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 is meticulously crafted through forty rigorous processes, each meticulously adhering to the ISO9001 quality system and ISO14001 environmental standards. Every product undergoes and passes a comprehensive integrity test, fostering continuous enhancement in quality traceability and assurance. Tailored to accommodate varying testing requirements across different dosage and packaging forms, we have handpicked diverse cups, filter materials, and matching needles, ingeniously developing collection incubators to seamlessly cater to all sterilization test needs.
Product Rinse Sterility Test
Combination Product: Our Product Rinse Sterility Test is expertly designed exclusively for products featuring hollow tubes, such as infusion sets, where soaking is unsuitable and the fluid channel is certified sterile. This elegantly simple procedure involves modifying FTM media with liquid D rinse products, followed by efficient membrane filtration of the eluate, and placement in FTM and SCDM. Generally, this method is not conventionally employed.
Bulk Drugs / Biopharmaceuticals
Bulk drugs (API) undergo sterilization in accordance with USP 71 before being introduced into the manufacturing process, ensuring pristine quality and reliability.
Bulk biologics are subjected to stringent sterility tests as per 21 CFR 610.12, mandating a medium (FTM) with specified sample test sizes and a volume of no less than 10 ml.
Interpretation of Sterility Test Results
Technicians undergo specialized training in growth testing methods during the cultivation process. Microbial growth becomes apparent by examining a generally clear medium against a light source, with any turbid areas indicating microbial presence. Upon detecting growth, the suspect container is meticulously tested to ascertain that the turbidity results from microbes, rather than sample degradation. Occasionally, cloudiness arises from particle shedding or chemical interactions with the medium. Post-testing, the sample is returned to the incubator for the remainder of the incubation period. On the 14th day, samples exhibiting turbidity are transferred and showcased for four days.
Tag:
Laboratory Petri Dish
Cell Culture Dish Bulkbuy
Petri Dish Products
Plastic Petri Dish
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