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 |
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
The collection incubator is meticulously crafted through a stringent 40-step process, adhering strictly to the ISO9001 quality management system and ISO14001 environmental standards. Every single product undergoes and passes the integrity test, ensuring unwavering commitment to quality enhancement and traceability. Tailored to meet diverse testing demands across various dosage and packaging forms, an array of cups, filter materials, and compatible needles are carefully chosen. This has driven the innovative development of various collection incubators designed to cater to a wide range of sterilization testing needs.
Product Rinse Sterility Test
Combination Product: The product rinse sterility test is specifically tailored for items with hollow tubes, such as infusion and transfusion sets, which are indicated as sterile but unsuitable for soaking. The fluid channel is marked sterile, and this user-friendly method necessitates the adaptation of FTM media with liquid D rinse products. The eluate is membrane-filtered and subsequently placed into FTM and SCDM. Despite its ease, this method is typically not widely adopted.
Bulk Drugs / Biopharmaceuticals
Bulk drugs (API) undergo sterilization in strict accordance with USP 71, ensuring they are pristine before proceeding to the manufacturing phase.
Bulk biologics are subject to sterility testing under the rigorous guidelines of 21 CFR 610.12, which mandates a specified medium (FTM) with sample test sizes as detailed in the documentation, requiring a capacity of no less than 10 ml.
Interpretation of Sterility Test Results
Technicians must be adeptly trained in growth testing methodologies during cultivation. Growth is assessed by examining the medium, which should generally be clear and transparent. Turbidity in the medium signals microbial growth. When growth is identified, the suspect container is further tested to ascertain that the turbidity results from microbes rather than sample decomposition. Occasionally, cloudiness occurs due to particle shedding or chemical reactions with the medium. After conducting tests, samples are returned to the incubator to complete the incubation period. Samples exhibiting turbidity in the medium are relocated and monitored over four days on the 14th test day.
Tag:
Laboratory Petri Dish
Cell Culture Dish Bulkbuy
Petri Dish Products
Plastic Petri Dish
){kind=link}