In-Depth 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 |
Specifications
| Products code |
Item |
Discreption |
Usage |
| CP020028 |
D55A |
|
|
| CPO20029 |
D90A |
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
Our meticulously crafted collection incubators undergo an intricate manufacturing process, comprising of forty precise steps, each adhering with unwavering dedication to the esteemed ISO9001 quality system and ISO14001 environmental standards. With an impeccable success rate, 100% of our products triumphantly pass the integrity test, ensuring unmatched quality traceability and continuous enhancement. We meticulously select a diverse range of cups, filter materials, and complementary needles tailored to the testing requirements of varying dosage and packaging forms. This enables us to design and develop versatile collection incubators, meticulously crafted to fulfill the diverse and demanding needs of sterilization tests with unparalleled precision and excellence.
Rinse Sterility Test
The combination product: Product rinse sterility test is expertly crafted for products designed with hollow tubes, such as infusion and infusion sets. These products, not suited for soaking, yet marked for sterile fluid channels, find an easy operational method here. It requires the FTM media modification with liquid D rinse products. The resulting eluate is meticulously membrane filtered, placed in FTM and SCDM, ensuring a robust testing process. However, this particular method is typically less favored in standard practice.
Bulk Pharmaceuticals / Biopharmaceuticals
Before integration into the manufacturing process, bulk drugs, also known as APIs, undergo a rigorous sterilization procedure in strict accordance with USP 71, ensuring the utmost quality and safety.
Bulk biologics are meticulously tested for sterility in alignment with 21 CFR 610.12, utilizing a designated medium (FTM) with specific sample test sizes as outlined in the standard document. This test specification requires a capacity of not less than 10 ml, ensuring comprehensive assessment.
Deciphering Sterility Test Results
Technicians, with specialized training in growth testing methods, play a crucial role during the cultivation process. The growth is identified by observing the transparency of the medium against a light source; any turbid sections indicate microorganism presence. Upon detecting growth, the suspect container undergoes rigorous testing to confirm that the turbidity is microbial in nature, rather than a result of sample decomposition. Occasionally, cloudiness arises from particle shedding or chemical interactions. Post-testing, samples return to incubation for the remainder of the period. On the 14th day of testing, medium-turbid samples are transferred and meticulously observed over four days, ensuring authentic results and reliable interpretation.
Category:
Petri Dish for Laboratory
Economical Cell Culture Dish Bulk Purchase
Petri Dish Collections
Durable Plastic Petri Dish
){kind=link}