Some standard content:
JB | |Released on 2004-02-05
Implemented on 2004-06-01
Released by the National Development and Reform Commission
ICS11.120.30
C93
JB| |tt||Pharmaceutical Machinery Industry Standard of the People's Republic of China JB20038-2004
Replaces ZB C91 001—1988
Extraction tank
Extractingtank
Released on 2004-02-05| |tt||2004-06-01 Implementation
Release
National Development and Reform Commission
Foreword
1 Scope
2 Normative Reference Documents| |tt||3 Classification and marking
4 Requirements
5 Test methods
6 Inspection rules
7 Marking, packaging, transportation and storage
Item
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JB20038—2004
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JB20038—2004
Foreword
This standard is based on the "Good Manufacturing Practice for Pharmaceuticals" and GB/T1.1-2000, GB/T1.22002 standardization work guide requirements, revision of ZBC91001-1988 "Extraction Tank". This standard replaces ZBC91001-1988 from the date of implementation. Compared with ZBC91001-1988, the main technical content changes of this standard are as follows: a) The main chapters and clauses of ZBC91001-1988 are deleted: product classification (3.2, 3.3);
technical requirements (4.1, 4.4, 4.5, 4.7, 4.9~4.15, 4.17, 4.18);—Test method (5.2.5.3);
Inspection rules (6.3, 6.4).
Revised the main chapters and articles of ZBC91001-1988: b)
Fan Gu (Chapter 1);
Normative reference documents (Chapter 2): ||tt| |Product classification (3.1, 3.4);
Technical requirements (4.2, 4.3, 4.6, 4.8, 4.16, 4.19, 4.20); Test methods (5.1);
Inspection rules (6.1, 6.2) ;
Marking, packaging, transportation, storage (7.1, 7.2). e) Main chapters and clauses added to this standard:
requirements (see 4.2.2, 4.3, 4.4);
test methods (see 5.1.1~5.1.3.5.1.5, 5.2~5.4 ); Inspection rules (see 6.3.2, 6.4);
Marking, packaging, transportation and storage (see 7.1.2, 7.2.1). 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: Wuhan Pharmaceutical Machinery Factory. The main drafter of this standard: Yi Yuying.
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1 Scope
Extraction tank
JB20038—2004
This standard specifies the classification and marking, requirements, test methods, and inspection of extraction tanks Rules and markings, packaging, transportation and storage. This standard is recommended for static and dynamic extraction ends. 2 Normative reference documents
The provisions in the following documents become provisions of this standard by being cited in this standard. For dated referenced documents, all subsequent amendments (excluding corrigenda) or revised versions 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. GB150—1998 Steel Pressure Vessels
GB/T191 Packaging, Storage and Transportation Pictorial Marks
GB3836.1 Electrical Equipment for Explosive Gas Environments Part 1: General Requirements GB/T6060.4 Surface Roughness Comparison Polished surface of the sample block GB/T9969.1 General instructions for use of industrial products GB5226.1-2002 Mechanical safety mechanical and electrical equipment Part 1: General technical conditions GB/T10111 Method of random sampling using random numbers GB/T13306 Label | |tt||GB/T13384 General technical conditions for mechanical and electrical product packaging GB/T16769 Method for measuring noise and sound pressure level of metal cutting machine tools JB/T4711—2003 Pressure vessel coating and transportation packaging YY/T0216 Pharmaceutical machinery model compilation method Pharmacopoeia of the People's Republic of China ( 2000 Edition) National Pharmacopoeia Commission Good Manufacturing Practice for Drugs (1998 Revised Edition) State Food and Drug Administration Pressure Vessel Safety Technical Supervision Regulations (1999 Edition) State Administration of Quality and Technical Supervision 3 Classification and Marking
3.1 Classification|| tt||There are two types of extraction tanks: static type and dynamic type. Extraction tanks are divided into four types according to their shape and structure: straight-dimensional type, oblique cone type, coneless type, and mushroom type. The extraction tank is divided into two types: top-opening type and bottom-opening type according to the slag discharging method. 3.2 Marking
3.2.1 The extraction terminal model shall comply with the provisions of YY/T0216. 25
JB20038—2004
3.2.2 Model preparation
T number
3.2.3 Marking example
Improved design sequence number
Specification code: Each volume (m) is used to express the structural characteristics. Code: Z - positive cone type, D represents the product function code: extraction screen
TDZ3.0 type: represents a dynamic forward cone extraction tank with an equipment volume of 3m. 4 Requirements
4.1 Material requirements
4.1.1 The pressure components to be extracted shall comply with the provisions of 4.1 in GB150-1998, and the materials must have a quality certificate. 4.1.2 All parts and components in contact with drugs should be made of non-toxic, corrosion-resistant materials that do not chemically react with or adsorb materials.
4.1.3 The materials used to extract the seals of Echigami should comply with the provisions of Article 32 of the "Good Manufacturing Practice for Pharmaceutical Products" (1998 revised edition).
4.1.4 The outer surface of the extraction tank should be flat and smooth, with the same color of the plating (coating) layer, and should comply with the relevant regulations of JB/T4711. 4.1.5 The surface roughness Ra value of the material in contact with the extraction tank and the material should not be greater than 0.8m. The surface should be flat, smooth, without dead corners, easy to clean, and in compliance with the "Good Manufacturing Practice for Pharmaceuticals" (1998 revised edition), which does not allow material gaps. Requirements for cross-contamination. 4.2 Performance requirements
4.2.1 The locking mechanism of the feeding door and slag discharge door should be easy to operate and flexible. When closing the feeding door and slag discharge door, the mechanism should be able to lock in place and the joint surface should be close. Combined.
4.2.2 The extraction tank should operate smoothly, the transmission system should have no abnormal noise, and the noise level should not exceed 75dB(A) during no-load operation.
4.3.1 Electrical system. The continuity of the protective grounding circuit shall comply with the provisions of 19.2 of GB5226.1-2002. 4.3.2 The insulation resistance of the electrical system shall comply with the provisions of 19.3 of CB5226.1-2002. 4.3.3 The withstand voltage of the electrical system shall comply with GB5226.1. --The provisions of 19.4 of 2002. 4.3.4 The protective grounding circuit of the electrical system shall comply with the provisions of 8.2 of GB5226.1-2002. 4.3.5 The buttons of the electrical system shall comply with the provisions of 10.3 of GB5226.1-2002. 6 The indicators and displays of the electrical system shall comply with the provisions of 10.3 of GB5226.1-2002. 4.3.7 The wiring of the electrical system shall comply with the provisions of Chapter 14 of GB5226.1-2002. Marking and marking of the electrical system. Warning signs and project codes should comply with the provisions of Chapter 17 of B5226.1-2002. 4.3.9 The explosion-proof electrical device of the extraction tank should comply with the requirements of the corresponding explosion-proof level of the category and level of explosive hazardous locations, and the electrical performance should comply with GB3836. 1. 4.4 Safety requirements
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4.4.1 The sealing of the feeding door and the discharge door should be safe and reliable JB20038-2004
4.4.2. The feeding door and discharge door where the working pressure in the extraction tank exceeds 0.1MPa should have safety interlocking devices. Their devices should comply with the provisions of Article 49 of the "Safety Technical Supervision Regulations for Pressure Vessels" (1999 edition), and shall be tested and tested by technology. identification. 4.4.3 A pressure gauge and safety valve should be installed on the extraction tank and at the entrance of the jacket, and should comply with the provisions of Chapter 7 of the "Safety Technical Supervision Regulations for Pressure Vessels" (1999 Edition).
5 Test methods
5.1 Tests required for materials
Visually inspect the material certificate of the material used for the pressure components of the extraction tank. 5.1.1
Visually inspect the materials used in the extraction tank.
5.1.2
5.1.3 Visually inspect the material of the seal used on the extraction tank. 5.1.4 Check the appearance of the extraction pavement according to the test method specified in Chapter 3 of JB/T4711-2003. 5.1.5 Use the comparison sample block to check the surface roughness of the extraction chain according to the method specified in GB/T6060.4. 5.2 Test of performance requirements
5.2.1 Visually inspect the locking device of the extraction tank feeding door and slag discharge door. 5.2.2 Use a sound level meter to test the no-load noise of the extraction tank according to the method specified in GB/T16769. 5.3 Tests for safety requirements of electrical systems
5.3.1 The continuity, insulation resistance, and withstand voltage tests of the protective grounding circuit of the electrical system shall be inspected according to the methods specified in 19.2, 19.3, and 19.4 of CB5226.12002 respectively. 5.3.2 The protective grounding circuit, buttons, indicators and displays, wiring, markings, warning signs and project codes of the electrical system shall be carried out according to the methods specified in 8.2, 10.2, 10.3, Chapter 14 and Chapter 17 of GB5226.12002 respectively. examine. 5.3.3 The explosion-proof electrical device of the extraction tank shall be inspected according to the method specified in CB3836.1. 5.4 Test of safety requirements
5.4.1 Check the sealing device of the extraction tank feeding door and slag discharge door. 5.4.2 Check the safety interlock device of the extraction tank. 5.4.3 Visually inspect the extraction tank pressure gauge and safety valve. 6 Inspection Rules
6.1 Each extraction tank must be inspected by the quality inspection department of the manufacturing unit in accordance with the factory inspection regulations and the local pressure vessel equipment safety supervision agency before it can leave the factory.
6.2 Extraction end inspection includes factory inspection and type inspection. 6.3 Factory inspection
6.3.1 Factory inspection shall be carried out one by one according to the provisions of Table 1. If the product is qualified, the product certificate shall be attached. 27
JB20038—2004
Project Category
General Performance
Main Performance
Appearance
6.3.2 Judgment Rules||tt| |Table 1 Factory inspection items
Inspection items
4.1.4,4.1.5
4.1.1,4.1.2,4.1.3,4.3,4.4
4.2
If any unqualified items are found during the factory inspection, they are allowed to be returned for repair and re-inspection. If the items are still unqualified, the product will be judged as a substandard product.
6.4 Type inspection
6.4.1 When one of the following situations occurs, type inspection shall be carried out when the product trial production is completed or when the product is transferred to the factory for production:
a
b) formal production Later, when there are major changes in structure, materials, and processes; c) When the product resumes production after 2 years of suspension; d) When the national quality supervision and management agency proposes a requirement for type inspection. 6.4.2 Sampling
The prototypes for type inspection shall be selected from 10% of the products that have passed the factory inspection according to the method specified in GB/T10111, and one unit shall be tested. 6.4.3 Judgment rules
If any one of the continuity, insulation resistance and withstand voltage of the protective grounding circuit of the electrical safety performance fails during the type inspection, the product will be judged to have failed the type inspection. If other items are unqualified, the unqualified items should be retested twice. If they are still unqualified, the product will be judged to have failed the type inspection.
7 Marking, packaging, transportation and storage
7.1 Marking
7.1.1 The label of each extraction tank should be fixed according to the position specified on the drawing. The label should comply with GB/T13306 and (Pressure vessel product nameplates and registration nameplates). The nameplate includes the following: a) Product name and model:
b)
Main technical parameters;
product Serial number and manufacturing date;
e
d) Product weight;
e)
Manufacturer name:
Registered trademark;||tt| |f
g)
Container category;
Supervisory inspection mark;
h)
Pressure vessel manufacturing license number:
i)
Product standard number.
7.1.2 The mark on the packaging box should comply with the regulations of GB/T191 and have the following content: 28
a)
Product model and name:
发Shipping unit and shipping station name:
b)
c) Receiving unit and shipping station name;
d) Shipping date;
e) Gross weight , Dimensions:
f) Storage and transportation symbols should indicate "Afraid of rain", "No rolling", "Lifted here." 7.2 Packaging
JB 20038—2004
The packaging of the extraction tank should comply with the regulations of GB/T13384 and JB/T4711. The movable parts and the packaging box should be securely packed. 7.2.1
7.2.2
The following technology should be included in the packaging box. Documents: a) Product certificate;
Product completion drawing:
b)
c
Instructions for use:
d) Packing list;
e) Calibration certificates for instruments, meters, etc. specified in this standard. Product instructions shall comply with the provisions of GB/T9969.1. 7.3 Transportation
shall be firmly attached to the transportation vehicle during transportation. , rolling and collision are strictly prohibited, and comply with the provisions of JB/T4711. 7.4 Storage
After packaging, the extraction tank should be stored in a place with a relative humidity of no more than 85%, good ventilation, and no corrosive gases 29
1. Factory inspection shall be carried out one by one according to the provisions of Table 1. If the products are qualified, the product certificate shall be attached. 27
JB20038—2004
Project Category
General Performance
Main Performance
Appearance
6.3.2 Judgment Rules||tt| |Table 1 Factory inspection items
Inspection items
4.1.4,4.1.5
4.1.1,4.1.2,4.1.3,4.3,4.4
4.2
If any unqualified items are found during the factory inspection, they are allowed to be returned for repair and re-inspection. If the items are still unqualified, the product will be judged as a substandard product.
6.4 Type inspection
6.4.1 When one of the following situations occurs, type inspection shall be carried out when the product trial production is completed or when the product is transferred to the factory for production:
a
b) formal production Later, when there are major changes in structure, materials, and processes; c) When the product resumes production after 2 years of suspension; d) When the national quality supervision and management agency proposes a requirement for type inspection. 6.4.2 Sampling
The prototypes for type inspection shall be selected from 10% of the products that have passed the factory inspection according to the method specified in GB/T10111, and one unit shall be tested. 6.4.3 Judgment rules
If any of the continuity of the protective grounding circuit, insulation resistance, and withstand voltage of the electrical safety performance fails during the type inspection, the product will be judged to have failed the type inspection. If other items are unqualified, the unqualified items should be retested twice. If they are still unqualified, the product will be judged to have failed the type inspection.
7 Marking, packaging, transportation and destocking
7.1 Marking
7.1.1 The label of each extraction tank shall be fixed according to the position specified on the drawing. The label shall comply with GB/T13306 and (Pressure vessel product nameplates and registration nameplates). The nameplate includes the following: a) Product name and model:
b)
Main technical parameters;
product Serial number and manufacturing date;
e
d) Product weight;
e)
Manufacturer name:
Registered trademark;||tt| |f
g)
Container category;
Supervisory inspection mark;
h)
Pressure vessel manufacturing license number: bzxz.net
i)
Product standard number.
7.1.2 The mark on the packaging box should comply with the regulations of GB/T191 and have the following content: 28
a)
Product model and name:
发Shipping unit and shipping station name:
b)
c) Receiving unit and shipping station name;
d) Shipping date;
e) Gross weight , Dimensions:
f) Storage and transportation symbols should indicate "Afraid of rain", "No rolling", "Lifted here." 7.2 Packaging
JB 20038—2004
The packaging of the extraction tank should comply with the regulations of GB/T13384 and JB/T4711. The movable parts and the packaging box should be securely packed. 7.2.1
7.2.2
The following technology should be included in the packaging box. Documents: a) Product certificate;
Product completion drawing:
b)
c
Instructions for use:
d) Packing list;
e) Calibration certificates for instruments, meters, etc. specified in this standard. Product instructions shall comply with the provisions of GB/T9969.1. 7.3 Transportation
shall be firmly attached to the transportation vehicle during transportation. , rolling and collision are strictly prohibited, and comply with the provisions of JB/T4711. 7.4 Storage
After packaging, the extraction tank should be stored in a place with a relative humidity of no more than 85%, good ventilation, and no corrosive gases 29
1 Factory inspection shall be carried out according to the provisions of Table 1. The qualified ones shall be accompanied by product certificates. 27
JB20038—2004
Item category
General performance
Main performance
Appearance
6.3.2 Judgment rules
Table 1 Factory inspection items
Inspection items
4.1.4,4.1.5
4.1.1,4.1.2,4.1.3,4.3,4.4
4.2
If any unqualified items are found in the factory inspection, they are allowed to be returned for repair and re-inspection. If they are still unqualified, the product shall be judged as unqualified.
6.4 Type inspection
6.4.1 Type inspection shall be conducted when any of the following situations occurs: a) When the product is completed in trial production or when it is transferred to another factory for production: b) After formal production, when there are major changes in structure, materials, and processes; c) When the product is resumed after being discontinued for 2 years; d) When the national quality supervision and management agency proposes a requirement for type inspection. 6.4.2 Sampling
The type inspection samples shall be selected from the qualified products of the factory inspection according to the method specified in GB/T10111, and one-unit shall be tested. 6.4.3 Judgment rules
If one of the continuity, insulation resistance, and withstand voltage of the protective grounding circuit of the electrical safety performance fails in the type inspection, the product shall be judged to have failed the type inspection. If other items fail, the unqualified items shall be doubled and retested. If they still fail, the product shall be judged to have failed the type inspection.
7 Marking, packaging, transportation and storage
7.1 Marking
7.1.1 The label of each extraction tank shall be fixed at the position specified on the drawing. The label shall comply with the provisions of GB/T13306 and "Nameplate and Registration Nameplate of Pressure Vessel Products". The label shall include the following contents: a) Product name and model:
b)
Main technical parameters;
Product number and manufacturing date;
e
d) Product weight;
e)
Manufacturer name:
Registered trademark;
f
g)
Container category;
Supervisory inspection mark;
h)
Pressure vessel manufacturing license number:
i)
Product standard number.
7.1.2 The markings on the packaging box shall comply with the provisions of GB/T191 and have the following contents:28
a)
Product model and name:
Shipping unit and shipping station name:
b)
c) Receiving unit and receiving station name;
d) Shipping date;
e) Gross weight and dimensions:
f) Storage and transportation symbols should indicate "Avoid rain", "No rolling", "Lift from here".7.2 Packaging
JB 20038—2004
The packaging of the extraction tank shall comply with the provisions of GB/T13384 and JB/T4711. The movable parts shall be firmly fixed to the packaging box during packaging. 7.2.1
7.2.2
The following technical documents shall be attached to the packaging box: a) Product certificate;
Product construction drawing:
b)
c
Instruction manual:
d) Packing list ;
e) Calibration certificates of instruments and meters specified in this standard. The product manual shall comply with the provisions of GB/T9969.1. 7.3 Transportation
During transportation, it should be firmly placed on the transport vehicle, and rolling and collision are strictly prohibited. It shall comply with the provisions of JB/T4711. 7.4 Storage
After packaging, the extraction tank should be stored in a place with a relative humidity not exceeding 85%, good ventilation and no corrosive gas. 29
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