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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Our collection incubator embodies excellence, crafted through a meticulous 40-step process. Adhering strictly to ISO9001 quality and ISO14001 environmental standards, every product undergoes rigorous integrity testing ensuring unrivaled quality and traceability. Tailored to diverse testing needs, we offer an array of cups, filter materials, and precision-matched needles. Each incubator is uniquely designed to cater to varied sterilization requirements, elevating the reliability of your sterilization tests.
Product Rinse Sterility Test
Combination Product: Our Product Rinse Sterility Test is strategically designed for hollow-tube products such as infusion sets. Ideal for items not suited for soaking, where fluid channels are marked sterile. This method simplifies operations, utilizing FTM media modified with Liquid D rinse products. The eluate is membrane-filtered and carefully placed in FTM and SCDM. Although not typically employed, this method provides precision and ease for specific applications.
Bulk Drugs / Biopharmaceuticals
Our Bulk Drugs (API) meet the highest standards, undergoing sterilization in compliance with USP 71 before entering the manufacturing process, ensuring impeccable safety and efficacy.
Bulk biologics undergo stringent sterility testing following 21 CFR 610.12 guidelines. This involves precise use of medium (FTM) with sample sizes as specified, maintaining a minimum capacity of 10 ml, guaranteeing reliability and compliance with industry standards.
Interpretation of Sterility Test Results
Our technicians are expertly trained in growth testing techniques, ensuring precision in the cultivation process. Growth is carefully monitored by observing the transparency of the medium against a light source. Turbidity indicates microorganism growth; upon detection, suspected containers undergo further verification to ascertain if turbidity results from microbial presence or sample decomposition. Occasionally, cloudiness may arise from particle shedding or chemical reactions. Post-testing, samples return to the incubator for the full incubation period, with observations extending to the 14th day of the test, ensuring comprehensive analysis.
Tag:
Laboratory Petri Dish
Cell Culture Dish Bulkbuy
Petri Dish Products
Plastic Petri Dish
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