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 meticulously crafted collection incubator goes through a rigorous 40-step manufacturing process, ensuring each phase aligns with the highest standards of ISO9001 quality and ISO14001 environmental systems. Every single product undergoes and passes integrity testing, signifying our commitment to consistent quality improvements and traceability. Designed to cater to a variety of sterilization tests, these incubators are equipped with diverse cups, filter materials, and compatible needles, meticulously selected based on unique testing needs across different dosage and packaging forms.
Product Rinse Sterility Test
Combination Product: The product rinse sterility test is crafted specifically for items with hollow tubes, such as infusion and infusion sets. This method is ideally suited for products where the fluid channel is marked sterile and is impractical for soaking. The process involves a simple operation requiring the modification of FTM media with liquid D rinse products. The eluate then undergoes membrane filtration and is subsequently placed in FTM and SCDM. While effective, this method is not commonly employed.
Bulk Drugs / Biopharmaceuticals
Our bulk drugs (Active Pharmaceutical Ingredients, API) are sterilized in strict adherence to USP 71 standards before they proceed to the manufacturing process, ensuring utmost safety and quality.
Bulk biologics are subjected to thorough sterility testing aligned with 21 CFR 610.12 guidelines. This involves using a medium (FTM) and adhering to sample test sizes as specified in the document, with a minimum capacity of 10 ml to ensure precise and reliable results.
Interpretation of Sterility Test Results
Our highly trained technicians are experts in growth testing methodologies during cultivation. Microbial growth is identified by inspecting the medium's transparency against a light source, where any turbidity signals microorganism presence. When growth is detected, the suspect container is retested to confirm whether the turbidity results from microbial activity or is merely a chemical reaction or particle shedding within the medium. Post-testing, samples are returned to the incubator for the remainder of the incubation period. These samples, if turbid, are carefully monitored and displayed over four days by the 14th day of the testing cycle.
Tag:
Laboratory Petri Dish
Cell Culture Dish Bulkbuy
Petri Dish Products
Plastic Petri Dish
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