In-Depth Product Overview
| 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 |
Product Specifications
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Item |
Discreption |
Usage |
| CP020028 |
D55A |
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| CPO20029 |
D90A |
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The precision-crafted collection incubator is meticulously manufactured through a series of forty rigorous processes. Each step adheres strictly to the ISO9001 quality management system and ISO14001 environmental stewardship standards. With an impeccable integrity test pass rate of 100%, we ensure consistent excellence in quality traceability and improvement. Tailored to the testing requirements of varying dosage and packaging forms, we offer an array of cups, filter materials, and compatible needles, culminating in the development of diverse collection incubators that cater to the comprehensive needs of sterilization testing.
Sterility Testing for Product Rinse
Combination Product: The Product Rinse Sterility Test is specifically designed for products with hollow tubes, such as infusion and transfusion sets. This method is ideal when soaking is not applicable, and a sterile fluid channel is required. Its simplicity lies in modifying FTM media using liquid D rinse products. The eluate undergoes membrane filtration before being placed in FTM and SCDM. Typically, this method is not the standard choice.
Bulk Pharmaceuticals / Biopharmaceuticals
Bulk Drugs (Active Pharmaceutical Ingredients) undergo sterilization in compliance with USP 71 before proceeding to the manufacturing phase, ensuring safety and efficacy.
Bulk Biologics undergo sterility testing as prescribed by 21 CFR 610.12. This regulation mandates the use of a specific medium (FTM) with detailed sample test sizes, each having a minimum capacity of 10 ml.
Understanding Sterility Test Outcomes
Technicians undergo thorough training in growth testing methodologies during cultivation. Growth is identified by examining the transparent medium against a light source; any turbidity signals microbial presence. Upon detecting growth, further tests determine if turbidity is microbial or a result of sample decomposition. Occasionally, cloudiness may arise from particle shedding or chemical interactions with the medium. Post-testing, samples return to the incubator for the remaining incubation period. On the 14th day, turbid samples are transferred for observation over a four-day span to ensure accuracy.
Category:
Laboratory Grade Petri Dish
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Petri Dish Product Line
Durable Plastic Petri Dish
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