A kind of aseptic weighing and the proportioning process isolator
Technical field
The present invention relates to a kind ofly asepticly weigh, the proportioning process isolator, this device provides A level aseptic area stable, low pollution risk, that isolate fully for weighing in the sterile bulk drug production process, proportioning process link.
Background technology
Sterile bulk drug is according to the difference of the character of medicine, and the technology of making also is not quite similar.In entire making process, weigh and batching is indispensable two processes.
Weighing process be for the content of each composition that makes a kind of medicine can be more accurate operating process; Blending process is the process of each composition of a kind of medicine proportionally being carried out the proportioning mixing.The correctness of operating of weighing and prepare burden is the prerequisite that guarantees medicine effectiveness.
At present, in sterile bulk drug was produced, there was drawback in the operating procedure of weighing and prepare burden:
1, all operations of aseptic raw material before batching can be accomplished under airtight aseptic environments; But at present production of raw medicine producer or bulk drug use producer to weigh, the blending process protection also rests on simple hundred grades of laminar flow hood or hundred grades of structures of holding court from behind a screen; But can't accomplish real isolation; Can't make the internal pair production ambient parameter controlled fully; Particularly when producing high sensitization or highly toxic product, how can not only guarantee the aseptic of product but also can guarantee that operating personnel's safety just becomes a difficult problem that needs solution;
2, sterile bulk drug is in weighing, preparing burden operating process, and it is a lot of to adopt laminar flow hood to carry out non-enclosed isolation drawback.At first, can not satisfy the requirement of " the potent drug article must be avoided contacting with operating personnel as far as possible "; Secondly, strict for the Production Regional ambient parameter, it is controlled fully to reach parameter, and can't reach the requirement that can verify; At last, CIP (Clean in place on-line cleaning) and SIP (the online sterilization of Sterilize in Place) can't be accomplished in Production Regional inside;
3, involving great expense of aseptic workspace, the operating personnel that wear aseptic work clothes not only reduce production efficiency, and need to increase the pollution cost that the processing operating personnel bring.
Also there is not a kind of equipment to address the above problem at present.
Summary of the invention
The objective of the invention is provides A level aseptic area stable, low pollution risk, that isolate fully for weighing in the sterile bulk drug production process, proportioning process link; Fundamentally solve the problem of bringing by the artificial contamination, make the operator avoid the harm of high sensitization, highly toxic product.
In order to achieve the above object; Technical scheme of the present invention has provided a kind of aseptic weighing and the proportioning process isolator; It is characterized in that: comprise the glove box assembly, on the glove box assembly, be provided with the sterile transfer interface, air treatment system places the top of glove box assembly; Be connected with aseptic butt joint valve member in the bottom of glove box assembly, the glove box assembly links to each other with drainage system.
The present invention can realize that through aseptic isolator being in a controlled environment all the time in the aseptic poisonous bulk drug weighing and burden process carries out; Make inner noxious material can not jeopardize operating personnel; Also stoped the pollutant in the external environment condition to get into isolator internal contamination sterile bulk drug, also reduced the requirement of Production Regional simultaneously the lustration class of background environment.Asepticly weigh, the change of the inner any ambient parameter of proportioning process isolator, all can obtain corresponding regulation and control, thereby realize that aseptic raw material is at the isolation of weighing with compounding links.
Advantage of the present invention is that internal pair production environment and operator and external environment condition are kept apart fully, has reduced artificial contamination's risk, has also reduced the pollution of product to operator and external environment condition simultaneously; And make the clean zone of production dwindle, make the controllability of Production Regional to increase greatly, and then reduced operating cost and maintenance cost.
Description of drawings
Fig. 1 is a kind of aseptic weighing and proportioning process spacer structures sketch map provided by the invention;
Fig. 2 A is an air conditioner unit assembly front view;
Fig. 2 B is an air conditioner unit components side view;
Fig. 3 A is a glove box assembly front view;
Fig. 3 B is a glove box components side view;
Fig. 4 is a sterile transfer device assembly structural representation;
Fig. 5 A is aseptic butt joint valve member internal structure sketch map;
Fig. 5 B is the outside sketch map of aseptic butt joint valve member.
The specific embodiment
Specify the present invention below in conjunction with embodiment.
Embodiment
As shown in Figure 1; Be a kind of aseptic weighing and the proportioning process isolator provided by the invention; Comprise top air treatment system 1; Glove box assembly 2, sterile transfer interface 3 are installed in the aseptic transfer that realizes material on the divider wall of glove box assembly 2, and aseptic butt joint valve member 4 is installed in the aseptic butt joint that glove box assembly 2 bottoms are used for realizing proportion container; Drainage system 5 is installed in the waste liquid that glove box assembly 2 bottoms are used for collecting isolator CIP, and under(-)chassis assembly 6 is used for supporting on all not isolator assemblies.
Shown in Fig. 2 A and Fig. 2 B; Air treatment system 1 comprises casing 14, and air draft blower fan 10 is located on the casing 14, and air draft blower fan 10 pipelines connect exhaust-air filter 12; On casing 14, be provided with continuous prefilter 7 and air intake filter 8, on exhaust-air filter 12, be provided with exhaust outlet 13.On casing 14, be provided with the toilet with tear lamp 11.On casing 14, be provided with the differential pressure indicator 9 that overhauls cover plate 15 and be used for detecting exhaust-air filter 12 and air intake filter 8.
Since aseptic weigh and the environment for use of proportioning process isolator minimum can be the D level; So need install 7 pairs of new wind that get into internal system of prefilter additional handles; Native system is primarily aimed at high sensitization, and highly toxic product, air intake filter 8 use single-stage PUSH-PUSH air intake H14 level high efficiency particulate air filter that new wind is handled; Can carry out the safety of filter changes; Differential pressure indicator 9 is the resistances that are used for monitoring new wind filter 8 and exhaust-air filter 12, judges whether to need to change filter through Resistance Value, and system controls whole system phase pressure to external world through the air quantity of control air draft blower fan 10; The toilet is the clean light fixtures that can be applied under hundred grades of environment with tear lamp 11; Can make system's operating surface illumination reach 500-700LUX through tear 11 installation quantity and position, be the operation that the operator can be more comfortable, and the native system inner air is discharged to background environment through exhaust-air filter 12 (selecting two-stage PUSH-PUSH air draft H14 level high efficiency particulate air filter for use) through exhaust outlet 13; Adopt two-stage filter promptly environment to be played duplicate protection; Also when changing filter, make the operator safer, all air-treatment components and parts all are installed in air treatment system casing 14, and the parts that are installed in box house through 15 pairs of cover plates of maintenance keep in repair and change.
Shown in Fig. 3 A and Fig. 3 B; Glove box assembly 2 comprises stainless steel casing 16; On stainless steel casing 16, be provided with operator running-on 17, operation gloves 24 are connected on the operator running-on 17, on stainless steel casing 16, are provided with the operation window 19 that has handle 20; Link to each other through nitrogen spring 23 between operation window 19 and the stainless steel casing 16; Operation window 19 is provided with batching docking port 21 and hydrogen peroxide solution and imports and exports 25 through 22 lockings of window locking device on stainless steel casing 16, projection electronic weighing scale 18 is located in the stainless steel casing 16.
The fence structure of stainless steel casing 16 and operation window 19 construction systems is opened internal system production environment and external environment condition and the complete isolator of operator, and the operator only allows to lead to and operates the technological operation that gloves 24 are accomplished internal system.
As shown in Figure 4; Sterile transfer interface 3 comprises material storage silo 36; Material storage silo 36 is located on the vessel flange 32 (BETA vessel flange); Be respectively equipped with a turning handle 33 in the both sides of vessel flange 32, in vessel flange 32, be provided with first flange 35 (BETA flange), seal through flange seal circle 34 (BETA flange seal circle) between first flange 35 and the vessel flange 32; First flange 35 links to each other with second flange 28; Through sealing ring 30 (ALPHA sealing ring) sealing, vessel flange 32 and second flange 28 outside, be provided with sealing flange 26 and lock between first flange 35 and second flange 28 (ALPHA flange), shake hands 29 to be located on second flange 28 by sealing snap close 27.Can realize the spreading out of of the inner discarded object of material transmission and aseptic isolator between aseptic isolator and other sterile equipment through the sterile transfer device assembly.
Shown in Fig. 5 A and Fig. 5 B; Aseptic butt joint valve member 4 comprises that upper valve body 37 reaches valve body 46 down;, upper valve body 37 is embedded with a valve seat 39 respectively in the end of valve body 46 under reaching; Be respectively equipped with valve plate 38 and lower valve plate 47 in the bottom of upper valve body 37 and at the top of following valve body 46, last valve plate 38 docks through the jockey of being located at upper valve body 37 two ends with lower valve plate 47, is provided with sealing gasket 40 at last valve plate 38 with lower valve plate 47 joints; The end of lower valve plate 47 fastens the end of valve plate 38; On last valve plate 38 and lower valve plate 47, be respectively equipped with the handle cover plate 50 and the second valve plate fixed block 48, lower valve plate 47 and on be provided with handle cover 49 outside the end of valve plate 38, rotary handle 45 links to each other with handle cover 49.
Jockey comprises the first valve plate fixed block 51; One end of the first valve plate fixed block 51 passes valve plate 38 and is located in the lower valve plate 47; Link to each other through spring 52 between outside the other end of the first valve plate fixed block 51, being with end that thimble buckles 53, the first valve plate fixed blocks 51 and thimble buckleing 53.
Use aseptic butt joint valve member 4 and can realize the aseptic aseptic that guarantees in the blending process of docking between material-compound tank and the isolator.
A kind of aseptic weigh and the work of proportioning process isolator the time is kept apart with operating personnel and background environment fully provided by the invention; The endless form of inner totally-enclosed self-loopa makes the isolator internal environment parameter can be by real-time monitoring; The production asepticize degree that is sterile bulk drug improves greatly, has also reduced the harm of poisonous high sensitization medicine to operating personnel simultaneously.