Some standard content:
ICS55.200
Machinery Industry Standard of the People's Republic of China
JBrT10169-2000
Medicine blister packaging machine
Medicine blister packaging machine2000-04-24 Issued
National Machinery Industry Bureau
2000-10-01 Implementation
JB/T10169—200#
This standard is formulated for the first time.
This standard is proposed and managed by the Packaging Machinery Branch of the National Packaging Standardization Technical Committee. This standard was drafted by Jinzhou Oushi Packaging Machinery Co., Ltd. The main drafters of this standard are: Han Chunlin, Zhang Lianhua. Scope
Machinery Industry Standard of the People's Republic of China
Medical blister packaging machine
Medicfae blister packaging machineJB/T10169—2008
This standard specifies the classification, requirements, test methods, inspection rules, marking, product instructions, packaging, transportation and storage of medical blister packaging machines.
This standard applies to aluminum-plastic medical blister packaging machines and also to aluminum-aluminum medical blister packaging machines (hereinafter referred to as packaging transfer machines) 2 Reference standards
The texts contained in the following standards constitute the provisions of this standard through reference in and standards. When this standard is published, the versions shown are all valid. All standards will be revised. Parties using this standard should consider the possibility of using the latest version of the following standards: GB 19I—1990
GB 2894-1996
GB.3768—1996
GB/T 5226.1---1996
GB 56631985
GB/T6388—1986
GB/T#311—1987
GB.9969.1—1998
GB12255—1990
Packaging storage and transportation pictorial signs
Safety signs
Acoustic sound pressure method to determine the sound power level of the beam sound source, the envelope residual volume is used to transmit back to the upper surface of the simple method of industrial machinery and electrical equipment Part 1: General technical conditions Medicinal PVC sheet
Transport packaging delivery and receipt marks
Creation machine model compilation method
Industrial product instruction manual
Aluminum pins for medicinal packaging
GB/ T13306—1991
GB/T13384—1992
0E16179-—1996
JB7233—1994
3 Classification
3.1 Type
General technical conditions for packaging of electromechanical products
Guidelines for the use of safety signs
Requirements for packaging machine models
According to their structural types, packaging machines are divided into roller type [G], plate type (H) and flat type (B). 3.2 Model compilation
The model of the packaging machine should comply with the provisions of 0B.T7311. The National Machinery Industry Association issued the standard on April 24, 2000
2000-10-01 implementation
DPH130 A
1R/T10169-2000
Input frequency serial number (in Chinese pinyin A, B, and H in turn) Packing width (in Arabic numerals, single mm) Fast vertical type (G, H, B, see 3.J)
Blister packaging machine
Improved design
Packing material width 130mm
Structure type is plate type
Blister packaging machine
The packaging material shall comply with the provisions of this standard and be manufactured according to the drawings and technical documents approved by the prescribed procedures. 4.
4.2.TWorking conditions
4.2.1 The polyvinyl chloride (PVC) hard sheet used shall comply with the requirements specified in G5663. 4.2.2 Armor pins for drug packaging It shall meet the requirements specified in GB12255 4.3 Basic size
The basic size and deviation of the drug cover packaging plate shall meet the requirements in Table 1. Table 1 Basic size and deviation of blister packaging short block
Material range
Board length
Board width
Minimum distance between edges
Filter block height
Minimum distance between edges
4.4 Basic requirements
Basic size
Determined by user requirements
Determined by user requirements
Allowable deviation
The packaging machine shall be able to make appropriate adjustments to the packaging plate size and packaging object arrangement within a certain range according to user requirements. The packaging machine's air control system, point-empty system, and cooling system must not have rate leakage. The packaging machine's positive belt is busy, and the action conversion of each moving part and mechanism should be flexible and reliable without stagnation. The frequency of the packaging machine's impulses should be adjusted, and its value should not be less than the requirements in Table 2. Table 2 Basic number
Run-in plate type
Times min
4.4.5 The packaging machine is equipped with a batch number device, JB door 10169-2060
4.4.6 There is no abnormality when the packaging machine is working, and the operating noise is not more than 85dB(A)4.5 Packaging quality requirements
The appearance quality of the packaged finished product meets the requirements of Table 34.5.1
Table 3 Appearance quality of finished product
Batch number handwriting
Discount increase
4.5.2 The external specification qualification rate is not less than 98%,
4.5.3 The sealing rotation rate is not less than 99%,
4.5.4 The filling qualification rate is not less than 98.5%. Smooth, smooth, even, without palm lines, the net effect is smooth and clear, and the surface is clear. Good breakability and no burrs on the cut surface. Note: For dry and special-shaped pieces, appropriate auxiliary filling materials are allowed. 4.6 Safety and sanitation requirements 4.6.1 The electrical system is safe and reliable, and should be sensitive during operation. 4.6.2 The circuit system of the packaging machine has a continuous and reliable grounding circuit and should comply with the relevant provisions of 6B 5226.1-1996 20.2. 4.6.3 The measured insulation resistance between the power circuit wire of the packaging machine and the protective circuit shall not be less than IM14.6.4 The packaging machine can withstand 50H2! The positive wave AC voltage 1000V withstand voltage test for at least 1s, without shock or flashing. 4.6.5 The packaging machine should have clear operation, lubrication, safety or warning signs. The safety signs should comply with the provisions of GB2B94 and GB16:79. 4.0.6 The packaging machine should be equipped with safety protection devices and should comply with the provisions of JB7233-1994. 4.6.? The surface of the packaging machine in contact with sugar packaging and packaging materials should be made of materials that are stable to light and chemical corrosion. 4.68 The lubrication system of the packaging pillow and the air control system should not pollute the packaged materials. 4.7 Availability requirements 4.7.1 The availability (monthly) value of the packaging machine should not be less than 85%. 4.7.2 The cumulative working time of the packaging machine from the beginning of use to the first overhaul should not be less than 80U0h. 4.8 External quality requirements of packaging machine
4.1 The painted surface should be smooth, bright and evenly distributed. Defects such as spots, wrinkles, blistering, shedding and scratches are not allowed. 4.2 The surface of stainless steel parts should be flat and smooth. 4.8.3 The exposed parts should be treated with calcium. 5 Test method
5.1 Test conditions
JB/T10169-2000
5.1.1 The test site should be wide and the packaging machine layout should meet the installation technical requirements. The ambient temperature is 10~309, and the relative humidity is not more than 3%.
5.1.2 The rated voltage used by the packaging machine is 380V, the rated frequency is 50Hz, the voltage fluctuation value should not exceed ±10% of the rated value, and the vibration value should not exceed 2% of the rated value.
5.1.3 The packaging materials used in the test shall meet the requirements of 4.2. 5.2 Daily inspection
52.1 Self-inspection of the appearance quality of the whole machine shall meet the requirements of 4.8. 52.2 According to the material list or material inspection list provided by the packaging machine manufacturer, check whether the materials used meet the requirements of 4.6.7: 5.2.3 Daily inspection The packaging machine shall meet the requirements of 4.4.5, 4.6.5 and 4.6.6. 5. 3 Rate diffusion test
5.3.1 Air control system
Apply 0.75MPa compressed air, apply soapy water to each connection part, and visually check that there should be no leakage. 5.3.2 Vacuum system
When the machine is working normally, the vacuum gauge value is less than 0.09MPa. 5.3.3 Cooling system
Cooling water with a pressure of not less than 0.15MP is passed through, and there should be no leakage in the monthly inspection. 5.4 Idle operation test
Each packaging machine should be tested for idle operation after assembly, and the test duration should not be less than 2h. During the test, it should be operated from low speed to high speed step by step, and then stabilized at the rated speed, and should meet the requirements of 4.4.3, 4.6.1 and 4.6.8. 5.5 Packaging test
5.5.1 The test should be carried out after the idle operation is qualified, and the packaging test time shall not be less than 1. The continuous feeding time of the filling test shall not be less than 10mm, and the inspection of the quality of the packaged product shall meet the requirements of 4.5. 5.5.2 Sampling method for sampling and result counting
During the packaging test, sampling shall be carried out once every 1min, and 100 plates shall be continuously drawn each time, for a total of 3 times. 6) Inspection method
Use the daily measurement method to inspect the external elasticity and filling quality. If there is leakage in the plate, it is unqualified. The basic size and allowable deviation of the packaging plate are checked with a reverse standard caliper and a micrometer with an accuracy of 0.02mm, which should meet the requirements of 4.3 and 4.4.1.
Sealing test test force conversion: randomly select 200 poles from the total of 3 samplings for sealing test. Put the sample into the sealing tester and pull the vacuum. When the vacuum reaches 0.08MPa±0.01MPa, inject the colored water so that the pressure can pass through the plate 25mml, and maintain 309. Then return to normal. After draining the water, take out the sample. If there is no water in the daily test sample, it is qualified. Formula:
External specification conformity rate - the sum of 3 qualified plates of pulling samples and the sum of 3 throwing samples
Filling qualification rate - the sum of 3 qualified plates of additional samples, x100%
Total name of 3 sampling plates
Sealing qualification rate -
JB/T10169—20UM
Number of qualified products
Any 20 plates in the sum of 3 samplings
The calculation result should comply with the provisions of 4.5
5.5.3 Use a secret watch to time, 1. Record the number of punching times to detect the punching frequency of the packaging machine, which meets the requirements of 4, 4.4. 5.6 Noise test
After the packaging test, use a sound level meter to measure the working noise of the packaging machine according to the provisions of CD 3768, which meets the requirements of 4.4.6. The surface of the test mother is selected to be parallel to the corresponding side of the non-standard body, and the body surface is parallel to the blood. The microphone position is shown in Figure C5 of GB3768--[956. Only the packaging machine surface is not tested. 5.7 Electrical safety performance test
The electrical safety performance test of the packaging machine should be carried out before idling in accordance with the provisions of 20.2, 203 and 20.4 of GB/T5226.1-1996, and should comply with 4.6.2, 4.6.3 and 4.6. years. 5. Monthly wearability test
5.8. 1 The wearability of the packaging machine is expressed by the cost (A) value, and the test can be carried out during the user's use. During the test, the sum of the working time and the maintenance time shall not be less than 200h, and the availability (.4) value shall be calculated using formula (4). The calculated result shall meet the requirements of 4.7. Working time
Availability (4) - bzxz.net
Working time + Maintenance time
5.8.2 Packaging machine availability test The statutory inspection department determines the user and the inspection result of the user. 6 Inspection rules
6.1 Factory inspection
Before the packaging machine leaves the factory, it must be inspected by the quality inspection department in accordance with the provisions of 4.4, 4.5, 4.6 and 4.8. It can only leave the factory after passing the inspection and issuing a certificate of conformity.
6.2 Type inspection
6.2.1 Type inspection items shall include all requirements of this standard (except 4.7.2). 6.2.2 Type inspection shall be conducted in any of the following cases: a) When the product is put into production for appraisal
b) When the product is officially certified for production, the product structure or material or process has changed significantly after production, which affects the product performance; ) Once every three years during normal production; ) When the product is stopped and production is resumed after more than one year, when the national quality supervision agency proposes type test, 6.1.3 Sampling method
a) When the production batch is less than 50, sample 2 units from any batch; h) When the annual production is 50 to 100 units, sample 3 units from any batch; 6.3 Type inspection judgment rules
If one of the electrical safety performances of the packaging machine for disassembly inspection is unqualified, the batch of products shall be unqualified. If one of the other requirements does not meet the requirements, a sample will be taken and the unqualified items will be counted. If the pre-qualified items are still found, the product will be unqualified. The following information should be on the label: a) Product name and model: b) Power supply voltage: c) Rated power; d) Date of manufacture and number; e) Manufacturer name; Product standard number: 1.2 The following markings should be on the packaging box: a) Product model and name: b) Manufacturer name and address: c) Product factory group number: d) Date of manufacture; e) Gross weight and net weight: 3) Volume (length × width × h) Name of the shipping station and the destination station, h) Receiving unit; h) Lifting mark; k) Storage and transportation pictorial marks such as "Handle with care", "Upward", "Avoid moisture", etc. The packaging mark should comply with the relevant provisions of GB191 and GB/T6388. 7.2 Product instruction manual
The packaging machine should have a product instruction manual, and its writing requirements should comply with the provisions of GB9.1. Packaging, transportation, storage
8.1 Packaging
The packaging of the packaging machine should comply with the provisions of GB13384. 1.1 Each packaging machine should be covered with a film, packed in a box, and meet the following installation requirements; a) The exposed processing surface of the packaging machine should be rust-proof: b) The packaging machine should be firmly fixed in the box; c! Some parts of the packaged machine are allowed to be packed in groups. E.2 Each packaged machine should be accompanied by one copy of the above documents: a) Product instruction manual: 5) Installation order: c) Product certificate: d) Machine spare parts: e) Easy-to-use list. JB10169-2880 Packed in moisture-proof bags and fixed in the appropriate position in the packaging box. 8. 2 Transportation Under the condition of preventing vibration, any transportation method can be used. 83 Storage 8.3.1 The packaged machine should be placed in a room with good ventilation and no volatile gas or in a place with induction. 8.3.2 When the packaged machine is stored for more than 6 months, it should be unpacked and inspected, and then stored after treatment.5.5.3 Use a meter to measure the punching frequency of the packaging machine, and the number of punching times shall be recorded to meet the requirements of 4 and 4.4. 5.6 Noise test
After the packaging test, the sound level meter is used to measure the working noise of the packaging machine according to the provisions of 3768 in CD, and the noise level shall meet the requirements of 4.4.6. The surface of the measuring machine is parallel to the corresponding side of the body, and the microphone position is shown in Figure C5 of GB3768--[956. Only the surface of the packaging machine is not tested. 5.7 Electrical safety performance test
The electrical safety performance test of the packaging machine shall be carried out before idling according to the provisions of 20.2, 203 and 20.4 of GB/T5226.1-1996, and shall meet the requirements of 4.6.2, 4.6.3 and 4.6. 5. Monthly usability test
5.8.1 The usability of the packaging machine is expressed by the value of cost (A), and the test can be carried out during the user's use. During the test, the sum of the working time and the maintenance time shall not be less than 200h, and the availability (.4) value shall be calculated using formula (4). The calculation result shall meet the requirements of 4.7. Working time
Availability (4)-
Working time+maintenance end time
5.8.2 Packaging machine usability test The statutory inspection department determines the user and recognizes the inspection results of the user. 6 Inspection rules
6.1 Factory inspection
Before leaving the factory, the packaging machine must be inspected by the quality inspection department in accordance with the provisions of 4.4, 4.5, 4.6 and 4.8. It can only leave the factory after the inspection is passed and the certificate of conformity is issued.
6.2 Type inspection
6.2.1 Type inspection items shall include all requirements of this standard (except 4.7.2). 6.2.2 Type inspection shall be carried out in any of the following cases: a) When the product is put into production for appraisal
b) When the product is officially certified, the structure or material or process has changed significantly after production, which affects the product performance; ) Once every three years during normal production; ) When the production is stopped for more than one year and then resumed, when the national quality supervision agency proposes type test, 6.1.3 Sampling method
a) If the production batch is less than 50, sample 2 units from any batch; h) If the annual production is 50 to 100 units, sample 3 units from any batch; 6.3 Type inspection judgment rules
If one item of the electrical safety performance of the packaging machine for disassembly inspection is unqualified, the batch of products shall be unqualified. If one of the other requirements does not meet the requirements, a sample will be taken and the unqualified items will be counted. If the pre-qualified items are still found, the product will be unqualified. The following information should be on the label: a) Product name and model: b) Power supply voltage: c) Rated power; d) Date of manufacture and number; e) Manufacturer name; Product standard number: 1.2 The following markings should be on the packaging box: a) Product model and name: b) Manufacturer name and address: c) Product factory group number: d) Date of manufacture; e) Gross weight and net weight: 3) Volume (length × width × h) Name of the shipping station and the destination station, h) Receiving unit; h) Lifting mark; k) Storage and transportation pictorial marks such as "Handle with care", "Upward", "Avoid moisture", etc. The packaging mark should comply with the relevant provisions of GB191 and GB/T6388. 7.2 Product instruction manual
The packaging machine should have a product instruction manual, and its writing requirements should comply with the provisions of GB9.1. Packaging, transportation, storage
8.1 Packaging
The packaging of the packaging machine should comply with the provisions of GB13384. 1.1 Each packaging machine should be covered with a film, packed in a box, and meet the following installation requirements; a) The exposed processing surface of the packaging machine should be rust-proof: b) The packaging machine should be firmly fixed in the box; c! Some parts of the packaged machine are allowed to be packed in groups. E.2 Each packaged machine should be accompanied by one copy of the above documents: a) Product instruction manual: 5) Installation order: c) Product certificate: d) Machine spare parts: e) Easy-to-use list. JB10169-2880 Packed in moisture-proof bags and fixed in the appropriate position in the packaging box. 8. 2 Transportation Under the condition of preventing vibration, any transportation method can be used. 83 Storage 8.3.1 The packaged machine should be placed in a room with good ventilation and no volatile gas or in a place with induction. 8.3.2 When the packaged machine is stored for more than 6 months, it should be unpacked and inspected, and then stored after treatment.5.5.3 Use a meter to measure the punching frequency of the packaging machine, and the number of punching times shall be recorded to meet the requirements of 4 and 4.4. 5.6 Noise test
After the packaging test, the sound level meter is used to measure the working noise of the packaging machine according to the provisions of 3768 in CD, and the noise level shall meet the requirements of 4.4.6. The surface of the measuring machine is parallel to the corresponding side of the body, and the microphone position is shown in Figure C5 of GB3768--[956. Only the surface of the packaging machine is not tested. 5.7 Electrical safety performance test
The electrical safety performance test of the packaging machine shall be carried out before idling according to the provisions of 20.2, 203 and 20.4 of GB/T5226.1-1996, and shall meet the requirements of 4.6.2, 4.6.3 and 4.6. 5. Monthly usability test
5.8.1 The usability of the packaging machine is expressed by the value of cost (A), and the test can be carried out during the user's use. During the test, the sum of the working time and the maintenance time shall not be less than 200h, and the availability (.4) value shall be calculated using formula (4). The calculation result shall meet the requirements of 4.7. Working time
Availability (4)-
Working time+maintenance end time
5.8.2 Packaging machine usability test The statutory inspection department determines the user and recognizes the inspection results of the user. 6 Inspection rules
6.1 Factory inspection
Before leaving the factory, the packaging machine must be inspected by the quality inspection department in accordance with the provisions of 4.4, 4.5, 4.6 and 4.8. It can only leave the factory after the inspection is passed and the certificate of conformity is issued.
6.2 Type inspection
6.2.1 Type inspection items shall include all requirements of this standard (except 4.7.2). 6.2.2 Type inspection shall be carried out in any of the following cases: a) When the product is put into production for appraisal
b) When the product is officially certified, the structure or material or process has changed significantly after production, which affects the product performance; ) Once every three years during normal production; ) When the production is stopped for more than one year and then resumed, when the national quality supervision agency proposes type test, 6.1.3 Sampling method
a) If the production batch is less than 50, sample 2 units from any batch; h) If the annual production is 50 to 100 units, sample 3 units from any batch; 6.3 Type inspection judgment rules
If one item of the electrical safety performance of the packaging machine for disassembly inspection is unqualified, the batch of products shall be unqualified. If one of the other requirements does not meet the requirements, a sample will be taken and the unqualified items will be counted. If the pre-qualified items are still found, the product will be unqualified. The following information should be on the label: a) Product name and model: b) Power supply voltage: c) Rated power; d) Date of manufacture and number; e) Manufacturer name; Product standard number: 1.2 The following markings should be on the packaging box: a) Product model and name: b) Manufacturer name and address: c) Product factory group number: d) Date of manufacture; e) Gross weight and net weight: 3) Volume (length × width × h) Name of the shipping station and the destination station, h) Receiving unit; h) Lifting mark; k) Storage and transportation pictorial marks such as "Handle with care", "Upward", "Avoid moisture", etc. The packaging mark should comply with the relevant provisions of GB191 and GB/T6388. 7.2 Product instruction manual
The packaging machine should have a product instruction manual, and its writing requirements should comply with the provisions of GB9.1. Packaging, transportation, storage
8.1 Packaging
The packaging of the packaging machine should comply with the provisions of GB13384. 1.1 Each packaging machine should be covered with a film, packed in a box, and meet the following installation requirements; a) The exposed processing surface of the packaging machine should be rust-proof: b) The packaging machine should be firmly fixed in the box; c! Some parts of the packaged machine are allowed to be packed in groups. E.2 Each packaged machine should be accompanied by one copy of the above documents: a) Product instruction manual: 5) Installation order: c) Product certificate: d) Machine spare parts: e) Easy-to-use list. JB10169-2880 Packed in moisture-proof bags and fixed in the appropriate position in the packaging box. 8. 2 Transportation Under the condition of preventing vibration, any transportation method can be used. 83 Storage 8.3.1 The packaged machine should be placed in a room with good ventilation and no volatile gas or in a place with induction. 8.3.2 When the packaged machine is stored for more than 6 months, it should be unpacked and inspected, and then stored after treatment.2 Product Instructions
The packaging machine shall have a product instructions, and its writing requirements shall comply with the provisions of GB9.1. Packaging, transportation, storage
8.1 Packaging
The packaging of the packaging machine shall comply with the provisions of GB13384. 1.1 Each packaging machine shall be covered with a film, packed in a box, and meet the following packaging requirements; a) The exposed processing surface of the packaging machine shall be rust-proofed; b) The packaging machine shall be firmly fixed in the box; c! Some parts of the packaging machine are allowed to be packed in groups, and E.2 Each packaging machine shall be accompanied by one copy of the above documents: a) Product Instructions: 5) Installation Order: c) Product Certificate: d) Machine Spare Parts: e) Companion List.
JB10169—2880
Pack the package with moisture-proof bag and fix it in the appropriate position in the packaging box. 8. 2 Transportation
Under the condition of preventing vibration, any transportation method can be used to transport the wax. 83 Storage
8.3.1 The packaging machine should be placed in a room with good ventilation and no volatile gas or in a place with induction. 8.3.2 When the packaging machine is stored for more than 6 months, it should be unpacked and inspected, and then stored after treatment.2 Product Instructions
The packaging machine shall have a product instructions, and its writing requirements shall comply with the provisions of GB9.1. Packaging, transportation, storage
8.1 Packaging
The packaging of the packaging machine shall comply with the provisions of GB13384. 1.1 Each packaging machine shall be covered with a film, packed in a box, and meet the following packaging requirements; a) The exposed processing surface of the packaging machine shall be rust-proofed; b) The packaging machine shall be firmly fixed in the box; c! Some parts of the packaging machine are allowed to be packed in groups, and E.2 Each packaging machine shall be accompanied by one copy of the above documents: a) Product Instructions: 5) Installation Order: c) Product Certificate: d) Machine Spare Parts: e) Companion List.
JB10169—2880
Pack the package with moisture-proof bag and fix it in the appropriate position in the packaging box. 8. 2 Transportation
Under the condition of preventing vibration, any transportation method can be used to transport the wax. 83 Storage
8.3.1 The packaging machine should be placed in a room with good ventilation and no volatile gas or in a place with induction. 8.3.2 When the packaging machine is stored for more than 6 months, it should be unpacked and inspected, and then stored after treatment.
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