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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Elevating precision and quality, our collection incubator is crafted through a meticulous and comprehensive forty-step process, strictly adhering to ISO9001 and ISO14001 standards. Each product undergoes a rigorous integrity test, ensuring unmatched quality traceability and continuous enhancement. Catering to diverse testing needs, we provide an array of cups, filter materials, and compatible needles, expertly designed for various sterilization challenges.
Product Rinse Sterility Test
Combination Product: The Product Rinse Sterility Test is tailored for products featuring hollow tubes, such as infusion sets. Ideal for items unsuitable for soaking, where the fluid channel is certified sterile. This user-friendly method involves modifying FTM media with liquid D rinse products. The filtered eluate is then analyzed using FTM and SCDM. While straightforward, this method is sparingly used.
Bulk Drugs / Biopharmaceuticals
Bulk drugs (API) undergo sterilization conforming to USP 71 standards, ensuring sterility before proceeding to the manufacturing stage.
Bulk biologics adhere to rigorous sterility testing standards outlined in 21 CFR 610.12. This requires FTM media, with specified sample sizes and a minimum capacity of 10 ml, to ensure stringent compliance.
Interpretation of Sterility Test Results
Technicians, proficient in growth testing, assess medium transparency against a light source. Microbial growth manifests as turbidity in the medium. Once detected, tests confirm microbial presence, differentiating it from sample decomposition or reactions. The process involves incubating for the remainder of the period and monitoring turbidity changes, with a review on the 14th day to ensure comprehensive evaluation.
Tag:
Laboratory Petri Dish
Cell Culture Dish Bulkbuy
Petri Dish Products
Plastic Petri Dish
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