1
/
su
8
PayPal, credit cards. Download editable-PDF and invoice in 1 second!
GB/T 42398-2023 English PDF (GBT42398-2023)
GB/T 42398-2023 English PDF (GBT42398-2023)
Prezzo di listino
$260.00 USD
Prezzo di listino
Prezzo scontato
$260.00 USD
Prezzo unitario
/
per
Spese di spedizione calcolate al check-out.
Impossibile caricare la disponibilità di ritiro
Delivery: 3 seconds. Download true-PDF + Invoice.
Get QUOTATION in 1-minute: Click GB/T 42398-2023
Historical versions: GB/T 42398-2023
Preview True-PDF (Reload/Scroll if blank)
GB/T 42398-2023: Technical specifications of cleanroom design for cell culture
GB/T 42398-2023
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 13.040.35
CCS C 70
Technical specifications of cleanroom design for cell culture
ISSUED ON: MARCH 17, 2023
IMPLEMENTED ON: OCTOBER 01, 2023
Issued by: State Administration for Market Regulation;
Standardization Administration of the People's Republic of China.
Table of Contents
Foreword ... 3
Introduction ... 5
1 Scope ... 6
2 Normative references ... 6
3 Terms and definitions ... 6
4 Requirements ... 8
Bibliography ... 18
Technical specifications of cleanroom design for cell culture
1 Scope
This document specifies the general requirements for cleanroom design for cell culture,
ventilation and purification, enclosure structure, electrical and information technology,
water supply and drainage, gas pipelines, and safety requirements.
This document applies to cleanroom design for cell culture for human use. Other cell
culture cleanrooms refer to this document.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
GB 5749, Sanitary standard for drinking water
GB 17945, Fire Emergency Luminaries
GB/T 29469, Cleanrooms and associated controlled environments - Evaluation of
performance and rationality
GB/T 36372, Cleanrooms and associated controlled environments - General
technical requirements of combined envelope structure
GB 50016, Code of Design on Building Fire Protection and Prevention
GB 50457, Code for design of pharmaceutical industry cleanroom
GB 50472, Code for design of electronic industry cleanroom
GB 50591, Code for Construction and Acceptance of Cleanroom
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 cell culture
A process of growing, expanding, and maintaining the biological properties of extracted
cells.
4 Requirements
4.1 General requirements
4.1.1 The design of site selection, ventilation and purification, envelope structure,
electrical and information technology, water supply and drainage, gas pipelines, safety
and other aspects shall be carried out in combination with the cell culture process and
environmental requirements.
4.1.2 An area with less vibration, electromagnetic radiation, and noise shall be selected.
When the area of a new cleanroom is greater than or equal to 3000 m2, while meeting
the above requirements, the building where it is located shall be selected in an area with
good natural environment and low gas pollution.
4.1.3 When the area of a newly built, renovated or expanded cleanroom is greater than
or equal to 3000 m2, the design of the cleanroom shall be closely connected with the
overall design of the building where it is located. After negotiating with the user to
determine the process requirements and cleanroom location, the design will be
prioritized based on consultation with the overall design. Propose requirements for
building structure, power, HVAC, water supply and drainage, electrical and other
aspects to the overall design.
4.1.4 Full consideration shall be given to preparation process flow, equipment
configuration, safety and reliability of equipment and facilities, various interfaces, flow
of people, logistics, storage of items (necessary) in-situ inactivation and disinfection of
hazardous waste products, construction and installation, equipment installation,
inspection and maintenance and other related requirements.
4.1.5 The cleanliness and other relevant requirements of each area shall comply with
4.2.
4.1.6 The purpose shall be to protect personal safety. Consider a plan to evacuate
cleanroom staff as soon as possible in an emergency and minimize damage to the
cleanroom and support areas.
4.1.7 On the basis of meeting the process requirements and operating cycle, it shall
focus on saving energy, protecting the environment, and being economically reasonable.
4.1.8 When the cleanroom area is greater than or equal to 2000 m2, the design evaluation
shall be carried out in accordance with the requirements of GB/T 29469. If the area is
less than 2000 m2, it can choose whether to conduct design evaluation.
4.1.9 For cleanrooms containing cell cultures carrying infectious agents, a biosafety
plan shall be developed based on risk assessment. Ensure that its production and
operation process does not cause pollution or harm to personnel and the environment.
Avoid cross contamination.
humidity loads of various equipment within the system need to be considered at the
same time).
NOTE: Pay attention to extreme climates, especially the demand for cold and heat sources with
sustained extreme temperatures and humidity.
4.3.1.3 The division of purification air-conditioning systems shall be determined after
technical and economic comparison based on process requirements, floor plan,
biological safety, etc. Take effective measures to avoid contamination and cross-
contamination. Meet the following requirements:
a) The air conditioning system shall be set up separately from areas without
cleanliness requirements.
b) Production units with different process requirements shall be equipped with
separate purification and air-conditioning systems.
c) Functional areas with different operating shifts or usage times shall be equipped
with separate purification and air-conditioning systems.
d) In areas with large differences in indoor heat and moisture load characteristics,
separate purification air conditioning systems shall be installed.
4.3.1.4 When there are ventilation equipment such as biological safety cabinets and
local exhaust devices in the cleanroom, measures shall be taken to maintain indoor
pressure stability during the opening, closing and operation of the equipment.
4.3.1.5 It must be conducive to cleanroom disinfection, sterilization, automatic control
and energy-saving operation. Comply with the following regulations:
a) Positive pressure cleanrooms shall use circulating air conditioning systems.
b) When toxic, harmful, or combustible gases are involved (excluding cell culture
areas carrying infectious agents), a partial or overall full exhaust system shall be
adopted based on risk assessment.
c) Measures shall be taken to dilute and replace room gas after disinfection and
sterilization.
4.3.1.6 The design of the cleanroom exhaust system meets the following requirements:
a) The exhaust systems of different purification air-conditioning systems shall be set
up independently.
b) When harmful substances, odors, large amounts of heat, moisture or volatile gases
are produced, a separate exhaust system shall be set up.
c) Measures shall be taken to prevent the infiltration of outdoor gas.
d) For exhaust systems containing water vapor and condensable substances, a slope
shall be set. Set up a discharge port at the local lowest point of the pipeline.
4.3.1.7 For air conditioning systems that use circulating air, a primary (medium)
efficiency air filter shall be installed at the return air outlet of the cleanroom as
appropriate.
4.3.1.8 The opening and closing of the supply air, return air and exhaust air of the
purification air conditioning system shall be interlocked and comply with the following
regulations:
a) The chain procedure of the positive pressure cleanroom is to s...
Get QUOTATION in 1-minute: Click GB/T 42398-2023
Historical versions: GB/T 42398-2023
Preview True-PDF (Reload/Scroll if blank)
GB/T 42398-2023: Technical specifications of cleanroom design for cell culture
GB/T 42398-2023
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 13.040.35
CCS C 70
Technical specifications of cleanroom design for cell culture
ISSUED ON: MARCH 17, 2023
IMPLEMENTED ON: OCTOBER 01, 2023
Issued by: State Administration for Market Regulation;
Standardization Administration of the People's Republic of China.
Table of Contents
Foreword ... 3
Introduction ... 5
1 Scope ... 6
2 Normative references ... 6
3 Terms and definitions ... 6
4 Requirements ... 8
Bibliography ... 18
Technical specifications of cleanroom design for cell culture
1 Scope
This document specifies the general requirements for cleanroom design for cell culture,
ventilation and purification, enclosure structure, electrical and information technology,
water supply and drainage, gas pipelines, and safety requirements.
This document applies to cleanroom design for cell culture for human use. Other cell
culture cleanrooms refer to this document.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
GB 5749, Sanitary standard for drinking water
GB 17945, Fire Emergency Luminaries
GB/T 29469, Cleanrooms and associated controlled environments - Evaluation of
performance and rationality
GB/T 36372, Cleanrooms and associated controlled environments - General
technical requirements of combined envelope structure
GB 50016, Code of Design on Building Fire Protection and Prevention
GB 50457, Code for design of pharmaceutical industry cleanroom
GB 50472, Code for design of electronic industry cleanroom
GB 50591, Code for Construction and Acceptance of Cleanroom
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 cell culture
A process of growing, expanding, and maintaining the biological properties of extracted
cells.
4 Requirements
4.1 General requirements
4.1.1 The design of site selection, ventilation and purification, envelope structure,
electrical and information technology, water supply and drainage, gas pipelines, safety
and other aspects shall be carried out in combination with the cell culture process and
environmental requirements.
4.1.2 An area with less vibration, electromagnetic radiation, and noise shall be selected.
When the area of a new cleanroom is greater than or equal to 3000 m2, while meeting
the above requirements, the building where it is located shall be selected in an area with
good natural environment and low gas pollution.
4.1.3 When the area of a newly built, renovated or expanded cleanroom is greater than
or equal to 3000 m2, the design of the cleanroom shall be closely connected with the
overall design of the building where it is located. After negotiating with the user to
determine the process requirements and cleanroom location, the design will be
prioritized based on consultation with the overall design. Propose requirements for
building structure, power, HVAC, water supply and drainage, electrical and other
aspects to the overall design.
4.1.4 Full consideration shall be given to preparation process flow, equipment
configuration, safety and reliability of equipment and facilities, various interfaces, flow
of people, logistics, storage of items (necessary) in-situ inactivation and disinfection of
hazardous waste products, construction and installation, equipment installation,
inspection and maintenance and other related requirements.
4.1.5 The cleanliness and other relevant requirements of each area shall comply with
4.2.
4.1.6 The purpose shall be to protect personal safety. Consider a plan to evacuate
cleanroom staff as soon as possible in an emergency and minimize damage to the
cleanroom and support areas.
4.1.7 On the basis of meeting the process requirements and operating cycle, it shall
focus on saving energy, protecting the environment, and being economically reasonable.
4.1.8 When the cleanroom area is greater than or equal to 2000 m2, the design evaluation
shall be carried out in accordance with the requirements of GB/T 29469. If the area is
less than 2000 m2, it can choose whether to conduct design evaluation.
4.1.9 For cleanrooms containing cell cultures carrying infectious agents, a biosafety
plan shall be developed based on risk assessment. Ensure that its production and
operation process does not cause pollution or harm to personnel and the environment.
Avoid cross contamination.
humidity loads of various equipment within the system need to be considered at the
same time).
NOTE: Pay attention to extreme climates, especially the demand for cold and heat sources with
sustained extreme temperatures and humidity.
4.3.1.3 The division of purification air-conditioning systems shall be determined after
technical and economic comparison based on process requirements, floor plan,
biological safety, etc. Take effective measures to avoid contamination and cross-
contamination. Meet the following requirements:
a) The air conditioning system shall be set up separately from areas without
cleanliness requirements.
b) Production units with different process requirements shall be equipped with
separate purification and air-conditioning systems.
c) Functional areas with different operating shifts or usage times shall be equipped
with separate purification and air-conditioning systems.
d) In areas with large differences in indoor heat and moisture load characteristics,
separate purification air conditioning systems shall be installed.
4.3.1.4 When there are ventilation equipment such as biological safety cabinets and
local exhaust devices in the cleanroom, measures shall be taken to maintain indoor
pressure stability during the opening, closing and operation of the equipment.
4.3.1.5 It must be conducive to cleanroom disinfection, sterilization, automatic control
and energy-saving operation. Comply with the following regulations:
a) Positive pressure cleanrooms shall use circulating air conditioning systems.
b) When toxic, harmful, or combustible gases are involved (excluding cell culture
areas carrying infectious agents), a partial or overall full exhaust system shall be
adopted based on risk assessment.
c) Measures shall be taken to dilute and replace room gas after disinfection and
sterilization.
4.3.1.6 The design of the cleanroom exhaust system meets the following requirements:
a) The exhaust systems of different purification air-conditioning systems shall be set
up independently.
b) When harmful substances, odors, large amounts of heat, moisture or volatile gases
are produced, a separate exhaust system shall be set up.
c) Measures shall be taken to prevent the infiltration of outdoor gas.
d) For exhaust systems containing water vapor and condensable substances, a slope
shall be set. Set up a discharge port at the local lowest point of the pipeline.
4.3.1.7 For air conditioning systems that use circulating air, a primary (medium)
efficiency air filter shall be installed at the return air outlet of the cleanroom as
appropriate.
4.3.1.8 The opening and closing of the supply air, return air and exhaust air of the
purification air conditioning system shall be interlocked and comply with the following
regulations:
a) The chain procedure of the positive pressure cleanroom is to s...
Share







