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 meticulous precision, our collection incubator undergoes a rigorous journey through forty specialized processes. Each step is executed in strict adherence to ISO9001 quality and ISO14001 environmental standards, ensuring an impeccable performance. By surpassing the integrity test with a 100% success rate, our incubators exemplify excellence in quality traceability and continuous enhancement. To cater to the diverse needs of sterilization tests across various dosage forms and packaging variations, we offer a selection of specialized cups, filter materials, and matching needles, alongside a suite of customized collection incubators.
Product rinse sterility test
Combination product: Specifically designed for hollow-tube products such as infusion and transfusion sets marked sterile within their fluid channels, the product rinse sterility test offers a user-friendly method of operation. By modifying FTM media with liquid D rinse products, this process involves membrane filtration of the eluate which is subsequently placed in FTM and SCDM. While not commonly employed, this technique provides a refined approach for these specific applications.
Bulk drugs / biopharmaceuticals
Embracing rigorous standards, bulk drugs (APIs) undergo sterilization in accordance with USP 71, ensuring they are impeccably prepared for the subsequent manufacturing process.
Bulk biologics are subjected to stringent sterility testing as mandated by 21 CFR 610.12. This process necessitates the use of an FTM medium, accommodating sample test sizes as specified, with a minimum capacity requirement of 10 ml, guaranteeing the utmost reliability and safety.
Interpretation of sterility test results
In the realm of cultivation, technicians are meticulously trained in growth testing methods. Growth determination relies on scrutinizing a generally transparent medium against a light source. Any turbid regions signal potential microorganism proliferation. Upon detection of growth, the suspect container undergoes further testing to ensure that turbidity is microbe-induced rather than resulting from sample degradation or particle shedding. Occasionally, cloudiness may arise from a chemical reaction with the medium. Once testing is concluded, samples are returned to the incubator to complete the incubation period. Observations of turbidity are documented over a four-day period on the 14th day.
Tag:
Laboratory Petri Dish
Cell Culture Dish bulkbuy
Petri Dish Products
Plastic Petri Dish
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