Some standard content:
JB | tt||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
ICS11.120.30
C92
JB
Pharmaceutical Machinery Industry Standard of the People's Republic of China JB20027—2004
Replace YY0224-1995
Model soft capsule machine
Rotarydieencapsulator
Released on 2004-02-05
Implemented on 2004-06-01
Released by the National Development and Reform Commission
Foreword| |tt||Scope
1
Normative reference documents
2
3 Terms and definitions
4
Classification and labeling| |tt||5 requirements
Test methods
6
7
Inspection rules
8 Marking, packaging, transportation and storage
Appendix A (informative appendix) capsule shape and size Appendix B (informative appendix)
mesh
times
soft capsule filling series and the number of grooves in the roll mold JB20027 —2004
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JB20027—2004
Foreword
This standard is based on the Good Manufacturing Practice for Pharmaceutical Products and CB/ T1.1-2000, GB/T1.2-2002 standardization work guide requirements, revision of YY0224-1995 "Rolling Mode Soft Capsule Machine". This standard replaces YY0224-1995 from the date of implementation. Compared with YY0224-1995, the main technical content changes of this standard are as follows: a) The main clauses of YY0224-1995 are deleted: 3.2; 4.1, 4.2, 4.3, 4.4, 4.5, 4.64.7, 4.8, 4.12, 4.13, 4.15, 4.19.2, 4.19.4, 4.19.5, 4.20.3.4.21.3.4.23;
Clauses corresponding to the above requirements in "Test Methods". b) Revised the main chapters and articles of YY0224-1995: Chapter 1, Chapter 2, 3.1;
—4.16.4.17, 4.18 in "Technical Requirements"; "Technical Requirements\" will be specified separately for single machines Revised to "overall regulations and requirements for a complete set of equipment"; "test methods" and clauses corresponding to "technical requirements". e) The main chapters and clauses added to this standard are:
Terms and definitions (Chapter 3);
Material and appearance, safety requirements (see 5.1, 5.3). Appendix A and Appendix B of this standard are both informative appendices. This standard is proposed by 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 Changzheng Tianmin High-Tech Co., Ltd. The main drafters of this standard: Cong Xisheng, Shi Haifeng, Zhang Qingfu, Fan Zongqi, Liu Wei. The previous versions of the standards replaced by this standard are: CB10251-1988, YY0224-1995. 34
1 scope
Roll mode soft capsule machine
JB20027—2004||tt| |This standard specifies the terms and definitions, classification and labeling, requirements, test methods, inspection rules and markings, packaging, transportation and storage of roll-mode soft capsule machines.
This standard applies to rolling mode soft capsule machines (hereinafter referred to as soft capsule machines). 2 Normative reference documents
The provisions of the following documents become the 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 Pictorial signs for packaging, storage and transportation
GB/T1958 Shape and position tolerance testing regulations GB5226.1-2002 Mechanical safety mechanical and electrical equipment Part 1: General technical conditions signs
GB/T13306| | tt | |tt||YY/T0216
3 Terms and Definitions
The following terms and definitions apply to this standard. 3.1
spreaderbox
A device in which the gelatin liquid flows out to the gelatin spreading wheel through an outlet with a certain width and height adjustable. 3.2
The gelatin spreading wheel gelatinespreaddrum is a device that spreads the gelatin liquid flowing out from the spreading box into a gelatin film with a certain width and uniform thickness. 3.3
Injection wedge
A device that injects liquid medicine between two layers of gelatin film. 3.4
dieroll
A device used for soft capsule forming.
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JB20027—2004
3.5
capsulestripper
Will adhere to the soft glue in the rolling mold cavity or on the mesh belt A device that peels off and causes the mesh glue to fall along a certain path. 3.6
Container fillmaterial
Liquid (mixed total medicinal liquid), thick paste, granular or flake solid materials, etc. enclosed in the soft capsule shell. 3.7
Unqualified soft capsules rejectedcapsule
Soft capsules with one of the following conditions are unqualified soft capsules: adhesion, deformation, leakage, bubbles and filling error exceeding the specified value. 3.8
stablestatetemperaturedeviation Temperature steady-state error
The error when the measured temperature changes slowly or remains stable. 4 Classification and labeling
The soft capsule machine consists of a soft capsule forming system, a conveying system, a drying system, a feeding system and a glue supplying system. 4.1 Marking of soft capsule machine
The marking of soft capsule machine shall be carried out in accordance with the provisions of YY/T0216. OOXOO0
RG
Improved design sequence number: A, B, C.
Cooling form: F - air cooling, S - water cooling
Single injection plug feed capacity : Use the single-injection plug supply volume (mL) Dry granular powder, P-represents tablets, D-represents multi-functional product type and feature code: G-represents rolling mode product function code: R-represents soft capsule manufacturing equipment marking example:
RGY6×20SA: Indicates that the content is an oily liquid, the maximum feeding capacity of a single injection plug is 2mL, a total of 6 injection plugs on one side, a water-cooled, once-improved rolling mode soft capsule machine. 4.2 Rolling mold mark
The model of the soft rubber discarded rolling mold consists of four parts: 36
口口x口
JB20027—2004
Soft capsule type code: press Lingke’s special requirements are given, if not, the hole position distribution code on the rolling mold will not be marked: number of rows × number of holes per row Capsule shape code: cylindrical shape is OB (obkong), general shape is OV (oval), spherical shape is R (mound), the tube shape is T (Tube), the plug shape is S (Supxsitoxy), and other shapes are represented by the English abbreviations of their shapes. The nominal loading code: the unit is a measuring drop (minim), 1 measuring drop = 0.0616115mL Example: To press a cylindrical soft capsule with a nominal filling capacity of 8 drops (0.493mL), the hole distribution on the rolling mold is 6 rows, and each row has 23 holes. The rolling mold code is: 080B/6×23||tt| |Please refer to Appendix A and Appendix B for the shape, filling volume and number of grooves of the roll mold of the soft capsule. 5Requirements
5.1 Material and appearance
5.1.1. Parts in contact with the container, gelatin liquid and gelatin film should be made of non-toxic, corrosion-resistant and non-polluting materials. 5.1.2 The outer surface of the soft capsule machine should be smooth and flat, without obvious scratches or rust. 5.1.3 The parts in contact with the container, gelatin liquid and gelatin film should have a smooth surface to facilitate cleaning and disinfection. 5.2 Structure and performance
5.2.1 The parallelism of the two rolling mold axes of the soft capsule forming system shall not be greater than 0.05mm. 5.2.2 The outer cylindrical surface roughness Ra value of the spreading wheel shall not be greater than 0.8 μm, and the total radial runout of the spreading wheel shall not be greater than 0.03 mm. 5.2.3 The inner surface of the drum of the dry coal system shall be smooth and shall have no sharp corners or burrs. 5.2.4 The temperature control devices of the spreading box, spray body and glue supply insulation barrel should be able to be set arbitrarily within the range of room temperature to 99.9°C and controlled according to the set value. The temperature control steady-state error: spreading box, spray The temperature of the body is within ±0.1℃, and the temperature of the glue supply insulation barrel is within ±0.5℃. 5.2.5 Each system of the soft capsule machine should operate smoothly, without jamming or abnormal noise, and the lubrication system should work normally. 5.2.6 During no-load operation, the noise shall not be greater than 82dB(A). 5.2.7 The difference in soft capsule filling volume shall not exceed ±2%. 5.2.8 When pressing soft capsules, the pill peeling device can 100% remove the soft capsules from the mesh glue. 5.2.9 After the soft capsule is pressed and formed, the thickness of the capsule at the joint should not be less than 50% of the thickness of the capsule at other locations. 5.2.10 The pass rate of soft capsules shall not be less than 97%. 5.2.11 When the soft capsules are shaped and dried in the drying system, they must not be scratched, squeezed or leaked out of the rolling cage. 5.3 Safety requirements
5.3.1 The protective grounding circuit of the electrical system shall comply with the provisions of 8.2 in GB5226.1-2002. 5.3.2 The continuity of protective grounding of the electrical system shall comply with the provisions of 19.2 in CB5226.1-2002. 5.3.3 The insulation resistance of the electrical system should meet the requirements of 19.3 in GB5226.1-2002. 5.3.4 The withstand voltage in the electrical system should comply with the provisions of 19.4 in GB5226.1--2002. 5.3.5 The buttons of the electrical system shall comply with the provisions of 10.2 of CB5226.1-2002. 37
JB20027-2004
5.3.6 The indicators and displays of the electrical system should comply with the provisions of 10.3 in GB5226.1-2002. 5.3.7 The wiring of the electrical system should comply with the provisions of Chapter 14 of GB5226.1-2002. 6 Test Methods
6.1 Material and Appearance Inspection
6.1.1 Inspect the material certificate of parts in contact with the container, gelatin liquid and gelatin film, 6.1.2 Self-visual inspection of the appearance of the soft capsule machine. 6.1.3 Visually inspect the surfaces of parts in contact with the container, gelatin liquid, and gelatin film. 6.2 Structure and performance inspection
6.2.1 Check the parallelism of the rolling mold shaft according to the parallelism detection method specified in GB/T1958 (choose one). 6.2.2 Use the sample block comparison method to test the roughness of the outer cylindrical surface of the spreading wheel, and detect its radial runout according to the method specified in GB/T1958.
6.2.3 Inspect the inner surface of the drying system roller cage with visual inspection and hand feeling. 6.2.4 Set the temperature of the spreading wheel, spray body, and glue supply insulation barrel at 50°C. After the temperature stabilizes, visually observe the corresponding temperature display value.
6.2.6 Run the soft capsule machine dry for 2 hours, and check the operation visually and aurally. 6.2.6 When the rolling mold speed is the maximum speed and no-load operation, measure the sound pressure level noise of the soft capsule wing forming system according to the provisions of GB/T16769.
6.2.7 Under the environmental conditions of temperature 18℃~26℃ and relative humidity 20%~60%, use 080B or 080V mold with medicinal liquid paraffin oil as the container to press soft Capsule and setting drying tests. After adjusting to normal working condition, perform 30 minutes. During the pressing process, soft capsules that are visually unqualified are removed from the conveyor and retained. a) Check the difference in filling volume: After finalizing and drying, select 20 soft capsules (the number of soft capsules corresponding to each row of holes in the roll mold should be guaranteed to be no less than two) and mark the number. Use a precision balance to calculate the relative error. ≤0.01) Weigh out the amount of each soft capsule and make a record: Pour out the contents, wash the capsule shell with acetaldehyde, and place it in a ventilated place. After the solvent has evaporated, weigh out the amount of each capsule shell. Mass, after getting the filling capacity of each capsule, calculate the average filling capacity of 20 soft capsules. Calculate the maximum loading capacity difference according to formula (1):
Maximum loading capacity difference (%) Maximum (minimum) grain loading amount-Average loading capacity Average loading capacity
b) Check the pill peeling device: During the process of pressing soft capsules, observe the situation of the pill peeling device breaking the pills. X 100 -.. || TT || .. (1) || TT || C) Check the soft capsule seams: choose 10 soft capsules to check the thickness and non -non -seams of the seams on the maximum cross section Ratio of film thickness at joints.
d) Test the soft capsule pass rate: Screen the soft capsules pressed within 30 minutes, remove and count the unqualified soft capsules, add them to the soft capsules removed on the conveyor, the total number is unqualified soft capsules The number of capsules is calculated according to formula (2): the number of unqualified soft capsules
passed.%). The soft capsules made... (
e) Inspection of the dryer: after shaping Check the working condition of the dryer during the drying process. Note: The use of B-marrow to clean and lift the shell is limited to use during detection of excitation. 38
6.3 Electrical safety performance inspection
6.3.1 According to the provisions of 8.2 in CB5226.1-2002, check the protective grounding circuit of the electrical system. 6.3.2 According to the provisions of 19.2 in GB5226.1-2002, check the continuity of the protective grounding circuit of the electrical system. 6.3.3 Carry out insulation resistance inspection according to the provisions of 19.3 in GB5226.1--2002. 6.3.4 Carry out voltage resistance inspection according to the provisions of 19.4 in GB5226.1-2002. 6.3.5 Check the buttons of the electrical system according to the provisions of 10.2 in GB5226.1-2002. 6.3.6 According to the provisions of 10.3 in GB5226.1-2002, check the indicators and displays of the electrical system. 6.3.7
According to the provisions of Chapter 14 of CB5226.1-2002, check the wiring of the electrical system. 7 Inspection Rules
Inspection Classification
7.1
The inspection of the glue manure machine is divided into factory inspection and type inspection. 7.2 Factory inspection
7.2.1 The soft capsule machines shall be inspected one by one according to the provisions of Table 1. Only those that pass the test shall be allowed to leave the factory and be accompanied by a product certificate. Table 1 Factory inspection items
Monthly category
General performance
Main performance
Electrical safety performance
Inspection items
JB200272004|| tt||5.1,5.2.1,5.2.2,5.2.3,5.2.4,5.2.5,5.2.6,5.3.1,5.3.5,5.3.6,5.3.75.2.7,5.2.8 ,5.2.9,5.2.10,5.2.115.3.2, 5.3.3, 5.3.4
7.2.2 If any unqualified product is found during the inspection process, the soft capsule machine is allowed to return it for correction and reissue. If the product still fails to pass the inspection, the product will be judged as a non-conforming product.
7.3 Type inspection
Type inspection shall be carried out under one of the following conditions: 7.3.12
a)
New products or old products are transferred to the factory for production Trial prototype identification: After formal production, if there are major changes in product structure, materials, and processes, product performance may be affected; b)
product resumes production after long-term (more than 2 years) discontinuation; factory inspection results are the same as above There are big differences between sub-type inspections: d)
The national quality supervision agency puts forward the requirements for type inspection. e)
Type 7.3.2
prototypes for type inspection shall be randomly selected at a rate of 10% from the products that have passed the factory inspection, at least one. 7.3.3 During the type inspection, if any of the electrical safety performance of the protective grounding circuit continuity, insulation resistance, and withstand voltage fails, the soft capsule machine will be deemed to have failed the type inspection. If one of the main performance is unqualified or the general performance is unqualified for two, the unqualified items should be retested twice. If the unqualified items are still unqualified, the product will be deemed to have failed the type inspection. 8 Marking, packaging, transportation and storage
8.1 Marking
8.1.1 Each soft capsule host should fix the product label at the position specified in the drawing, and the label should comply with the regulations of GB/T13306. Signage 39
3. The parts in contact with the container, gelatin liquid and gelatin film should have a smooth surface to facilitate cleaning and disinfection. 5.2 Structure and performance
5.2.1 The parallelism of the two rolling mold axes of the soft capsule forming system shall not be greater than 0.05mm. 5.2.2 The outer cylindrical surface roughness Ra value of the spreading wheel shall not be greater than 0.8 μm, and the total radial runout of the spreading wheel shall not be greater than 0.03 mm. 5.2.3 The inner surface of the drum of the dry coal system shall be smooth and shall have no sharp corners or burrs. 5.2.4 The temperature control devices of the spreading box, spray body and glue supply insulation barrel should be able to be set arbitrarily within the range of room temperature to 99.9°C and controlled according to the set value. The temperature control steady-state error: spreading box, spray The temperature of the body is within ±0.1℃, and the temperature of the glue supply insulation barrel is within ±0.5℃. 5.2.5 Each system of the soft capsule machine should operate smoothly, without jamming or abnormal noise, and the lubrication system should work normally. 5.2.6 During no-load operation, the noise shall not be greater than 82dB(A). 5.2.7 The difference in soft capsule filling volume shall not exceed ±2%. 5.2.8 When pressing soft capsules, the pill peeling device can 100% remove the soft capsules from the mesh glue. 5.2.9 After the soft capsule is pressed and formed, the thickness of the capsule at the joint should not be less than 50% of the thickness of the capsule at other locations. 5.2.10 The pass rate of soft capsules shall not be less than 97%. 5.2.11 When the soft capsules are shaped and dried in the drying system, they must not be scratched, squeezed or leaked out of the rolling cage. 5.3 Safety requirements
5.3.1 The protective grounding circuit of the electrical system shall comply with the provisions of 8.2 in GB5226.1-2002. 5.3.2 The continuity of protective grounding of the electrical system shall comply with the provisions of 19.2 in CB5226.1-2002. 5.3.3 The insulation resistance of the electrical system should meet the requirements of 19.3 in GB5226.1-2002. 5.3.4 The withstand voltage in the electrical system should comply with the provisions of 19.4 in GB5226.1--2002. 5.3.5 The buttons of the electrical system shall comply with the provisions of 10.2 of CB5226.1-2002. 37
JB20027-2004
5.3.6 The indicators and displays of the electrical system should comply with the provisions of 10.3 in GB5226.1-2002. 5.3.7 The wiring of the electrical system should comply with the provisions of Chapter 14 of GB5226.1-2002. 6 Test Methods
6.1 Material and Appearance Inspection
6.1.1 Inspect the material certificate of parts in contact with the container, gelatin liquid and gelatin film, 6.1.2 Self-visual inspection of the appearance of the soft capsule machine. 6.1.3 Visually inspect the surfaces of parts in contact with the container, gelatin liquid, and gelatin film. 6.2 Structure and performance inspection
6.2.1 Check the parallelism of the rolling mold shaft according to the parallelism detection method specified in GB/T1958 (choose one). 6.2.2 Use the sample block comparison method to test the roughness of the outer cylindrical surface of the spreading wheel, and detect its radial runout according to the method specified in GB/T1958.
6.2.3 Inspect the inner surface of the drying system roller cage with visual inspection and hand feeling. 6.2.4 Set the temperature of the spreading wheel, spray body, and glue supply insulation barrel at 50°C. After the temperature stabilizes, visually observe the corresponding temperature display value.
6.2.6 Run the soft capsule machine dry for 2 hours, and check the operation visually and aurally. 6.2.6 When the rolling mold speed is the maximum speed and no-load operation, measure the sound pressure level noise of the soft capsule wing forming system according to the provisions of GB/T16769.
6.2.7 Under the environmental conditions of temperature 18℃~26℃ and relative humidity 20%~60%, use 080B or 080V mold with medicinal liquid paraffin oil as the container to press soft Capsule and setting drying tests. After adjusting to normal working condition, perform 30 minutes. During the pressing process, soft capsules that are visually unqualified are removed from the conveyor and retained. a) Check the difference in filling volume: after finalizing and drying, select 20 soft capsules (the number of soft capsules corresponding to each row of holes in the roll mold should be guaranteed to be no less than two) and mark the number. Use a precision balance to determine the relative error. ≤0.01) Weigh out the amount of each soft capsule and make a record: Pour out the contents, wash the capsule shell with acetaldehyde, and place it in a ventilated place. After the solvent has evaporated, weigh out the amount of each capsule shell. Mass, after getting the filling capacity of each capsule, calculate the average filling capacity of 20 soft capsules. Calculate the maximum loading capacity difference according to formula (1):
Maximum loading capacity difference (%) Maximum (minimum) grain loading amount-Average loading capacity Average loading capacity
b) Check the pill peeling device: During the process of pressing soft capsules, observe the situation of the pill peeling device breaking the pills. X 100 -.. || TT || .. (1) || TT || C) Check the soft capsule seams: choose 10 soft capsules to check the thickness and non -non -seams of the seams on the maximum cross section Ratio of film thickness at joints. www.bzxz.net
d) Test the soft capsule pass rate: Screen the soft capsules pressed within 30 minutes, remove and count the unqualified soft capsules, add them to the soft capsules removed on the conveyor, the total number is unqualified soft capsules The number of capsules is calculated according to formula (2): the number of unqualified soft capsules
passed.%). The soft capsules made... (
e) Inspection of the dryer: after shaping Check the working condition of the dryer during the drying process. Note: The use of B-marrow to clean and lift the shell is limited to use during detection of excitation. 38
6.3 Electrical safety performance inspection
6.3.1 According to the provisions of 8.2 in CB5226.1-2002, check the protective grounding circuit of the electrical system. 6.3.2 According to the provisions of 19.2 in GB5226.1-2002, check the continuity of the protective grounding circuit of the electrical system. 6.3.3 Carry out insulation resistance inspection according to the provisions of 19.3 in GB5226.1--2002. 6.3.4 Carry out voltage resistance inspection according to the provisions of 19.4 in GB5226.1-2002. 6.3.5 Check the buttons of the electrical system according to the provisions of 10.2 in GB5226.1-2002. 6.3.6 According to the provisions of 10.3 in GB5226.1-2002, check the indicators and displays of the electrical system. 6.3.7
Check the wiring of the electrical system according to the provisions of Chapter 14 of CB5226.1-2002. 7 Inspection Rules
Inspection Classification
7.1
The inspection of the glue manure machine is divided into factory inspection and type inspection. 7.2 Factory inspection
7.2.1 Soft capsule machines shall be inspected one by one according to the provisions of Table 1. Only those that pass the test shall be allowed to leave the factory and be accompanied by a product certificate. Table 1 Factory inspection items
Monthly category
General performance
Main performance
Electrical safety performance
Inspection items
JB200272004|| tt||5.1,5.2.1,5.2.2,5.2.3,5.2.4,5.2.5,5.2.6,5.3.1,5.3.5,5.3.6,5.3.75.2.7,5.2.8 ,5.2.9,5.2.10,5.2.115.3.2, 5.3.3, 5.3.4
7.2.2 If any unqualified product is found during the inspection process, the soft capsule machine is allowed to return it for correction and reissue. If the product still fails to pass the inspection, it will be judged as a defective product.
7.3 Type inspection
Type inspection shall be carried out under one of the following conditions: 7.3.12
a)
New products or old products are transferred to the factory for production Trial prototype identification: After formal production, if there are major changes in product structure, materials, and processes, product performance may be affected; b)
product resumes production after long-term (more than 2 years) discontinuation; factory inspection results are the same as above There are big differences between sub-type inspections: d)
The national quality supervision agency puts forward the requirements for type inspection. e)
Type 7.3.2
prototypes for type inspection shall be randomly selected at a rate of 10% from the products that have passed the factory inspection, at least one. 7.3.3 During the type inspection, if any of the electrical safety performance of the protective grounding circuit continuity, insulation resistance, and withstand voltage fails, the soft capsule machine will be deemed to have failed the type inspection. If one of the main performance is unqualified or the general performance is unqualified for two, the unqualified items should be retested twice. If the unqualified items are still unqualified, the product will be deemed to have failed the type inspection. 8 Marking, packaging, transportation and storage
8.1 Marking
8.1.1 Each soft capsule host should fix the product label at the position specified in the drawing, and the label should comply with the regulations of GB/T13306. Signage 39
3. The parts in contact with the container, gelatin liquid and gelatin film should have a smooth surface to facilitate cleaning and disinfection. 5.2 Structure and performance
5.2.1 The parallelism of the two rolling mold axes of the soft capsule forming system shall not be greater than 0.05mm. 5.2.2 The outer cylindrical surface roughness Ra value of the spreading wheel shall not be greater than 0.8 μm, and the total radial runout of the spreading wheel shall not be greater than 0.03 mm. 5.2.3 The inner surface of the drum of the dry coal system shall be smooth and shall have no sharp corners or burrs. 5.2.4 The temperature control devices of the spreading box, spray body and glue supply insulation barrel should be able to be set arbitrarily within the range of room temperature to 99.9°C and controlled according to the set value. The temperature control steady-state error: spreading box, spray The temperature of the body is within ±0.1℃, and the temperature of the glue supply insulation barrel is within ±0.5℃. 5.2.5 Each system of the soft capsule machine should operate smoothly, without jamming or abnormal noise, and the lubrication system should work normally. 5.2.6 During no-load operation, the noise shall not be greater than 82dB(A). 5.2.7 The difference in soft capsule filling volume shall not exceed ±2%. 5.2.8 When pressing soft capsules, the pill peeling device can 100% remove the soft capsules from the mesh glue. 5.2.9 After the soft capsule is pressed and formed, the thickness of the capsule at the joint should not be less than 50% of the thickness of the capsule at other locations. 5.2.10 The pass rate of soft capsules shall not be less than 97%. 5.2.11 When the soft capsules are shaped and dried in the drying system, they must not be scratched, squeezed or leaked out of the rolling cage. 5.3 Safety requirements
5.3.1 The protective grounding circuit of the electrical system shall comply with the provisions of 8.2 in GB5226.1-2002. 5.3.2 The continuity of the protective grounding of the electrical system shall comply with the provisions of 19.2 in CB5226.1-2002. 5.3.3 The insulation resistance of the electrical system should meet the requirements of 19.3 in GB5226.1-2002. 5.3.4 The withstand voltage in the electrical system should comply with the provisions of 19.4 in GB5226.1--2002. 5.3.5 The buttons of the electrical system shall comply with the provisions of 10.2 of CB5226.1-2002. 37
JB20027-2004
5.3.6 The indicators and displays of the electrical system should comply with the provisions of 10.3 in GB5226.1-2002. 5.3.7 The wiring of the electrical system should comply with the provisions of Chapter 14 of GB5226.1-2002. 6 Test Methods
6.1 Material and Appearance Inspection
6.1.1 Inspect the material certificate of parts in contact with the container, gelatin liquid and gelatin film, 6.1.2 Self-visual inspection of the appearance of the soft capsule machine. 6.1.3 Visually inspect the surfaces of parts in contact with the container, gelatin liquid, and gelatin film. 6.2 Structure and performance inspection
6.2.1 Check the parallelism of the rolling mold shaft according to the parallelism detection method specified in GB/T1958 (choose one). 6.2.2 Use the sample block comparison method to test the roughness of the outer cylindrical surface of the spreading wheel, and detect its radial runout according to the method specified in GB/T1958.
6.2.3 Inspect the inner surface of the drying system roller cage with visual inspection and hand feeling. 6.2.4 Set the temperature of the spreading wheel, spray body, and glue supply insulation barrel at 50°C. After the temperature stabilizes, visually observe the corresponding temperature display value.
6.2.6 Run the soft capsule machine dry for 2 hours, and check the operation visually and aurally. 6.2.6 When the rolling mold speed is the maximum speed and no-load operation, measure the sound pressure level noise of the soft capsule wing forming system according to the provisions of GB/T16769.
6.2.7 Under the environmental conditions of temperature 18℃~26℃ and relative humidity 20%~60%, use 080B or 080V mold with medicinal liquid paraffin oil as the container to press soft Capsule and setting drying tests. After adjusting to normal working condition, perform 30 minutes. During the pressing process, soft capsules that are visually unqualified are removed from the conveyor and retained. a) Check the difference in filling volume: After finalizing and drying, select 20 soft capsules (the number of soft capsules corresponding to each row of holes in the roll mold should be guaranteed to be no less than two) and mark the number. Use a precision balance to calculate the relative error. ≤0.01) Weigh out the amount of each soft capsule and make a record: Pour out the contents, wash the capsule shell with acetaldehyde, and place it in a ventilated place. After the solvent has evaporated, weigh out the amount of each capsule shell. Mass, after getting the filling capacity of each capsule, calculate the average filling capacity of 20 soft capsules. Calculate the maximum loading capacity difference according to formula (1):
Maximum loading capacity difference (%) Maximum (minimum) grain loading amount-Average loading capacity Average loading capacity
b) Check the pill peeling device: During the process of pressing soft capsules, observe the situation of the pill peeling device breaking the pills. X 100 -.. || TT || .. (1) || TT || C) Check the soft capsule seams: choose 10 soft capsules to check the thickness and non -non -seams of the seams on the maximum cross section Ratio of film thickness at joints.
d) Test the soft capsule pass rate: Screen the soft capsules pressed within 30 minutes, remove and count the unqualified soft capsules, add them to the soft capsules removed on the conveyor, the total number is unqualified soft capsules The number of capsules is calculated according to formula (2): the number of unqualified soft capsules
passed.%). The soft capsules made... (
e) Inspection of the dryer: after shaping Check the working condition of the dryer during the drying process. Note: The use of B-marrow to clean and lift the shell is limited to use during detection of excitation. 38
6.3 Electrical safety performance inspection
6.3.1 According to the provisions of 8.2 in CB5226.1-2002, check the protective grounding circuit of the electrical system. 6.3.2 According to the provisions of 19.2 in GB5226.1-2002, check the continuity of the protective grounding circuit of the electrical system. 6.3.3 Carry out insulation resistance inspection according to the provisions of 19.3 in GB5226.1--2002. 6.3.4 Carry out voltage resistance inspection according to the provisions of 19.4 in GB5226.1-2002. 6.3.5 Check the buttons of the electrical system according to the provisions of 10.2 in GB5226.1-2002. 6.3.6 According to the provisions of 10.3 in GB5226.1-2002, check the indicators and displays of the electrical system. 6.3.7
According to the provisions of Chapter 14 of CB5226.1-2002, check the wiring of the electrical system. 7 Inspection Rules
Inspection Classification
7.1
The inspection of the glue manure machine is divided into factory inspection and type inspection. 7.2 Factory inspection
7.2.1 The soft capsule machines shall be inspected one by one according to the provisions of Table 1. Only those that pass the test shall be allowed to leave the factory and be accompanied by a product certificate. Table 1 Factory inspection items
Monthly category
General performance
Main performance
Electrical safety performance
Inspection items
JB200272004|| tt||5.1,5.2.1,5.2.2,5.2.3,5.2.4,5.2.5,5.2.6,5.3.1,5.3.5,5.3.6,5.3.75.2.7,5.2.8 ,5.2.9,5.2.10,5.2.115.3.2, 5.3.3, 5.3.4
7.2.2 If any unqualified product is found during the inspection process, the soft capsule machine is allowed to return it for correction and reissue. If the product still fails to pass the inspection, the product will be judged as a non-conforming product.
7.3 Type inspection
Type inspection shall be carried out under one of the following conditions: 7.3.12
a)
New products or old products are transferred to the factory for production Trial prototype identification: After formal production, if there are major changes in product structure, materials, and processes, product performance may be affected; b)
product resumes production after long-term (more than 2 years) discontinuation; factory inspection results are the same as above There are big differences between sub-type inspections: d)
The national quality supervision agency puts forward the requirements for type inspection. e)
Type 7.3.2
prototypes for type inspection shall be randomly selected at a rate of 10% from the products that have passed the factory inspection, at least one. 7.3.3 During the type inspection, if any of the electrical safety performance of the protective grounding circuit continuity, insulation resistance, and withstand voltage fails, the soft capsule machine will be deemed to have failed the type inspection. If one of the main performance is unqualified or the general performance is unqualified for two, the unqualified items should be retested twice. If the unqualified items are still unqualified, the product will be deemed to have failed the type inspection. 8 Marking, packaging, transportation and storage
8.1 Marking
8.1.1 Each soft capsule host should fix the product label at the position specified in the drawing, and the label should comply with the regulations of GB/T13306. Signage 39
It can be set arbitrarily within the range of 9℃ and controlled according to the set value. The temperature control steady-state error: the spread box and spray body are within ±0.1℃, and the glue supply insulation barrel is within ±0.5℃. 5.2.5 Each system of the soft capsule machine should operate smoothly, without jamming or abnormal noise, and the lubrication system should work normally. 5.2.6 During no-load operation, the noise shall not be greater than 82dB(A). 5.2.7 The difference in soft capsule filling volume shall not exceed ±2%. 5.2.8 When pressing soft capsules, the pill peeling device can 100% remove the soft capsules from the mesh glue. 5.2.9 After the soft capsule is pressed and formed, the thickness of the capsule at the joint should not be less than 50% of the thickness of the capsule at other locations. 5.2.10 The pass rate of soft capsules shall not be less than 97%. 5.2.11 When the soft capsules are shaped and dried in the drying system, they must not be scratched, squeezed or leaked out of the rolling cage. 5.3 Safety requirements
5.3.1 The protective grounding circuit of the electrical system shall comply with the provisions of 8.2 in GB5226.1-2002. 5.3.2 The continuity of protective grounding of the electrical system shall comply with the provisions of 19.2 in CB5226.1-2002. 5.3.3 The insulation resistance of the electrical system should meet the requirements of 19.3 in GB5226.1-2002. 5.3.4 The withstand voltage in the electrical system should comply with the provisions of 19.4 in GB5226.1--2002. 5.3.5 The buttons of the electrical system shall comply with the provisions of 10.2 of CB5226.1-2002. 37
JB20027-2004
5.3.6 The indicators and displays of the electrical system should comply with the provisions of 10.3 in GB5226.1-2002. 5.3.7 The wiring of the electrical system should comply with the provisions of Chapter 14 of GB5226.1-2002. 6 Test Methods
6.1 Material and Appearance Inspection
6.1.1 Inspect the material certificate of parts in contact with the container, gelatin liquid and gelatin film, 6.1.2 Self-visual inspection of the appearance of the soft capsule machine. 6.1.3 Visually inspect the surfaces of parts in contact with the container, gelatin liquid, and gelatin film. 6.2 Structure and performance inspection
6.2.1 Check the parallelism of the rolling mold shaft according to the parallelism detection method specified in GB/T1958 (choose one). 6.2.2 Use the sample block comparison method to test the roughness of the outer cylindrical surface of the spreading wheel, and detect its radial runout according to the method specified in GB/T1958.
6.2.3 Inspect the inner surface of the drying system roller cage with visual inspection and hand feeling. 6.2.4 Set the temperature of the spreading wheel, spray body, and glue supply insulation barrel at 50°C. After the temperature stabilizes, visually observe the corresponding temperature display value.
6.2.6 Run the soft capsule machine dry for 2 hours, and check the operation visually and aurally. 6.2.6 When the rolling mold speed is the maximum speed and no-load operation, measure the sound pressure level noise of the soft capsule wing forming system according to the provisions of GB/T16769.
6.2.7 Under the environmental conditions of temperature 18℃~26℃ and relative humidity 20%~60%, use 080B or 080V mold with medicinal liquid paraffin oil as the container to press soft Capsule and setting drying tests. After adjusting to normal working condition, perform 30 minutes. During the pressing process, soft capsules that are visually unqualified are removed from the conveyor and retained. a) Check the difference in filling volume: After finalizing and drying, select 20 soft capsules (the number of soft capsules corresponding to each row of holes in the roll mold should be guaranteed to be no less than two) and mark the number. Use a precision balance to calculate the relative error. ≤0.01) Weigh out the amount of each soft capsule and make a record: Pour out the contents, wash the capsule shell with acetaldehyde, and place it in a ventilated place. After the solvent has evaporated, weigh out the amount of each capsule shell. Mass, after getting the filling capacity of each capsule, calculate the average filling capacity of 20 soft capsules. Calculate the maximum loading capacity difference according to formula (1):
Maximum loading capacity difference (%) Maximum (minimum) grain loading amount-Average loading capacity Average loading capacity
b) Check the pill peeling device: During the process of pressing soft capsules, observe the situation of the pill peeling device breaking the pills. X 100 -.. || TT || .. (1) || TT || C) Check the soft capsule seams: choose 10 soft capsules to check the thickness and non -non -seams on the seams on the maximum cross section Ratio of film thickness at joints.
d) Test the soft capsule pass rate: Screen the soft capsules pressed within 30 minutes, remove and count the unqualified soft capsules, add them to the soft capsules removed on the conveyor, the total number is unqualified soft capsules The number of capsules is calculated according to formula (2): the number of unqualified soft capsules
passed.%). The soft capsules made... (
e) Inspection of the dryer: after shaping Check the working condition of the dryer during the drying process. Note: The use of B-marrow to clean and lift the shell is limited to use during detection of excitation. 38
6.3 Electrical safety performance inspection
6.3.1 According to the provisions of 8.2 in CB5226.1-2002, check the protective grounding circuit of the electrical system. 6.3.2 According to the provisions of 19.2 in GB5226.1-2002, check the continuity of the protective grounding circuit of the electrical system. 6.3.3 Carry out insulation resistance inspection according to the provisions of 19.3 in GB5226.1--2002. 6.3.4 Carry out voltage resistance inspection according to the provisions of 19.4 in GB5226.1-2002. 6.3.5 Check the buttons of the electrical system according to the provisions of 10.2 in GB5226.1-2002. 6.3.6 According to the provisions of 10.3 in GB5226.1-2002, check the indicators and displays of the electrical system. 6.3.7
According to the provisions of Chapter 14 of CB5226.1-2002, check the wiring of the electrical system. 7 Inspection Rules
Inspection Classification
7.1
The inspection of the glue manure machine is divided into factory inspection and type inspection. 7.2 Factory inspection
7.2.1 The soft capsule machines shall be inspected one by one according to the provisions of Table 1. Only those that pass the test shall be allowed to leave the factory and be accompanied by a product certificate. Table 1 Factory inspection items
Monthly category
General performance
Main performance
Electrical safety performance
Inspection items
JB200272004|| tt||5.1,5.2.1,5.2.2,5.2.3,5.2.4,5.2.5,5.2.6,5.3.1,5.3.5,5.3.6,5.3.75.2.7,5.2.8 ,5.2.9,5.2.10,5.2.115.3.2, 5.3.3, 5.3.4
7.2.2 If any unqualified product is found during the inspection process, the soft capsule machine is allowed to return it for correction and reissue. If the product still fails to pass the inspection, the product will be judged as a non-conforming product.
7.3 Type inspection
Type inspection shall be carried out under one of the following conditions: 7.3.12
a)
New products or old products are transferred to the factory for production Trial prototype identification: After formal production, if there are major changes in product structure, materials, and processes, product performance may be affected; b)
product resumes production after long-term (more than 2 years) discontinuation; factory inspection results are the same as above There are big differences between sub-type inspections: d)
The national quality supervision agency puts forward the requirements for type inspection. e)
Type 7.3.2
prototypes for type inspection shall be randomly selected at a rate of 10% from the products that have passed the factory inspection, at least one. 7.3.3 During the type inspection, if any of the electrical safety performance of the protective grounding circuit continuity, insulation resistance, and withstand voltage fails, the soft capsule machine will be deemed to have failed the type inspection. If one of the main performance is unqualified or the general performance is unqualified for two, the unqualified items should be retested twice. If the unqualified items are still unqualified, the product will be deemed to have failed the type inspection. 8 Marking, packaging, transportation and storage
8.1 Marking
8.1.1 Each soft capsule host should fix the product label at the position specified in the drawing, and the label should comply with the regulations of GB/T13306. Signage 39
It can be set arbitrarily within the range of 9℃ and controlled according to the set value. The temperature control steady-state error: the spread box and spray body are within ±0.1℃, and the glue supply insulation barrel is within ±0.5℃. 5.2.5 Each system of the soft capsule machine should operate smoothly, without jamming or abnormal noise, and the lubrication system should work normally. 5.2.6 During no-load operation, the noise shall not be greater than 82dB(A). 5.2.7 The difference in soft capsule filling volume shall not exceed ±2%. 5.2.8 When pressing soft capsules, the pill peeling device can 100% remove the soft capsules from the mesh glue. 5.2.9 After the soft capsule is pressed and formed, the thickness of the capsule at the joint should not be less than 50% of the thickness of the capsule at other locations. 5.2.10 The pass rate of soft capsules shall not be less than 97%. 5.2.11 When the soft capsules are shaped and dried in the drying system, they must not be scratched, squeezed or leaked out of the rolling cage. 5.3 Safety requirements
5.3.1 The protective grounding circuit of the electrical system shall comply with the provisions of 8.2 in GB5226.1-2002. 5.3.2 The continuity of the protective grounding of the electrical system shall comply with the provisions of 19.2 in CB5226.1-2002. 5.3.3 The insulation resistance of the electrical system should meet the requirements of 19.3 in GB5226.1-2002. 5.3.4 The withstand voltage in the electrical system should comply with the provisions of 19.4 in GB5226.1--2002. 5.3.5 The buttons of the electrical system shall comply with the provisions of 10.2 of CB5226.1-2002. 37
JB20027-2004
5.3.6 The indicators and displays of the electrical system should comply with the provisions of 10.3 in GB5226.1-2002. 5.3.7 The wiring of the electrical system should comply with the provisions of Chapter 14 of GB5226.1-2002. 6 Test Methods
6.1 Material and Appearance Inspection
6.1.1 Inspect the material certificate of parts in contact with the container, gelatin liquid and gelatin film, 6.1.2 Self-visual inspection of the appearance of the soft capsule machine. 6.1.3 Visually inspect the surfaces of parts in contact with the container, gelatin liquid, and gelatin film. 6.2 Structure and performance inspection
6.2.1 Check the parallelism of the rolling mold shaft according to the parallelism detection method specified in GB/T1958 (choose one). 6.2.2 Use the sample block comparison method to test the roughness of the outer cylindrical surface of the spreading wheel, and detect its radial runout according to the method specified in GB/T1958.
6.2.3 Inspect the inner surface of the drying system roller cage with visual inspection and hand feeling. 6.2.4 Set the temperature of the spreading wheel, spray body, and glue supply insulation barrel at 50°C. After the temperature stabilizes, visually observe the corresponding temperature display value.
6.2.6 Run the soft capsule machine dry for 2 hours, and check the operation visually and aurally. 6.2.6 When the rolling mold speed is the maximum speed and no-load operation, measure the sound pressure level noise of the soft capsule wing forming system according to the provisions of GB/T16769.
6.2.7 Under the environmental conditions of temperature 18℃~26℃ and relative humidity 20%~60%, use 080B or 080V mold with medicinal liquid paraffin oil as the container to press soft Capsule and setting drying tests. After adjusting to normal working condition, perform 30 minutes. During the pressing process, soft capsules that are visually unqualified are removed from the conveyor and retained. a) Check the difference in filling volume: After finalizing and drying, select 20 soft capsules (the number of soft capsules corresponding to each row of holes in the roll mold should be guaranteed to be no less than two) and mark the number. Use a precision balance to calculate the relative error. ≤0.01) Weigh out the amount of each soft capsule and make a record: Pour out the contents, wash the capsule shell with acetaldehyde, and place it in a ventilated place. After the solvent has evaporated, weigh out the amount of each capsule shell. Mass, after getting the filling capacity of each capsule, calculate the average filling capacity of 20 soft capsules. Calculate the maximum loading capacity difference according to formula (1):
Maximum loading capacity difference (%) Maximum (minimum) grain loading amount-Average loading capacity Average loading capacity
b) Check the pill peeling device: During the process of pressing soft capsules, observe the situation of the pill peeling device breaking the pills. X 100 -.. || TT || .. (1) || TT || C) Check the soft capsule seams: choose 10 soft capsules to check the thickness and non -non -seams of the seams on the maximum cross section Ratio of film thickness at joints.
d) Test the soft capsule pass rate: Screen the soft capsules pressed within 30 minutes, remove and count the unqualified soft capsules, add them to the soft capsules removed on the conveyor, the total number is unqualified soft capsules The number of capsules is calculated according to formula (2): the number of unqualified soft capsules
passed.%). The soft capsules made... (
e) Inspection of the dryer: after shaping Check the working condition of the dryer during the drying process. Note: The use of B-marrow to clean and lift the shell is limited to use during detection of excitation. 38
6.3 Electrical safety performance inspection
6.3.1 According to the provisions of 8.2 in CB5226.1-2002, check the protective grounding circuit of the electrical system. 6.3.2 According to the provisions of 19.2 in GB5226.1-2002, check the continuity of the protective grounding circuit of the electrical system. 6.3.3 Carry out insulation resistance inspection according to the provisions of 19.3 in GB5226.1--2002. 6.3.4 Carry out voltage resistance inspection according to the provisions of 19.4 in GB5226.1-2002. 6.3.5 Check the buttons of the electrical system according to the provisions of 10.2 in GB5226.1-2002. 6.3.6 According to the provisions of 10.3 in GB5226.1-2002, check the indicators and displays of the electrical system. 6.3.7
According to the provisions of Chapter 14 of CB5226.1-2002, check the wiring of the electrical system. 7 Inspection Rules
Inspection Classification
7.1
The inspection of the glue manure machine is divided into factory inspection and type inspection. 7.2 Factory inspection
7.2.1 The soft capsule machines shall be inspected one by one according to the provisions of Table 1. Only those that pass the test shall be allowed to leave the factory and be accompanied by a product certificate. Table 1 Factory inspection items
Monthly category
General performance
Main performance
Electrical safety performance
Inspection items
JB200272004|| tt||5.1,5.2.1,5.2.2,5.2.3,5.2.4,5.2.5,5.2.6,5.3.1,5.3.5,5.3.6,5.3.75.2.7,5.2.8 ,5.2.9,5.2.10,5.2.115.3.2, 5.3.3, 5.3.4
7.2.2 If any unqualified product is found during the inspection process, the soft capsule machine is allowed to return it for correction and reissue. If the product still fails to pass the inspection, the product will be judged as a non-conforming product.
7.3 Type inspection
Type inspection shall be carried out under one of the following conditions: 7.3.12
a)
New products or old products are transferred to the factory for production Trial prototype identification: After formal production, if there are major changes in product structure, materials, and processes, product performance may be affected; b)
product resumes production after long-term (more than 2 years) discontinuation; factory inspection results are the same as above There are big differences between sub-type inspections: d)
The national quality supervision agency puts forward the requirements for type inspection. e)
Type 7.3.2
prototypes for type inspection shall be randomly selected at a rate of 10% from the products that have passed the factory inspection, at least one. 7.3.3 During the type inspection, if any of the electrical safety performance of the protective grounding circuit continuity, insulation resistance, and withstand voltage fails, the soft capsule machine will be deemed to have failed the type inspection. If one of the main performance is unqualified or the general performance is unqualified for two, the unqualified items should be retested twice. If the unqualified items are still unqualified, the product will be deemed to have failed the type inspection. 8 Marking, packaging, transportation and storage
8.1 Marking
8.1.1 Each soft capsule host should fix the product label at the position specified in the drawing, and the label should comply with the regulations of GB/T13306. Signage 39
The provisions of 19.3 of 1-2002. 5.3.4 The withstand voltage in the electrical system should comply with the provisions of 19.4 in GB5226.1--2002. 5.3.5 The buttons of the electrical system shall comply with the provisions of 10.2 of CB5226.1-2002. 37
JB20027-2004
5.3.6 The indicators and displays of the electrical system should comply with the provisions of 10.3 in GB5226.1-2002. 5.3.7 The wiring of the electrical system should comply with the provisions of Chapter 14 of GB5226.1-2002. 6 Test Methods
6.1 Material and Appearance Inspection
6.1.1 Inspect the material certificate of parts in contact with the container, gelatin liquid and gelatin film, 6.1.2 Self-visual inspection of the appearance of the soft capsule machine. 6.1.3 Visually inspect the surfaces of parts in contact with the container, gelatin liquid, and gelatin film. 6.2 Structure and performance inspection
6.2.1 Check the parallelism of the rolling mold shaft according to the parallelism detection method specified in GB/T1958 (choose one). 6.2.2 Use the sample block comparison method to test the roughness of the outer cylindrical surface of the spreading wheel, and detect its radial runout according to the method specified in GB/T1958.
6.2.3 Inspect the inner surface of the drying system roller cage with visual inspection and hand feeling. 6.2.4 Set the temperature of the spreading wheel, spray body, and glue supply insulation barrel at 50°C. After the temperature stabilizes, visually observe the corresponding temperature display value.
6.2.6 Run the soft capsule machine dry for 2 hours, and check the operation visually and aurally. 6.2.6 When the rolling mold speed is the maximum speed and no-load operation, measure the sound pressure level noise of the soft capsule wing forming system according to the provisions of GB/T16769.
6.2.7 Under the environmental conditions of temperature 18℃~26℃ and relative humidity 20%~60%, use 080B or 080V mold with medicinal liquid paraffin oil as the container to press soft Capsule and setting drying tests. After adjusting to normal working condition, perform 30 minutes. During the pressing process, soft capsules that are visually unqualified are removed from the conveyor and retained. a) Check the difference in filling volume: After finalizing and drying, select 20 soft capsules (the number of soft capsules corresponding to each row of holes in the roll mold should be guaranteed to be no less than two) and mark the number. Use a precision balance to calculate the relative error. ≤0.01) Weigh out the amount of each soft capsule and make a record: Pour out the contents, wash the capsule shell with acetaldehyde, and place it in a ventilated place. After the solvent has evaporated, weigh out the amount of each capsule shell. Mass, after getting the filling capacity of each capsule, calculate the average filling capacity of 20 soft capsules. Calculate the maximum loading capacity difference according to formula (1):
Maximum loading capacity difference (%) Maximum (minimum) grain loading amount-Average loading capacity Average loading capacity
b) Check the pill peeling device: During the process of pressing soft capsules, observe the situation of the pill peeling device breaking the pills. X 100 -.. || TT || .. (1) || TT || C) Check the soft capsule seams: choose 10 soft capsules to check the thickness and non -non -seams of the seams on the maximum cross section Ratio of film thickness at joints.
d) Test the soft capsule pass rate: Screen the soft capsules pressed within 30 minutes, remove and count the unqualified soft capsules, add them to the soft capsules removed on the conveyor, the total number is unqualified soft capsules The number of capsules is calculated according to formula (2): the number of unqualified soft capsules
passed.%). The soft capsules made... (
e) Inspection of the dryer: after shaping Check the working condition of the dryer during the drying process. Note: The use of B-marrow to clean and lift the shell is limited to use during detection of excitation. 38
6.3 Electrical safety performance inspection
6.3.1 According to the provisions of 8.2 in CB5226.1-2002, check the protective grounding circuit of the electrical system. 6.3.2 According to the provisions of 19.2 in GB5226.1-2002, check the continuity of the protective grounding circuit of the electrical system. 6.3.3 Carry out insulation resistance inspection according to the provisions of 19.3 in GB5226.1--2002. 6.3.4 Carry out voltage resistance inspection according to the provisions of 19.4 in GB5226.1-2002. 6.3.5 Check the buttons of the electrical system according to the provisions of 10.2 in GB5226.1-2002. 6.3.6 According to the provisions of 10.3 in GB5226.1-2002, check the indicators and displays of the electrical system. 6.3.7
According to the provisions of Chapter 14 of CB5226.1-2002, check the wiring of the electrical system. 7 Inspection Rules
Inspection Classification
7.1
The inspection of the glue manure machine is divided into factory inspection and type inspection. 7.2 Factory inspection
7.2.1 The soft capsule machines shall be inspected one by one according to the provisions of Table 1. Only those that pass the test shall be allowed to leave the factory and be accompanied by a product certificate. Table 1 Factory inspection items
Monthly category
General performance
Main performance
Electrical safety performance
Inspection items
JB200272004|| tt||5.1,5.2.1,5.2.2,5.2.3,5.2.4,5.2.5,5.2.6,5.3.1,5.3.5,5.3.6,5.3.75.2.7,5.2.8 ,5.2.9,5.2.10,5.2.115.3.2, 5.3.3, 5.3.4
7.2.2 If any unqualified product is found during the inspection process, the soft capsule machine is allowed to return it for correction and reissue. If the product still fails to pass the inspection, the product will be judged as a non-conforming product.
7.3 Type inspection
Type inspection shall be carried out under one of the following conditions: 7.3.12
a)
New products or old products are transferred to the factory for production Trial prototype identification: After formal production, if there are major changes in product structure, materials, and processes, product performance may be affected; b)
product resumes production after long-term (more than 2 years) discontinuation; factory inspection results are the same as above There are big differences between sub-type inspections: d)
The national quality supervision agency puts forward the requirements for type inspection. e)
Type 7.3.2
prototypes for type inspection shall be randomly selected at a rate of 10% from the products that have passed the factory inspection, at least one. 7.3.3 During the type inspection, if any of the electrical safety performance of the protective grounding circuit continuity, insulation resistance, and withstand voltage fails, the soft capsule machine will be deemed to have failed the type inspection. If one of the main performance is unqualified or the general performance is unqualified for two, the unqualified items should be retested twice. If the unqualified items are still unqualified, the product will be deemed to have failed the type inspection. 8 Marking, packaging, transportation and storage
8.1 Marking
8.1.1 Each soft capsule host should fix the product label at the position specified in the drawing, and the label should comply with the regulations of GB/T13306. Signage 39
The provisions of 19.3 of 1-2002. 5.3.4 The withstand voltage in the electrical system should comply with the provisions of 19.4 in GB5226.1--2002. 5.3.5 The buttons of the electrical system shall comply with the provisions of 10.2 of CB5226.1-2002. 37
JB20027-2004
5.3.6 The indicators and displays of the electrical system should comply with the provisions of 10.3 in GB5226.1-2002. 5.3.7 The wiring of the electrical system should comply with the provisions of Chapter 14 of GB5226.1-2002. 6 Test Methods
6.1 Material and Appearance Inspection
6.1.1 Inspect the material certificate of parts in contact with the container, gelatin liquid and gelatin film, 6.1.2 Self-visual inspection of the appearance of the soft capsule machine. 6.1.3 Visually inspect the surfaces of parts in contact with the container, gelatin liquid, and gelatin film. 6.2 Structure and performance inspection
6.2.1 Check the parallelism of the rolling mold shaft according to the parallelism detection method specified in GB/T1958 (choose one). 6.2.2 Use the sample block comparison method to test the roughness of the outer cylindrical surface of the spreading wheel, and detect its radial runout according to the method specified in GB/T1958.
6.2.3 Inspect the inner surface of the drying system roller cage with visual inspection and hand feeling. 6.2.4 Set the temperature of the spreading wheel, spray body, and glue supply insulation barrel at 50°C. After the temperature stabilizes, visually observe the corresponding temperature display value.
6.2.6 Run the soft capsule machine dry for 2 hours, and check the operation visually and aurally. 6.2.6 When the rolling mold speed is the maximum speed and no-load operation, measure the sound pressure level noise of the soft capsule wing forming system according to the provisions of GB/T16769.
6.2.7 Under the environmental conditions of temperature 18℃~26℃ and relative humidity 20%~60%, use 080B or 080V mold with medicinal liquid paraffin oil as the container to press soft Capsule and setting drying tests. After adjusting to normal working condition, perform 30 minutes. During the pressing process, soft capsules that are visually unqualified are removed from the conveyor and retained. a) Check the difference in filling volume: After finalizing and drying, select 20 soft capsules (the number of soft capsules corresponding to each row of holes in the roll mold should be guaranteed to be no less than two) and mark the number. Use a precision balance to calculate the relative error. ≤0.01) Weigh out the amount of each soft capsule and make a record: Pour out the contents, wash the capsule shell with acetaldehyde, and place it in a ventilated place. After the solvent has evaporated, weigh out the amount of each capsule shell. Mass, after getting the filling capacity of each capsule, calculate the average filling capacity of 20 soft capsules. Calculate the maximum loading capacity difference according to formula (1):
Maximum loading capacit
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