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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Our collection incubator represents the pinnacle of meticulous craftsmanship, subjected to a rigorous 40-step manufacturing process. Each phase aligns with the ISO9001 quality management and ISO14001 environmental standards, ensuring perfection. Every single product passes the integrity test, demonstrating our commitment to unwavering quality and traceability enhancement. Tailored to diverse testing demands, we offer a selection of cups, filter materials, and precision-matched needles, creating a versatile array of collection incubators designed to meet the highest sterilization testing standards.
Product Rinse Sterility Test
Combination Product: The Product Rinse Sterility Test is expertly tailored for hollow tube products, such as infusion and infusion sets. These products require a sterile fluid channel and are unsuitable for soaking. This method stands out for its operational ease, involving the modification of FTM media with liquid D rinse products. Following this, the eluate undergoes membrane filtration before placement in FTM and SCDM. However, this method is generally reserved for specific applications.
Bulk Drugs / Biopharmaceuticals
Bulk drugs (API) undergo thorough sterilization in alignment with USP 71, ensuring they are in pristine condition before entering the manufacturing process.
Bulk biologics are subject to rigorous sterility testing as per 21 CFR 610.12. This regulation mandates the use of a medium (FTM), with specified test sizes detailed in the documentation, ensuring a minimum capacity of 10 ml.10 for reliable sterility assurance.
Interpretation of Sterility Test Results
Technicians are meticulously trained in growth testing methods during cultivation, with growth indicated by turbid areas in an otherwise transparent medium. If growth is observed, the suspect container undergoes further testing to verify microbial presence rather than sample decomposition. Occasionally, cloudiness results from particle shedding or chemical reactions with the medium. Post-testing, samples return to the incubator to complete the incubation period. On the 14th day, turbid samples are carefully transferred and examined over a four-day span.
Tag:
Laboratory Petri Dish
Cell Culture Dish Bulkbuy
Petri Dish Products
Plastic Petri Dish
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