CN104847139B - Cell produces clean room - Google Patents

Cell produces clean room Download PDF

Info

Publication number
CN104847139B
CN104847139B CN201510172240.4A CN201510172240A CN104847139B CN 104847139 B CN104847139 B CN 104847139B CN 201510172240 A CN201510172240 A CN 201510172240A CN 104847139 B CN104847139 B CN 104847139B
Authority
CN
China
Prior art keywords
room
cell
clean
operating
corridor
Prior art date
Application number
CN201510172240.4A
Other languages
Chinese (zh)
Other versions
CN104847139A (en
Inventor
王晓明
卫培培
金宜强
Original Assignee
上海安集协康生物技术股份有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 上海安集协康生物技术股份有限公司 filed Critical 上海安集协康生物技术股份有限公司
Priority to CN201510172240.4A priority Critical patent/CN104847139B/en
Publication of CN104847139A publication Critical patent/CN104847139A/en
Application granted granted Critical
Publication of CN104847139B publication Critical patent/CN104847139B/en

Links

Abstract

The present invention provides a kind of cell production clean room, it is characterised in that including:Decontamination room, for carrying out cleaning and sterilizing to logistics;Produce dust proof workshop, the air lock and consumptive material transfer chamber being connected with multiple operating units, dressing cubicle, with dressing cubicle;And between the positive, it is mutually independent with production dust proof workshop, with single stream of people's logistics half-duplex channel, wherein, operating unit lines up two rows, clean corridor is formed in the middle of two row's operating units, the outside of two row's operating units forms dirt corridor, and consumptive material transfer chamber one end is connected with decontamination room by pass-through box, and the other end is connected with an operating unit foremost, the stream of people enters clean corridor by dressing cubicle and air lock, and logistics enters clean corridor by decontamination room and consumptive material transfer chamber.The cell production clean room of the present invention, due to stream of people's logistics shunting and the design of one-way fluid path line, therefore minimizes the cross pollution that stream of people's logistics route is brought.

Description

Cell produces clean room
Technical field
The present invention relates to a kind of building, more particularly to a kind of cell production clean room.
Background technology
With the progress of medical technology, the application of cell therapy clinically is more and more extensive, small-scale laboratory life The mode of production cell can not meet demand.Therefore the factory building of large-scale production cell is occurred in that.But, traditional cell life Producing factory building, there are the following problems:
First, the non-unidirectional Flow Line of the stream of people in factory building, clean area personnel easily cause cross pollution.Material flow line in factory building Road is nor unidirectional stream, easily causes cross pollution.
Second, the cleaning apparatus of operation object (referring to clinical grade cell) experience is not under B grades of backgrounds, is added The possibility of operation object pollution.
3rd, when a cleaning apparatus is damaged in operation room, overhaul of the equipments personnel need to carry out it into clean area Maintenance, causes normal operating in the operating area not carry out.And after maintenance, room need to carry out bromogeramine scouring, ozone is purple Outer sterilization, consumes more manpower, financial resources and the time.
4th, oneself is used alone using every CO2gas incubator in the supply of existing CO2gas incubator The mode that is supplied of gas cylinder, there are many CO2gas incubators in factory building, once the gas for having indivedual gas cylinders exhausts, meeting CO2gas incubator is caused not work.Therefore, periodical inspection need to be carried out, but can not also be understood in real time even if periodical inspection Every sets cushion gas situation, significantly increases because incubator abnormal work causes the risk of abnormal growth of cells.
5th, the cleanliness factor of decontamination room is not required, and prevents material cleaning and sterilizing from reaching requirement;And it is clean after decontamination Net article is transferred to clean area through non-clean area, and article easily causes secondary pollution.
6th, with operation volatile harmful substance the only independent multidomain treat-ment of operation object, but air-conditioning, air draft and its He is connected at operating area, may occur cross pollution with other operation objects, or operator is damaged.
7th, clean area humiture is by the way of time recording, airborne periodic detection, it is impossible to reach in real time Monitoring, the purpose handled in time.
Disadvantages described above causes traditional factory building easily to pollute, and cell quality cannot be effectively ensured.
The content of the invention
Clean room is produced it is an object of the invention to provide a kind of cell, to minimize mass cell production process In, cell is influenceed by factors such as environment and the problem of growth failure, so as to ensure the quality of cell.
The present invention provides a kind of cell production clean room, it is characterised in that including:Decontamination room, for being carried out to logistics Cleaning and sterilizing;Produce dust proof workshop, the air lock and consumptive material being connected with multiple operating units, dressing cubicle, with dressing cubicle Transfer chamber;And between the positive, it is mutually independent with production dust proof workshop, with single stream of people's logistics half-duplex channel, wherein, operation is single Member is lined up and clean corridor is formed in the middle of two rows, two row's operating units, and the outside of two row's operating units forms dirt corridor, consumptive material Transfer chamber one end is connected with decontamination room by pass-through box, and the other end is connected with an operating unit foremost, people's circulation Cross dressing cubicle and air lock enters clean corridor, logistics enters clean corridor by decontamination room and consumptive material transfer chamber.
In addition, the cell production clean room of the present invention, can also have the feature that:Wherein, operating unit has Operating space and maintenance area, the entrance of operating space are communicated with clean corridor, and the outlet of operating space is communicated with dirt corridor, entrance with go out One-way isolation door is provided with mouthful, maintenance area is located at the back side of operating space, communicated with dirt corridor.
In addition, the cell production clean room of the present invention, can also have the feature that:Wherein, have in operating unit There is cell production equipment, the operating surface of cell production equipment is arranged in operating space, maintenance face is arranged in maintenance area.
In addition, the cell production clean room of the present invention, can also have the feature that:Wherein, cell production equipment Top be provided with laminar flow hood, blow unidirectional stream pure air to cell production equipment, it is B grades to make cell manipulation environment cleanliness A levels under background.
In addition, the cell production clean room of the present invention, can also have the feature that:Also include gas cylinder room, gas cylinder Room is arranged at outside production dust proof workshop, is connected by gas pipeline with cell production equipment, is supplied to cell production equipment.
In addition, the cell production clean room of the present invention, can also have the feature that:Wherein, the environment of decontamination room Cleanliness class is C grades, and is connected by pass-through box with consumptive material transfer chamber.
In addition, the cell production clean room of the present invention, can also have the feature that:Also include the first air draft system System, is that decontamination room and operating unit provide unidirectional cleaning gas tream;And second exhaust system, it is to provide unidirectional cleaning gas between the positive Stream, the first exhaust system and the second exhaust system are not communicated with.
In addition, the cell production clean room of the present invention, can also have the feature that:Wherein, dust proof workshop is produced Interior installation temperature-humidity sensor, dust particle sampling pipe passes through the real-time monitoring of environmental state of third party software.
In addition, the cell production clean room of the present invention, can also have the feature that:Wherein, cell production equipment Including CO2gas incubator, temperature, carbon dioxide sensor are installed in CO2gas incubator, it is real-time by third party software Detection device running status.
The beneficial effect of invention
Clean room is produced according to the cell of the present invention, due to stream of people's logistics shunting and the highway route design of one-way flow, because This minimizes the cross pollution that stream of people's logistics route is brought.
Further, since safety cabinet, incubator, centrifuge, microscope, the equipment such as operating desk is respectively positioned on below room laminar flow hood Region, it is ensured that the A levels of cell processing procedure strictly under B grades of backgrounds, reduces the possibility of cell contamination.
Further, since incubator, safety cabinet are designed using incarceration formula, equipment is placed in operating space using area, and maintenance area is put Beyond operation room.After one device damage, maintenance can be carried out simultaneously with operation, while can avoid in maintenance to cleaning The pollution that zone is come.
Further, since carbon dioxide uses central gas supply, gas surplus amount can be understood in time, timely processing is made.
Further, since decontamination room is joined directly together by pass-through box with production clean area, shorten material transmission distance, it is to avoid thing The secondary pollution of material.
Further, since clean area temperature humidity and dust particle are monitored in real time, it is different therefore, it is possible to processing room state in time Often.
Further, since clear production area cell cultivation equipment CO2gas incubator installs temperature carbon dioxide sensor, It is abnormal therefore, it is possible to timely processing device status.
Brief description of the drawings
Fig. 1 is the overall structure diagram that cell produces clean room;
Fig. 2 is the structural representation of operating unit;
Fig. 3 is the schematic diagram of exhaust system;
Fig. 4 is the distribution schematic diagram of steam line;
Fig. 5 is the distribution schematic diagram of steam line.
Embodiment
Illustrate the embodiment of the present invention below in conjunction with accompanying drawing.
Fig. 1 is the overall structure diagram that cell produces clean room, as shown in figure 1, cell production clean room includes: Decontamination room 11, produces dust proof workshop 12, and 13 between the positive.
The environment cleanliness rank of decontamination room 11 is that two-door sterilizing cabinet 111 and pass-through box 112 are provided with C grades, decontamination room 11, Communicated by pass-through box 112 with consumptive material transfer chamber 126, shorten material transmission distance, it is to avoid the secondary pollution of material.Logistics is from thing Inflow entrance, which enters after decontamination room 11, to be sent into through pass-through box 112 in consumptive material transfer chamber 126.If logistics needs sterilizing, need Consumptive material transfer chamber 126 is re-fed into after the sterilizing of two-door sterilizing cabinet 111.
Producing has multiple operating units 123, dressing cubicle 124, the air-lock being connected with dressing cubicle 124 in dust proof workshop 12 Room 127 and consumptive material transfer chamber 126.
It is sequentially connected between each operating unit 123, as shown in figure 1, the operating unit 123 in present embodiment has ten Two, six rows line up two rows, and the major trunk roads of stream of people's logistics corridor are formed between two row's operating units, i.e., clean corridor 122.The outside of two row's operating units forms dirt corridor 121.
It is connected positioned at operating unit 123 foremost with consumptive material transfer chamber 126.One-way isolation is provided with branched bottom Door, the opening direction of one-way isolation door is from major trunk roads to the direction of both sides branched bottom.The direct of travel of the stream of people and logistics is such as Stream of people direction 128 in Fig. 1 and shown in the direction of arrow in logistics direction 129.
The stream of people is introduced into dressing cubicle 124 from people's inflow entrance and changes work clothes, air lock 127 is entered back into, subsequently into cleaning Corridor 122,
Fig. 2 is to show the situation that two operating unit dorsal parts are oppositely arranged in the structural representation of operating unit, Fig. 2. As shown in Fig. 2 an operating unit 123 has a jacket cell production equipment, cell production equipment includes:Refrigerator 135, titanium dioxide Carbon incubator 136, safety cabinet 137 and workbench 138.Region drawn by oblique stroke shade is the position of workbench 138.Workbench Side where 138 forms operating space.Refrigerator 135, CO2gas incubator 136 and the incarceration of safety cabinet 137 among wall, What equipment was used one is placed in operating space, and the dorsal part of equipment is placed in beyond operating space, and two operating unit north sides are with respect to institute's ring Around space formed maintenance area.Between two operating units, maintenance is also separated with 125 between consumptive material, for keeping in consumptive material before area. The position in maintenance area, can cause after a device damage, and maintenance is carried out simultaneously with operation, to behaviour when can avoid overhauling again Make the pollution that zone is come.Laminar flow hood is provided with above cell production equipment, it is clean empty to blow unidirectional stream to cell production equipment Gas.The cell production equipment that need to be used during operation such as safety cabinet 137, incubator 126, centrifuge, microscope, workbench 138, Positioned at room laminar flow hood region below, it is ensured that the A levels of cell processing procedure strictly under B grades of backgrounds, reduce cell contamination Possibility.
13 between the positive, processing carries in 13 between the operation object of operation volatile harmful substance, the positive and uses II grades of B2 Biohazard Safety Equipment, and there are single exhaust system, i.e. the second exhaust system in room, is the 13 unidirectional cleaning gas treams of offer between the positive, Air draft is full row.The stream of people and logistics by different entrances enter it is positive between among 13, stream of people's route 131 and logistics route 132 As shown in Figure 1.
Fig. 3 is the schematic diagram of exhaust system, it is shown that exhaust system and the position relationship of the other structures in factory building, individually Exhaust system it is as shown in Figure 4.The first exhaust system is shown in Fig. 4 a, is that decontamination room and operating unit provide unidirectional cleaning gas Stream;The first exhaust system has every on main exhaust duct 15, and branch's exhaust duct 151, main exhaust duct 15 as shown in fig. 4 a Air outlet 152 is provided with every a segment distance.Air outlet 153 is provided with the top of each operating space.With the every pipeline end in figure The square dice at place represents air outlet 153, and label is no longer marked one by one.
Fig. 4 b show the structure of the second exhaust system, as shown in Fig. 2 the second exhaust system and the first exhaust system not phase It is logical.Second exhaust system has multiple exhaust outlets, and the top of people's circulation road and operating space is opened in respectively, circulation road and operation is made one Area keeps clean.
Fig. 5 is the distribution schematic diagram of steam line, as shown in figure 5, the carbon dioxide culture of each operating unit and positive sound Gas needed for case or other cell production equipments is provided by gas cylinder room 16 is unified, gas cylinder room be arranged at production dust proof workshop it Outside, three gas pipelines are passed through:First gas pipeline 161, second gas pipeline 162, third gas pipeline 163 and carbon dioxide Incubator or other cell production equipments for needing gas are connected, and are supplied to cell production equipment.Because gas cylinder room 16 is set It is placed in outside operating unit 123, therefore facilitates the service condition of Centralized Monitoring gas.In addition, when the gas for having gas cylinder exhausts, needing When changing, it is not required that operating personnel enter to be changed in the cleaning region of operating unit 123, it is to avoid Migrant women Pollution is produced to the environment in operating unit 123.
Humidity temperature pickup and display screen are respectively mounted between operating unit and the positive in cell production clean room, and is led to Third party software gathered data is crossed, humiture real time and on line monitoring is realized, when humiture exceedes preset value, then short message report is carried out It is alert.Dust particle sampling pipe is installed in each room, by third party software gathered data, realizes dust particle real-time online control System.Incubator installs humiture and carbon dioxide sensor, by third party software gathered data, realizes that equipment running status are real When on-line monitoring, when equipment state exceed preset value, then realize SMS alarm, so as in time processing.

Claims (6)

1. a kind of cell produces clean room, it is characterised in that bag
Include:Decontamination room, for carrying out cleaning and sterilizing to logistics;
Produce dust proof workshop, the air lock being connected with multiple operating units, dressing cubicle, with dressing cubicle and consumptive material handing-over Room;And
It is mutually independent with production dust proof workshop between the positive, with single stream of people's logistics half-duplex channel,
Wherein, the operating unit lines up two rows, and clean corridor, two rows operation are formed in the middle of operating unit described in two rows
The outside of unit forms dirt corridor,
Described consumptive material transfer chamber one end is connected with the decontamination room by pass-through box, the other end and the behaviour foremost It is connected as unit,
The stream of people enters the clean corridor by dressing cubicle and air lock, and logistics enters described by decontamination room and consumptive material transfer chamber Clean corridor, wherein, the operating unit has operating space and maintenance area, the entrance of the operating space and the clean corridor phase Logical, the outlet of the operating space is communicated with the dirt corridor, and the entrance and the exit are provided with one-way isolation door, The maintenance area is located at the back side of the operating space, is communicated with the dirt corridor, and two operating unit dorsal parts are relative to be surround Space form maintenance area, there is cell production equipment, incarceration is among wall, and the cell production is set in the operating unit Standby operating surface is arranged in the operating space, and maintenance face is arranged in the maintenance area,
Also include the first exhaust system, be that the decontamination room and the operating unit provide unidirectional cleaning gas tream, the second air draft system System, be it is described it is positive between unidirectional cleaning gas tream is provided, first exhaust system and second exhaust system are not communicated with.
2. cell according to claim 1 produces clean room, it is characterised in that:
Wherein, laminar flow hood is provided with above the cell production equipment, it is clean to blow unidirectional stream to the cell production equipment Air, it is the A levels under B grades of backgrounds to make cell manipulation environment cleanliness.
3. cell according to claim 1 produces clean room, it is characterised in that also include:
Gas cylinder room, the gas cylinder room is arranged at outside the production dust proof workshop, is set by gas pipeline with cell production It is standby to be connected, supplied to the cell production equipment.
4. cell according to claim 1 produces clean room, it is characterised in that:
Wherein, the environment cleanliness rank of the decontamination room is C grades, and is connected by pass-through box with the consumptive material transfer chamber.
5. cell according to claim 1 produces clean room, it is characterised in that:
Wherein, temperature-humidity sensor is installed in the production dust proof workshop, dust particle sampling pipe passes through third party software Real-time monitoring of environmental state.
6. cell according to claim 1 produces clean room, it is characterised in that:
Wherein, the cell production equipment includes installing temperature, dioxy in CO2gas incubator, the CO2gas incubator Change carbon sensor, pass through third party software care testing device running status.
CN201510172240.4A 2015-04-13 2015-04-13 Cell produces clean room CN104847139B (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201510172240.4A CN104847139B (en) 2015-04-13 2015-04-13 Cell produces clean room

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201510172240.4A CN104847139B (en) 2015-04-13 2015-04-13 Cell produces clean room

Publications (2)

Publication Number Publication Date
CN104847139A CN104847139A (en) 2015-08-19
CN104847139B true CN104847139B (en) 2017-09-29

Family

ID=53847075

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201510172240.4A CN104847139B (en) 2015-04-13 2015-04-13 Cell produces clean room

Country Status (1)

Country Link
CN (1) CN104847139B (en)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106401224A (en) * 2016-11-24 2017-02-15 中国电子工程设计院 Clean room factory structure
CN106988567B (en) * 2017-04-24 2019-04-02 中船第九设计研究院工程有限公司 A kind of design method of Experiment on Microbiology process layout
CN107558759B (en) * 2017-07-28 2020-04-03 广东依浦赛生物科技有限公司 Medical cell preparation room and using method thereof
CN108220161A (en) * 2018-01-24 2018-06-29 北京臻溪谷医学研究中心(有限合伙) A kind of many cells prepare laboratory placement scheme
CN110761594A (en) * 2019-01-24 2020-02-07 中船第九设计研究院工程有限公司 Clinical cell preparation engineering environment barrier system

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100707985B1 (en) * 2006-03-10 2007-04-16 세원셀론텍(주) Facility module for production and storage of cell therapy product
CN101619285B (en) * 2009-07-15 2014-08-27 闫铭杰 Production platform system of human body fluid and tissue cells
CN103266787B (en) * 2013-05-24 2015-06-17 中国电子系统工程第二建设有限公司 Air lock chamber

Also Published As

Publication number Publication date
CN104847139A (en) 2015-08-19

Similar Documents

Publication Publication Date Title
US10654036B2 (en) Modular, self-contained, mobile clean room
Mora et al. Microorganisms in confined habitats: microbial monitoring and control of intensive care units, operating rooms, cleanrooms and the International Space Station
JP6081269B2 (en) Isolator system
AU632812B2 (en) Method and apparatus for cleaning and sanitizing hvac systems
KR101719498B1 (en) Modular, self-contained, mobile clean room
EP1471138B1 (en) Aseptic system and method for using the same
EP2604679B1 (en) Cell culture treatment system, and method for connection of modules for cell culture treatment system
Zhao et al. Abiotic and microbiotic factors controlling biofilm formation by thermophilic sporeformers
US10161147B2 (en) Method for connecting modular mobile rooms
JP2006115798A (en) Automatic cell-culturing device by utilizing autoclave disinfection and method for using the same
KR100707985B1 (en) Facility module for production and storage of cell therapy product
JP6427269B2 (en) Modular parts that supply utilities to clean rooms, isolation or containment cubicles, pods or modules
US4304224A (en) Positive environmental enclosure
US8298054B2 (en) System and method for manufacturing
Xu et al. Efficacy of ultraviolet germicidal irradiation of upper-room air in inactivating airborne bacterial spores and mycobacteria in full-scale studies
JP4656485B2 (en) Aseptic culture method and apparatus
CN101987205B (en) Sterilizer
CN104261076B (en) A kind of radioactivity material movement system
US20200255779A1 (en) Liquid transport method
KR20110098671A (en) Isolator for cell culture
CA2632520A1 (en) Prevalidated, modular good manufacturing practice-compliant facility
JP5746047B2 (en) Flexible manufacturing system and method for providing flexible manufacturing system
Engelhart et al. Hospital-acquired legionellosis originating from a cooling tower during a period of thermal inversion
Hadi et al. Biofilm removal by medical device cleaners: comparison of two bioreactor detection assays
JPWO2004114378A1 (en) CLEAN UNIT, CLEAN UNIT SYSTEM, FUNCTIONAL UNIT, FUNCTIONAL UNIT SYSTEM, MATERIAL PROCESSING METHOD, ELEMENT MANUFACTURING METHOD, CELL SYSTEM GROWING METHOD AND PLANT BODY GROWING METHOD

Legal Events

Date Code Title Description
C06 Publication
PB01 Publication
EXSB Decision made by sipo to initiate substantive examination
SE01 Entry into force of request for substantive examination
COR Change of bibliographic data
CB02 Change of applicant information

Address after: 201318 Shanghai City, Pudong New Area Road No. 588 building 3 indigo

Applicant after: SHANGHAI ANGECON BIOTECHNOLOGY CO., LTD.

Address before: 201318 Shanghai City, Pudong New Area Road No. 588 building 3 indigo

Applicant before: Shanghai Angecon Biotechnology Co., Ltd.

GR01 Patent grant
GR01 Patent grant