Detailed Product Description
| products appearance |
Light yellow, flat surface, no cracks, no visible impurities and bubbles |
| physicochemical property |
PH acceptable, gel strength 500-750g/cm2 |
| Sterility and water retention |
30-35ºC,Culture for 5 days, no bacterial growth,Culture for 5 days, no bacterial growth, no obvious water loss phenomenon |
| Packing |
Class A laminar flow production line automatic canning, to avoid the risk of personnel pollution |
| Growth experiment |
Inoculate the corresponding strains 50-100CFU according to the pharmacopoeia, and the ratio of the mean number of colonies on the test solid medium to the mean number of colonies on the control medium should be within the range of 0.5-2, and the size of the colonies should be consistent with the colonies on the control medium |
Parameter
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Item |
Discreption |
Usage |
| CP020028 |
D55A |
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| CPO20029 |
D90A |
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The collection incubator stands as a testament to meticulous craftsmanship, crafted through a series of forty precise processes, each rigorously adhering to the esteemed ISO9001 quality management and ISO14001 environmental standards. Every single product emerges from the production line having achieved a flawless integrity check, ensuring unparalleled consistency in quality traceability and excellence. Catering to the diverse needs of various dosage forms and packaging, our selection process for cups, filter materials, and compatible needles is conducted with acute precision. This dedication results in a range of expertly designed collection incubators, each tailored to fulfill an array of sterilization test requirements.
Product Rinse Sterility Test
Combination Product: The Product Rinse Sterility Test is meticulously designed for products featuring hollow tubes, such as infusion and infusion sets, which are marked with a sterile fluid channel and not suited for soaking. This method, renowned for its simplicity, involves modifying FTM media with liquid D rinse. The resulting eluate undergoes membrane filtration and is then placed in FTM and SCDM. Although not frequently employed, it offers a streamlined approach to sterility testing.
Bulk Drugs / Biopharmaceuticals
Bulk Drugs (API) undergo a rigorous sterilization process, aligned with USP 71 standards, before being released into the manufacturing pipeline, ensuring they meet the highest quality and safety benchmarks.
Bulk biologics undergo sterility testing as specified in 21 CFR 610.12, which mandates the use of a medium (FTM) with defined sample test sizes, each possessing a minimum capacity of 10 ml, to guarantee precise and reliable results.
Interpretation of Sterility Test Results
During the cultivation process, technicians are extensively trained in growth testing methodologies. The identification of growth is based on observing the medium's transparency against a light source; turbid areas signify microbial presence. Once growth is detected, the suspect container is meticulously examined to ascertain that the turbidity is indeed microbial rather than resulting from sample degradation. Occasionally, cloudiness may stem from particle shedding or chemical interactions with the medium. Post-testing, the sample is returned to the incubator to complete the incubation cycle. Any samples exhibiting turbidity are transferred and observed for four additional days, culminating on the 14th day of testing.
Tag:
Laboratory Petri Dish
Cell Culture Dish Bulkbuy
Petri Dish Products
Plastic Petri Dish
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