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
| Products code |
Item |
Discreption |
Usage |
| CP020028 |
D55A |
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| CPO20029 |
D90A |
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Our meticulously crafted collection incubator undergoes a sophisticated process, ensuring excellence through forty rigorous stages. Each step aligns with the stringent criteria set by the ISO9001 quality system and ISO14001 environmental standards. This commitment to quality assurance means that 100% of our products surpass the integrity test, continuously enhancing traceability and quality. Adapted for various testing demands across diverse dosage and packaging forms, we offer an array of cups, filter materials, and precise needles, resulting in the development of versatile collection incubators tailored to fulfill an array of sterilization testing requirements.
Product Rinse Sterility Test
Combination Product: The product rinse sterility test is specifically crafted for items possessing hollow tubes, such as infusion and injection sets. Inapplicable for soaking, it accommodates fluid channels marked sterile. This user-friendly method involves the modification of FTM media with liquid D rinse products. The eluate undergoes membrane filtration and is subsequently placed in FTM and SCDM. However, note that this method is not commonly employed.
Bulk Drugs / Biopharmaceuticals
Our Bulk Drugs (API) adhere to sterilization protocols as per USP 71 before they are seamlessly integrated into the manufacturing process.
Bulk Biologics are rigorously tested for sterility following the guidelines of 21 CFR 610.12, which necessitates the use of a medium (FTM) with documented sample test sizes and a minimum capacity of 10 ml.
Interpretation of Sterility Test Results
Technicians undergo comprehensive training in growth testing methodologies throughout the cultivation process. Growth is gauged by examining a typically clear medium against a light source, with any turbidity indicating microbial growth. Upon detection, the suspect container is scrutinized to establish that the turbidity arises from microbial presence and not sample decomposition. Occasionally, cloudiness may result from particle shedding or a chemical interaction with the medium. Post-testing, samples are returned to the incubator for the remainder of the incubation period. Cloudy samples in the medium are transferred for observation on the 14th day, allowing for four days of detailed display.
Tag:
Laboratory Petri Dish
Cell Culture Dish Bulkbuy
Petri Dish Products
Plastic Petri Dish
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