Some standard content:
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Released on 2004-02-05
Implemented on 2004-06-01
Released by the National Development and Reform Commission
Foreword
Scope
2Normative reference documents
3 Classification and marking
4 Requirements
5 Test methods
6 Inspection rules
Marking, instructions for use, packaging and storage Item
times
JB20035--2004
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JB20035—2004
Foreword
This standard is based on the "Good Manufacturing Practice for Pharmaceuticals" In accordance with the requirements of the standardization work guidelines of GB/T1.1-2000 and GB/T1.2--2002, the revision of YY0258-1997 "Powder Removal Sieve" was carried out. This standard replaces YY0258-1997 from the date of implementation. Compared with YY0258--1997, the main content changes of this standard are as follows: a) Chapter 2 adds introductory words and newly quoted standards. The content of Chapter 4 has changed as follows:
b)
- Added the content related to GMP that "the working room of the powder removal screen should be isolated from the outside world, pollution-free, easy to disassemble and easy to clean"; added The requirements for safety marks, warning signs, etc. in the electrical system safety requirements have been clarified: the overall machine performance requirements have been modified and supplemented accordingly. Yiyou made a noise requirement.
c) Chapter 5 test methods correspond to the requirements one-to-one, and the content of "test conditions\" is added; the noise test method is changed from the original ZBJ50004 to CB/T16769.
d) Chapter 6 Chapter 7 Inspection Rules adds the content of "Inspection Classification". e) Chapter 7 adds the content of connection with the power supply; the content of the instruction manual and storage requirements are supplemented with the content of storage (including transportation) validity period
The standard is proposed by the China Pharmaceutical Equipment Industry Association. This standard is under the jurisdiction of the Pharmaceutical Equipment Industry Standardization Technical Committee. The main drafters of this standard are: Beijing Aerospace Changfeng Co., Ltd. Honghua Pharmaceutical Machinery Branch. Hua. 38
1Scope
Powder removal sieve
JB200352004
This standard specifies the classification and marking, requirements, test methods, inspection rules and signs of powder removal sieves , instructions for use, packaging, and storage. This standard applies to vibrating powder removal screens for automatic powder removal of tablets, blocks, and granular drugs. 2 Normative reference documents
The provisions in the following documents are cited in this standard. And become the terms of this standard. For dated referenced documents, all subsequent amendments (excluding corrigenda) or revisions do not apply to this standard. However, parties who reach 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 version applies to this standard. GB/T191 Packaging, storage and transportation pictorial markings (eqvIS0780:1997) GB5226.1-2002 Machine board safety mechanical and electrical equipment. Part 1: General technical conditions (EC60204-1:2000, IDT
8 Transport packaging receipt and delivery marks
GB/T6388
CB/T9969.1 General provisions of industrial product instructions for use GB /T13306 Signs
GB/T 13384
General technical conditions for mechanical and electrical product packaging
CB/T16769 Measurement method of noise and sound pressure level of metal cutting machine tools (negIS0/DIS230~5-2) Pharmaceutical Mechanical product model compilation method
YY/T0216
3 classification and marking
3.1 model
Powder removal screen model compilation is in accordance with the provisions of YY/T0216 3.2 marking|| tt | Function code: S-powder removal screen
Marking example
SZ300A type: represents the vibrating rotary powder removal screen with a sieve plate diameter of 300mm after the first improved design 39
JB20035—2004
4 requirements
4.1 Basic requirements
4.1.1 The outer surface of the powder removal screen should be flat, smooth, without obvious scratches, without rust, and have rounded corners. Treatment: The coating has the same color, no blistering, and no shedding.
4.1.2 The working room of the powder removal screen should be isolated from the outside world, pollution-free, easy to disassemble and easy to clean. 4.1.3 All fasteners should be tightened evenly and have anti-loosening measures; all exposed fasteners must be galvanized or chromed, and stainless pins must be polished and decorated.
4.1.4 The surface of the parts in direct contact with the medicine should be clear, smooth, non-shedding, easy to clean or disinfect, and should not have dead corners, blisters, slits, etc. that cannot be cleaned.
4.1.5 Parts that are in direct contact with materials and tablets should be made of materials that are corrosion-resistant and do not chemically react with or adsorb drugs.
4.2 Electrical system safety requirements
4.2.1 The continuity of the protective grounding circuit of the electrical system shall comply with the provisions of 19.2 of CB5226.1-2002; 4.2.2 The insulation resistance of the electrical system shall comply with CB5226. 1--The provisions of 19.3 in 2002; 4.2.3 The withstand voltage of the electrical system shall comply with the provisions of 19.4 in GB5226.1-2002: 4.2.4 The markings, warning signs and project codes of the electrical system shall comply with the provisions in GB5226.1-2002 The provisions of Chapter 17. 4.3 Complete machine performance requirements
4.3.1 The structure of the powder removal screen should have shock-absorbing measures, and the work should be stable and safe. 4.3.2 The dust removal sieve should have a dust suction pipe, the pipe joints of the gas line should be firmly installed, and the connection with the hose should be sealed. 4.3.3 The output speed of the powder removal screen should be continuously adjustable. 4.3.4 The powder removal rate of the powder removal screen is greater than 99%. 4.3.5 The damage rate of the powder removal screen is less than 0.5%. 4.4 Noise requirements
When the powder removal screen is running at the highest speed without load, the noise shall not exceed 80dB(A). 5 Test methods
5.1 Basic requirements inspection
5.1.1 Visually inspect the outer surface of the powder removal screen and the color of the coating. 5.1.2 Visually inspect the sealing quality of the powder removal sieve work case. 5.1.3 Check all fasteners by hand.
5.1.4 Touch detection of the surface in direct contact with the drug. 5.1.5 Check the materials of parts that are in direct contact with materials and tablets against the material list. 5.2 Inspection of electrical system safety requirements
5.2.1 Check the continuity of the protective grounding circuit of the electrical system according to the method of 19.2 in GB5226.1-2002. 5.2.2 Measure the insulation resistance of the electrical system according to the method in 19.3 of GB5226.1-2002. 5.2.3 Measure the withstand voltage of the electrical system according to the method in 19.4 of GB5226.12002. 40
JB 20035—2004
5.2.4 Check the markings, warning signs and project codes of the electrical system according to the provisions of Chapter 17 of GB5226.1-2002: 5.3 Complete machine performance test|| tt||5.3.1 Test conditions:
5.3.1.1 1.5kg of qualified tablets and 0.5kg of blank powder. 5.3.1.2 The test environment is:
a) altitude below 1000m;
temperature 18℃~24℃;
b)
relative humidity 45%~65% .
c)
5.3.2 Test method:
5.3.2.1 Adjust the powder removal screen to the "middle\discharge position, run continuously for more than 1 hour without load, and check the stability. 5.3.2.2 Use 1.5kg of qualified chips and 0.0kg of empty self-powder.5kg, after mixing, add a powder removal sieve to remove the powder. After the powder removal is completed, weigh the tablet weight after the powder removal, and use formula (1) to calculate the powder removal rate S.
S=[(1.5 +0.5) -A]/0.5×100%
Where:
A The weight after sieving, kg.
5.3.2.3 Check the connection of the vacuum pipe and the pipe joint of the gas line during the powder removal process. 5.3.2.4 Take out 500 pieces from the powder-removed pieces, count the number of damaged pieces, and calculate the damage rate using equation (2). f = B/500 × 100%
where:
B—the number of damaged pieces, pieces.
5.3.2.5 Adjust the speed adjustment component during the powder removal process and check the output speed adjustability. 5.4 Noise test
When running at maximum speed without load, use a sound level meter to measure the noise according to the method specified in GB/T16769. 6 Inspection Rules
6.1 Inspection Categories
Powder removal, screening, factory inspection and type inspection. 6.2 Factory inspection
6.2.1 Inspect each unit according to the provisions of Table 1. Only those that pass the test will be allowed to leave the factory and be accompanied by a product certificate. Table 1 Factory inspection items
Item category
General performance
Main performance
Inspection items
4.1.1~4.1.4
4.2, 4.3.1~4.3.3
(1)
(2)
6.2.2 If unqualified products are found during the inspection process, they are allowed to be returned for repair and repair. If the product still fails to pass the inspection, the product will be judged as a non-conforming product.
6.3.Type inspection
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JB20035—2004
6.3.1 When there is one of the following situations, type inspection should generally be carried out: a) New products or old products Trial prototype appraisal for factory transfer; b) After formal production, if there are major changes in structure, materials, and processes, which may affect product performance; c) During normal production, inspections should be carried out regularly or after accumulating a certain amount of output; d ) When the product has been out of production for more than 2 years and resumes production; e) When the factory inspection results are significantly different from the last type inspection; f) When the national quality supervision agency proposes type inspection requirements. 6.3.2 Type inspection items shall be carried out according to the requirements of Chapter 4. If all the indicators are met, the product shall be considered qualified. 6.3.3 Judgment rules:
Type inspection shall randomly select one unit from the batch that passed the factory inspection. During the inspection, if any of the items in 4.2.1, 4.2.2, and 4.2.3 is unqualified, it will be judged as a type Inspection failed. If one of the other items is unqualified, the unqualified item should be re-inspected twice. If the re-inspection still fails, the product will be deemed to have failed the type inspection.
7 Logo, Instructions for Use, Packaging and Storage 7.1 Logo
7.1.1 Each powder removal screen should be equipped with a nameplate according to the drawings. The size and requirements of the nameplate should comply with the regulations of CB/T13306. The nameplate should include the following:
a) Name;
b) Model;
c) The connection to the power supply should include the following: Power frequency:
One can be connected Supply voltage or voltage range; power supply category, such as number of phases.
d) Input power;
e) Manufacturer’s name or address:
f) Factory number:
g) Factory date;
h) Use standard numbers.
7.1.2 Transportation packaging markings should comply with CB/T6388 regulations. The content of the packaging mark includes: a) name;
b) model number;
overall dimensions:
e)
d) weight;
e) collection Shipping location and unit:
f) Shipping location and unit.
7.1.3 Packaging, storage and transportation pictorial marks shall comply with CB/T191 regulations. The content of the graphic mark includes: a) center of gravity;
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b) fear of rain:
e) upward.
7.2 Instructions for use
The preparation of instructions for use shall comply with the provisions of CB/T9969.1. 7.2.1
7.2.2
The instruction manual generally contains the following content: product name, manufacturer name, address, postal code and contact number: a) Product standards implemented by
;
b)
c)
d)
JB20035—2004
The main structure, performance, specifications, product use, scope of application, and operation of the product Methods, failure analysis and treatment, precautions, warnings and reminder instructions, safety measures to protect operators and products, installation and use instructions; explanation of labels, logo graphics, symbols, abbreviations, etc.; e) Product maintenance and maintenance methods , special storage method; f)
Installation and usage instructions diagram, mechanical protection diagram. 7.3 Packaging
7.3.1 Packaging should comply with CB/T13384 regulations, and measures should be taken to prevent moisture and rain. The following random documents are included in the packaging box:
7.3.2
a) Product certificate:
b) Packing list;
c) Product instruction manual.
7.4 Storage
After packaging, the powder removal screen should be stored in a dry coal and well-ventilated warehouse. Cover with rain cover when storing and transporting in the open air. 43
2. Transport packaging markings should comply with CB/T6388 regulations. The content of the packaging mark includes: a) name;
b) model number;
overall dimensions:
e)
d) weight;
e) collection Shipping location and unit:
f) Shipping location and unit. bzxZ.net
7.1.3 Packaging, storage and transportation pictorial marks shall comply with CB/T191 regulations. The content of the icon logo includes: a) center of gravity;
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b) fear of rain:
e) upward.
7.2 Instructions for use
The preparation of instructions for use shall comply with the provisions of CB/T9969.1. 7.2.1
7.2.2
The instruction manual generally contains the following content: product name, manufacturer name, address, postal code and contact number: a) Product standards implemented by
;
b)
c)
d)
JB20035—2004
The main structure, performance, specifications, product use, scope of application, and operation of the product Methods, failure analysis and treatment, precautions, warnings and reminder instructions, safety measures to protect operators and products, installation and use instructions; explanation of labels, logo graphics, symbols, abbreviations, etc.; e) Product maintenance and maintenance methods , special storage method; f)
Installation and usage instructions diagram, mechanical protection diagram. 7.3 Packaging
7.3.1 Packaging should comply with CB/T13384 regulations, and measures should be taken to prevent moisture and rain. The following random documents are included in the packaging box:
7.3.2
a) Product certificate:
b) Packing list;
c) Product instruction manual.
7.4 Storage
After packaging, the powder removal screen should be stored in a dry coal and well-ventilated warehouse. Cover with rain cover when storing and transporting in the open air. 43
2. Transport packaging markings should comply with CB/T6388 regulations. The content of the packaging mark includes: a) name;
b) model number;
overall dimensions:
e)
d) weight;
e) collection Shipping location and unit:
f) Shipping location and unit.
7.1.3 Packaging, storage and transportation pictorial marks shall comply with CB/T191 regulations. The content of the icon logo includes: a) center of gravity;
42
b) fear of rain:
e) upward.
7.2 Instructions for use
The preparation of instructions for use shall comply with the provisions of CB/T9969.1. 7.2.1
7.2.2
The instruction manual generally contains the following content: product name, manufacturer name, address, postal code and contact number: a) Product standards implemented by
;
b)
c)
d)
JB20035—2004
The main structure, performance, specifications, product use, scope of application, and operation of the product Methods, failure analysis and treatment, precautions, warnings and reminder instructions, safety measures to protect operators and products, installation and use instructions; explanation of labels, logo graphics, symbols, abbreviations, etc.; e) Product maintenance and maintenance methods , special storage method; f)
Installation and usage instructions diagram, mechanical protection diagram. 7.3 Packaging
7.3.1 Packaging should comply with CB/T13384 regulations, and measures should be taken to prevent moisture and rain. The following random documents are included in the packaging box:
7.3.2
a) Product certificate:
b) Packing list;
c) Product instruction manual.
7.4 Storage
After packaging, the powder removal screen should be stored in a dry coal and well-ventilated warehouse. Cover with rain cover when storing and transporting in the open air. 43
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