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 is a masterpiece of precision, meticulously crafted through forty distinct processes. Each step is executed in strict alignment with the rigorous standards of the ISO9001 quality system and the ISO14001 environmental system. We take pride in boasting a 100% success rate in our integrity tests, ensuring unwavering quality traceability and improvement. Tailored to meet the diverse testing requirements of varied dosage and packaging forms, we've curated an extensive range of cups, filter materials, and compatible needles. This painstaking selection has birthed a suite of collection incubators perfectly designed to accommodate an array of sterilization tests.
Product Rinse Sterility Test
Combination Product: The Product Rinse Sterility Test is meticulously tailored for products featuring hollow tubes, such as infusion and infusion sets, where soaking is unsuitable and the fluid channel is sterile-marked. Renowned for its simplicity, this method requires the adaptation of FTM media with liquid D rinse products. The eluate is then membrane filtered and introduced into FTM and SCDM, though it's not a commonly employed method.
Bulk Drugs / Biopharmaceuticals
Bulk Drugs (API) undergo stringent sterilization following the USP 71 standards before they are released into the manufacturing process, ensuring supreme safety and efficacy.
Bulk Biologics are subject to rigorous sterility testing in compliance with 21 CFR 610.12, mandating the use of a specialized medium (FTM) with clearly defined sample test sizes as per the documentation, and a minimum capacity of 10 ml.
Interpretation of Sterility Test Results
Technicians are required to be adept in growth testing methods throughout the cultivation process. The presence of growth is confirmed by observing the medium's clarity against a light source, where turbidity signifies microbial proliferation. If growth is detected, the suspect container undergoes further testing to ensure the turbidity is due to microbial activity and not sample decomposition, which can sometimes cause cloudiness due to particle shedding or chemical reactions. Post-testing, the samples are returned to the incubator for the rest of the incubation period, with observations made on the 14th day to track turbidity developments over four subsequent days.
Tag:
Laboratory Petri Dish
Cell Culture Dish Bulkbuy
Petri Dish Products
Plastic Petri Dish
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