JB/T 20137-2011Mechanical stirred-tank bioreactor for animal cell cultivation (English PDF)
机械搅拌式动物细胞培养罐
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Issued by
MIIT
Level / Type
Industry · Recommended
Issue date
May 18, 2011
Implementation date
August 1, 2011
Scope
JB/T 20137-2011 is the English-translated version of 机械搅拌式动物细胞培养罐.
Animal cell culture equipment is the subject of JB/T 20137-2011, a recommended Chinese machinery industry standard for mechanically stirred tanks used to grow animal cells.
It fixes the terminology and definitions, the marking, the requirements, the test methods and the inspection rules, and it covers the signs, the instruction manual, the packaging and the transport and storage of the tanks.
The equipment addressed is used in approved biopharmaceutical production of vaccines, antibodies and recombinant protein drugs, by batch or perfusion culture of animal cells.
The standard carries the Chinese classification C91 and the international classification 11.120.30. Among the documents it cites are GB 150-1998, GB 5226.1-2008, GB/T 19738-2005, JB/T 4711-2003, HG/T 3935-2007, YY/T 0216-1995, TSG R0004-2009 and TSG D0001-2009.
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Document preview — JB/T 20137-2011
National Standard of the People's Republic of China
- ICS
- 11.120.30
Issued by: Ministry of Industry and Information Technology of the People's Republic of China
Contents
- Foreword
- Scope
- Normative references
- About this standard
- Classification and status
1 Foreword
JB/T 20137-2011 was issued by MIIT on 18 May 2011 and has been in force since 1 August 2011.
2 Scope
Animal cell culture equipment is the subject of JB/T 20137-2011, a recommended Chinese machinery industry standard for mechanically stirred tanks used to grow animal cells. It fixes the terminology and definitions, the marking, the requirements, the test methods and the inspection rules, and it covers the signs, the instruction manual, the packaging and the transport and storage of the tanks. The equipment addressed is used in approved biopharmaceutical production of vaccines, antibodies and recombinant protein drugs, by batch or perfusion culture of animal cells. The standard carries the Chinese classification C91 and the international classification 11.120.30. Among the documents it cites are GB 150-1998, GB 5226.1-2008, GB/T 19738-2005, JB/T 4711-2003, HG/T 3935-2007, YY/T 0216-1995, TSG R0004-2009 and TSG D0001-2009.
3 Normative references
JB/T 20137-2011 cites a number of standards, which apply in full or in part through the references made to them in its clauses. Those listed below are the ones the catalogue record shows; the record cuts the list short, so it may not be complete.
GB 150-1998
GB/T 191
GB/T 1226
GB 5226.1-2008
GB/T 6388
GB/T 9969
GB/T 10111
GB/T 12243
GB/T 13306
GB/T 19738 - 2005
JB/T 4711-2003 — Coating and transport packaging of pressure vessels
HG/T 3935-2007 — Mammalian cell culture media
YY/T 0216-1995 — Method for compiling model designations of pharmaceutical machinery products
TSG R0004-2009
TSG D0001-2009
4 About this standard
Issued by: MIIT
English translation: about 15 pages
5 Classification and status
International classification (ICS): 11.120.30
Prefix JB/T: recommended standard.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 191Graphical symbols marking for handling and storage of packages
- GB/T 1226General pressure gauge
- GB/T 6388Transport package shipping mark
- GB/T 9969General principles for preparation of instructions for use of industrial products
- GB/T 10111Generation of random numbers and procedures applied to sampling inspection for product quality
- GB/T 12243Spring loaded safety valves
GB 150-1998 · GB 5226.1-2008 · GB/T 19738 - 2005 · TSG R0004-2009 · TSG D0001-2009
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Related Standards
GB/T 10111-2008 — Generation of random numbers and procedures applied to sampling inspection for product quality
GB/T 12243-2021 — Spring loaded safety valves
GB/T 1226-2017 — General pressure gauge
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