Comprehensive Insight into Our Product
| 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 |
Technical Specifications
| Products code |
Item |
Discreption |
Usage |
| CP020028 |
D55A |
|
|
| CPO20029 |
D90A |
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
Crafted with precision, our collection incubator undergoes a meticulous 40-stage manufacturing process, adhering strictly to ISO9001 and ISO14001 standards. Each product we offer has triumphantly passed integrity assessments, a testament to our unwavering dedication to quality enhancement and traceability. Tailored to meet diverse testing needs, we provide a range of cups, filter materials, and needles, designed to accommodate various sterilization tests with utmost efficacy.
Sterility Testing of Product Rinses
For specialized products with hollow tubes like infusion sets, the product rinse sterility test is a perfect fit. This innovative method is designed for items unsuitable for soaking and marked sterile on fluid channels. It simplifies the process, requiring the FTM media to be adapted with liquid D rinse products. The eluate is then filtered through a membrane and placed in FTM and SCDM. While not frequently employed, this method exemplifies ease of operation.
Active Pharmaceuticals and Biopharmaceuticals
Our active pharmaceutical ingredients (API) undergo rigorous sterilization adhering to USP 71 standards before advancing to the manufacturing stage.
Our bulk biologics are meticulously tested for sterility, compliant with 21 CFR 610.12. This regulation necessitates the use of a medium like FTM with specified sample test sizes and a minimum capacity of 10 ml, guaranteeing uncompromising sterility assurance.
Understanding Sterility Test Outcomes
Technicians are expertly trained in growth assessment methods during cultivation. Growth is identified by inspecting a usually clear medium against light, where turbidity signifies microbial presence. Confirmatory tests distinguish microbial growth from sample decomposition or particulate contamination. After initial tests, samples return to incubation. On day 14, turbid samples are transferred and observed for an additional four days.
Classification:
Lab-Standard Petri Dish
Bulk Purchase for Cell Culture Dishes
Range of Petri Dish Products
Durable Plastic Petri Dishes
){kind=link}