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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Crafted with meticulous precision, our collection incubator undergoes a rigorous journey through forty meticulous processes, each aligned with the highest standards of the ISO9001 quality system and ISO14001 environmental system. Every single product triumphs in the integrity test, illustrating our dedication to enhancing quality traceability and excellence. Tailored to meet the diverse demands of various dosage and packaging forms, we offer a broad spectrum of cups, filter materials, and compatible needles. Our collection incubators are ingeniously designed to cater to a multitude of sterilization test requirements.
Product Rinse Sterility Test
Combination Product: The Product Rinse Sterility Test delivers seamless precision for products featuring hollow tubes, such as infusion and infusion sets, particularly those unsuitable for soaking with fluid channels marked sterile. This user-friendly method involves a simple modification of FTM media with liquid D rinse products. The eluate undergoes membrane filtration and is carefully placed into FTM and SCDM. Although this method is not typically utilized, it offers a straightforward approach.
Bulk Drugs / Biopharmaceuticals
Bulk drugs (API) undergo meticulous sterilization as per USP 71 before entering the manufacturing process, ensuring top-tier quality and precision.
Bulk biologics are rigorously assessed for sterility in accordance with 21 CFR 610.12. This process involves a medium (FTM) with specified sample test sizes, ensuring a minimum capacity of 10 ml to maintain stringent quality control.
Interpretation of Sterility Test Results
Technicians undergo comprehensive training in growth testing methods during cultivation. Growth detection is achieved by examining the medium's clarity against a light source. Any turbidity indicates microbial presence. Once detected, the suspect container undergoes further testing to confirm microbial growth, ruling out decomposition, particle shedding, or chemical reactions. After testing, samples are returned to the incubator for the complete incubation period. On the 14th day, turbidity in the medium is monitored for four consecutive days to ensure accurate results.
Tag:
Laboratory Petri Dish
Cell Culture Dish Bulkbuy
Petri Dish Products
Plastic Petri Dish
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