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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The collection incubator is meticulously crafted through a comprehensive and rigorous forty-step process, each adhering stringently to the esteemed ISO9001 quality standards and ISO14001 environmental protocols. Achieving a flawless 100% pass rate in integrity testing, our products consistently demonstrate excellence in quality traceability and improvement. Catering to the diverse testing requirements dictated by varying dosage and packaging forms, we offer an array of options including cups, filter materials, and complementary needles. Our innovative designs and developments in collection incubators ensure they are perfectly suited to meet all sterilization test requirements.
Product Rinse Sterility Test
Combination Product: The Product Rinse Sterility Test is exclusively tailored for products featuring hollow tubes, such as infusion sets, where soaking is not feasible. With fluid channels marked as sterile, this method is both straightforward and efficient, requiring only the modification of FTM media with liquid D rinse products. The process involves membrane filtration of the eluate, which is subsequently placed in FTM and SCDM. Due to its specificity, this method is not commonly employed.
Bulk Drugs / Biopharmaceuticals
Bulk drugs (API) undergo stringent sterilization in accordance with USP 71 standards before they are released into the manufacturing process, ensuring top-tier safety and efficacy.
Bulk biologics are subjected to sterility testing as per the stringent guidelines of 21 CFR 610.12. This necessitates the use of a medium (FTM) with sample sizes specified within the documentation, mandating a capacity of no less than 10 ml.
Interpretation of Sterility Test Results
During growth testing, technicians must be adeptly trained in precise methodologies. Growth indication is ascertained by observing the normally transparent medium against a light source. Turbidity signifies microorganism growth. Upon detection, the suspect sample is rigorously tested to verify microbial presence rather than sample decomposition. Occasionally, cloudiness arises from particle shedding or chemical interactions. Post-assessment, the sample returns to incubation for the remaining period. On day 14, samples exhibiting turbidity are meticulously transferred for four days of additional observation.
Tag:
Laboratory Petri Dish
Cell Culture Dish Bulkbuy
Petri Dish Products
Plastic Petri Dish
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