|
US$329.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
JB/T 20079-2021: Liquid filling and stoppering machine for antibiotic vial
Status: Valid JB/T 20079: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| JB/T 20079-2021 | English | 329 |
Add to Cart
|
3 days [Need to translate]
|
Liquid filling and stoppering machine for antibiotic vial
| Valid |
JB/T 20079-2021
|
| JB/T 20079-2006 | English | 479 |
Add to Cart
|
3 days [Need to translate]
|
Liquid filling and stoppering machine for antibiotic vial
| Obsolete |
JB/T 20079-2006
|
PDF similar to JB/T 20079-2021
Basic data | Standard ID | JB/T 20079-2021 (JB/T20079-2021) | | Description (Translated English) | Liquid filling and stoppering machine for antibiotic vial | | Sector / Industry | Mechanical & Machinery Industry Standard (Recommended) | | Classification of Chinese Standard | C92 | | Word Count Estimation | 14,124 | | Issuing agency(ies) | Ministry of Industry and Information Technology | JB/T 20079-2021: Liquid filling and stoppering machine for antibiotic vial---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.
Liquid filling and stoppering machine for antibiotic vial
ICS 11:120:30
CCSC92
Record number: 84143-2021
People's Republic of China Pharmaceutical Machinery Industry Standard
Replacing JB/T 20079-2006
Antibiotic bottle liquid filling and stopper machine
Published on 2021-05-17
2021-10-01 Implementation
Published by the Ministry of Industry and Information Technology of the People's Republic of China
directory
Preface III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Classification and model 1
5 Requirements 2
6 Test method 4
7 Inspection Rules 7
8 Logo, instruction manual, packaging, transportation and storage 7
foreword
This document is in accordance with the provisions of GB/T 1:1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents"
drafted:
This document replaces JB/T 20079-2006 "Antibiotic bottle liquid filling and corking machine", compared with JB/T 20079-2006, except for structural adjustment
In addition to the adjustment and editorial changes, the main technical changes are as follows:
--- Modified the model (see 4:2, 3:2 of the:2006 edition);
--- Deleted working conditions (see 4:3 of the:2006 edition);
--- Deleted the requirements for the certification of instruments and meters (see 4:4:5 of the:2006 edition);
--- Deleted the fault alarm shutdown (see 4:4:10:4 of the:2006 edition);
--- Deleted the requirement for adjusting the handle (see 4:4:10:3 of the:2006 edition);
--- Modify the filling volume error requirements and test methods (see 5:3:1:3, 6:1:2:3, 4:4:1:3, 5:4:1:3 of the:2006 edition);
--- Modified the requirements for the pass rate of tampons (see 5:3:2:3, 4:4:2:3 of the:2006 edition);
--- Revised the requirements for the breakage rate of bottles (see 5:3:3, 4:4:3 of the:2006 edition);
--- Added jog function requirements and test methods (see 5:3:7, 6:1:6);
--- Modify the level 3 login authority requirements and test methods (see 5:3:9, 6:1:8, 4:4:9, 5:4:9 of the:2006 edition);
--- Modified the interlocking control requirements and test methods (see 5:3:10:1, 6:1:10:1, 4:4:10:1, 5:4:10:1 of the:2006 edition);
--- Added automatic sampling requirements and test methods (see 5:3:10:3, 6:1:10:3);
--- Added automatic rejection requirements and test methods (see 5:3:10:4, 6:1:10:4);
--- Increased the requirements and test methods for counting and production capacity (see 5:3:10:5, 6:1:10:5);
--- Increased the requirements and test methods for residual oxygen (see 5:3:10:6, 6:1:10:6);
--- Increased the requirements and test methods for operation in isolators (see 5:3:10:7);
--- Increased the requirements and test methods for operation under the air shower device (see 5:3:10:8);
--- Increased the requirements and test methods for unobstructed objects (see 5:3:10:9):
Please note that some content of this document may be patented: The issuing agency of this document assumes no responsibility for identifying patents:
This document is proposed by China Pharmaceutical Equipment Industry Association:
This document is under the jurisdiction of the National Standardization Technical Committee of Pharmaceutical Equipment (SAC/TC356):
This document is drafted by: Chutian Technology Co:, Ltd:
The main drafters of this document: Zhang Jiaowu, Liu Zhi, Li Xinhua, Yi Bo:
This document was first published in:2006 and this is the first revision:
Antibiotic bottle liquid filling and stopper machine
1 Scope
This document specifies the classification and model, requirements, test methods, inspection rules and signs, and instructions for use of antibiotic bottle liquid filling and corking machines
Books, packaging, transportation and storage:
This document is applicable to the antibiotic bottle liquid filling and corking machine (hereinafter referred to as the filling and corking machine) for antibiotic liquid injection or freeze-dried powder injection:
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text: Among them, dated citations
documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to
this document:
GB/T 191 Graphical signs of packaging, storage and transportation
GB/Z 2640 Molded injection bottle
GB/T 3768 Acoustic sound pressure method to determine the sound power level and sound energy level of noise sources
easy law
GB/T 6388 Receipt and Delivery Marks for Transport Packaging
GB/T 9969 General Principles of Instruction Manual for Industrial Products
GB/T 10111 Generation of random numbers 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 16292-2010 Test method for suspended particles in clean room (area) of pharmaceutical industry
GB/T 36035 General Requirements for Electrical Safety of Pharmaceutical Machinery
JB/T 20175-2017 Aseptic isolator
JB/T 20188-2017 Preparation method of pharmaceutical machinery product model
YY0169:2 Butyl rubber antibiotic stopper
Pharmacopoeia of the People's Republic of China (No: 78 [2020] of the National Health Commission of the State Food and Drug Administration)
3 Terms and Definitions
There are no terms and definitions that need to be defined in this document:
4 Classification and model
4:1 Classification
4:1:1 Filling and corking machines are divided into intermittent and continuous types according to the bottle conveying structure:
4:1:2 The filling and plugging machine is divided into linear type and rotary type according to the operation mode:
4:2 Model
Prepared in accordance with the provisions of JB/T 20188-2017 as follows:
Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of JB/T 20079-2021_English be delivered?Answer: Upon your order, we will start to translate JB/T 20079-2021_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time. Question 2: Can I share the purchased PDF of JB/T 20079-2021_English with my colleagues?Answer: Yes. The purchased PDF of JB/T 20079-2021_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet. Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. If you need your currency to be printed on the invoice, please write an email to [email protected]. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay. Question 5: Should I purchase the latest version JB/T 20079-2021?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version JB/T 20079-2021 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.
|