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 |
|
|
| CPO20029 |
D90A |
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
Our state-of-the-art collection incubator is a masterpiece, meticulously crafted through forty distinct processes. Each step aligns strictly with the rigorous ISO9001 quality system and the ISO14001 environmental standards. With a 100% pass rate in our integrity tests, we've made significant strides in quality traceability and enhancement. Tailored to meet diverse testing needs, we offer an array of cups, high-performance filter materials, and matching needles, developed to cater to various sterilization tests, ensuring precision and efficiency in every application.
Product Rinse Sterility Test
Combination Product: Our specialized Product Rinse Sterility Test is innovatively designed for products featuring hollow tubes, such as infusion and infusion sets. These are unsuitable for soaking, and if the fluid channel is sterilized, our method offers seamless operation. By ingeniously modifying the FTM media with liquid D rinse products, the eluate undergoes membrane filtration, then is placed in FTM and SCDM. While typically not the first choice, this procedure ensures the utmost sterility and quality assurance.
Bulk Drugs / Biopharmaceuticals
Our Bulk Drugs (API) are diligently sterilized following the esteemed USP 71 standards, ensuring they are impeccably safe and ready for the manufacturing process.
Bulk Biologics adhere to the stringent sterility testing of 21 CFR 610.12. This requires the use of a sophisticated medium (FTM) with exacting sample test sizes as prescribed in the documentation, maintaining a minimum capacity of 10 ml to ensure reliable and accurate results.
Interpretation of Sterility Test Results
During cultivation, our technicians are expertly trained in advanced growth testing methods. Growth is meticulously assessed by examining a generally transparent medium against a light source. Any turbid areas signal microorganism growth. Upon detection, we rigorously test the suspect container to ascertain that observed turbidity arises from microbial presence rather than sample decomposition. Occasionally, samples may turn cloudy due to particle shedding or chemical reactions with the medium. After thorough testing, samples return to the incubator to complete the incubation period. By the 14th day, turbid samples are transferred and displayed for additional observation over four days, ensuring comprehensive verification.
Tag:
Laboratory Petri Dish
Cell Culture Dish Bulkbuy
Petri Dish Products
Plastic Petri Dish
){kind=link}