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
| Products code |
Item |
Discreption |
Usage |
| CP020028 |
D55A |
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| CPO20029 |
D90A |
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The collection incubator is masterfully crafted through a meticulous process encompassing forty distinct stages, each adhering strictly to ISO9001 quality and ISO14001 environmental standards. Every product undergoes a rigorous integrity test, ensuring unparalleled quality traceability and consistency. Tailored to accommodate varying testing requirements across diverse dosage and packaging forms, an array of cups, filter materials, and compatible needles are meticulously selected. Consequently, a diverse range of collection incubators has been innovatively designed and engineered to precisely cater to various sterilization testing needs.
Product Rinse Sterility Test
Combination Product: The Product Rinse Sterility Test is specifically designed for hollow tube products, such as infusion and infusion sets, where soaking is unsuitable, and the fluid channel is marked sterile. This method is straightforward and involves the modification of FTM media using liquid D rinse products. The eluate is membrane filtered before being placed into FTM and SCDM, though it is typically reserved for select applications.
Bulk Drugs / Biopharmaceuticals
Bulk Drugs (API) undergo sterilization according to USP 71 guidelines before advancing to the manufacturing process, ensuring unparalleled safety and efficacy.
Bulk Biologics are rigorously tested for sterility in alignment with 21 CFR 610.12. This protocol mandates a medium (FTM) that adheres to specific test sample sizes as stipulated in the documentation, boasting a capacity of no less than 10 ml.10.
Interpretation of Sterility Test Results
Technicians receive comprehensive training in growth testing methodologies during the cultivation phase. Growth is discerned by examining a generally clear medium against a light source, where any turbid area signifies microbial proliferation. Upon detecting growth, the suspect container undergoes further testing to ascertain whether the turbidity arises from microbial activity or sample decomposition. Occasionally, cloudiness may result from particle shedding or chemical reactions with the medium. Post-testing, samples return to the incubator for the duration of the incubation period. Cloudy samples in the medium are re-evaluated on the 14th day of the test, ensuring accuracy and reliability.
Tag:
Laboratory Petri Dish
Cell Culture Dish Bulkbuy
Petri Dish Products
Plastic Petri Dish
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