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 a masterpiece of meticulous craftsmanship, undergoing an extensive manufacturing process with over forty carefully executed stages. Each step adheres stringently to the prestigious ISO9001 quality system and ISO14001 environmental standards, ensuring unparalleled excellence. Every single product triumphs through rigorous integrity tests, achieving a benchmark of quality that is continuously traceable and consistently improving. Designed with versatility in mind, our incubators are equipped with a wide array of cups, filter materials, and precision needles, tailored to suit diverse dosage forms and packaging requirements, thus addressing comprehensive sterilization testing needs with unmatched efficiency.
Product Rinse Sterility Test
Combination Product: The product rinse sterility test is specifically tailored for hollow-tube products such as infusion and infusion sets. Unlike soaking, this method uniquely suits products where the fluid channel is marked sterile, offering user-friendly operation. It requires the modification of FTM media alongside liquid D rinse products. The resulting eluate undergoes membrane filtration and is placed in both FTM and SCDM. However, this method is generally reserved for specific use cases.
Bulk Drugs / Biopharmaceuticals
Bulk drugs (API) undergo stringent sterilization according to the rigorous standards of USP 71 before they are released for manufacturing, ensuring their utmost purity and safety.
Bulk biologics are subjected to comprehensive sterility testing in accordance with 21 CFR 610.12. This demands a medium (FTM) with meticulously defined sample test sizes detailed in the document, boasting a capacity of no less than 10 ml, thereby guaranteeing rigorous quality assurance.
Interpretation of Sterility Test Results
Technicians are required to master growth testing methods throughout the cultivation process. Growth is meticulously determined by inspecting a medium that is typically clear and transparent against a light source. Observing any turbidity or cloudiness indicates potential microbial growth. Upon detecting such growth, the suspect container undergoes further testing to confirm microbial presence, ensuring it is not simply due to sample decomposition. Occasionally, cloudiness may arise from particle shedding or chemical interactions with the medium. Following the testing phase, samples return to the incubator to complete the incubation period. Notably, any turbidity observed in the medium is reassessed after fourteen days, with particular scrutiny on the fourth day.
Tag:
Laboratory Petri Dish
Cell Culture Dish Bulkbuy
Petri Dish Products
Plastic Petri Dish
){kind=link}