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 an astounding forty-step process, adhering stringently to the ISO9001 quality management and ISO14001 environmental standards. Each creation is subjected to a rigorous integrity test, achieving unparalleled quality traceability and continual quality enhancement. Tailored to meet diverse testing demands across various dosage and packaging formats, an array of cups, filter materials, and compatible needles are meticulously selected, culminating in the development of sophisticated collection incubators designed to excel in various sterilization tests.
Product Rinse Sterility Test
Combination Product: The product rinse sterility test is exclusively crafted for items with hollow tubes, such as infusion and infusion sets, which preclude suitability for soaking. The fluid channel is designated as sterile. This method is lauded for its ease of operation, requiring the adaptation of FTM media with liquid D rinse products. The eluate undergoes meticulous membrane filtration before being placed in FTM and SCDM. However, this method is traditionally not prevalent.
Bulk Drugs / Biopharmaceuticals
Bulk Drugs (API) are subjected to sterilization in accordance with USP 71 prior to being released into the manufacturing process, ensuring uncompromised purity and safety.
Bulk biologics undergo rigorous sterility testing as stipulated by 21 CFR 610.12. This necessitates the usage of a medium (FTM) with specified sample test sizes documented, ensuring a minimum capacity of 10 ml.
Interpretation of Sterility Test Results
Technicians receive comprehensive training in growth testing methodologies during the cultivation phase. Growth is discerned by examining a medium that remains generally transparent when aligned with the light source, while the turbid regions within the medium signify microbial proliferation. Once growth is identified, the suspect container is thoroughly examined to ascertain whether the turbidity is microbial in origin, distinct from decomposition, or due to other factors such as particle shedding or chemical reactions with the medium. Post-testing, samples are returned to the incubator to complete the remaining incubation duration. Any samples exhibiting turbidity within the medium are meticulously transferred and observed over a four-day period leading up to the 14th day of testing.
Tag:
Laboratory Petri Dish
Cell Culture Dish Bulk Buy
Petri Dish Products
Plastic Petri Dish
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