CN106098128B - The hot cell system of radiopharmaceutical is repeatedly produced in short time - Google Patents
The hot cell system of radiopharmaceutical is repeatedly produced in short time Download PDFInfo
- Publication number
- CN106098128B CN106098128B CN201610678168.7A CN201610678168A CN106098128B CN 106098128 B CN106098128 B CN 106098128B CN 201610678168 A CN201610678168 A CN 201610678168A CN 106098128 B CN106098128 B CN 106098128B
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- exhaust
- chamber
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- hot cell
- main chamber
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- 239000012217 radiopharmaceutical Substances 0.000 title claims abstract description 13
- 229940121896 radiopharmaceutical Drugs 0.000 title claims abstract description 13
- 230000002799 radiopharmaceutical effect Effects 0.000 title claims abstract description 13
- 239000007788 liquid Substances 0.000 claims abstract description 28
- 239000002699 waste material Substances 0.000 claims abstract description 23
- 230000004224 protection Effects 0.000 claims abstract description 12
- 239000000463 material Substances 0.000 claims abstract description 8
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 28
- 238000010276 construction Methods 0.000 claims description 15
- 230000002285 radioactive effect Effects 0.000 claims description 15
- 238000001179 sorption measurement Methods 0.000 claims description 12
- 230000015572 biosynthetic process Effects 0.000 claims description 11
- 238000003786 synthesis reaction Methods 0.000 claims description 10
- 230000001681 protective effect Effects 0.000 claims description 7
- 238000010521 absorption reaction Methods 0.000 claims description 5
- 238000004519 manufacturing process Methods 0.000 abstract description 10
- 239000012459 cleaning agent Substances 0.000 abstract description 2
- 238000000746 purification Methods 0.000 abstract description 2
- 238000003904 radioactive pollution Methods 0.000 abstract description 2
- 238000011160 research Methods 0.000 abstract description 2
- 239000002351 wastewater Substances 0.000 abstract description 2
- 239000007789 gas Substances 0.000 description 8
- 239000000700 radioactive tracer Substances 0.000 description 5
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 4
- 239000003153 chemical reaction reagent Substances 0.000 description 4
- 238000012856 packing Methods 0.000 description 4
- 239000003610 charcoal Substances 0.000 description 3
- 238000004140 cleaning Methods 0.000 description 3
- 239000013064 chemical raw material Substances 0.000 description 2
- 238000010924 continuous production Methods 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 238000000605 extraction Methods 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 229910052757 nitrogen Inorganic materials 0.000 description 2
- 239000002994 raw material Substances 0.000 description 2
- JGSARLDLIJGVTE-UHFFFAOYSA-N 3,3-dimethyl-7-oxo-6-[(2-phenylacetyl)amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid Chemical compound O=C1N2C(C(O)=O)C(C)(C)SC2C1NC(=O)CC1=CC=CC=C1 JGSARLDLIJGVTE-UHFFFAOYSA-N 0.000 description 1
- 239000000443 aerosol Substances 0.000 description 1
- 230000006835 compression Effects 0.000 description 1
- 238000007906 compression Methods 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 230000007613 environmental effect Effects 0.000 description 1
- 210000004907 gland Anatomy 0.000 description 1
- 238000010253 intravenous injection Methods 0.000 description 1
- 239000005355 lead glass Substances 0.000 description 1
- 239000010808 liquid waste Substances 0.000 description 1
- 230000000149 penetrating effect Effects 0.000 description 1
- 239000006187 pill Substances 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 230000005855 radiation Effects 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
Classifications
-
- G—PHYSICS
- G21—NUCLEAR PHYSICS; NUCLEAR ENGINEERING
- G21F—PROTECTION AGAINST X-RADIATION, GAMMA RADIATION, CORPUSCULAR RADIATION OR PARTICLE BOMBARDMENT; TREATING RADIOACTIVELY CONTAMINATED MATERIAL; DECONTAMINATION ARRANGEMENTS THEREFOR
- G21F5/00—Transportable or portable shielded containers
- G21F5/06—Details of, or accessories to, the containers
- G21F5/10—Heat-removal systems, e.g. using circulating fluid or cooling fins
-
- G—PHYSICS
- G21—NUCLEAR PHYSICS; NUCLEAR ENGINEERING
- G21F—PROTECTION AGAINST X-RADIATION, GAMMA RADIATION, CORPUSCULAR RADIATION OR PARTICLE BOMBARDMENT; TREATING RADIOACTIVELY CONTAMINATED MATERIAL; DECONTAMINATION ARRANGEMENTS THEREFOR
- G21F5/00—Transportable or portable shielded containers
- G21F5/06—Details of, or accessories to, the containers
-
- G—PHYSICS
- G21—NUCLEAR PHYSICS; NUCLEAR ENGINEERING
- G21F—PROTECTION AGAINST X-RADIATION, GAMMA RADIATION, CORPUSCULAR RADIATION OR PARTICLE BOMBARDMENT; TREATING RADIOACTIVELY CONTAMINATED MATERIAL; DECONTAMINATION ARRANGEMENTS THEREFOR
- G21F5/00—Transportable or portable shielded containers
- G21F5/06—Details of, or accessories to, the containers
- G21F5/12—Closures for containers; Sealing arrangements
Landscapes
- Physics & Mathematics (AREA)
- Engineering & Computer Science (AREA)
- General Engineering & Computer Science (AREA)
- High Energy & Nuclear Physics (AREA)
- Nuclear Medicine (AREA)
Abstract
The invention discloses the hot cell system for repeatedly producing radiopharmaceutical in a kind of short time, it is related to handling radioactive pollution material.The present invention includes main chamber, synthesizer is provided only in the main chamber, and be connected to respectively with feed compartment, vacuum pump chamber, waste liquid chamber, canyon and control room by air-tightness pipeline passway.Original hot cell is divided into multiple portions by the present invention; charging, exhaust gas, waste water, ancillary equipment etc. are removed into main chamber; full-shield or shadow shield, purification, laminar flow protection, negative pressure protection are individually carried out according to demand; it in this way can be after primary production; directly filling cleaning agent is cleaned; charging is produced again again, and without waiting for the time of 10 half-life period, capacity utilization greatly improves.The present invention substantially increases clinical and scientific research efficiency, has broad application prospects.
Description
Technical field
The present invention relates to processing radioactive pollution materials, and the heat of radiopharmaceutical is repeatedly produced in specifically a kind of short time
Chamber system.
Background technology
Positron emitting tracer has compared with intense radiation, and production needs to operate in shielding shielded box, the shielding shielded box
Referred to as hot cell.Since the half-life period of positron-emitting radionuclides is shorter, general production be all in dedicated synthesis module it is complete from
It is dynamic to carry out.
Currently, the hot cell that shielding positron emission sex pill is automatically synthesized module is generally designing two portions.First, in C
Synthesis module is placed in grade clean area and shields hot cell, has air intake/outtake system in hot cell, to ensure the working environment of synthesis module
It is C grades.Sintetics is by collecting and dispensing in Pipe transfer to packing hot cell.Dispense in hot cell equipped with laminar flow protective device and
Air intake/outtake system ensures that it is A grades to collect packing environment.
It is that synthesis module is put in hot cell using the method that existing hot cell carries out positron emitting tracer production, to
It is automatically synthesized the raw materials consumptive material such as filling chemical reagent in module, shield door is shut, is automatically synthesized by dedicated shielded-plate tube road direction
Module injects radiological materials and starts to produce, and product, which is transported to product bottle packing, after full-automatic synthesis uses.Production knot
Shu Hou, shield door (10 times of generally operated nucleic half-life period) can be opened by waiting for that nucleic is decay to, and carried out equipment cleaning, held
Row produces next time.Such production model, needs interruption to carry out, and capacity utilization is relatively low.Moreover, being fed using above-mentioned hot cell
Process pricks seep through plug with syringe, or syringe needle is penetrated cillin bottle, belongs to risk operations, is protected without laminar flow.
Invention content
The present invention is exactly to be proposed to solve the problems, such as that existing hot cell is unable to continuous production positron emitting tracer
A kind of short time in repeatedly produce the hot cell system of radiopharmaceutical.
The present invention is realized according to following technical scheme.
The hot cell system of radiopharmaceutical, including main chamber are repeatedly produced in a kind of short time, are provided only in the main chamber
Synthesizer, and by air-tightness pipeline passway respectively with feed compartment, vacuum pump chamber, waste liquid chamber, be internally provided with ancillary equipment
Canyon is connected to, and control room controls entire hot cell system；
The main chamber is set as lead screen, airtight construction, and the exhaust system by being arranged in system makes to be formed in it
Negative relative；The main chamber is additionally provided with exhaust duct with activated carbon adsorption formula exhaust-air filter, with air inlet high efficiency filter
The blast pipe and individual row wind turbine of device, the exhaust duct and blast pipe are all made of air-tightness channel；The indoor synthesis of master
Device is also connected with Spent Radioactive air pipe.
The feed compartment is set as airtight construction, and the exhaust system by being arranged in system keeps formation in it relatively negative
Pressure；The indoor stock bottle that feeds provides synthesis material by indoor synthesizer based on air-tightness pipeline passway；The charging
Room is additionally provided with exhaust duct, laminar flow protective device and individual row wind turbine with activated carbon adsorption formula exhaust-air filter.
The vacuum pump chamber is set as lead screen, airtight construction, and the exhaust system by being arranged in system makes in it
Form negative relative；Vacuum pump and protection cold-trap are provided in the vacuum pump room, the two passes through air-tightness pipeline passway and master
Indoor synthesizer connection, and exhaust gas is discharged by Spent Radioactive air pipe；The vacuum pump chamber is additionally provided with work
The exhaust duct of property charcoal absorption type exhaust-air filter.
The waste liquid chamber is set as lead screen, airtight construction, and the exhaust system by being arranged in system makes its interior shape
At negative relative；The waste liquid bottle being arranged in the waste liquid chamber is connect by air-tightness pipeline passway with main indoor synthesizer,
And exhaust gas is discharged by Spent Radioactive air pipe；The waste liquid chamber is additionally provided with activated carbon adsorption formula exhaust-air filter
Exhaust duct.
The hot cell system be additionally provided with lead screen, airtight construction for placing the collecting chamber of product collecting tank；The production
Product collecting tank is connect by air-tightness pipeline passway with main indoor synthesizer；The collecting chamber is additionally provided with activated carbon
Exhaust duct, laminar flow protective device and the individual row wind turbine of absorption type exhaust-air filter.
It is additionally provided with gas resistance device on the vacuum pump chamber and the exhaust duct of waste liquid chamber.
Present invention obtains following advantageous effects.
The problem of existing hot cell of effective solution of the present invention is unable to continuous production positron emitting tracer.It sets in this way
Original hot cell is divided into multiple portions by the present invention of meter, and charging, exhaust gas, waste water, ancillary equipment etc. are removed main chamber, independent root
Full-shield or shadow shield, purification, laminar flow protection, negative pressure protection are carried out according to demand, it in this way can be after primary production, directly
Filling cleaning agent is cleaned, then charging is produced again, (most commonly used at present without waiting for the time of 10 half-life period
Positron radionuclide is18F, half-life period 110min wait for the decay of 10 half-life period almost to need for 24 hours), capacity utilization is big
It is big to improve.Meanwhile positron emitting tracer is generally intravenous injection, needs to be produced in clean environment.With existing
GMP requirements, the filling of all drugs is carried out in C grades of environment, and only finally exposure link is needed in C grades of environmental protections
A grades of regions carry out.The raw material filling of the present invention removes main chamber, can place it in A grades of environment, drug quality is ensured more
Added with profit.The present invention substantially increases clinical and scientific research efficiency, has broad application prospects.
Description of the drawings
Fig. 1 is the structural schematic diagram of the present invention.
Wherein：1. main chamber；2. feed compartment；
3. vacuum pump chamber；4. waste liquid chamber；
5. canyon；6. collecting chamber；
7. control room；8. synthesizer；
9. stock bottle；10. cold-trap；
11. vacuum pump；12. waste liquid bottle；
13. ancillary equipment；14. product collecting tank；
15. control panel；16. exhaust duct；
17. blast pipe；18. activated carbon adsorption formula exhaust-air filter；
19. air inlet high efficiency particulate air filter；20. laminar flow protective device；
21. individual row wind turbine；22. Spent Radioactive air pipe；
23. air-tightness pipeline passway；24. gas resistance device.
Specific implementation mode
The present invention is described further with reference to the accompanying drawings and embodiments.
As shown in Figure 1, repeatedly producing the hot cell system of radiopharmaceutical, including main chamber 1 in a kind of short time, feature exists
In：(or the synthesizer 8 and what must be installed together with synthesizer 8 attached set of synthesizer 8 is provided only in the main chamber
It is standby), and by air-tightness pipeline passway 23 respectively with feed compartment 2, vacuum pump chamber 3, waste liquid chamber 4, be internally provided with ancillary equipment 13
Canyon 5 be connected to, control room 7 controls entire hot cell system；
The main chamber 1 is set as lead screen, airtight construction, and the exhaust system by being arranged in system makes to be formed in it
Negative relative；The main chamber 1 is additionally provided with exhaust duct 16 with activated carbon adsorption formula exhaust-air filter 18, efficient with air inlet
The blast pipe 17 and individual row wind turbine 21 of filter 19, the exhaust duct 16 and blast pipe 17 are all made of air-tightness channel；Institute
The synthesizer 8 stated in main chamber 1 is also connected with Spent Radioactive air pipe 22.
The feed compartment 2 is located at 1 top of main chamber, is set as airtight construction, and the exhaust system by being arranged in system
Make to form negative relative in it；Stock bottle 9 (chemical reagent, disposable extraction column and chromatogram flow phase etc.) in feed compartment 2 is logical
It is that the synthesizer 8 in main chamber 1 provides synthesis material to cross air-tightness pipeline passway 23；The feed compartment 2 is additionally provided with work
Exhaust duct 16, laminar flow protective device 20 and the individual row wind turbine 21 of property charcoal absorption type exhaust-air filter 18.
The part that original chemical raw material bottle being fixed on synthesizer 8 and extraction column etc. are needed replacing or loaded is moved on to
Outside main chamber 1, A grades of isolator laminar flows are set and are protected, as feed compartment 2, shielding protection is needed to carry out shadow shield.Chemical raw material can
It is contained using the gland vial with rubber plug, penetrates bottom of bottle with long syringe needle and take liquid, it is original to connect that rubber plug penetrates hour hand head
Compression system is to drive feed liquid to enter synthesizer 8；Or exhaust system, feed liquid is transmitted with negative pressure mode.Feed compartment 2 uses laminar flow
It protects, A grades of environment in guarantee system, it is easier to ensure sterile, it is easier to meet the demand of GMP.
The vacuum pump chamber 3 is set as lead screen, airtight construction, and the exhaust system by being arranged in system makes in it
Form negative relative；Vacuum pump 11 and protection cold-trap 10 are provided in the vacuum pump chamber 3, the two passes through air-tightness pipeline passway
23 connect with the synthesizer 8 in main chamber 1, and exhaust gas is discharged by Spent Radioactive air pipe 22；The vacuum pump chamber 3 is also set
It is equipped with the exhaust duct 16 with activated carbon adsorption formula exhaust-air filter 18.
Vacuum pump 11 and protection cold-trap 10 have radioactivity residual, and cold-trap 10 need to add liquid nitrogen, therefore are moved out
Main chamber 1, is placed on the lower section of main chamber 1, and is shielded.This design can mitigate main chamber radioactivity residual, failure or its
He can reduce radioactive dosage in main chamber 1 by Emergency time.The Spent Radioactive air pipe 22 of vacuum pump 11 and putting for synthesizer 8
Penetrating property exhaust pipe 22 is attached.
The waste liquid chamber 4 is set as lead screen, airtight construction, and the exhaust system by being arranged in system makes its interior shape
At negative relative；The waste liquid bottle 12 being arranged in the waste liquid chamber 4 passes through the synthesizer in air-tightness pipeline passway 23 and main chamber 1
8 connections, and exhaust gas is discharged by Spent Radioactive air pipe 22；The waste liquid chamber 4 is additionally provided with arranges with activated carbon adsorption formula
The exhaust duct 16 of wind filter 18.
The waste liquid of generated radioactive liquid waste and cleaning equipment has a large amount of radioactivity residuals in production, is moved out leading
Room 1 can substantially reduce the residual of main chamber 1, and radioactive dosage in main chamber 1 can be reduced in failure or other Emergency times.Waste liquid bottle
12 exhaust may carry radgas or aerosol, it need to be connected with Spent Radioactive air pipe 22.
The canyon 5 is the region for not needing specially treated, and ancillary equipment 13 is arranged inside, and ancillary equipment 13 includes
The devices such as electrical cabinet, liquid nitrogen charging-tank；The ancillary equipment 13 passes through the synthesizer in air-tightness pipeline passway 23 and main chamber 1
8 connections.
The hot cell system be additionally provided with lead screen (front shield or use lead glass), airtight construction for placing product receipts
Collect the collecting chamber 6 of tank 14；The product collecting tank 14 is connect by air-tightness pipeline passway 23 with the synthesizer 8 in main chamber 1；
The collecting chamber 6 be additionally provided with exhaust duct 16 with activated carbon adsorption formula exhaust-air filter 18, laminar flow protective device 20 and
Individual row wind turbine 21.The collecting chamber 6 of the present invention is the packing hot cell of miniaturization, can be also not provided with, and 2 space of feed compartment part is utilized
It is subject to shielding.
Control room 7 is the region for not needing specially treated, by the control panel 15 that sets within it to hot cell system into
Row regulation and control.
Independent wind turbine is arranged in region of the present invention with laminar flow, and partial common exhaust fan, and can share work
Property charcoal absorption type exhaust-air filter 18.Since waste liquid chamber 4 and vacuum pump chamber 3 need not take a breath, without air inlet high efficiency particulate air filter 19,
Therefore larger air-flow is had when opening door.It is happened here to be anti-, gas resistance device 24 is set on exhaust duct 16, is prevented
To the influence of 1 vacuum degree of main chamber when enabling.
The present invention can be immediately performed cleaning after manufacturing, replace consumptive material, add reagent, and execution produces next time.And
New installed reagents can need not be filled with syringe again by pharmaceutical factory direct-furnish, and all exposed links have laminar flow protection, it is easier to accord with
Close GMP.
Claims (6)
1. repeatedly producing the hot cell system of radiopharmaceutical in a kind of short time, including main chamber (1), it is characterised in that：The master
Interior is provided only with synthesizer (8), and by air-tightness pipeline passway (23) respectively with feed compartment (2), vacuum pump chamber (3),
Waste liquid chamber (4), canyon (5) connection for being internally provided with ancillary equipment (13), control room (7) control entire hot cell system
System；The main chamber (1) is set as lead screen, airtight construction, and the exhaust system by being arranged in system makes to form phase in it
To negative pressure；The main chamber (1) is additionally provided with exhaust duct (16) with activated carbon adsorption formula exhaust-air filter (18), with air inlet
The blast pipe (17) and individual row wind turbine (21) of high efficiency particulate air filter (19), the exhaust duct (16) and blast pipe (17) are all made of
Air-tightness channel；Synthesizer (8) in the main chamber (1) is also connected with Spent Radioactive air pipe (22).
2. repeatedly producing the hot cell system of radiopharmaceutical in a kind of short time according to claim 1, it is characterised in that：
The feed compartment (2) is set as airtight construction, and the exhaust system by being arranged in system makes to form negative relative in it；Add
Expect that the stock bottle (9) in room (2) provides synthesis original by air-tightness pipeline passway (23) for the synthesizer (8) in main chamber (1)
Material；The feed compartment (2) is additionally provided with exhaust duct (16), laminar flow protection dress with activated carbon adsorption formula exhaust-air filter (18)
Set (20) and individual row wind turbine (21).
3. repeatedly producing the hot cell system of radiopharmaceutical in a kind of short time according to claim 1, it is characterised in that：
The vacuum pump chamber (3) is set as lead screen, airtight construction, and the exhaust system by being arranged in system makes to form phase in it
To negative pressure；Vacuum pump (11) and protection cold-trap (10) are provided in the vacuum pump chamber (3), the two passes through air-tightness pipeline passway
(23) it connect with the synthesizer (8) in main chamber (1), and exhaust gas is discharged by Spent Radioactive air pipe (22)；The vacuum
Pump chamber (3) is additionally provided with the exhaust duct (16) with activated carbon adsorption formula exhaust-air filter (18).
4. repeatedly producing the hot cell system of radiopharmaceutical in a kind of short time according to claim 1, it is characterised in that：
The waste liquid chamber (4) is set as lead screen, airtight construction, and the exhaust system by being arranged in system makes to be formed relatively in it
Negative pressure；The waste liquid bottle (12) being arranged in the waste liquid chamber (4) is filled by the synthesis in air-tightness pipeline passway (23) and main chamber (1)
(8) connection is set, and exhaust gas is discharged by Spent Radioactive air pipe (22)；The waste liquid chamber (4) is additionally provided with activated carbon
The exhaust duct (16) of absorption type exhaust-air filter (18).
5. repeatedly producing the hot cell system of radiopharmaceutical in a kind of short time according to claim 1, it is characterised in that：
The hot cell system be additionally provided with lead screen, airtight construction for placing the collecting chambers (6) of product collecting tank (14)；The product
Collecting tank (14) is connect by air-tightness pipeline passway (23) with the synthesizer (8) in main chamber (1)；The collecting chamber (6) is also
It is provided with exhaust duct (16), laminar flow protective device (20) and independent exhausting with activated carbon adsorption formula exhaust-air filter (18)
Machine (21).
6. repeatedly producing the hot cell system of radiopharmaceutical in a kind of short time according to claim 3 or 4, feature exists
In：It is additionally provided with gas resistance device (24) on the exhaust duct (16) of the vacuum pump chamber (3) and waste liquid chamber (4).
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610678168.7A CN106098128B (en) | 2016-08-17 | 2016-08-17 | The hot cell system of radiopharmaceutical is repeatedly produced in short time |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610678168.7A CN106098128B (en) | 2016-08-17 | 2016-08-17 | The hot cell system of radiopharmaceutical is repeatedly produced in short time |
Publications (2)
| Publication Number | Publication Date |
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| CN106098128A CN106098128A (en) | 2016-11-09 |
| CN106098128B true CN106098128B (en) | 2018-07-24 |
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| CN201610678168.7A Expired - Fee Related CN106098128B (en) | 2016-08-17 | 2016-08-17 | The hot cell system of radiopharmaceutical is repeatedly produced in short time |
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Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111161899A (en) * | 2018-11-07 | 2020-05-15 | 上海原子科兴药业有限公司 | Hot chamber for synthesis of radiopharmaceuticals |
| CN113393951A (en) * | 2021-06-07 | 2021-09-14 | 江苏华益科技有限公司 | Waste gas collecting device and method for radionuclide synthesis |
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| US7577228B2 (en) * | 2002-10-28 | 2009-08-18 | General Electric Company | Transportable manufacturing facility for radioactive materials |
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| Publication number | Publication date |
|---|---|
| CN106098128A (en) | 2016-11-09 |
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