This standard specifies the classification and labeling, requirements, test methods, inspection rules and markings, packaging, transportation and storage of swing pellet machines. This standard applies to swing pellet machines. JB 20018-2004 Swing pellet machine JB20018-2004 standard download and decompression password: www.bzxz.net

JB | |tt||Water chestnut type coating machine
Swing granulator
Released on 2004-02-05
Implemented on 2004-06-01
National Development and Reform Commission Release
ICS11.120.30
C92
JB
Pharmaceutical Machinery Industry Standard of the People's Republic of China JB20018--2004
replaces YY0220-1995||tt| |Oscillating granulation machine
Oscillating granulation machine2004-02-05 release
2004-06-01 implementation
National Development and Reform Commission release
Foreword
Scope
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2
Normative reference documents
3 Classification and labeling
4 Requirements
5
6| |tt||Test methods
Inspection rules
Marking, packaging, transportation and storage
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times
JB20018- —2004
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53 | | tt | | 49 | | tt | 2-2002 Standardization Work Guidelines requirements, revision of YY0220-1995 Swing-type Pellet Machine. This standard replaces YY0220-1995 from the date of implementation. Compared with YY0220-1995, the main contents of this standard have changed as follows: =) The "Product Classification" chapter has canceled the basic specifications and basic parameters. b) The relevant clauses in the original standard have been rearranged and supplemented in accordance with the relevant requirements of the "Good Manufacturing Practice for Pharmaceutical Products". c) Added and supplemented safety and performance requirements, emphasizing that the electrical system must comply with the relevant regulations in GB5226.1-2002.
d) Increases the operability of the test method, and the test method basically corresponds to the chapter content. This standard is proposed by China Pharmaceutical Equipment Industry Association. This standard is under the jurisdiction of the Pharmaceutical Equipment Industry Standardization Technical Committee. This standard was drafted by: Changsha Zhengzhong Pharmaceutical Machinery Factory. The main drafter of this standard: Kang Jun.
The previous versions of the standards replaced by this standard are: ZBC92003-1986, YY0220-1995. 50
1 range
Swing granulator
JB 20018— 2004
This standard specifies the classification and labeling, requirements, test methods, inspection rules and signs, packaging, transportation and storage of swing pellet machines. This standard applies to swing pellet machines (hereinafter referred to as pellet machines). 2 Normative reference documents
The clauses in the following documents become the clauses 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. CB/T191 Packaging, storage and transportation pictorial mark
GB/T3280 stainless steel cold-rolled steel plate
GB5226.12002 Mechanical safety mechanical and electrical equipment Part 1: General technical conditions GB/T9969.1 Industrial product instruction manual General GB/T10111 Random sampling method using random numbers GB/T13384 General technical conditions for mechanical and electrical product packaging GR/T13306 Labeling
GB/T16769 Method for measuring noise and sound pressure level of metal cutting machine tools YY/T0216 Pharmaceutical machinery products Model compilation method Pharmacopoeia of the People's Republic of China (2000 edition) Good Manufacturing Practice for Drugs of the National Pharmacopoeia Commission (1998 revised edition) State Food and Drug Administration 3 Classification and labeling
3.1 Type: Swing granulator. That is, a vertical machine in which the powder scraping shaft moves 120°. 3.2 Main structure: including machine base, transmission system, fuselage, hopper, stream drum, etc. 3.3 Model: Should comply with the provisions of YY/T0216. LYK
Improved design sequence number (A, B)
Specification code: Use ferry screen diameter (mm) to express type and feature code: Swing type (Y), granular (K) product function code : Granulation machinery
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JB200182004
Marking example
TYK160: Indicates a swing granulator with a granulation drum diameter of 160mm. 4 Requirements
4.1 The swing granulator should comply with the relevant requirements for equipment manufacturing of the "Good Manufacturing Practice for Pharmaceuticals" (1998 revised edition). 4.2 Material requirements
Parts that are in direct contact with materials should be made of austenitic stainless steel or materials that comply with the requirements of "Good Manufacturing Practice for Pharmaceutical Products" in GB/T3280, and have material certificates.
4.3 Manufacturing requirements
4.3.1 The inner surface of the pellet machine hopper should be flat and smooth, with no obvious unevenness, no dead corners, no correction angles, easy to disassemble and easy to clean. 4.3.2 The surface of the welding seam of the swing rotor should be flat and smooth, and the edges of the scraping strip should be rounded, and its value Ra should not be greater than 1.0gm. 4.3.3 The single-sided gap between the swing roller and the end cover is 0.5mm~1.0mm. 4.3.4 The matching gap between the rack and the sliding guide plate is 0.10mm~0.30mm. 4.4 Appearance quality requirements
4.4.1 The pellet machine should not have bulges, dents, roughness and other damage. 4.4.2 All external surfaces of the pellet machine shall be treated with anti-rust treatment. 4.5 Performance requirements
4.5.1 All moving parts of the pellet machine should operate smoothly without looseness, vibration or other abnormal phenomena. 4.5.2 No leakage or oil leakage is allowed at the seals of the pellet machine. 4.5.3 When the smoothing machine is operating normally, the noise shall not exceed 75dB(A). 4.5.4 The continuity of the protective grounding circuit of the electrical system complies with the provisions of 19.2 in CB5226.1-2002. 4.5.5 The insulation resistance of the electrical system complies with the provisions of 19.3 in GB5226.1-2002. 4.5.6 The withstand voltage of the electrical system complies with the provisions of 19.4 in CB5226.1--2002. 4.5.7 The protective grounding circuit of the electrical system complies with the provisions of 8.2 in GB5226.1-2002. 4.5.8 The buttons of the electrical system comply with the provisions of 10.2 in GB5226.1-2002. 4.5.9 The indicator lights of the electrical system comply with the provisions of 10.3 in GB5226.1-2002. 4.5.10 The wiring of the electrical system complies with the provisions of Chapter 14 of GB5226.1-2002. 4.5.11 The markings and warning signs of the electrical system comply with the provisions of Chapter 17 of GB5226.1-2002. 5 Test methods
5.1 Inspection of manufacturing and appearance, monthly testing with testing equipment. 5.2 Document inspection
Check the machine instruction manual, product certificate, material certificate, etc. 5.3 Performance test
5.3.1 No-load test
Start the machine without load and run it for no less than 2 hours without any abnormality. 5.3.2 Load test
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After the machine passes the no-load test, the load test is performed. The manufacturer adds materials during the test and runs for 30 minutes to simulate the normal process. Visual inspection There must be no leakage at each seal.
5.3.3 Noise inspection
After the machine load is running normally, the noise shall be tested according to the provisions of GB/T16769, and its value shall not be greater than 75dB(A). 5.3.4 Electrical safety inspection
5.3.4.1 The continuity, insulation resistance, withstand voltage, and protective grounding circuit of the electrical system's protective grounding circuit shall be carried out in accordance with the provisions of 19.2~19.4 and 8.2 in GB5226.1-2002 respectively. 5.3.4.2 The connectors, indicator lights, wiring, and other warning signs of the electrical system shall be carried out in accordance with the provisions of 10.2, 10.3, Chapter 14 and Chapter 17 of GB5226.1-2002 respectively.
6 Inspection Rules
6.1. Each product must be inspected by the manufacturer's inspection department in accordance with the requirements of this standard before it can leave the factory. It must have a product certificate when leaving the factory.
6.2 Product inspection includes factory inspection and type inspection. 6.2.1 Factory inspection
6.2.1.1 The pellet machine must be inspected item by item according to the items listed in Table 1. Table 1 Granulator factory inspection items
Item category
General performance
Main performance
Inspection items
4.2, 4.4, 4.3, 4.5.8, 4.5.9, 4.5.10, 4.5.114.5.1,4.5.2,4.5.3,4.5.4,4.5.5,4.5.6,4.5.76.2.1.2 If each product is found to be unqualified during the inspection process When the item is checked, it is allowed to be returned for repair and re-inspection. If the re-inspection still fails, it will be judged as unqualified product.
6.2.2 Type inspection
6.2.2.1 Type inspection is required in one of the following situations: Trial type identification of new products or old products transferred to factory production; a)
b)i
After formal production, if there are major changes in structure, materials, and processes that may affect product performance; c) When production is resumed after 3 years of suspension: d)
factory inspection results are consistent with When there is a big difference in the last type inspection: e) When the national quality supervision agency requests type inspection. 6.2.2.2 Type inspection items include all technical requirements of this standard. 6.2.2.3 The prototype for type inspection shall be selected from the products that have passed the factory inspection for testing in accordance with GB/T10111. During the inspection, if one of the main performances of the electrical system's protective grounding circuit continuity, insulation resistance, and withstand voltage fails, it will be judged as failed type inspection. If one of the other performance items is unqualified, the unqualified item will be retested twice, if it still fails. The product is deemed to have failed the type inspection.
7 Marking, packaging, transportation and storage
7.1 The product label shall be fixed on an obvious part of the machine. The size and technical requirements of the label shall comply with the provisions of GB/T13306. Signage 53
JB20018—2004
Contents include:
a) Machine model and name brand;
b) Specifications;
e) Number of swings;| |tt||d) Factory number:
e) Manufacturing date; wwW.bzxz.Net
f) Manufacturer name;
g) Standard number.
7.2 Product instructions for use shall comply with the provisions of GB/T9969.1. 7.3 The packaging of the product should comply with the regulations of CB/T13384. 7.4. The following documents should be attached to the packaging of the product when it leaves the factory: Packing list:
a)
b) Factory certificate;
e) Product instruction manual.
5 The shipping mark on the packaging box is clear and has the following content: 7.5
Transportation number;
a)
Product model and name:||tt| |b)
Delivery date:
c
shipping station name, receiving station name;
d)
shipping unit, receiving station Cargo unit;
e
f) Gross weight, external dimensions;
g) Storage and transportation symbols comply with the regulations of GB/T191. 6. After the product is packed, it should be stored indoors or under a shed in a dry and ventilated place without corrosive gases. It cannot be stored in the open air. 7.6
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