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 |
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
Meticulously crafted through an intricate series of forty processes, our collection incubator epitomizes precision by adhering strictly to ISO9001 quality management and ISO14001 environmental standards. Each product undergoes thorough integrity testing, ensuring excellence in quality traceability and continuous enhancement. We cater to diverse sterilization testing needs with an array of cups, filter materials, and compatible needles, all meticulously selected to suit varying dosage and packaging forms, thus designing and developing innovative collection incubators.
Product Rinse Sterility Examination
For combination products, the product rinse sterility test is ideal for items with hollow tubing, such as infusion sets. It caters specifically to those labeled sterile in fluid channels, offering a user-friendly method. This involves modifying FTM media with liquid D for rinse products, followed by membrane filtration of the eluate, which is then placed in FTM and SCDM. This method is sparingly employed due to its specificity.
Bulk Pharmaceuticals and Biopharmaceuticals
Bulk pharmaceuticals, or APIs, undergo thorough sterilization as per USP 71 standards prior to entering the manufacturing phase, ensuring premium quality and safety.
Bulk biologics undergo rigorous sterility testing guided by 21 CFR 610.12, necessitating a medium like FTM. The sample test sizes are precisely detailed, with a mandatory minimum capacity of 10 ml.
Analyzing Sterility Test Outcomes
Technicians, adept in cultivation methods, gauge growth by inspecting a medium's clarity against light. Turbidity within the medium signals microorganism proliferation. Upon detection, further testing on the suspect container determines if this turbidity stems from microbial growth or sample decomposition. Occasionally, cloudiness arises from particle shedding or chemical reactions. Post-test, samples re-enter the incubator to complete the incubation period. On day 14, turbid samples are transferred and examined for further clarity.
Category:
Lab-Ready Petri Dish
Cell Culture Dish Wholesale
Petri Dish Collections
Durable Plastic Petri Dish
){kind=link}