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JB/T 20064-2019: Pulse dropping type soft capsule machine
Status: Valid JB/T 20064: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| JB/T 20064-2019 | English | 169 |
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Pulse dropping type soft capsule machine
| Valid |
JB/T 20064-2019
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| JB/T 20064-2005 | English | 439 |
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3 days [Need to translate]
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Pulse dropping type soft capsule machine
| Obsolete |
JB/T 20064-2005
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PDF similar to JB/T 20064-2019
Basic data | Standard ID | JB/T 20064-2019 (JB/T20064-2019) | | Description (Translated English) | Pulse dropping type soft capsule machine | | Sector / Industry | Mechanical & Machinery Industry Standard (Recommended) | | Classification of Chinese Standard | C92 | | Classification of International Standard | 11.120.30 | | Word Count Estimation | 7,799 | | Date of Issue | 2019-08-02 | | Date of Implementation | 2020-01-01 | | Older Standard (superseded by this standard) | JB/T 20064-2005 | | Quoted Standard | GB/T 191; GB/T 3768-2017; GB/T 6388; GB/T 9969; GB/T 10111; GB/T 13306; GB/T 13384; GB/T 24342-2009; GB/T 36035-2018; JB/T 20188-2017 | | Regulation (derived from) | Natural Resources Department Announcement No. 7 of 2019 | | Issuing agency(ies) | Ministry of Industry and Information Technology | | Summary | This standard specifies the terms and definitions, markings, requirements, test methods, inspection rules and markings, instructions for use, packaging, transportation and storage requirements of the pulse cutting drop system soft gel pill machine. This standard is applicable to the pulse-cutting and dropping system soft capsule machine (hereinafter referred to as the capsule machine) where the containment is non-hydrophilic liquid medicine. | JB/T 20064-2019: Pulse dropping type soft capsule machine---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Pulse dropping type soft capsule machine
ICS 11.120.30
C92
Record number. 78289-2020
People's Republic of China Machinery Industry Standard
Replace JB/T 20064-2005
Pulse cutting and dropping system soft gel pill machine
2019-08-02 released
2020-01-01 Implementation
Issued by the Ministry of Industry and Information Technology of the People's Republic of China
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces JB/T 20064-2005 "Pulse Cutting and Dropping System Soft Pill Machine".
Compared with JB/T 20064-2005, the main technical content changes of this standard are as follows.
---Revised the normative reference documents and related content cited in accordance with the current standards;
--- Modified the mark (see 4.1, 4.2, 4.1, 4.2 of the.2005 edition);
---Modified the material requirements (see 5.1, 5.1.1 of the.2005 edition);
---Modified the appearance requirements (see 5.2.1, 5.2.2, 5.1.2 of the.2005 edition);
---Modified the electrical safety requirements (see 5.4, 5.3.1~5.3.9 of the.2005 edition);
---Modified the quality requirements of capsules (see 5.5, 5.2.5 and 5.2.6 of the.2005 edition);
---Modified the material test (see 6.1, 6.1.1 of the.2005 edition);
---Modified the appearance test (see 6.2.1, 6.2.2, 6.1.2 of the.2005 edition);
---Modified the electrical safety experiment (see 6.4, 6.3.1, 6.3.2 of the.2005 edition);
---Modified the quality test of capsules (see 6.5, 6.2.6, 6.2.7 of the.2005 edition);
--- Modified the factory inspection (see 7.2.1, 7.2.1 of the.2005 edition);
---Modified the type inspection (see 7.3.1, 7.3.3, 7.3.4, 7.3.1, 7.3.2, 7.3.3 of the.2005 edition);
---Added type inspection items (see 7.3.2);
---Increase the transportation and delivery signs (see 8.1.3).
This standard was proposed by the China Pharmaceutical Equipment Industry Association.
This standard is under the jurisdiction of the National Pharmaceutical Equipment Standardization Technical Committee (SAC/TC356).
This standard was drafted. Yantai Baiyaotai Chinese Medicine Technology Co., Ltd., Beijing Changzheng Tianmin High-Tech Co., Ltd.
The main drafters of this standard. Zhang Kejin, Tian Xiujiang, Wang Xiaohua, Zhang Mi Mi, Dong Mei, Chen Bin.
The previous versions of the standard replaced by this standard are as follows.
---JB/T 20064-2005.
Pulse cutting and dropping system soft gel pill machine
1 Scope
This standard specifies the terms and definitions, markings, requirements, test methods, inspection rules and signs, and use of the pulse cutting drop system soft gel pill machine.
Instructions for use, packaging, transportation and storage requirements.
This standard is applicable to the pulse-cutting and dropping system soft capsule machine (hereinafter referred to as the capsule machine) where the containment is non-hydrophilic liquid medicine.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document.
GB/T 191 Packaging, storage and transportation pictorial signs
GB/T 3768-2017 Acoustic sound pressure method is used to determine the sound power level and sound energy level of noise sources using the envelope measurement surface above the reflecting surface
Simple method
GB/T 6388 Transport packaging receiving and dispatching signs
GB/T 9969 General Rules for the Use of Industrial Products
The generation of GB/T 10111 random number and its application in product quality sampling inspection
GB/T 13306 signs
GB/T 13384 General technical conditions for packaging of mechanical and electrical products
GB/T 24342-2009 Specification for Continuity Test of Protective Grounding Circuit of Industrial Machinery and Electrical Equipment
GB/T 36035-2018 General requirements for electrical safety of pharmaceutical machinery
JB/T 20188-2017 Pharmaceutical machinery product model compilation method
The Pharmacopoeia of the People's Republic of China (2015 Edition) Four
3 Terms and definitions
The following terms and definitions apply to this standard
3.1
Medicine pump
A device that quantitatively transports the liquid medicine to the feeding pipeline.
3.2
Inclusion filmaterial
The substance encapsulated in the capsule shell.
3.3
Unqualified capsule
Soft gel pellets that are bonded, deformed, cracked, contain bubbles, or have a difference in content exceeding the specified value.
3.4
Dripper group droppersets
It can produce replaceable components with different loadings of soft gel pellets.
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