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 |
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
Crafted to perfection, our collection incubator undergoes a meticulous 40-step manufacturing process, ensuring unwavering adherence to the ISO9001 quality system and ISO14001 environmental system standards. Each product passes a rigorous integrity test, embodying our commitment to continuous quality enhancement and traceability. Tailored to diverse testing requirements across various dosage and packaging forms, we meticulously select an array of cups, filter materials, and matching needles. Our innovative designs cater to a wide spectrum of sterilization test needs, setting a benchmark for excellence.
Product Rinse Sterility Test
Combination Product: Our Product Rinse Sterility Test is meticulously devised for products featuring hollow tubes, like infusion sets. It excludes soaking and is relevant for fluid channels marked sterile. This user-friendly method involves modifying FTM media with liquid D rinse products. The eluate is meticulously membrane-filtered and incubated in FTM and SCDM. Although not commonly employed, it remains a reliable option when needed.
Bulk Drugs / Biopharmaceuticals
Bulk drugs (API) undergo stringent sterilization in alignment with USP 71 standards prior to their integration into the manufacturing process. This ensures uncompromising quality and safety.
Bulk biologics adhere to rigorous sterility testing per 21 CFR 610.12. This mandates the use of FTM media with specified sample test sizes and a minimum capacity of 10 ml, safeguarding product integrity and compliance.
Interpretation of Sterility Test Results
Technicians receive specialized training in growth testing methodologies throughout the cultivation process. Growth is meticulously monitored by examining a medium typically clear in transparency, juxtaposed against a light source. A turbid medium signals potential microbial growth. Upon detection, the suspect container undergoes further testing to confirm microbial presence rather than sample decomposition. Occasionally, cloudiness results from particulate shedding or chemical reactions with the medium. Post-testing, samples return to the incubator for the remaining incubation duration. On the 14th day, samples displaying turbidity are transferred and observed over a four-day span, ensuring precise analysis.
Tag:
Laboratory Petri Dish
Cell Culture Dish Bulkbuy
Petri Dish Products
Plastic Petri Dish
){kind=link}