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 |
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| CPO20029 |
D90A |
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Our collection incubator is a masterpiece crafted through forty meticulous processes, each rigorously adhering to the stringent standards of the ISO9001 quality management system and the ISO14001 environmental guidelines. With 100% of our products passing the integrity test, we ensure unwavering quality traceability and continuous improvements. To cater to the diverse testing requirements of various dosage forms and packaging styles, we offer a range of collection incubators, equipped with assorted cups, filter materials, and matching needles, specifically designed to meet all sterilization testing needs.
Product Rinse Sterility Test
Combination Product: The product rinse sterility test is specially designed for items with hollow tubes, such as infusion and transfusion sets. These are marked as sterile where fluid channels are involved. This user-friendly method requires the modification of FTM media with liquid D rinse for these products. The resulting eluate undergoes membrane filtration and is cultured in FTM and SCDM media. Although straightforward, this technique is seldom employed.
Bulk Drugs / Biopharmaceuticals
Bulk drugs (Active Pharmaceutical Ingredients, API) undergo sterilization as per the stringent requirements of USP 71 before being released into the manufacturing process, ensuring they meet the highest safety standards.
Bulk biologics are subjected to sterility testing according to 21 CFR 610.12, which mandates the use of FTM media with sample test sizes specified in the document, ensuring a minimum capacity of 10 ml for accurate and reliable results.
Interpretation of Sterility Test Results
During the cultivation process, technicians, well-trained in growth testing methods, meticulously observe the medium. Typically transparent, any turbidity indicates microbial growth. Once detected, the suspect container undergoes further testing to ascertain if the cloudiness is due to microbial presence rather than sample decomposition. Occasionally, cloudiness arises from particle shedding or chemical interactions with the medium. After rigorous testing, samples are returned to the incubator for the final incubation period, with turbid samples being assessed on the 14th day, and displayed over a four-day period.
Tag:
Laboratory Petri Dish
Cell Culture Dish Bulkbuy
Petri Dish Products
Plastic Petri Dish
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