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, our collection incubator undergoes an impressive forty-step manufacturing process, meticulously adhering to the stringent ISO9001 quality standards and ISO14001 environmental guidelines. Every product is subjected to a rigorous integrity test, ensuring quality traceability and fostering continuous excellence. Catering to diverse testing needs, we've carefully curated a range of cups, filter materials, and compatible needles. Our incubators are ingeniously designed to accommodate various sterilization tests, providing unmatched adaptability and precision.
Product Rinse Sterility Test
Combination Product: The Product Rinse Sterility Test is specifically crafted for items with hollow tubes, such as infusion and infusion sets. It is ideal for products not suited to soaking, with fluid channels explicitly marked as sterile. This method is simple to execute, requiring an adjustment of FTM media using liquid D rinse. The eluate is then membrane-filtered and placed in FTM and SCDM. Although effective, this method is not commonly employed.
Bulk Drugs / Biopharmaceuticals
Bulk drugs, also known as Active Pharmaceutical Ingredients (API), are meticulously sterilized in alignment with USP 71 standards before being introduced to the manufacturing process, ensuring uncompromised quality and safety.
Bulk biologics undergo stringent sterility testing as per 21 CFR 610.12 regulations, necessitating the use of FTM medium. This process involves specific sample test sizes, ensuring a capacity of no less than 10 ml, thereby safeguarding integrity and compliance.
Interpretation of Sterility Test Results
Technicians engaged in the cultivation process must be adept in growth testing methods. Growth determination is conducted by scrutinizing the medium, which remains mostly transparent under a light source. Any turbid regions signify microbial growth. Upon detection, the suspect container is critically evaluated to verify microbial presence rather than sample decomposition. Occasionally, cloudiness results from particle shedding or chemical reactions with the medium. Post-evaluation, samples are returned to the incubator to complete the incubation cycle. On the 14th day of testing, samples exhibiting turbidity are transferred for further display over a four-day period.
Tag:
Laboratory Petri Dish
Cell Culture Dish Bulkbuy
Petri Dish Products
Plastic Petri Dish
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