Ampoule breaker for aseptic isolator

An ampoule bottle and isolator technology is applied in the field of ampoule bottle breakers for sterile isolators. Effect

Active Publication Date: 2013-11-27
CHIATAI QINGCHUNBAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] According to the 2010 version of the GMP standard, the aseptic production process is adopted. Since it is a sterile preparation, the sterility inspection of the product is required. However, the existing ampoules have problems in breaking the ampoules before using the breaker: ① In the past Operating in a clean room, wearing gloves to break, due to the large sample volume (more than 200 bottles), on the one hand, it is laborious, on the other hand, it causes the risk of sample contamination; ② Gloves are in direct contact with the ampoules, and glass chips are often generated when breaking , scratched gloves, or even cut fingers, which greatly increased the risk of sample contamination while causing personal injury; ③ After using a sterile isolator, because the experimenter operates through gloves, the hand is more flexible than before in the clean area The operation has been reduced. If you still directly break the ampoule by hand, it will easily cause fatigue, and the defect of ② cannot be avoided; ④ According to our understanding, other manufacturers using sterile isolators sometimes use Hitting the neck of the ampoule directly with a hard object will easily cause glass debris to fall to the table of the isolator, and the liquid medicine will easily spill out, causing mess inside the isolator, and glass debris will easily scratch the surface of the cabin
Some of them are broken by hand directly, which cannot avoid the shortcomings of ①②③
[0003] It is troublesome to dispose of the ampoules that have absorbed the liquid medicine as experimental waste, especially when the sample volume is large, because the space inside the isolator is limited, the placement of empty ampoules will affect the subsequent experiments

Method used

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  • Ampoule breaker for aseptic isolator
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  • Ampoule breaker for aseptic isolator

Examples

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Embodiment Construction

[0020] Further illustrate the present invention below in conjunction with accompanying drawing

[0021] Referring to the attached picture:

[0022] The ampoule breaker for a sterile isolator of the present invention includes a rotor 1, a baffle plate 2, and a breaker bar 3. The rotor 1 is provided with at least one first through hole 11, and the side wall of the rotor 1 is With a handle 12; the baffle 2 is provided with a groove 21 matching the outer edge of the rotor 1, and the baffle 2 is distributed with the first through hole 11 corresponding to the position of the rotor 1 Two through holes 22, the side of the baffle plate 2 facing the rotor 1 is provided with two protrusions 23, positioning grooves 24 are formed between the protrusions 23, and the lower edge of the side wall of the rotor 1 is provided with a positioning groove Limiting rod 13, described limiting rod 13 is in contact with the protrusion on one side of positioning groove 24, and described first through hol...

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PUM

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Abstract

The invention provides an ampoule breaker for an aseptic isolator, which comprises a rotor, a baffle and a breaking rod, wherein one or more first through holes are formed in the rotor, and a rotating handle is arranged on the side wall of the rotor; a groove, which is matched with the rotor, is formed in the baffle, a second through hole, which corresponds to the first through hole, is formed in the baffle, two bulges are formed on the surface of the baffle facing the rotor, and a positioning groove is formed between the two bulges; a limited rod, which is clamped inside the positioning groove, is arranged at the lower edge of the side wall of the rotor, the limited rod is in contact with the bulge on one edge of the positioning groove, the first through hole and the second through hole are formed in a staggered manner; the limited rod is in contact with the other edge of the positioning groove, the axle line of the first through hole is overlapped with that of the second through hole; a sleeving head, which is matched with the upper end of the ampoule, is arranged at the head part of the break rod. The ampoule breaker provided by the invention has the advantages that labor is saved; an experimenter is not required to stop midway to treat rubbish; table board space of the isolator is saved; the service life of a glove is prolonged; the experimenter's hand is protected from being cut by glass chips; glass chips and medicine liquor can not be scattered in the cabin of the insulator.

Description

technical field [0001] The invention relates to an ampoule breaker for an aseptic isolator. Background technique [0002] According to the 2010 version of the GMP standard, the aseptic production process is adopted. Since it is a sterile preparation, the sterility inspection of the product is required. However, the existing ampoules have problems in breaking the ampoules before using the breaker: ① In the past Operating in a clean room, wearing gloves to break, due to the large sample volume (more than 200 bottles), on the one hand, it is laborious, on the other hand, it causes the risk of sample contamination; ② Gloves are in direct contact with the ampoules, and glass chips are often generated when breaking , scratched gloves, or even cut fingers, which greatly increased the risk of sample contamination while causing personal injury; ③ After using a sterile isolator, because the experimenter operates through gloves, the hand is more flexible than before in the clean area ...

Claims

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Application Information

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IPC IPC(8): B67B7/92
Inventor陈方军王建纲袁晓波
OwnerCHIATAI QINGCHUNBAO PHARMA