Some standard content:
JB
Pharmaceutical Machinery Industry Standard of the People's Republic of China JB20019~20023—2004
Electronic counting bottle filling machine for medicines
Rotary tablet press
High-speed rotary tablet press
Tablet press tablet punching machine
Aluminum-plastic blister packaging machine
2004-02-05 Issued
2004-06-01 Implementation
National Development and Reform Commission Issued
ICS11.120.30
C92
JB
Pharmaceutical Machinery Industry Standard of the People's Republic of China JB20023--2004
Replace YY/T0139—1993
Aluminum-plastic blister packaging machine
Aluminum-pl asticblisterpackagingmachine2004-02-05issued
2004-06-01implemented
National Development and Reform Commission
issued
Foreword
1
Scope
2Normative references
3Classification and marking
4Requirements
5Test methods
6Inspection rules
Marking, packaging, transportation and storage
Contents
JB20023—2004
50
51
51
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52
5S
56
49
JB 20023—2004
Foreword
This standard is a revision of YY/T0139—1993 "Aluminum-plastic Blister Packaging Machine" based on the requirements of "Good Manufacturing Practice for Pharmaceuticals" and GB/T1.1—2000 and GB/T1.2—2002 standardization guidelines. This standard replaces YY/T0139—1993 from the date of implementation. Compared with YYT01391993, the main technical content changes of this standard are as follows: a) In addition to the main chapters and articles of YY/T0139—1993: Basic requirements for packaging machines (4.1):
Requirements for aluminum parts (4.13);
Requirements for electroplated parts (4.14);
Requirements for painted parts (4.15).
The main chapters and articles of YY/T0139-1993 have been revised: b)
-Roller type is changed to roll type (T), roll plate type is changed to roll plate type (H) (3.1); Packaging machine working noise index (4.7);
Electrical safety performance of packaging machine (4.9.2, 4.9.3, 4.9.4); - The original reference standard ZBC08003 content is integrated into the packaging finished product test (see 5.8); Appendix A is changed to the content of 4.8 of this standard.
e) The main chapters and articles added to this standard:
Requirements for the unloading device of the packaging machine (see 4.3.4); - Signs and logos (see 4.4);
-Cross crack line test (see 5.7.1).
This standard is proposed by the China Pharmaceutical Equipment Industry Association. This standard is under the jurisdiction of the Pharmaceutical Equipment Industry Standardization Technical Committee. The main drafting unit of this standard: Beijing Shuanghe Pharmaceutical Equipment Co., Ltd. The main drafters of this standard are Zhao Lin and Feng Shuhong. 50
1 Scope
Aluminum-plastic blister packaging machine
JB20023—2004
This standard specifies the classification and marking, requirements, test methods, inspection rules and marking, packaging, transportation and storage requirements of aluminum-plastic blister packaging machines.
This standard applies to aluminum-plastic blister packaging machines (hereinafter referred to as packaging machines) and plastic-plastic blister packaging machines. 2 Normative references
The clauses in the following documents become the clauses of this standard through reference in this standard. For all dated references, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, the parties who reach an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. For all undated references, the latest versions are applicable to this standard. GB/T191 Pictorial signs for packaging, storage and transportation
GB5226.1-2002 Mechanical safety Mechanical electrical equipment Part 1: General technical conditions GB5663 Medicinal polyvinyl chloride (PVC) rigid sheet
GB/T6388 Transport packaging delivery and receipt marks
GB7231 Basic identification colors and identification symbols for industrial pipelines GB/T7311 Method for compiling packaging machinery models GB9706.1-1995 Medical electrical equipment Part 1: General safety requirements GB/T9969.1 Industrial Product Instructions General GB/T10111 Method of random sampling using machine numbers GB12255 Aluminum foil for pharmaceutical packaging
GB/T13306 Label
General technical conditions for packaging of electromechanical products
GB/T13384
GB/T16769 Method for measuring sound pressure level of noise from metal cutting machine tools 3 Classification and marking
3.1 Classification
The types of packaging machines are divided into simple type (T), roller type (H) and flat type (P) according to their structure. 3.2 Marking
The model marking of packaging machines shall comply with the provisions of CB/T7311. Model compilation:
51
JB20023—2004
Marking example
DP
Improvement design sequence number (in order of A, B, C) Main parameters: Maximum width of packaging materials used by packaging machine (mm) Structural type: Roller type (T), Roller type (HD and Flat type (P) Classification name: Blister packaging machine
DPH130A: Indicates that after the first improvement design, the maximum width of the packaging material used is 130mm. 4 Requirements
4.1 Working conditions
4.1.1 Polyvinyl chloride (PVC) materials should meet the requirements of CB5663. 4.1.2 Aluminum box materials should meet the requirements of GB12255. 4. 2 Basic requirements
Parts of the packaging machine that are in direct contact with the packaged objects and the packaging surface of the packaging materials should be made of stainless, non-toxic, corrosion-resistant materials that do not contaminate the packaged objects; materials sprayed or plated on the surface of the materials should be non-toxic, corrosion-resistant, not easy to fall off, and have high chemical stability within the heating temperature range of the packaging machine.
4.3 Appearance requirements
4.3.1 The surface of exposed metal parts should be rust-proofed. 4.3.2 The painted parts of the outer surface of the machine should be beautiful and harmonious in color, and the painted surface should not have obvious streaks or scratches. 4.3.3 The parts of each part of the packaging machine should have neat appearance, no burrs or obvious scratches, and the surfaces, corners and edges in contact with the packaged objects should be flat, smooth, easy to clean and disinfect. The packaging machine should be able to , equipped with corresponding feeding devices to adapt to different packaged objects, the structure should be easy to disassemble and assemble: the inner walls of the hopper (box) and the feeding device that are in contact with the medicine should be smooth, flat and without dead angles. 4.3.4 The feeding and loading should be in the form of stirring, and the brushes and stirring blades should not fall off or damage the packaged objects; for packaged objects with high dust content, dust collection and powder suction devices should be installed. 4.3.5 The coolant used in the packaging machine and the lubricant used in each component should have leakage prevention measures and should not contaminate the packaged objects and packaging materials.
4.4 Signs and logos
4.4.1 The cold water pipes and gas pipes of the packaging machine should comply with the provisions of CB7231. 4.4.2 The power cut-off switch of the packaging machine uses a switch isolating device, a height isolator or a circuit breaker to disconnect the electrical equipment from the power supply. The source isolation should be high, and there should be only one "off" and "on" position, which should be clearly marked with "\O" and "" and should comply with the provisions of 5.3 of GB5226.1-2002. 4.4.3 The marking of the packaging machine wires should comply with the provisions of 14.2 of GB5226.1-2002. 4.4.4 The positions of the control devices and switches of the packaging machine should be marked with numbers, words or other intuitive methods, and should comply with the provisions of 6.3.b) of GB9706.1-1995. 4.4.5 The buttons used in the packaging machine should comply with the provisions of 10.2 of GB5226.1-2002. 4.4.6 The color code and status of the indicator lights and displays used by the packaging machine to display the working status should comply with the provisions of 10.3 of GB5226.1-2002.
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4.5 Operation requirements
JB20023—2004
4.5.1 The connections of all parts of the packaging machine should be firm and reliable, and the air control, air circuit and water circuit systems should be unobstructed and free of leakage. 4.5.2. During the operation of the packaging machine, all moving parts should be coordinated, flexible, and accurate. The movement state switching of the movement mechanism should be flexible and reliable, and there should be no dead spots, hard collisions, or stagnation. 4.5.3 There should be no abnormal noise during the empty operation of the packaging machine, and the noise sound pressure level should not be greater than 82dB(A). 4.6 Safety requirements
4.6.1 There should be safety signs or safety shields in dangerous areas. 4.6.2 The electrical system should be safe and reliable, sensitive and accurate in operation, and should be equipped with safety protection devices or markings. 4.6.3 The circuit system of the packaging machine should be equipped with a reliable protective grounding device, and the continuity of the protective grounding circuit should comply with the provisions of 8.2 in GB5226.1-2002.
4.6.4 The insulation resistance between the short-circuited power circuit wires of the packaging machine and the protective grounding circuit wires should not be less than 1MQ4.6.5 All circuit wires of the packaging machine and the protective grounding circuit should be able to withstand 50Hz, 1000V The withstand voltage test lasts for at least 13 seconds and there is no breakdown. Components that are not suitable to withstand the test should be disconnected during the test. 4.7 Functional requirements
4.7.1 The packaging machine should be equipped with a batch number printing device, and the structure should be easy to disassemble and assemble. 4.7.2 The tear line of the packaged finished product should be kept intact, not exposed, consistent in depth, and easy to tear open by hand. 4.8 Requirements for finished products packaged by the packaging machine
4.8.1 Qualification rate:
The qualification rate of finished products should be greater than or equal to 96%.
4.8.2 Appearance of finished packaging:
The blister should be full, smooth, and crisp; the batch number in the plate should be clearly identifiable and accurately positioned, and there should be no contamination of the plate; PVC and aluminum boxes should be sealed The edges should be tight, smooth, with clear patterns, and there should be no wrinkling or pressing; the PVC and aluminum foil should not be separated at the corners of the plate; there should be no burrs at the corners of the plate.
4.8.3 Dimensions of packaged goods:
The size tolerance of board length and board width is ±0.3mm, the sealing distance between blisters is not less than 2.5mm, and the edge of the blister to the edge of the board The sealing distance between the tear line and the tear line shall not be less than 2.5mm.
4.8.4 Sealing of finished packaging:
The plates are tightly sealed and no liquid is allowed to penetrate into the blister or sealing layer. 4.8.5 Filling rate of finished packaging products:
There must be no missing particles in the filled plates. Appropriate auxiliary filling measures are allowed after consultation with the user for packaged items that are difficult to cut, such as capsules and special-shaped tablets.
5 Test methods
5.1 Test conditions
Inspect the relevant certificates of aluminum foil and polyvinyl chloride (PVC) used in the packaging machine testing process. 5.2 Material test
Check the list of raw materials. The raw materials in contact with the packaging and packaged objects should have material certificates or other relevant materials. 53
JB20023—2004
5.3 Appearance of the packaging machine
Visually inspect the appearance of the packaging machine.
5.4 Safety signs
Visually inspect the safety signs of the packaging machine. || tt | No air bubbles. Cooling system: The cooling water with a pressure less than 0.15MPa is passed through the water inlet and is naturally discharged from the water outlet without leakage. 5.5.2 Debugging operation test
5.5.2.1 No-load operation test: Adjust the batch number, loading, blanking and cheese line to reach a coordinated working state, and run continuously at high speed for 0.5h without load.
5.5.2.2 Packaging operation test: The cumulative load operation shall not be less than 0.5h, and the production frequency of the packaging machine shall be adjusted to reach 75%~85% of the production capacity, of which the filling drug test shall not be less than 10min. 5.5.2.3 In the above two types of operation tests, the cumulative operation interruption time shall not exceed 0.5h. 5.5.3 Noise test
The packaging machine is in a no-load high-speed working state, and the sound level meter is used to test according to the regulations of GB/T16769. 5.6 Electrical safety test
The electrical safety performance test of the packaging machine shall be tested according to the methods specified in 19.2, 19.3 and 19.4 of GB5226.1-2002. 5.7 Functional test
5.7.1 Tear line test
During the operation test of 5.5.2.2, take any five boards of packaged products, first visually observe the tear line marks, and then check all the cheese lines on each board Fold in half more than 90° four times and then tear along the tear line. 5.8 Packaging finished product test
During the operation test in 5.5.2.2, 300 boards of finished packaging products are taken as micro-samples, and the stopwatch is used for timing and manual counting. The sampling is done every 1 minute, and 100 boards of continuous punching are taken for testing each time. . 5.8.1 Appearance
Take any five plates from the sample, visually observe the blister, batch number, and pattern. Face the light source to see if there are light-transmitting spots at the sealing of the plates; gently touch the corners of the plates with your hands to see if they are light. clear.
5.8.2 Dimensions
Take any five plates from the sample and measure them with a general measuring tool or a special measuring tool. 5.8.3 Sealing performance
5.8.3.1 Test equipment:
A sealed container that can withstand more than 1 atmospheric pressure, equipped with a 2.5-level vacuum gauge and an exhaust pipe with a door connected to the vacuum pump , a vent pipe connected to the atmosphere, a water pipe connected to the water source, and a pressure plate built into the container with a diameter smaller than the inner diameter of the container. 5.8.3.2 Sampling;
Select 100 plates from the sample. Divided into four groups, each group has 25 plates as samples. 5.8.3.3 Test steps:
SA
JB20023-2004
Place the sample into a closed container, close the sealing lid tightly, close the air conditioner, start the vacuum pump, and keep the vacuum degree at 0.8MPa for 30 seconds, inject colored liquid, the liquid level is 25mm higher than the surface of the sample, and return to normal pressure; take out the sample, rinse it with clean water, wipe it clean, and then observe whether there is liquid penetration into the blister and sealing layer.
5.8.4 Filling pass rate
Pick 100 plates from the sample and check the number of missing plates. 5.8.5 Qualification rate of finished packaging products
Qualification rate of finished packaging products is calculated according to formula (1).
D
In the formula:
D packaging finished product qualification rate;
E is the number of packaging qualified sections.
6 Inspection Rules
6.1 Inspection Categories:
Charter inspection is divided into factory inspection and type inspection. 6.2 Factory inspection:
300×100%
6.2.1 Packaging machines shall be inspected one by one according to the provisions of Table 1. Only after passing the inspection shall they be allowed to leave the factory, and shall be accompanied by a product certificate. Table 1 Factory inspection items
Item category
Appearance
General performance
Main performance
Inspection items
4.3
4.4, 4.5, 4.7
4.6, 4.8.4, 4.8.5
(1)
6.2.2 The packaging machine is allowed to return if unqualified products are found during the inspection process Repair and conduct re-inspection. If the product is still unqualified, the product will be judged as a non-conforming product.
6.3 Type inspection:
When one of the following situations occurs in the production of packaging machines, type inspection should be carried out: 6.3.1
a)
New product testing or old product improvement finalization; continuous production for 2 to 3 years;
b)
After the official production, when the product structure, materials, and processes have undergone major changes: e)
Resumption after long-term suspension of production During production;
d)
When the factory inspection results are significantly different from the latest type inspection: e
When the national quality supervision agency proposes to conduct type testing. Sampling: For type inspection prototypes, 10% of the production batch 6.3.2
should be sampled from the products that have passed the factory inspection according to the method specified in CB/T10111. One. 6.3.3 Judgment rules: If one of the main properties fails to pass the type inspection, the batch of products will be judged to have failed the type inspection. If one of the other items is unqualified, the unqualified item should be re-inspected twice. If it is still unqualified, the batch of products will be judged to have failed the type inspection. 55
4. The insulation resistance between the short-circuited power circuit wires of the packaging machine and the protective grounding circuit wires should not be less than 1MQ4.6.5 All circuit wires of the packaging machine and the protective grounding circuit should be able to withstand a 50Hz, 1000V withstand voltage test, lasting at least 13. There is no breakdown phenomenon. Components that are not suitable to withstand the test should be disconnected during the test. 4.7 Functional requirements
4.7.1 The packaging machine should be equipped with a batch number printing device and the structure should be easy to disassemble and assemble. 4.7.2 The tear line of the packaged finished product should be kept intact, not exposed, consistent in depth, and easy to tear open by hand. 4.8 Requirements for finished products packaged by the packaging machine
4.8.1 Qualification rate:
The qualification rate of finished products should be greater than or equal to 96%.
4.8.2 Appearance of finished packaging:
The blister should be full, smooth, and crisp; the batch number in the plate should be clearly identifiable and accurately positioned, and there should be no contamination of the plate; PVC and aluminum boxes should be sealed The edges should be tight, smooth, with clear patterns, and there should be no wrinkling or pressing; the PVC and aluminum foil should not be separated at the corners of the plate; there should be no burrs at the corners of the plate.
4.8.3 Dimensions of packaged goods:
The size tolerance of board length and board width is ±0.3mm, the sealing distance between blisters is not less than 2.5mm, and the edge of the blister to the edge of the board The sealing distance between the tear line and the tear line shall not be less than 2.5mm.
4.8.4 Sealing of finished packaging:
The plates are tightly sealed and no liquid is allowed to penetrate into the blister or sealing layer. 4.8.5 Filling rate of finished packaging products:
There must be no missing particles in the filled plates. Appropriate auxiliary filling measures are allowed after consultation with the user for packaged items that are difficult to cut, such as capsules and special-shaped tablets.
5 Test methods
5.1 Test conditions
Inspect the relevant certificates of aluminum foil and polyvinyl chloride (PVC) used in the packaging machine testing process. 5.2 Material test
Check the list of raw materials. The raw materials in contact with the packaging and packaged objects should have material certificates or other relevant materials. 53
JB20023—2004
5.3 Appearance of the packaging machine
Visually inspect the appearance of the packaging machine.
5.4 Safety signs
Visually inspect the safety signs of the packaging machine. || tt | No air bubbles. Cooling system: The cooling water with a pressure less than 0.15MPa is passed through the water inlet and is naturally discharged from the water outlet without leakage. 5.5.2 Debugging operation test
5.5.2.1 No-load operation test: Adjust the batch number, loading, blanking and cheese line to reach a coordinated working state, and run continuously at high speed for 0.5h without load.
5.5.2.2 Packaging operation test: The cumulative load operation shall not be less than 0.5h, and the production frequency of the packaging machine shall be adjusted to reach 75%~85% of the production capacity, of which the filling drug test shall not be less than 10min. 5.5.2.3 In the above two operation tests, the cumulative operation interruption time shall not exceed 0.5h. 5.5.3 Noise test
The packaging machine is in a no-load high-speed working state, and the sound level meter is used to test according to the regulations of GB/T16769. 5.6 Electrical safety test
The electrical safety performance test of the packaging machine shall be tested according to the methods specified in 19.2, 19.3 and 19.4 of GB5226.1-2002. 5.7 Functional test
5.7.1 Tear line test
During the operation test of 5.5.2.2, take any five boards of packaged products, first visually observe the tear line traces, and then check all the cheese lines on each board Fold in half more than 90° four times and then tear along the tear line. 5.8 Packaging finished product test
During the operation test in 5.5.2.2, 300 boards of finished packaging products are taken as micro-samples, and the stopwatch is used for timing and manual counting. The sampling is done every 1 minute, and 100 boards of continuous punching are taken for testing each time. . 5.8.1 Appearance
Take any five plates from the sample, visually observe the blister, batch number, and pattern. Face the light source to see if there are light-transmitting spots at the sealing of the plates; gently touch the corners of the plates with your hands to see if they are light. clear.
5.8.2 Dimensions
Take any five plates from the sample and measure them with a general measuring tool or a special measuring tool. 5.8.3 Sealing performance
5.8.3.1 Test equipment:
A sealed container that can withstand more than 1 atmospheric pressure, equipped with a 2.5-level vacuum gauge and an exhaust pipe with a door connected to the vacuum pump , a vent pipe connected to the atmosphere, a water pipe connected to the water source, and a pressure plate built into the container with a diameter smaller than the inner diameter of the container. 5.8.3.2 Sampling;
Select 100 plates from the sample. Divided into four groups, each group has 25 plates as samples. 5.8.3.3 Test steps:
SA
JB20023-2004
Place the sample into a closed container, close the sealing lid tightly, close the air conditioner, start the vacuum pump, and keep the vacuum degree at 0.8MPa for 30 seconds, inject colored liquid, the liquid level is 25mm higher than the surface of the sample, and return to normal pressure; take out the sample, rinse it with clean water, wipe it clean, and then observe whether there is liquid penetration into the blister and sealing layer.
5.8.4 Filling pass rate
Pick 100 plates from the sample and check the number of missing plates. 5.8.5 Qualification rate of finished packaging products
Qualification rate of finished packaging products is calculated according to formula (1).
D
In the formula:
D packaging finished product qualification rate;
E is the number of packaging qualified sections.
6 Inspection Rules
6.1 Inspection Category:
Charter inspection is divided into factory inspection and type inspection. 6.2 Factory inspection:
300×100%
6.2.1 Packaging machines shall be inspected one by one according to the provisions of Table 1. Only after passing the inspection shall they be allowed to leave the factory, and shall be accompanied by a product certificate. Table 1 Factory inspection items
Item category
Appearance
General performance
Main performance
Inspection items
4.3
4.4, 4.5, 4.7
4.6, 4.8.4, 4.8.5
(1)
6.2.2 The packaging machine is allowed to return if unqualified products are found during the inspection process Repair and conduct re-inspection. If the product is still unqualified, the product will be judged as a non-conforming product.
6.3 Type inspection:
When one of the following situations occurs in the production of packaging machines, type inspection shall be carried out: 6.3.1
a)
New product testing or old product improvement Finalization; continuous production for 2 to 3 years;
b)
After the official production, when the product structure, materials, and processes have undergone major changes: e)
Resumption after long-term suspension of production During production;
d)
When the factory inspection results are significantly different from the latest type inspection: e
When the national quality supervision agency proposes to conduct type testing. Sampling: For type inspection prototypes, 10% of the production batch 6.3.2 | One. 6.3.3 Judgment rules: If one of the main properties fails to pass the type inspection, the batch of products will be judged to have failed the type inspection. If one of the other items is unqualified, the unqualified item should be re-inspected twice. If it is still unqualified, the batch of products will be judged to have failed the type inspection. 55
4. The insulation resistance between the short-circuited power circuit wires of the packaging machine and the protective grounding circuit wires should not be less than 1MQ4.6.5 All circuit wires of the packaging machine and the protective grounding circuit should be able to withstand a 50Hz, 1000V withstand voltage test, lasting at least 13. If there is no breakdown, components that are not suitable to withstand the test should be disconnected during the test. 4.7 Functional requirements
4.7.1 The packaging machine should be equipped with a batch number printing device, and the structure should be easy to disassemble and assemble. 4.7.2 The tear line of the packaged finished product should be kept intact, not exposed, consistent in depth, and easy to tear open by hand. 4.8 Requirements for finished products packaged by the packaging machine
4.8.1 Qualification rate:
The qualification rate of finished products should be greater than or equal to 96%.
4.8.2 Appearance of finished packaging:
The blister should be full, smooth, and crisp; the batch number in the plate should be clearly identifiable and accurately positioned, and there should be no contamination of the plate; PVC and aluminum boxes should be sealed The edges should be tight, smooth, with clear patterns, and there should be no wrinkling or pressing; the PVC and aluminum foil should not be separated at the corners of the plate; there should be no burrs at the corners of the plate.
4.8.3 Dimensions of packaged goods:
The size tolerance of board length and board width is ±0.3mm, the sealing distance between blisters is not less than 2.5mm, and the edge of the blister to the edge of the board The sealing distance between the tear line and the tear line shall not be less than 2.5mm.
4.8.4 Sealing of finished packaging:
The plates are tightly sealed and no liquid is allowed to penetrate into the blister or sealing layer. 4.8.5 Filling rate of finished packaging products:
There must be no missing particles in the filled plates. Appropriate auxiliary filling measures are allowed after consultation with the user for packaged items that are difficult to cut, such as capsules and special-shaped tablets.
5 Test methods
5.1 Test conditions
Inspect the relevant certificates of aluminum foil and polyvinyl chloride (PVC) used in the packaging machine testing process. 5.2 Material test
Check the list of raw materials. The raw materials in contact with the packaging and packaged objects should have material certificates or other relevant materials. 53
JB20023—2004
5.3 Appearance of the packaging machine
Visually inspect the appearance of the packaging machine.
5.4 Safety signs
Visually inspect the safety signs of the packaging machine. || tt | No air bubbles. Cooling system: The cooling water with a pressure less than 0.15MPa is passed through the water inlet and is naturally discharged from the water outlet without leakage. 5.5.2 Debugging operation test
5.5.2.1 No-load operation test: Adjust the batch number, loading, blanking and cheese line to reach a coordinated working state, and run continuously at high speed for 0.5h without load.
5.5.2.2 Packaging operation test: The cumulative load operation shall not be less than 0.5h, and the production frequency of the packaging machine shall be adjusted to reach 75%~85% of the production capacity, of which the filling drug test shall not be less than 10min. 5.5.2.3 In the above two operation tests, the cumulative operation interruption time shall not exceed 0.5h. 5.5.3 Noise test
The packaging machine is in a no-load high-speed working state, and the sound level meter is used to test according to the regulations of GB/T16769. 5.6 Electrical safety test
The electrical safety performance test of the packaging machine shall be tested according to the methods specified in 19.2, 19.3 and 19.4 of GB5226.1-2002. 5.7 Functional test
5.7.1 Tear line test
During the operation test in 5.5.2.2, take any five boards of packaged products, first visually observe the tear line traces, and then check all the cheese lines on each board Fold in half more than 90° four times and then tear along the tear line. 5.8 Packaging finished product test
During the operation test in 5.5.2.2, 300 boards of finished packaging products are taken as micro-samples, and the stopwatch is used for timing and manual counting. The sampling is done every 1 minute, and 100 boards of continuous punching are taken for testing each time. . 5.8.1 Appearance
Take any five plates from the sample, visually observe the blister, batch number, and pattern. Face the light source to see if there are light-transmitting spots at the sealing of the plates; gently touch the corners of the plates with your hands to see if they are light. clear.
5.8.2 Dimensions
Take any five plates from the sample and measure them with a general measuring tool or a special measuring tool. 5.8.3 Sealing performance
5.8.3.1 Test equipment:
A sealed container that can withstand more than 1 atmospheric pressure, equipped with a 2.5-level vacuum gauge and an exhaust pipe with a door connected to the vacuum pump , a vent pipe connected to the atmosphere, a water pipe connected to the water source, and a pressure plate built into the container with a diameter smaller than the inner diameter of the container. 5.8.3.2 Sampling;
Select 100 plates from the sample. Divided into four groups, each group has 25 plates as samples. 5.8.3.3 Test steps:
SA
JB20023-2004
Place the sample into a closed container, close the sealing lid tightly, close the air conditioner, start the vacuum pump, and keep the vacuum degree at 0.8MPa for 30 seconds, inject colored liquid, the liquid level is 25mm higher than the surface of the sample, and return to normal pressure; take out the sample, rinse it with clean water, wipe it clean, and then observe whether there is liquid penetration into the blister and sealing layer. Www.bzxZ.net
5.8.4 Filling pass rate
Pick 100 plates from the sample and check the number of missing plates. 5.8.5 Qualification rate of finished packaging products
Qualification rate of finished packaging products is calculated according to formula (1).
D
In the formula:
D packaging finished product qualification rate;
E is the number of packaging qualified sections.
6 Inspection Rules
6.1 Inspection Category:
Charter inspection is divided into factory inspection and type inspection. 6.2 Factory inspection:
300×100%
6.2.1 Packaging machines shall be inspected one by one according to the provisions of Table 1. Only after passing the inspection shall they be allowed to leave the factory, and shall be accompanied by a product certificate. Table 1 Factory inspection items
Item category
Appearance
General performance
Main performance
Inspection items
4.3
4.4, 4.5, 4.7
4.6, 4.8.4, 4.8.5
(1)
6.2.2 The packaging machine is allowed to return if unqualified products are found during the inspection process Repair and conduct re-inspection. If the product is still unqualified, the product will be judged as a non-conforming product.
6.3 Type inspection:
When one of the following situations occurs in the production of packaging machines, type inspection should be carried out: 6.3.1
a)
New product testing or old product improvement finalization; continuous production for 2 to 3 years;
b)
After the official production, when the product structure, materials, and processes have undergone major changes: e)
Resumption after long-term suspension of production During production;
d)
When the factory inspection results are significantly different from the latest type inspection: e
When the national quality supervision agency proposes to conduct type testing. Sampling: For type inspection prototypes, 10% of the production batch 6.3.2 | One. 6.3.3 Judgment rules: If one of the main properties fails to pass the type inspection, the batch of products will be judged to have failed the type inspection. If one of the other items is unqualified, the unqualified item should be re-inspected twice. If it is still unqualified, the batch of products will be judged to have failed the type inspection. 55
5mm.
4.8.4 Sealing of finished packaging:
The plates are tightly sealed and no liquid is allowed to penetrate into the blister or sealing layer. 4.8.5 Filling rate of finished packaging products:
There must be no missing particles in the filled plates. Appropriate auxiliary filling measures are allowed after consultation with the user for packaged items that are difficult to cut, such as capsules and special-shaped tablets.
5 Test methods
5.1 Test conditions
Inspect the relevant certificates of aluminum foil and polyvinyl chloride (PVC) used in the packaging machine testing process. 5.2 Material test
Check the list of raw materials. The raw materials in contact with the packaging and packaged objects should have material certificates or other relevant materials. 53
JB20023—2004
5.3 Appearance of the packaging machine
Visually inspect the appearance of the packaging machine.
5.4 Safety signs
Visually inspect the safety signs of the packaging machine. || tt | No air bubbles. Cooling system: The cooling water with a pressure less than 0.15MPa is passed through the water inlet and is naturally discharged from the water outlet without leakage. 5.5.2 Debugging operation test
5.5.2.1 No-load operation test: Adjust the batch number, loading, blanking and cheese line to reach a coordinated working state, and run continuously at high speed for 0.5h without load.
5.5.2.2 Packaging operation test: The cumulative load operation shall not be less than 0.5h, and the production frequency of the packaging machine shall be adjusted to reach 75%~85% of the production capacity, of which the filling drug test shall not be less than 10min. 5.5.2.3 In the above two types of operation tests, the cumulative operation interruption time shall not exceed 0.5h. 5.5.3 Noise test
The packaging machine is in a no-load high-speed working state, and the sound level meter is used to test according to the regulations of GB/T16769. 5.6 Electrical safety test
The electrical safety performance test of the packaging machine shall be tested according to the methods specified in 19.2, 19.3 and 19.4 of GB5226.1-2002. 5.7 Functional test
5.7.1 Tear line test
During the operation test of 5.5.2.2, take any five boards of packaged products, first visually observe the tear line marks, and then check all the cheese lines on each board Fold it in half more than 90° four times and then tear it along the tear line. 5.8 Packaging finished product test
During the operation test in 5.5.2.2, 300 boards of finished packaging products are taken as micro-samples, and the stopwatch is used for timing and manual counting. The sampling is done every 1 minute, and 100 boards of continuous punching are taken for testing each time. . 5.8.1 Appearance
Take any five plates from the sample, visually observe the blister, batch number, and pattern. Face the light source to see if there are light-transmitting spots at the sealing of the plates; gently touch the corners of the plates with your hands to see if they are light. clear.
5.8.2 Dimensions
Take any five plates from the sample and measure them with a general measuring tool or a special measuring tool. 5.8.3 Sealing performance
5.8.3.1 Test equipment:
A sealed container that can withstand more than 1 atmospheric pressure, equipped with a 2.5-level vacuum gauge and an exhaust pipe with a door connected to the vacuum pump , a vent pipe connected to the atmosphere, a water pipe connected to the water source, and a pressure plate built into the container with a diameter smaller than the inner diameter of the container. 5.8.3.2 Sampling;
Select 100 plates from the sample. Divided into four groups, each group has 25 plates as samples. 5.8.3.3 Test steps:
SA
JB20023-2004
Place the sample into a closed container, close the sealing lid tightly, close the air conditioner, start the vacuum pump, and keep the vacuum degree at 0.8MPa for 30 seconds, inject colored liquid, the liquid level is 25mm higher than the surface of the sample, and return to normal pressure; take out the sample, rinse it with clean water, wipe it clean, and then observe whether there is liquid penetration into the blister and sealing layer.
5.8.4 Filling pass rate
Pick 100 plates from the sample and check the number of missing plates. 5.8.5 Qualification rate of finished packaging products
Qualification rate of finished packaging products is calculated according to formula (1).
D
In the formula:
D packaging finished product qualification rate;
E is the number of packaging qualified sections.
6 Inspection Rules
6.1 Inspection Category:
Charter inspection is divided into factory inspection and type inspection. 6.2 Factory inspection:
300×100%
6.2.1 Packaging machines shall be inspected one by one according to the provisions of Table 1. Only after passing the inspection shall they be allowed to leave the factory, and shall be accompanied by a product certificate. Table 1 Factory inspection items
Item category
Appearance
General performance
Main performance
Inspection items
4.3
4.4, 4.5, 4.7
4.6, 4.8.4, 4.8.5
(1)
6.2.2 The packaging machine is allowed to return if unqualified products are found during the inspection process Repair and conduct re-inspection. If the product is still unqualified, the product will be judged as a non-conforming product.
6.3 Type inspection:
When one of the following situations occurs in the production of packaging machines, type inspection should be carried out: 6.3.1
a)
New product testing or old product improvement finalization; continuous production for 2 to 3 years;
b)
After the official production, when the product structure, materials, and processes have undergone major changes: e)
Resumption after long-term suspension of production During production;
d)
When the factory inspection results are significantly different from the latest type inspection: e
When the national quality supervision agency proposes to conduct type testing. Sampling: For type inspection prototypes, 10% of the production batch 6.3.2 | One. 6.3.3 Judgment rules: If one of the main properties fails to pass the type inspection, the batch of products will be judged to have failed the type inspection. If one of the other items is unqualified, the unqualified item should be re-inspected twice. If it is still unqualified, the batch of products will be judged to have failed the type inspection. 55
5mm.
4.8.4 Sealing of finished packaging:
The plates are tightly sealed and no liquid is allowed to penetrate into the blister or sealing layer. 4.8.5 Filling rate of finished packaging products:
There must be no missing particles in the filled plates. Appropriate auxiliary filling measures are allowed after consultation with the user for packaged items that are difficult to cut, such as capsules and special-shaped tablets.
5 Test methods
5.1 Test conditions
Inspect the relevant certificates of aluminum foil and polyvinyl chloride (PVC) used in the packaging machine testing process. 5.2 Material test
Check the list of raw materials. The raw materials in contact with the packaging and packaged objects should have material certificates or other relevant materials. 53
JB20023—2004
5.3 Appearance of the packaging machine
Visually inspect the appearance of the packaging machine.
5.4 Safety signs
Visually inspect the safety signs of the packaging machine. || tt | No air bubbles. Cooling system: The cooling water with a pressure less than 0.15MPa is passed through the water inlet and is naturally discharged from the water outlet without leakage. 5.5.2 Debugging operation test
5.5.2.1 No-load operation test: Adjust the batch number, loading, blanking and cheese line to reach a coordinated working state, and run continuously at high speed for 0.5h without load.
5.5.2.2 Packaging operation test: The cumulative load operation shall not be less than 0.5h, and the production frequency of the packaging machine shall be adjusted to reach 75%~85% of the production capacity, of which the filling drug test shall not be less than 10min. 5.5.2.3 In the above two types of operation tests, the cumulative operation interruption time shall not exceed 0.5h. 5.5.3 Noise test
The packaging machine is in a no-load high-speed working state, and the sound level meter is used to test according to the regulations of GB/T16769. 5.6 Electrical safety test
The electrical safety performance test of the packaging machine shall be tested according to the methods specified in 19.2, 19.3 and 19.4 of GB5226.1-2002. 5.7 Functional test
5.7.1 Tear line test
During the operation test of 5.5.2.2, take any five boards of packaged products, first visually observe the tear line marks, and then check all the cheese lines on each board Fold in half more than 90° four times and then tear along the tear line. 5.8 Packaging finished product test
During the operation test in 5.5.2.2, 300 boards of finished packaging products are taken as micro-samples, and the stopwatch is used for timing and manual counting. The sampling is done every 1 minute, and 100 boards of continuous punching are taken for testing each time. . 5.8.1 Appearance
Take any five plates from the sample, visually observe the blister, batch number, and pattern. Face the light source to see if there are light-transmitting spots at the sealing of the plates; gently touch the corners of the plates with your hands to see if they are light. clear.
5.8.2 Dimensions
Take any five plates from the sample and measure them with a general measuring tool or a special measuring tool. 5.8.3 Sealing performance
5.8.3.1 Test equipment:
A sealed container that can withstand more than 1 atmospheric pressure, equipped with a 2.5-level vacuum gauge and an exhaust pipe with a door connected to the vacuum pump , a vent pipe connected to the atmosphere, a water pipe connected to the water source, and a pressure plate built into the container with a diameter smaller than the inner diameter of the container. 5.8.3.2 Sampling;
Select 100 plates from the sample. Divided into four groups, each group has 25 plates as samples. 5.8.3.3 Test steps:
SA
JB20023-2004
Place the sample into a closed container, close the sealing lid tightly, close the air conditioner, start the vacuum pump, and keep the vacuum degree at 0.8MPa for 30 seconds, inject colored liquid, the liquid level is 25mm higher than the surface of the sample, and return to normal pressure; take out the sample, rinse it with clean water, wipe it clean, and then observe whether there is liquid penetration into the blister and sealing layer.
5.8.4 Filling pass rate
Pick 100 plates from the sample and check the number of missing plates. 5.8.5 Qualification rate of finished packaging products
Qualification rate of finished packaging products is calculated according to formula (1).
D
In the formula:
D packaging finished product qualification rate;
E is the number of packaging qualified sections.
6 Inspection Rules
6.1 Inspection Category:
Charter inspection is divided into factory inspection and type inspection. 6.2 Factory inspection:
300×100%
6.2.1 Packaging machines shall be inspected one by one according to the provisions of Table 1. Only after passing the inspection shall they be allowed to leave the factory, and shall be accompanied by a product certificate. Table 1 Factory inspection items
Item category
Appearance
General performance
Main performance
Inspection items
4.3
4.4, 4.5, 4.7
4.6, 4.8.4, 4.8.5
(1)
6.2.2 The packaging machine is allowed to return if unqualified products are found during the inspection process Repair and conduct re-inspection. If the product is still unqualified, the product will be judged as a non-conforming product.
6.3 Type inspection:
When one of the following situations occurs in the production of packaging machines, type inspection should be carried out: 6.3.1
a)
New product testing or old product improvement finalization; continuous production for 2 to 3 years;
b)
After the official production, when the product structure, materials, and processes have undergone major changes: e)
Resumption after long-term suspension of production During production;
d)
When the factory inspection results are significantly different from the latest type inspection: e
When the national quality supervision agency proposes to conduct type testing. Sampling: For type inspection prototypes, 10% of the production batch 6.3.2 | One. 6.3.3 Judgment rules: If one of the main properties fails to pass the type inspection, the batch of products will be judged to have failed the type inspection. If one of the other items is unqualified, the unqualified item should be re-inspected twice. If it is still unqualified, the batch of products will be judged to have failed the type inspection. 55
2. During the operation test, 300 boards of packaged finished products were taken as micro-samples, and the stopwatch was used for timing and manual counting. The samples were taken every 1 minute, and 100 boards of continuous punching were taken for testing each time. 5.8.1 Appearance
Take any five plates from the sample, visually observe the blister, batch number, and pattern. Face the light source to see if there are light-transmitting spots at the sealing of the plates; gently touch the corners of the plates with your hands to see if they are light. clear.
5.8.2 Dimensions
Take any five plates from the sample and measure them with a general measuring tool or a special measuring tool. 5.8.3 Sealing performance
5.8.3.1 Test equipment:
A sealed container that can withstand more than 1 atmospheric pressure, equipped with a 2.5-level vacuum gauge and an exhaust pipe with a door connected to the vacuum pump , a vent pipe connected to the atmosphere, a water pipe connected to the water source, and a pressure plate built into the container with a diameter smaller than the inner diameter of the container. 5.8.3.2 Sampling;
Select 100 plates from the sample. Divided into four groups, each group has 25 plates as samples. 5.8.3.3 Test steps:
SA
JB20023-2004
Place the sample into a closed container, close the sealing lid tightly, close the air conditioner, start the vacuum pump, and keep the vacuum degree at 0.8MPa for 30 seconds, inject colored liquid, the liquid level is 25mm higher than the surface of the sample, and return to normal pressure; take out the sample, rinse it with clean water, wipe it clean, and then observe whether there is liquid penetration into the blister and sealing layer.
5.8.4 Filling pass rate
Pick 100 plates from the sample and check the number of missing plates. 5.8.5 Qualification rate of finished packaging products
Qualification rate of finished packaging products is calculated according to formula (1).
D
In the formula:
D packaging finished product qualification rate;
E is the number of packaging qualified sections.
6 Inspection Rules
6.1 Inspection Category:
Charter inspection is divided into factory inspection and type inspection. 6.2 Factory inspection:
300×100%
6.2.1 Packaging machines shall be inspected one by one according to the provisions of Table 1. Only after passing the inspection shall they be allowed to leave the factory, and shall be accompanied by a product certificate. Table 1 Factory inspection items
Item category
Appearance
General performance
Main performance
Inspection items
4.3
4.4, 4.5, 4.7
4.6, 4.8.4, 4.8.5
(1)
6.2.2 The packaging machine is allowed to return if unqualified products are found during the inspection process Repair and conduct re-inspection. If the product is still unqualified, the product will be judged as a non-conforming product.
6.3 Type inspection:
When one of the following situations occurs in the production of packaging machines, type inspection shall be carried out: 6.3.1
a)
New product testing or old product improvement finalization; continuous production for 2 to 3 years;
b)
After the official production, when the product structure, materials, and processes have undergone major changes: e)
Resumption after long-term suspension of production During production;
d)
When the factory inspection results are significantly different from the latest type inspection: e
When the national quality supervision agency proposes to conduct type testing. Sampling: For type inspection prototypes, 10% of the production batch 6.3.2 | One. 6.3.3 Judgment rules: If one of the main properties fails to pass the type inspection, the batch of products will be judged to have failed the type inspection. If one of the other items is unqualified, the unqualified item should be re-inspected twice. If it is still unqualified, the batch of products will be judged to have failed the type inspection. 55
2. During the operation test, 300 boards of packaged finished products were taken as micro-samples, and the stopwatch was used for timing and manual counting. The samples were taken every 1 minute, and 100 boards of continuous punching were taken for testing each time. 5.8.1 Appearance
Take any five plates from the sample, visually observe the blister, batch number, and pattern. Face the light source to see if there are light-transmitting spots at the sealing of the plates; gently touch the corners of the plates with your hands to see if they are light. clear.
5.8.2 Dimensions
Take any five plates from the sample and measure them with a general measuring tool or a special measuring tool. 5.8.3 Sealing performance
5.8.3.1 Test equipment:
A sealed container that can withstand more than 1 atmospheric pressure, equipped with a 2.5-level vacuum gauge and an exhaust pipe with a door connected to the vacuum pump , a vent pipe connected to the atmosphere, a water pipe connected to the water source, and a pressure plate built into the container with a diameter smaller than the inner diameter of the container. 5.8.3.2 Sampling;
Select 100 plates from the sample. Divided into four groups, each group has 25 plates as samples. 5.8.3.3 Test steps:
SA
JB20023-2004
Place the sample into a closed container, close the sealing lid tightly, close the air conditioner, start the vacuum pump, and keep the vacuum degree at 0.8MPa for 30 seconds, inject colored liquid, the liquid level is 25mm higher than the surface of the sample, and return to normal pressure; take out the sample, rinse it with clean water, wipe it clean, and then observe whether there is liquid penetration into the blister and sealing layer.
5.8.4 Filling pass rate
Pick 100 plates from the sample and check the number of missing plates. 5.8.5 Qualification rate of finished packaging products
Qualification rate of finished packaging products is calculated according to formula (1).
D
In the formula:
D packaging finished product qualification rate;
E is the number of packaging qualified sections.
6 Inspection Rules
6.1 Inspection Category:
Charter inspection is divided into factory inspection and type inspection. 6.2 Factory inspection:
300×100%
6.2.1 Packaging machines shall be inspected one by one according to the provisions of Table 1. Only after passing the inspection shall they be allowed to leave the factory, and shall be accompanied by a product certificate. Table 1 Factory inspection items
Item category
Appearance
General performance
Main performance
Inspection items
4.3
4.4, 4.5, 4.7
4.6, 4.8.4, 4.8.5
(1)
6.2.2 The packaging machine is allowed to return if unqualified products are found during the inspection process Repair and conduct re-inspection. If the product is still unqualified, the product will be judged as a non-conforming product.
6.3 Type inspection:
When one of the following situations occurs in the production of packaging machines, type inspection should be carried out: 6.3.1
a)
New product testing or old product improvement finalization; continuous production for 2 to 3 years;
b)
After the official production, when the product structure, materials, and processes have undergone major changes: e)
Resumption after long-term suspension of production During production;
d)
When the factory inspection results are significantly different from the latest type inspection: e
When the national quality supervision agency proposes to conduct type testing. Sampling: For type inspection prototypes, 10% of the production batch 6.3.2 | One. 6.3.3 Judgment rules: If one of the main properties fails to pass the type inspection, the batch of products will be judged to have failed the type inspection. If one of the other items is unqualified, the unqualified item should be re-inspected twice. If it is still unqualified, the batch of products will be judged to have failed the type inspection. 55
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