Object taking mechanism for sterile isolator and sterile isolator

Abstract

The object taking mechanism comprises a sleeve and a piston capable of moving in the axial direction of the sleeve, the sleeve is arranged on the wall of the isolator and extends towards the outer side of the isolator, the outer diameter of the piston is matched with the inner diameter of the sleeve, a containing groove is formed in the piston, and the containing groove is communicated with the sleeve. The isolator is provided with an opening matched with the containing groove, the opening is located on the outer side of the isolator, the length of the piston is larger than that of the sleeve, and at least part of the containing groove can extend out of the sleeve and is located in the isolator. According to the object taking mechanism for the sterile isolator, the fixed sleeve and the movable piston are matched, and the opening in the sleeve is matched with the containing groove in the piston, so that a biological indicator in the isolator is transferred out of the isolator, and the damage to the internal integrity of the isolator is effectively reduced.

Description

Technical Field

[0001] The utility model specifically relates to a taking mechanism for taking out a biological indicator from a sterile isolator and a sterile isolator comprising the taking mechanism. Background Art

[0002] The manufacture and testing of sterile drugs requires a sterile environment, which is usually carried out in a sterile isolator. Sterile isolators use a closed method to isolate the operating process from the environment, which can meet the sterile environment requirements for the manufacture and testing of sterile drugs.

[0003] The common method for disinfection inside the isolator is to use hydrogen peroxide aerosol fumigation (VHP). Hydrogen peroxide aerosol reacts with microorganisms and kills them by over-oxidation.

[0004] In order to prove the disinfection effect of hydrogen peroxide in the isolator, a biological indicator (BI) is used to prove the disinfection effect. BI is a method of inoculating a certain concentration (10 3 or 10 6 Place the BI in an isolator and perform the disinfection procedure. After disinfection, the inoculated Geobacillus stearothermophilus should be killed, proving that the disinfection procedure is effective.

[0005] Before using the Bacillus stearothermophilus BI, the quality of the BI must first be identified. If the quality of the BI does not meet the requirements of relevant regulations (such as the Chinese Pharmacopoeia), then this BI cannot be used to prove the disinfection effect of the isolator. According to relevant regulations, one of the indicators of BI quality is the D value. The D value means the time required for 90% of the Bacillus stearothermophilus in the BI to be killed, and the D value is in minutes.

[0006] To test the D value, 10 (or 10 groups) of BI are placed in an isolator and VHP fumigation is turned on. When the isolator is filled with VHP, one (or a group) of BI is taken out of the isolator every minute to remove it from the VHP environment. The BI taken out of the isolator is tested in the laboratory to obtain the remaining amount of Bacillus stearothermophilus at different times, thereby calculating the D value of the BI.

[0007] Since the isolator is a closed system, it is a challenge to take one (or a group of) BIs out of the isolator every minute without compromising the integrity of the isolator.

[0008] There are two main methods currently:

[0009] 1. In the first minute, open the isolator and take out the BI, then prepare the isolator again. In the second cycle, at the second minute, open the isolator. This action is repeated 10 times, which is inaccurate and inconvenient.

[0010] Second, make a hole in the glove of the sterile isolator, seal the hole and then take out the BI through the opening of the glove. It is inconvenient and there is a risk of contaminating personnel. Utility Model Content

[0011] In view of this, in order to solve the problems of the prior art, the utility model provides a retrieval mechanism for a sterile isolator, which effectively reduces damage to the integrity of the isolator.

[0012] In order to achieve the above purpose, the utility model adopts the following technical solutions:

[0013] A retrieval mechanism for a sterile isolator, comprising a sleeve and a piston that can move axially along the sleeve, the sleeve is arranged on the wall of the isolator and extends toward the outside of the isolator, the outer diameter of the piston matches the inner diameter of the sleeve, the piston is provided with a receiving groove, the isolator is provided with an opening that matches the receiving groove, the opening is located on the outside of the isolator, the length of the piston is greater than the length of the sleeve, and the receiving groove can at least partially extend outside the sleeve and is located inside the isolator. The retrieval mechanism for a sterile isolator of the present application ensures that the overall sealing of the isolator is not affected when taking out items from the isolator.

[0014] According to some preferred implementation aspects of the utility model, the object-taking mechanism for the sterile isolator has a first state and a second state. In the first state, the receiving groove at least partially extends outside the sleeve and is located inside the isolator; in the second state, the receiving groove corresponds to the opening. In the first state, it is used to place the items inside the isolator in the receiving groove; in the second state, it is used to take out the items in the receiving groove through the opening. The transition process from the first state to the second state is the overlap process of the receiving groove and the opening.

[0015] According to some preferred implementation aspects of the utility model, the opening faces downward, and in the first state, the receiving groove faces upward, and in the second state, the receiving groove faces downward. The opening can also face upward, so that the piston can move axially during the transition from the first state to the second state. The advantage of the opening facing downward is that when the receiving groove overlaps with the opening, the biological indicator can fall directly.

[0016] According to some preferred implementation aspects of the utility model, the end of the piston away from the isolator has a limit portion, and the outer diameter of the limit portion is larger than the outer diameter of the piston and larger than the outer diameter of the sleeve. In the first state, the limit portion and the end of the sleeve are in conflict, preventing the piston from being unable to move outward after completely entering the sleeve. On the other hand, the limit portion can serve as a handle to enable the piston to move in the sleeve.

[0017] According to some preferred implementation aspects of the utility model, a sealing ring is provided between the inner wall of the sleeve and the outer wall of the piston. Preferably, sealing rings are provided on both sides of the opening to avoid further damage to the internal integrity of the isolator.

[0018] According to some preferred implementation aspects of the utility model, an annular groove is provided on the inner wall of the sleeve, and the sealing ring is arranged in the annular groove.

[0019] According to some preferred implementation aspects of the utility model, a fixing groove is provided on the outer wall of the sleeve, and the fixing groove is used to be connected to the wall of the isolator.

[0020] According to some preferred implementation aspects of the present invention, the depth of the accommodating groove is smaller than the diameter of the piston.

[0021] According to some preferred implementation aspects of the utility model, the sterile isolator taking mechanism is used to take out the biological indicator from the isolator.

[0022] The utility model also provides a sterile isolator comprising the above-mentioned object-taking mechanism for the sterile isolator.

[0023] Compared with the prior art, the utility model is advantageous in that the sterile isolator retrieval mechanism of the utility model can transfer the biological indicator in the isolator to the outside of the isolator through the cooperation of a fixed sleeve and a movable piston, and an opening on the sleeve and a receiving groove on the piston, and effectively reduce the damage to the internal integrity of the isolator. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings required for use in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0025] Figure 1 This is a schematic diagram of the structure of a sleeve in a retrieval mechanism for a sterile isolator according to a preferred embodiment of the utility model;

[0026] Figure 2This is a schematic structural diagram of a piston in a sterile isolator retrieval mechanism according to a preferred embodiment of the utility model;

[0027] Figure 3 It is a structural schematic diagram of the first state of the object-retrieving mechanism for the sterile isolator in the preferred embodiment of the utility model;

[0028] Figure 4 It is a structural schematic diagram of the sterile isolator taking mechanism in the second state in the preferred embodiment of the utility model;

[0029] Among them: sleeve-1, piston-2, limiting part-3, accommodating groove-4, opening-5, annular groove-6, fixing groove-7, first state-8, second state-9, isolator-10. DETAILED DESCRIPTION

[0030] In order to enable those skilled in the art to better understand the technical solution of the present invention, the following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solution in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work should fall within the scope of protection of the present invention.

[0031] The sterile isolator 10 in this embodiment includes conventional components of the isolator 10 and a sterile isolator retrieval mechanism fixed to the wall of the isolator 10 . The sterile isolator retrieval mechanism is used to retrieve the biological indicator from the isolator 10 .

[0032] like Figure 1-4 As shown, the object-retrieving mechanism for the sterile isolator in this embodiment includes a sleeve 1 and a piston 2 that can move axially along the sleeve 1. The sleeve 1 is fixedly arranged on the wall of the isolator 10 and extends toward the outside of the isolator 10. The outer diameter of the piston 2 matches the inner diameter of the sleeve 1. The piston 2 is provided with a receiving groove 4. The isolator 10 is provided with an opening 5 that matches the receiving groove 4. The opening 5 is located outside the isolator 10. The length of the piston 2 is greater than the length of the sleeve 1. The receiving groove 4 at least partially moves outside the sleeve 1 and is located inside the isolator 10. The depth of the receiving groove 4 is less than the diameter of the piston 2.

[0033] A sealing ring is provided between the inner wall of the sleeve 1 and the outer wall of the piston 2. An annular groove 6 is provided on the inner wall of the sleeve 1, and the sealing ring is provided in the annular groove 6. In this embodiment, sealing rings are preferably provided on both sides of the opening 5 to avoid further damage to the internal integrity of the isolator 10. A fixing groove 7 is provided on the outer wall of the sleeve 1, and the fixing groove 7 is used to connect with the wall of the isolator 10.

[0034] The object-retrieving mechanism for the sterile isolator in this embodiment has a first state 8 and a second state 9. In the first state 8, the receiving groove 4 is at least partially moved to the outside of the sleeve 1 and is located inside the isolator 10; in the second state 9, the receiving groove 4 corresponds to the opening 5. In the first state 8, it is used to place the items inside the isolator 10 in the receiving groove 4; in the second state 9, it is used to take out the items in the receiving groove 4 through the opening 5. The transition process from the first state 8 to the second state 9 is the overlap process of the receiving groove 4 and the opening 5. The opening 5 faces downward. In the first state 8, the receiving groove 4 faces upward, and in the second state 9, the receiving groove 4 faces downward. The advantage of the opening 5 facing downward is that when the receiving groove 4 overlaps with the opening 5, the biological indicator can fall directly.

[0035] In some other embodiments, the opening 5 may also be oriented upward, and in the process of transitioning from the first state 8 to the second state 9 , the piston 2 may simply move axially.

[0036] The end of the piston 2 away from the isolator 10 has a stopper 3, and the outer diameter of the stopper 3 is larger than the outer diameter of the piston 2 and larger than the outer diameter of the sleeve 1. In the first state 8, the stopper 3 and the end of the sleeve 1 are in conflict, preventing the piston 2 from being unable to move outward after completely entering the sleeve 1. On the other hand, the stopper 3 can act as a handle to enable the piston 2 to move in the sleeve 1.

[0037] The sleeve 1 is made of high-density polyethylene, preferably transparent, so that the movement of the piston 2 can be observed. In this embodiment, the sleeve 1 is a hollow shell structure with an opening 5; the piston 2 is a solid cylinder with a receiving groove 4. The sterile isolator retrieval mechanism in this embodiment is installed on the side of the isolator 10 with the operating gloves.

[0038] After the aseptic isolator retrieval mechanism is installed on the aseptic isolator 10, when in use, the piston 2 is first pushed inwards so that the receiving groove 4 on the piston 2 enters the interior of the isolator 10 and is exposed, and the retrieval mechanism is in the first state 8. Operate the gloves next to the retrieval mechanism to put one (or a group) of BI into the receiving groove 4 of the piston 2.

[0039] The piston 2 is pulled outward by the stopper 3 so that the receiving groove 4 is aligned with the opening 5. If the opening 5 of the sleeve 1 faces downward, the piston 2 is rotated 180° so that the BI falls through the opening 5. At this time, the object-retrieving mechanism is in the second state 9.

[0040] The above steps are then repeated, and the object-retrieving mechanism repeats the first state 8 and the second state 9 at regular intervals (for example, one minute) until all BIs complete the exposure time specified in the verification scheme.

[0041] The size of the receiving tank 4 in the present application is compatible with the size of the BI. Although the receiving tank 4 is in contact with the external environment, due to its relatively small size, the volume of the receiving tank 4 is negligible relative to the internal space of the entire isolator 10. Compared with the means of removing the BI in the prior art, the damage to the internal integrity of the isolator 10 is greatly reduced.

[0042] The above embodiments are only for illustrating the technical concept and features of the utility model, and their purpose is to enable people familiar with this technology to understand the content of the utility model and implement it accordingly. They cannot be used to limit the protection scope of the utility model. All equivalent changes or modifications made according to the spirit of the utility model should be included in the protection scope of the utility model.

Claims

1. A retrieval mechanism for a sterile isolator, characterized in that: It includes a sleeve and a piston which can move axially along the sleeve, wherein the sleeve is arranged on the wall of the isolator and extends toward the outside of the isolator, the outer diameter of the piston matches the inner diameter of the sleeve, the piston is provided with a receiving groove, the isolator is provided with an opening which matches the receiving groove, the opening is located on the outside of the isolator, the length of the piston is greater than the length of the sleeve, and the receiving groove can be at least partially located outside the sleeve and inside the isolator.

2. The object-taking mechanism for a sterile isolator according to claim 1, characterized in that: The retrieval mechanism for the sterile isolator has a first state and a second state. In the first state, the receiving groove is at least partially located outside the sleeve and inside the isolator; in the second state, the receiving groove corresponds to the opening.

3. The object-taking mechanism for the sterile isolator according to claim 2, characterized in that: The opening faces downward, and in the first state, the receiving groove faces upward. In the second state, the receiving groove faces downward.

4. The object-taking mechanism for a sterile isolator according to claim 1, characterized in that: The end of the piston away from the isolator has a limiting portion, and the outer diameter of the limiting portion is larger than the outer diameter of the piston.

5. The object-taking mechanism for a sterile isolator according to claim 1, characterized in that: A sealing ring is arranged between the inner wall of the sleeve and the outer wall of the piston.

6. The object-taking mechanism for the sterile isolator according to claim 5, characterized in that: An annular groove is provided on the inner wall of the sleeve, and the sealing ring is arranged in the annular groove.

7. The object-taking mechanism for a sterile isolator according to claim 1, characterized in that: A fixing groove is provided on the outer wall of the sleeve, and the fixing groove is used to be connected with the wall of the isolator.

8. The object-taking mechanism for a sterile isolator according to claim 1, characterized in that: The depth of the accommodating groove is smaller than the diameter of the piston.

9. The object-retrieving mechanism for a sterile isolator according to any one of claims 1 to 8, characterized in that: The sterile isolator taking mechanism is used for taking out the biological indicator from the isolator.

10. A sterile isolator comprising the sterile isolator retrieval mechanism according to any one of claims 1 to 9.

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