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GB/T 42398-2023 (GB/T42398-2023)

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GB/T 42398-2023: PDF in English (GBT 42398-2023)
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 start the air supply
fan first, then start the return air fan (if any) and exhaust fan. The chain procedure
shall be reversed when closing.
b) The chain procedure of the negative pressure cleanroom is to start the return air
fan and exhaust fan (if any) first, and then start the air supply fan. The chain
procedure shall be reversed when closing.
4.3.2 Airflow organization
4.3.2.1 Airflow complies with the following regulations:
a) The clean area shall adopt a one-way flow pattern.
b) Areas outside the clean area may use non-unidirectional flow patterns. Non-
unidirectional flow patterns need to reduce the vortex area.
c) Airflow distribution shall be even. The air flow rate shall meet the requirements
of production technology and human hygiene.
4.3.2.2 When setting up a unidirectional flow workbench in a non-unidirectional flow
cleanroom, its location shall avoid being close to the air supply and return vents.
4.3.2.3 If there is a local exhaust device, it shall be arranged on the downwind side of
the cleanroom (area).
4.3.3 Parts and materials
They shall comply with the relevant requirements of GB 50457 and GB 50591.
4.3.4 Special requirements for cell culture areas carrying infectious agents
4.3.4.1 Biosafety plans for various working conditions in the area (operating or not,
entry and exit of equipment and facilities, maintenance, troubleshooting, etc.) shall be
jointly developed with relevant process personnel.
4.3.4.2 The cell culture area carrying the virus and the adjacent room or area shall
maintain a negative pressure. The pressure difference shall not be less than 10 Pa.
GB 50016.
4.5.2 Illumination
4.5.2.1 Lighting fixtures shall be dedicated to cleanrooms. The maintenance and
replacement of lamps shall avoid adverse effects on the cleanroom environment.
4.5.2.2 The illumination and illumination uniformity of each area meet the requirements
of Table 3.
4.5.2.3 Emergency lighting and evacuation lighting shall be set up. It shall comply with
the regulations of GB 17945.
4.5.3 Intelligent information system
4.5.3.1 Fire safety emergency broadcasts shall be set up.
4.5.3.2 The following terms apply to cell culture cleanrooms with intelligent
information requirements.
4.5.3.3 The architecture and system configuration shall meet the requirements of
business systems and management systems for network segmentation. Information
security requirements for network physical isolation and logical isolation shall be met.
It shall meet energy-related functional requirements. Improve operational efficiency,
reliability and safety.
4.5.3.4 Communication interfaces and protocols that are open and comply with
international and current national standards shall be provided.
4.5.3.5 The user operation interface shall be able to be set according to usage
requirements.
4.5.3.6 A monitoring system for controlled environmental parameters shall be set up.
4.5.3.7 A closed-circuit television surveillance system can be set up according to the
requirements of production management and production technology, which can watch
and record the entire process in real time from multiple angles and without blind spots.
NOTE: The automatic monitoring device is installed on the ceiling.
4.5.3.8 The access control management system shall be set up according to functional
partitions. The access control management system shall realize linkage control with the
emergency escape and automatic fire alarm systems. The access control system shall be
automatically deactivated in the event of an emergency or fire. Ensure that emergency
escape routes are clear during evacuation.
4.5.3.9 There shall be a communication system to facilitate contact with relevant
departments.
4.5.3.10 When using flammable, explosive and other dangerous media, corresponding
monitoring and alarm devices shall be set up indoors and in the monitoring room.
NOTE: Subclauses 4.5.1 and 4.5.3 are applicable to pharmaceutical and cell culture cleanrooms
used for cell therapy.
4.6 Drainage
4.6.1 General provisions
4.6.1.1 It shall comply with the relevant requirements of GB 50472 and GB 50457.
4.6.1.2 Casings shall be installed where the water supply and drainage branch pipes
pass through the ceiling, walls and floors of the cleanroom. There shall be reliable
sealing measures between pipes and sleeves.
4.6.1.3 Measures shall be taken to prevent condensation and burns on the outer surface
of the pipe.
NOTE: This article applies to pharmaceutical and cell culture cleanrooms used for cell therapy.
4.6.2 Water supply
4.6.2.1 Water quality shall comply with the requirements of GB 5749.
4.6.2.2 Water supply pipes and accessories shall be corrosion-resistant and easy to
install and connect.
4.6.3 Drainage
4.6.3.1 The drainage system shall be determined based on the characteristics,
concentration and volume of discharged wastewater.
4.6.3.2 The drainage equipment in the cleanroom and the equipment connected to the
gravity return pipe shall be equipped with a water sealing device below the discharge
outlet. The water seal height shall not be less than 50 mm. Drainage outlets of process
equipment shall be equipped with air blocking devices. The drainage system shall have
a complete ventilation system.
4.6.3.3 The drainage riser shall not pass through a cleanroom with a cleanliness level
higher than or equal to ISO 6 and its corresponding level. There shall be no inspection
opening when the drainage riser passes through other cleanrooms.
4.6.3.4 Floor drains shall not be installed in ISO levels 5, 6 and corresponding
cleanrooms. If a cleanroom lower than the above-mentioned requirements must be
installed, the floor drain must be made of material that is not prone to corrosion, has a
smooth inner surface, is not prone to scaling, has a sealing cover, is easy to open, must
be resistant to sterilization, and can prevent the backflow of waste water and gas.
......

BASIC DATA
Standard ID GB/T 42398-2023 (GB/T42398-2023)
Description (Translated English) Technical specifications of cleanroom design for cell culture
Sector / Industry National Standard (Recommended)
Classification of Chinese Standard C70
Classification of International Standard 13.040.35
Word Count Estimation 14,130
Date of Issue 2023-03-17
Date of Implementation 2023-10-01
Drafting Organization Beijing Technology and Business University, Shanghai Chenchuan Biotechnology Development Co., Ltd., China Electronics System Engineering Fourth Construction Co., Ltd., China Electronics Engineering Design Institute Co., Ltd., Suzhou Antai Air Technology Co., Ltd., Military Medical Research Institute of the Chinese Academy of Military Sciences, Hunan Yuanpin Cell Biotechnology Co., Ltd., Henan Brilliant Air Conditioning Purification Engineering Co., Ltd., Zhongke Testing Technology Service (Guangzhou) Co., Ltd., Zhongdian Jingtai Electronic Engineering Co., Ltd., Shenzhen Beike Biotechnology Co., Ltd., National Health Commission Science and Technology Research Institute, China Medical Biotechnology Association, Institute of Zoology, Chinese Academy of Sciences, East China University of Science and Technology, China Institute for Food and Drug Control, China Academy of Building Research Co., Ltd., Jiangsu Provincial People's Hospital, Zhongyi Wood Engineering Co., Ltd., BOE
Administrative Organization National Cleanroom and Related Controlled Environment Standardization Technical Committee (SAC/TC 319)
Issuing agency(ies) State Administration for Market Regulation, National Standardization Management Committee