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 collection incubator is crafted with precision through forty meticulous processes, each stringently adhering to the esteemed ISO9001 quality system and the ISO14001 environmental system standards. Every single product undergoes a comprehensive integrity test, ensuring we surpass expectations in quality traceability and excellence. Tailored to meet the diverse testing requirements of various dosage and packaging forms, we meticulously select assorted cups, filter materials, and compatible needles. This dedication results in the innovative design and development of versatile collection incubators, perfectly suited for a range of sterilization tests.
Product Rinse Sterility Test
Combination Product: The Product Rinse Sterility Test is specifically designed for items with hollow tubes, such as infusion or infusion sets. It is unsuitable for soaking, ideal for sterile-marked fluid channels. This test is user-friendly, involving the modification of FTM media with liquid D rinse products. The eluate is subsequently membrane filtered and incubated in FTM and SCDM. Although effective, this method is typically less favored.
Bulk Drugs / Biopharmaceuticals
Before being released into the manufacturing process, Bulk Drugs (API) undergo rigorous sterilization in accordance with USP 71, ensuring the utmost safety and quality.
For Bulk Biologics, sterility testing is conducted per the stringent guidelines of 21 CFR 610.12. This requires utilizing a medium (FTM) with specified sample test sizes, each boasting a capacity of no less than 10 ml, ensuring comprehensive assessment and safety.
Interpretation of Sterility Test Results
Technicians, expertly trained in sophisticated growth testing methods, play a pivotal role in the cultivation process. Growth detection involves inspecting a medium that is typically clear and translucent relative to a light source. The emergence of a turbid section signifies microbial growth. Upon detecting growth, the suspect container undergoes further testing to ascertain if the turbidity stems from microbial activity or other factors like sample decomposition. Occasionally, particle shedding or chemical reactions can cause cloudiness. Following these examinations, the sample is returned to the incubator to complete the incubation period. To ensure thorough assessment, turbid samples are transferred and observed over a four-day period on the 14th day of the test.
Tag:
Laboratory Petri Dish
Cell Culture Dish Bulkbuy
Petri Dish Products
Plastic Petri Dish
){kind=link}