CN215260821U

CN215260821U - Freeze-drying isolation device

Info

Publication number: CN215260821U
Application number: CN202120365939.3U
Authority: CN
Inventors: 王春娥; 李康; 刘文宾; 叶大林; 夏信群; 赵振波
Original assignee: Zhejiang Tailin Medical Engineering Co ltd; National Institutes for Food and Drug Control
Current assignee: Zhejiang Tailin Medical Engineering Co ltd; National Institutes for Food and Drug Control
Priority date: 2021-02-09
Filing date: 2021-02-09
Publication date: 2021-12-21
Anticipated expiration: 2031-02-09

Abstract

The utility model discloses a freeze-drying isolating device, including aseptic isolator and freeze dryer, aseptic isolator is connected with the freeze dryer, and the freeze dryer wholly is located outside the aseptic isolator, and the butt joint is sealed between aseptic isolator and freeze dryer, and butt joint department is equipped with the activity compartment door. The utility model discloses optimize the cooperation structure of freeze dryer and aseptic isolator, improve aseptic isolator inner space utilization, improve the operation field of vision, it is incomplete unobstructed to ventilate to arrange, and sterilization effect is good.

Description

Freeze-drying isolation device

Technical Field

The utility model relates to a pharmaceutical equipment, more specifically say that it relates to a freeze-drying isolating device.

Background

The freeze-drying system commonly used in the biological and pharmaceutical fields mainly comprises a freeze dryer and an aseptic isolator, wherein the input end of the freeze dryer is usually embedded into a cabin of the aseptic isolator in order to avoid pollution caused by the freeze-drying process of the conventional freeze-drying system. This not only crowds the inner space who has occupied aseptic isolator considerable part, influences the operation field of vision and ventilates and arrange incomplete smoothness, and various concave-convex structure of freeze dryer input still very easily form the dead angle that the medicament of disinfecting is difficult to cover, provide the environment of breeding for harmful bacterium. The invention patent application with publication number CN106016978A discloses an aseptic freeze-drying isolator system for laboratory medicines in 2016, 10, 12, and belongs to the field of pharmaceutical equipment. The sterile injection system is simple in structure, high in cleanliness and good in sealing performance, can provide a safe and reliable sterile environment for freeze-drying experiments of novel sterile medicines, can effectively prevent experimenters from being invaded by toxic medicines during experiments of the toxic medicines, provides effective safety protection for health of the experimenters, reduces requirements of the background environment of equipment, is beneficial to saving operation cost, and has high practicability. However, the invention also has the defects that the input end of the freeze dryer is embedded into the cabin of the sterile isolator, and the utilization rate of the internal space of the sterile isolator, the operation visual field, the ventilation and residue discharge smoothness and the sterilization effect are influenced.

SUMMERY OF THE UTILITY MODEL

Among the current freeze-drying system, the cooperation structure of freeze dryer and aseptic isolator is unreasonable, and to aseptic isolator inner space utilization, operation field of vision, the incomplete unobstructed degree of row that ventilates and sterilization effect all have adverse effect, for overcoming these defects, the utility model provides an optimize the cooperation structure of freeze dryer and aseptic isolator, aseptic isolator inner space utilization is high, and the operation field of vision is good, ventilates to arrange incomplete unobstructed, the freeze-drying isolating device that sterilization effect is good.

The technical scheme of the utility model is that: the utility model provides a freeze-drying isolating device, includes aseptic isolator and freeze dryer, and aseptic isolator is connected with the freeze dryer, and the freeze dryer is whole to be located outside aseptic isolator, and the sealed butt joint between aseptic isolator and freeze dryer, butt joint department are equipped with the activity partition door. The utility model discloses improved structural design, freeze dryer and the sealed butt joint of aseptic isolator set up the activity partition door between freeze dryer and the aseptic isolator, realize that freeze dryer and isolator sterilize jointly or sterilize alone. The freeze dryer is not required to be embedded into the sterile isolator, so that space waste, time consumption increase of sterilization and sterilization dead angles cannot be caused in the sterile isolator. The aseptic isolator and the freeze dryer can be kept relatively independent on the premise of not influencing intercommunication, isolation protection is carried out on the key operation process of strain freeze-drying, the risk that the operation process is polluted by the external environment is reduced to the maximum extent, meanwhile, the risk that the environment is possibly polluted is also reduced, and a smooth, standard and effective strain freeze-drying control flow is provided.

Preferably, the sterile isolator is connected with the freeze dryer through a butt flange. The sealing connection between the sterile isolator and the freeze dryer can be conveniently realized through the butt flange.

Preferably, the sterile isolator comprises an isolator transfer cabin and an isolator experiment cabin, a transfer door is arranged between the isolator transfer cabin and the isolator experiment cabin, and the isolator experiment cabin is connected with the freeze dryer. Inputting strains and experimental instruments required by strain freeze-drying into a sterile isolator from an isolator transfer chamber, reversely transferring the strains after freeze-drying, and outputting the strains from the isolator transfer chamber; the isolator experiment chamber is used for performing pre-treatment and post-treatment of strain freeze-drying; opening the transfer door and the movable partition door, opening the isolator for sterilizing, biologically decontaminating the articles, equipment surface and space in the isolator experiment chamber and the isolator transfer chamber, and sterilizing the freeze dryer and the isolator.

Preferably, a hydrogen peroxide decomposition device is provided in the aseptic isolator. The hydrogen peroxide decomposition device realizes the rapid decomposition of the sterilized hydrogen peroxide so as to reach the safe concentration meeting the emission requirement, shorten the sterilization and residue discharge time and greatly reduce the time cost.

Preferably, the sterile isolator is connected with a vacuum device, and a strain tube sealing device is arranged in the sterile isolator. The vacuum device can provide a vacuum environment for the sterile isolator, so that the strain is subjected to vacuum packaging work in the sterile environment of the isolator after being freeze-dried in the freeze dryer.

Preferably, a vacuum line is connected between the freeze dryer and the sterile isolator. The gas that the freeze dryer vacuumed can be discharged to the isolator cavity, need not freeze dryer external exhaust pipeline, reduces design cost and material cost.

Preferably, the freeze-drying isolation device further comprises a freeze-drying machine condensed water collection device, and the freeze-drying machine condensed water collection device is communicated with the sterile isolator. The freeze dryer condensed water collecting device is used for collecting condensed water generated in the freeze drying process of the freeze dryer and discharging the condensed water from the sterile isolator, so that a pipeline is simplified, and the design cost and the material cost are reduced.

The utility model has the advantages that:

the matching structure of the freeze dryer and the sterile isolator is optimized, the utilization rate of the inner space of the sterile isolator is improved, and the operation visual field is improved. The utility model discloses in well freeze dryer need not to imbed aseptic isolator, aseptic isolator inside can not consequently lead to the space extravagant and the field of vision is obstructed.

The ventilation and residue discharge are smooth, and the sterilization effect is good. The utility model discloses inside well freeze dryer need not the aseptic isolator of embedding, it is more unobstructed to ventilate to arrange the incomplete, still can eliminate the sterilization dead angle, gains better sterilization effect.

Drawings

Fig. 1 is a schematic structural view of the present invention;

fig. 2 is a front view of the present invention;

fig. 3 is a schematic view of an internal structure of the present invention;

fig. 4 is a top view of the present invention.

In the figure, 1-a sterile isolator, 2-a freeze dryer, 3-a movable partition door, 4-an isolator transfer chamber, 5-an isolator experiment chamber, 6-a transfer door, 7-a butt flange, 8-a residue discharge port, 9-a glass chamber door, 10-a glove operation port, 11-an experiment chamber air taking port, 12-a hydrogen peroxide liquid storage bottle and 13-a freeze dryer condensate water collecting device.

Detailed Description

The present invention will be further described with reference to the following detailed description of the embodiments.

Example 1:

as shown in fig. 1 to 4, a freeze-drying isolation device comprises an aseptic isolator 1 and a freeze dryer 2, wherein the aseptic isolator 1 is connected with the freeze dryer 2, the freeze dryer 2 is integrally positioned outside the aseptic isolator 1, the aseptic isolator 1 is in sealed butt joint with the freeze dryer 2, and a movable partition door 3 made of transparent glass is arranged at the butt joint position. The sterile isolator 1 and the freeze dryer 2 are respectively provided with an opening with corresponding positions, the two openings are connected through a butt flange 7, and the movable partition door 3 is hinged on the opening of the sterile isolator 1. The sterile isolator 1 comprises an isolator transmission cabin 4 and an isolator experiment cabin 5, a transmission door 6 is arranged between the isolator transmission cabin 4 and the isolator experiment cabin 5, the isolator experiment cabin 5 is connected with a freeze dryer 2, a glass cabin door 9 of an upturning structure is arranged on the front face of the isolator experiment cabin 5, and four glove operation ports 10 are arranged on the glass cabin door 9. The top of the isolator experiment chamber 5 is provided with an experiment chamber air intake 11 and a residue discharge port 8 for discharging air and discharging residues, a hydrogen peroxide decomposition device is arranged in the sterile isolator 1, and a hydrogen peroxide liquid storage bottle 12 is arranged on the sterile isolator 1. The sterile isolator 1 is connected with a vacuum device, and a strain tube sealing device is arranged in the sterile isolator 1. A vacuum pipeline is connected between the freeze dryer 2 and the sterile isolator 1. Still include freeze dryer comdenstion water collection device 13, freeze dryer comdenstion water collection device and aseptic isolator 1 intercommunication.

Putting strains, experimental instruments and the like required by strain freeze-drying into an isolator transfer chamber 4; opening a transfer door 6 and a movable partition door 3 between an isolator transfer chamber 4 and an isolator experiment chamber 5, starting a co-sterilization procedure of the sterile isolator 1, simultaneously performing biological decontamination on articles, equipment surfaces and spaces in the isolator experiment chamber 5 and the isolator transfer chamber 4, and sterilizing the freeze dryer 2 and the sterile isolator 1 together. Ventilating according to the set time to remove residues, and reducing the concentration of vaporized hydrogen peroxide in the sterile isolator 1 to the sterile test safety concentration; after the biological decontamination cycle is finished, the related operation of strain freeze-drying is finished through the glove operation port 10; completing vacuum packaging of the sample in the isolator experiment chamber 5; after the experiment is finished, transferring the sample from the isolator experiment chamber 5 to the isolator transfer chamber 4 through the transfer door 6 and taking out the sample; after the whole strain is freeze-dried, opening the material inlet and outlet door of the isolator transfer chamber 4, and finally taking out the waste and cleaning the chamber body.

Example 2:

three glove operating openings 10 are arranged on the glass hatch 9. The rest is the same as example 1.

Claims

1. The utility model provides a freeze-drying isolating device, includes aseptic isolator (1) and freeze dryer (2), aseptic isolator (1) is connected with freeze dryer (2), and characterized by freeze dryer (2) wholly is located aseptic isolator (1) outside, and aseptic isolator (1) and freeze dryer (2) are sealed to be docked, and butt joint department is equipped with movable partition door (3), is equipped with hydrogen peroxide decomposition device (8) in aseptic isolator (1).

2. Lyophilization/isolation apparatus as claimed in claim 1, characterized in that the sterile isolator (1) is connected to the lyophilizer (2) by means of a docking flange (7).

3. The lyophilization isolator as claimed in claim 1, wherein the sterile isolator (1) comprises an isolator transfer compartment (4) and an isolator experiment compartment (5), a transfer door (6) is provided between the isolator transfer compartment (4) and the isolator experiment compartment (5), and the isolator experiment compartment (5) is connected with the lyophilizer (2).

4. The freeze-drying isolation device as claimed in claim 1, wherein the sterile isolator (1) is connected with a vacuum device, and a strain tube sealing device is arranged in the sterile isolator (1).

5. Lyophilization/isolation device according to claim 1, characterized in that a vacuum line is connected between the lyophilizer (2) and the sterile isolator (1).

6. Lyophilization isolator apparatus as claimed in claim 1 or 2 or 3 or 4 or 5, further comprising a lyophilizer condensate collecting means, the lyophilizer condensate collecting means being in communication with the sterile isolator (1).