.4.1 Each filling machine shall undergo a loading probability test after the mechanical operation test. 6.4.2 Test conditions:
8) The test should be conducted indoors with a temperature of 18°C ??~ 24 and a relative intensity of 45% ~ 65%: b) The test capsule should comply with the regulations of GB13731; (1)
c) The filling used for the drug-loading test is medicinal starch, and the requirements for starch should be in accordance with the provisions of Part 2 of the "Pharmacopoeia of the People's Republic of China" (2000 edition);
d) For testing without drug-filling The rotation speed and running time are: 17
JB20025-2004
1) Run at 70% of the maximum speed for 5 minutes: 2) Run at the maximum speed for 5 minutes.
e) The rotation speed and operating time for the charge test are: 1) Run at 70% of the maximum speed for 10 minutes; 2) Run at the maximum speed for 10 minutes.
6.4.3 No-loading test: Calculate the capsule loading probability according to the test results of the two rotation speeds according to formula (2), and then calculate the average of the capsule loading probability as the loading probability. || tt | The number of glue for side, neck concave, deformation and other defects, in grains; the number of capsules put into the test, in grains.
·(2)
6.4.4 Charging test: Calculate the capsule loading probability according to the test results of the two rotation speeds according to Equation (2), and then calculate the average value of the capsule loading rate as the loading probability .
6.5 Charge difference test
6.5.1 test is allowed to be performed by the user.
6.5.2 The test conditions shall be as specified in a), b), c) and e) of 6.4.2. 6.5.3 The filling difference limit shall be based on the provisions of the capsule filling difference inspection method in Appendix E of the Pharmacopoeia of the People's Republic of China (2000 Edition).
6.6 Noise test
When the filling machine is at its maximum no-load speed, use a sound level meter to measure the noise according to the method specified in GB/T16769. 7 Inspection rules
7.1 Inspection classification
Filling machines are divided into factory inspection and type inspection. 7.2 Factory inspection
7.2.1 Each filling machine shall undergo factory inspection by the quality department of the manufacturer. It must pass the inspection and be accompanied by a certificate of conformity before it can leave the factory. 7.2.2 The inspection items shall be in accordance with the requirements of 5.1.1, 5.1.3.5.2.1~5.2.3, 5.3, and 5.4, and shall be considered 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 the performance may be significantly improved; when production is resumed after two years of suspension;
When the factory inspection results are significantly different from the last type inspection; d)
e) The national quality supervision agency proposes a type When inspection is required. 7.3.2 Type inspection shall be carried out in accordance with the requirements of Chapter 5, and all inspections shall be considered qualified. 7.3.3 Judgment rules:
18
JB20025—2004
Type inspection prototypes should be selected from 10% of the products that pass the factory inspection. If there are less than three prototypes (including three), random testing One unit. If the prototype is larger than three units, two units shall be randomly tested. The sampling method shall be implemented in accordance with the relevant provisions in GB/T10111. During the inspection, if any one of 5.2.1~5.2.3 fails, the type inspection will be deemed unqualified. If one of the other items is unqualified, the unqualified item should be added for re-inspection. If the item is still unqualified, the product will be deemed to have failed the type inspection. 8 Logo, instruction manual, packaging and purchase and inventory 8.1 Logo
8.1.1 Each filling machine should be equipped with a nameplate according to the drawings. The size and technical requirements of the nameplate should comply with the provisions of GB/T13306. The nameplate emergency contains the following contents:
a) name;
b) model number;
e) trademark;
d) power connection contents include: ||tt| |1) Power frequency:
2) Connectable power supply voltage or voltage range; 3) Power supply category, such as number of phases.
e) Input power;
f) Manufacturer’s name or address;
g
Factory number;
h)
Factory date:
adopts standard number.
8.1.2
The transportation packaging mark should comply with the provisions of GB/T6388. The packaging mark content contains the name:
a)
b)
c )
d)
e)
Model number;
Dimensions:
Weight:
Receiving location and unit:|| tt||f
Shipping location and unit.
Packaging, storage and transportation pictorial signs should comply with the provisions of CB/T191. The pictorial signs include: 8.1.3
a) center of gravity;
b) fear of rain; ||tt| |e) upward.
8.2 Instructions for use
8.2.1
The preparation of instructions for use shall comply with the requirements of GB/T9969.1. The content of the instruction manual should include:
8.2.2
a) product name, manufacturer name, address, postal code and contact number: b) implemented product standards;
19| |tt||2. The continuous working time of the maximum speed is not less than 2 hours, and the machine runs smoothly. Use a thermometer to measure the temperature of the motor, vacuum and reducer, and calculate the temperature rise according to formula (1).
At=t- to
In the formula:
At—temperature rise.℃;
tactually measured component temperature,℃;
to— —Actual ambient temperature, °C.
6.4 Loading probability test
6.4.1 Each filling machine shall undergo a loading probability test after the mechanical operation test. 6.4.2 Test conditions:
8) The test should be conducted indoors with a temperature of 18°C ??~ 24 and a relative intensity of 45% ~ 65%: b) The test capsule should comply with the regulations of GB13731; (1)
c) The filling used for the drug-loading test is medicinal starch, and the requirements for starch should be in accordance with the provisions of Part 2 of the "Pharmacopoeia of the People's Republic of China" (2000 edition);
d) For testing without drug-filling The rotation speed and running time are: 17
JB20025-2004
1) Run at 70% of the maximum speed for 5 minutes: 2) Run at the maximum speed for 5 minutes.
e) The rotation speed and operating time for the charge test are: 1) Run at 70% of the maximum speed for 10 minutes; 2) Run at the maximum speed for 10 minutes.
6.4.3 No-loading test: Calculate the capsule loading probability according to the test results of the two rotation speeds according to formula (2), and then calculate the average of the capsule loading probability as the loading probability. || tt | The number of glue for side, neck concave, deformation and other defects, in grains; the number of capsules put into the test, in grains.
·(2)
6.4.4 Charging test: Calculate the capsule loading probability according to the test results of the two rotation speeds according to equation (2), and then calculate the average of the capsule loading rates as the loading probability .
6.5 Charge difference test
6.5.1 test is allowed to be performed by the user.
6.5.2 The test conditions shall be as specified in a), b), c) and e) of 6.4.2. 6.5.3 The filling difference limit shall be based on the provisions of the capsule filling difference inspection method in Appendix E of the Pharmacopoeia of the People's Republic of China (2000 Edition).
6.6 Noise test
When the filling machine is at its maximum no-load speed, use a sound level meter to measure the noise according to the method specified in GB/T16769. 7 Inspection rules
7.1 Inspection classification
Filling machines are divided into factory inspection and type inspection. 7.2 Factory inspection
7.2.1 Each filling machine shall undergo factory inspection by the quality department of the manufacturer. It must pass the inspection and be accompanied by a certificate of conformity before it can leave the factory. 7.2.2 The inspection items shall be in accordance with the requirements of 5.1.1, 5.1.3.5.2.1~5.2.3, 5.3, and 5.4, and shall be considered 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 the performance may be significantly improved; when production is resumed after two years of suspension;
When the factory inspection results are significantly different from the last type inspection; d)
e) The national quality supervision agency proposes a type When inspection is required. 7.3.2 Type inspection shall be carried out in accordance with the requirements of Chapter 5, and all inspections shall be considered qualified. 7.3.3 Judgment rules:
18
JB20025—2004
Type inspection prototypes shall be selected from 10% of the products that pass the factory inspection. If there are less than three prototypes (including three), random testing shall be carried out. One unit. If the prototype is larger than three units, two units shall be randomly tested. The sampling method shall be implemented in accordance with the relevant provisions in GB/T10111. During the inspection, if any one of 5.2.1~5.2.3 fails, the type inspection will be deemed unqualified. If one of the other items is unqualified, the unqualified item should be added for re-inspection. If the item is still unqualified, the product will be deemed to have failed the type inspection. 8 Logo, instruction manual, packaging and purchase and inventory 8.1 Logo
8.1.1 Each filling machine should be equipped with a nameplate according to the drawings. The size and technical requirements of the nameplate should comply with the regulations of GB/T13306. The nameplate emergency contains the following contents:
a) name;
b) model number;
e) trademark;
d) power connection contents include: ||tt| |1) Power frequency:
2) Connectable power supply voltage or voltage range; 3) Power supply category, such as number of phases.
e) Input power;
f) Manufacturer’s name or address;
g
Factory number;
h)
Factory date:
adopts standard number.
8.1.2
The transportation packaging mark should comply with the provisions of GB/T6388. The packaging mark content contains the name:
a)
b)
c )
d)
e)
Model number;
Dimensions:
Weight:
Receiving location and unit:|| tt||f
Shipping location and unit.
Packaging, storage and transportation pictorial signs should comply with the provisions of CB/T191. The pictorial signs include: 8.1.3
a) center of gravity;
b) fear of rain; ||tt| |e) upward.
8.2 Instructions for use
8.2.1
The preparation of instructions for use shall comply with the requirements of GB/T9969.1. The content of the instruction manual should include:
8.2.2
a) product name, manufacturer name, address, postal code and contact number: b) implemented product standards;
19| |tt||1 Type inspection should be carried out when one of the following situations occurs: a) Trial prototype identification of new products or old products transferred to factory production; b) When the design, process or materials used of the product involve major performance or major improvements; production is suspended for two years When production is resumed again;
When the factory inspection results are significantly different from the last type inspection; d)
e) When the national quality supervision agency proposes type inspection requirements. 7.3.2 Type inspection shall be carried out in accordance with the requirements of Chapter 5, and all inspections shall be considered qualified. 7.3.3 Judgment rules:
18
JB20025—2004
Type inspection prototypes shall be selected from 10% of the products that pass the factory inspection. If there are less than three prototypes (including three), random testing shall be carried out. One unit. If the prototype is larger than three units, two units shall be randomly tested. The sampling method shall be implemented in accordance with the relevant provisions in GB/T10111. During the inspection, if any one of 5.2.1~5.2.3 fails, the type inspection will be deemed unqualified. If one of the other items is unqualified, the unqualified item should be added for re-inspection. If the item is still unqualified, the product will be deemed to have failed the type inspection. 8 Logo, instruction manual, packaging and purchase and inventory 8.1 Logo
8.1.1 Each filling machine should be equipped with a nameplate according to the drawings. The size and technical requirements of the nameplate should comply with the provisions of GB/T13306. The nameplate emergency contains the following contents:
a) name;
b) model number;
e) trademark;
d) power connection contents include: ||tt| |1) Power frequency:
2) Connectable power supply voltage or voltage range; 3) Power supply category, such as number of phases.
e) Input power;
f) Manufacturer’s name or address;
g
Factory number;
h)
Factory date:
adopts standard number.
8.1.2
The transportation packaging mark should comply with the provisions of GB/T6388. The packaging mark content contains the name:
a)
b)
c )
d)
e)
Model number;
Dimensions:
Weight:
Receiving location and unit:|| tt||f
Shipping location and unit.
Packaging, storage and transportation pictorial signs should comply with the provisions of CB/T191. The pictorial signs include: 8.1.3
a) center of gravity;
b) fear of rain; ||tt| |e) upward.
8.2 Instructions for use
8.2.1
The preparation of instructions for use shall comply with the requirements of GB/T9969.1. The content of the instruction manual should include:
8.2.2
a) product name, manufacturer name, address, postal code and contact number: b) implemented product standards;
19| |tt||1 Type inspection should be carried out when one of the following situations occurs: a) Trial prototype identification of new products or old products transferred to factory production; b) When the design, process or materials used of the product involve major performance or major improvements; production is suspended for two years When production is resumed again;
When the factory inspection results are significantly different from the last type inspection; d)
e) When the national quality supervision agency proposes type inspection requirements. 7.3.2 Type inspection shall be carried out in accordance with the requirements of Chapter 5, and all inspections shall be considered qualified. 7.3.3 Judgment rules:
18
JB20025—2004
Type inspection prototypes shall be selected from 10% of the products that pass the factory inspection. If there are less than three prototypes (including three), random testing shall be carried out. One unit. If the prototype is larger than three units, two units shall be randomly tested. The sampling method shall be implemented in accordance with the relevant provisions in GB/T10111. During the inspection, if any one of 5.2.1~5.2.3 fails, the type inspection will be deemed unqualified. If one of the other items is unqualified, the unqualified item should be added for re-inspection. If the item is still unqualified, the product will be deemed to have failed the type inspection. 8 Logo, instruction manual, packaging and purchase and inventory 8.1 Logo
8.1.1 Each filling machine should be equipped with a nameplate according to the drawings. The size and technical requirements of the nameplate should comply with the provisions of GB/T13306. The nameplate emergency contains the following contents:
a) name;
b) model number;
e) trademark;
d) power connection contents include: ||tt| |1) Power frequency:
2) Connectable power supply voltage or voltage range; 3) Power supply category, such as number of phases.
e) Input power;
f) Manufacturer’s name or address; www.bzxz.net
g
Factory number;
h)
Factory date:
adopts standard number.
8.1.2
The transportation packaging mark should comply with the provisions of GB/T6388. The packaging mark content contains the name:
a)
b)
c )
d)
e)
Model number;
Dimensions:
Weight:
Receiving location and unit:|| tt||f
Shipping location and unit.
Packaging, storage and transportation pictorial signs should comply with the provisions of CB/T191. The pictorial signs include: 8.1.3
a) center of gravity;
b) fear of rain; ||tt| |e) upward.
8.2 Instructions for use
8.2.1
The preparation of instructions for use shall comply with the requirements of GB/T9969.1. The content of the instruction manual should include:
8.2.2
a) product name, manufacturer name, address, postal code and contact number: b) implemented product standards;
19| |tt||
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