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 |
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
Exquisitely crafted through a meticulous 40-step process, our collection incubator embodies the pinnacle of precision and quality. Each stage strictly adheres to the rigorous standards of the ISO9001 quality system and the ISO14001 environmental system, ensuring unparalleled excellence. Every single product undergoes a comprehensive integrity test, guaranteeing consistent quality traceability and seamless enhancement in quality. Tailored to meet the diverse testing needs of various dosage and packaging forms, we have curated a selection of cups, filter materials, and matching needles, and engineered a variety of collection incubators to fulfill the comprehensive requirements of sterilization testing.
Product Rinse Sterility Test
Combination Product: The Product Rinse Sterility Test is specifically designed for products featuring hollow tubes, such as infusion sets, which are unsuitable for soaking. In instances where the fluid channel is designated as sterile, this method is both straightforward and efficient. It necessitates the modification of FTM media by utilizing liquid D rinse products. The resulting eluate undergoes membrane filtration and is subsequently placed in FTM and SCDM. Although this approach is highly effective, it is not commonly employed.
Bulk Drugs / Biopharmaceuticals
Bulk drugs (API) undergo sterilization in accordance with the stringent protocols of USP 71 prior to their release into the manufacturing process, ensuring optimal safety and efficacy.
Bulk biologics are subjected to sterility testing as per the rigorous guidelines of 21 CFR 610.12. This requires the use of a medium (FTM) with sample test sizes meticulously outlined in the documentation, each with a minimum capacity of 10 ml. This ensures stringent compliance and reliability.
Interpretation of Sterility Test Results
Technicians specializing in the cultivation process receive comprehensive training in growth testing methods. Microbial growth is identified by observing the medium against a light source, looking for turbid areas which signal microorganism presence. Upon detection, suspect containers are meticulously tested to determine if the turbidity is due to microbial activity rather than sample decomposition. Occasionally, turbidity may result from particle shedding or chemical interactions with the medium. Post-testing, samples return to the incubator for continued observation. On the 14th day, turbid samples are transferred and displayed for further examination, ensuring thorough and accurate results.
Tag:
Laboratory Petri Dish
Cell Culture Dish Bulkbuy
Petri Dish Products
Plastic Petri Dish
){kind=link}