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 collection incubator stands as a paragon of precision engineering, meticulously crafted through forty distinct processes. Each step is executed with unwavering fidelity to ISO9001 and ISO14001 standards, ensuring that every product not only passes but excels in the integrity test. The result? Unparalleled quality traceability and improvement. Tailored to diverse testing requisites, we offer an array of cups, filter materials, and needles, all designed to harmonize seamlessly, catering to the most exacting sterilization test requirements.
Product Rinse Sterility Test
Combination Product: The Product Rinse Sterility Test is ingeniously tailored for hollow tube products, such as infusion and infusion sets. It deftly bypasses the need for soaking, ideal for products marked sterile in fluid channels. This method shines in its simplicity and efficiency, utilizing modified liquid D rinse products in FTM media. The eluate is expertly filtered through a membrane, then precisely placed in FTM and SCDM. Although a specialized approach, it remains an integral option for specific applications.
Bulk Drugs / Biopharmaceuticals
Bulk Drugs (API) are meticulously sterilized per USP 71 standards, ensuring absolute sterility before they seamlessly transition into the manufacturing process.
Bulk Biologics undergo rigorous sterility testing as mandated by 21 CFR 610.12. This calls for medium (FTM) testing, with prescribed sample sizes and a minimum capacity of 10 ml.10, to ensure uncompromising safety and reliability.
Interpretation of Sterility Test Results
Technicians are expertly trained in growth testing, a pivotal aspect of cultivation. The hallmark of growth is observed within a transparent medium against a light source, where turbidity signals microorganism presence. Upon detecting growth, the container undergoes further scrutiny to verify if turbidity is microbial rather than from sample decomposition or chemical reactions. Post-confirmation, samples return to incubation, with turbid samples prominently assessed by day 14.
Tag:
Laboratory Petri Dish
Cell Culture Dish Bulkbuy
Petri Dish Products
Plastic Petri Dish
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