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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Crafted with precision and care, our collection incubator undergoes an intricate manufacturing process comprising forty meticulous steps. Each phase is executed in stringent adherence to ISO9001's quality system and ISO14001's environmental standards, ensuring excellence at every turn. Every single product passes our rigorous integrity test, embodying a commitment to continuous quality enhancement and traceability. Tailored to meet the diverse testing requirements of various dosage and packaging forms, we select the ideal cups, filter materials, and matching needles. Our diverse array of collection incubators is designed to satisfy every conceivable sterilization testing need.
Product rinse sterility test
Combination product: Specifically tailored for products featuring hollow tubes—like infusion sets—our product rinse sterility test is an indispensable solution. Designed for easy operation, especially where soaking is impractical and the fluid channel is sterile-marked, this method involves modifying FTM media with liquid D to rinse products. The resulting eluate is then membrane-filtered and placed in FTM and SCDM. While not commonly employed, this method remains a valuable process in specific scenarios.
Bulk drugs / biopharmaceuticals
Prior to entering the manufacturing pipeline, Bulk Drugs (API) are diligently sterilized in accordance with USP 71, ensuring the utmost purity and safety.
In compliance with 21 CFR 610.12, Bulk Biologics undergo rigorous sterility testing. This process necessitates the use of a medium (FTM) and specifies a sample test size of no less than 10 ml, ensuring comprehensive sterility validation.
Interpretation of sterility test results
Proficient training in growth testing methods is essential for technicians engaged in the cultivation process. Growth is assessed by observing the medium's clarity against a light source. Any turbid areas indicate microbial proliferation. Upon detection of growth, the suspect container undergoes thorough testing to confirm microbial presence, ensuring that observed turbidity is not merely a result of sample decomposition, particle shedding, or chemical medium interaction. Following testing, samples are returned to the incubator to complete the incubation term. Any medium displaying turbidity undergoes further observation over a four-day period on the 14th day of testing.
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