一种无菌瓶装液体敷料的微生物屏障测试工装
Microbial barrier testing of bottled sterile liquid dressings was conducted using a microbial immersion method. Staphylococcus aureus suspension was used to simulate microbial invasion, solving the problems of inaccurate detection and inability to simulate real-world environments in existing technologies. This enabled accurate identification of packaging leakage channels and assurance of product quality.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- SHANGHAI SHAGE MEDICAL TECH CO LTD
- Filing Date
- 2025-06-11
- Publication Date
- 2026-07-17
AI Technical Summary
Existing methods for testing the sealing performance of sterile liquid dressing packaging have problems such as inaccurate testing, inability to simulate actual use environments, especially inability to identify minute leaks, and may affect the chemical properties of the product or lead to inaccurate testing.
The microbial barrier of bottled products was tested using the microbial immersion method. Staphylococcus aureus bacterial suspension was used to simulate microbial invasion. Sterile sample culture medium was inverted in the bacterial suspension and fixed with a silicone sealing layer to detect whether there were leakage channels in the packaging.
It can intuitively reflect whether there are leakage channels for microbial invasion in the packaging, improving the accuracy and safety of detection, ensuring product quality, and avoiding the impact of chemical testing on the product.
Smart Images
Figure CN224513500U_ABST
Abstract
Claims
1. A microbial barrier testing fixture for aseptic bottled liquid dressings, characterized in that, The device includes a stainless steel vessel (1), in which several limiting rings (101) are fixedly installed in the lower half of the interior of the stainless steel vessel (1), and sterile sample culture medium (102) is attached to the inner wall of the several limiting rings (101). A fixed cover plate (2) is attached to the top of the stainless steel vessel (1), and a silicone sealing layer (206) is fixedly installed at the bottom of the fixed cover plate (2). Several circular locking grooves (207) are opened at the bottom of the silicone sealing layer (206), and the silicone sealing layer (206) is attached to the interior of each of the several circular locking grooves (207). The liquid dressing was removed from the bottle, and the remaining liquid in the bottle was repeatedly rinsed with sterile water. The bottle was then dried upside down under controlled conditions. Approximately 15 ml of sterilized TSB culture medium was injected into the bottle. The prepared Staphylococcus aureus suspension was diluted to 10⁶ CFU / ml. The challenge suspension was poured into an open stainless steel dish (1). The sterile sample culture medium (102) was inverted in the challenge suspension. The outer surface and neck of the sterile sample culture medium (102) should be completely immersed in the bacterial suspension. The sterile sample culture medium (102) was then dried at room temperature. The sample was inverted in the bacterial suspension for 4 hours. After the experiment, the bacterial suspension in the open container was taken to determine the bacterial concentration. The sterile sample culture medium (102) was taken out of the bacterial suspension, the residual bacterial solution on the outside of the bottle was wiped clean, and then the outside of the bottle was rinsed with sterile water. The cleaned sterile sample culture medium (102) was placed in a plastic bag and incubated at 30℃~35℃ for 14 days. After the incubation, the culture medium in each bottle was streaked on Columbia blood agar plates for verification. After 24 hours of incubation, growth on the plate was marked as "+" and no growth was marked as "-". The results were recorded.
2. A microbial barrier test kit for a sterile bottled liquid dressing according to claim 1, characterized in that: Two sets of extension plates (201) are fixedly installed on both sides of the fixed cover plate (2). A connecting shaft (202) is fixedly installed inside the two sets of extension plates (201). A flip plate (203) is movably connected to the surface of the connecting shaft (202). A threaded rod (204) is attached to the inside of the flip plate (203).
3. A microbial barrier test kit for a sterile bottled liquid dressing according to claim 1, wherein: The inner wall of the stainless steel vessel (1) is in contact with the periphery of the silicone sealing layer (206).
4. A microbial barrier test kit for a sterile bottled liquid dressing according to claim 1, wherein: A threaded rod 2 (3) is fixedly installed on the side of the stainless steel vessel (1), and a linkage washer (302) is attached to the surface of the threaded rod 2 (3).
5. A microbial barrier test kit for a sterile bottled liquid dressing according to claim 2, wherein: The threaded rod (204) has an internal threaded sleeve (205) threaded to its surface, and a flip plate (203) is attached to the side of the internal threaded sleeve (205).
6. A microbial barrier test kit for a sterile bottled liquid dressing according to claim 4, wherein: The threaded rod 2 (3) is threaded with a fastening nut (301), and a linkage washer (302) is attached to the inner side of the fastening nut (301).