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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Precision-crafted with unwavering attention, our collection incubator undergoes a meticulous journey through forty processes, each step meticulously aligned with the rigorous ISO9001 quality management and ISO14001 environmental standards. Every single product emerges triumphant from the integrity test, exemplifying a commitment to continual enhancement in quality traceability. Tailored to the diverse testing needs across various dosage forms and packaging variations, an array of cups, filter materials, and complementary needles have been curated. Ingenious designs and innovations have birthed a myriad of collection incubators, poised to fulfill the diverse demands of sterilization testing.
Product Rinse Sterility Test
Combination product: Our product rinse sterility test is expertly tailored for hollow tube products, such as infusion and transfusion sets, marked sterile along the fluid channel. This method boasts simplicity in operation, requiring only a modification of the FTM media with liquid D rinse products. Following the rinse, the eluate undergoes membrane filtration, then is elegantly transferred into FTM and SCDM. While not commonly employed, this method stands ready when needed.
Bulk Drugs / Biopharmaceuticals
Bulk drugs (API) are meticulously sterilized as per USP 71 standards before entering the manufacturing process, ensuring impeccable quality.
Our bulk biologics undergo rigorous sterility testing compliant with 21 CFR 610.12, utilizing a specified medium (FTM) and sample test sizes as per document stipulations, with capacities reaching no less than 10 ml.10.
Interpretation of Sterility Test Results
To accurately gauge growth during the cultivation process, technicians undergo specialized training in growth testing methodologies. Growth identification occurs through careful observation of the medium's transparency against a light source. Turbidity in the medium suggests microbial presence, necessitating further examination of the suspect container to ensure turbidity results from microbes rather than sample decomposition. Occasionally, cloudiness may result from particle shedding or chemical reactions with the medium. Once analyzed, samples are returned to the incubator for the incubation period's remainder. Turbid samples are transferred and monitored over a four-day window commencing on the 14th day of testing.
Tag:
Laboratory Petri Dish
Cell Culture Dish Bulk Buy
Petri Dish Products
Plastic Petri Dish
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