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 |
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
This exceptional collection incubator, crafted with precision through forty meticulous processes, adheres strictly to ISO9001 and ISO14001 standards. Each product undergoes a comprehensive integrity test, guaranteeing 100% perfection and enabling continuous quality advancement. Designed to accommodate diverse sterilization needs, various cups, filter materials, and compatible needles are selected, while an array of specialized collection incubators are developed to cater to the demands of different dosage and packaging forms.
Product Rinse Sterility Test
Combination Product: The Product Rinse Sterility Test is uniquely suited for products featuring hollow tubes, such as infusion and infusion sets, where soaking isn’t feasible and fluid channels are marked as sterile. This user-friendly method involves modifying FTM media with liquid D rinse products. The eluate is subsequently membrane-filtered and introduced into FTM and SCDM. While typically not the method of choice, it serves its purpose effectively.
Bulk Drugs / Biopharmaceuticals
Bulk drugs (API) undergo rigorous sterilization as per USP 71 before being released into the manufacturing process, ensuring superior quality and safety.
Bulk biologics undergo sterility testing in alignment with 21 CFR 610.12 standards. This requires a medium (FTM) with specified sample test sizes as documented, maintaining a minimum capacity of 10 ml, ensuring compliance and reliable results.
Interpretation of Sterility Test Results
Technicians, trained in sophisticated growth testing methods, carefully monitor the cultivation process. Growth is indicated by turbidity in a generally clear medium against light. Upon detection, the suspect container undergoes analysis to verify microbial presence, ruling out decomposition or chemical reactions as causes. Occasionally, turbidity arises from particle shedding. After testing, samples are returned to the incubator for the remaining incubation duration. Turbid samples are transferred and observed for four days, specifically on the 14th day of testing, ensuring thorough examination.
Tag:
Laboratory Petri Dish
Cell Culture Dish Bulkbuy
Petri Dish Products
Plastic Petri Dish
){kind=link}