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 meticulously crafted collection incubator undergoes an impressive forty-step manufacturing process, adhering rigorously to ISO9001 and ISO14001 standards. Each product undergoes a 100% integrity test, ensuring seamless quality traceability and enhancement. Tailored to diverse testing requirements for various dosage forms and packaging, our range includes assorted cups, filters, and needles. Designed to cater to all sterilization testing needs, our collection incubators exemplify precision and innovation.
Product Rinse Sterility Test
Combination Product: The product rinse sterility test is exclusively designed for items with hollow tubes, such as infusion and infusion sets. Ideal for sterile fluid channels, this method is straightforward, requiring the adaptation of FTM media with liquid D to rinse the products. Post-elution, membrane filtration is conducted, followed by FTM and SCDM placement. Although not commonly used, this method offers simplicity and reliability.
Bulk Drugs / Biopharmaceuticals
Bulk drugs (API) undergo sterilization as per USP 71 guidelines before proceeding to the manufacturing stage, ensuring utmost safety and compliance.
Bulk biologics must adhere to sterility testing as specified by 21 CFR 610.12, utilizing a medium like FTM. Documented sample test sizes require a capacity of no less than 10 ml, ensuring meticulous adherence to standards.
Interpretation of Sterility Test Results
Technicians undergo thorough training in growth testing methods during cultivation. Microbial growth is identified by observing the medium's clarity against a light source, with turbidity indicating microbial presence. Suspect containers are further tested to differentiate microbial growth from sample decomposition. Occasionally, cloudiness arises from particle shedding or chemical reactions. Following testing, samples return to the incubator to complete the incubation period, with turbid samples monitored until the 14th day for precise assessment.
Tag:
Laboratory Petri Dish
Cell Culture Dish Bulkbuy
Petri Dish Products
Plastic Petri Dish
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