In-Depth 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 |
Specifications and Parameters
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Item |
Discreption |
Usage |
| CP020028 |
D55A |
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| CPO20029 |
D90A |
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Crafted with precision, the collection incubator undergoes a meticulous forty-step manufacturing process. Each step adheres rigorously to ISO9001 quality and ISO14001 environmental standards. With a 100% success rate in integrity tests, our commitment to quality and traceability is unwavering. To cater to diverse testing requirements across various dosage and packaging forms, we offer an array of cups, filter materials, and compatible needles. Our innovative designs for collection incubators meet the comprehensive needs of sterilization testing, ensuring unparalleled reliability.
Sterility Test for Product Rinse
Combination Product Insight: Our Product Rinse Sterility Test is specifically tailored for products featuring hollow tubes, such as infusion and infusion sets. This method, ideal for items marked as sterile, simplifies the testing process. It involves modifying the FTM media with liquid D rinse products, followed by membrane filtration of the eluate, which is then placed in FTM and SCDM. Although this method is less commonly employed, it offers an efficient solution for fluid channel sterility testing.
Bulk Drug / Biopharmaceutical Applications
Bulk drugs (API) are meticulously sterilized pursuant to USP 71 before entering the manufacturing phase, ensuring safety and efficacy.
Bulk biologics undergo rigorous sterility testing as outlined in 21 CFR 610.12. This involves using a medium (FTM) with specified sample test sizes, with a minimum capacity of 10 ml.10 to guarantee comprehensive sterility assurance.
Sterility Test Results Analysis
Our technicians are expertly trained in growth testing methodologies during the cultivation stage. Growth is identified by examining the medium for clarity against a light source. Turbidity in the medium signals microbial growth. Upon detection, suspect containers undergo additional testing to verify that turbidity arises from microorganisms and not from sample decomposition. Occasionally, cloudiness results from particle shedding or chemical interactions with the medium. Post-testing, samples return to the incubator for extended incubation. On the 14th day of the test, samples showing turbidity are meticulously transferred and analyzed over a four-day period.
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