In-Depth Product Overview
| 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 and Features
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Item |
Discreption |
Usage |
| CP020028 |
D55A |
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| CPO20029 |
D90A |
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Our state-of-the-art collection incubator is meticulously crafted through a rigorous forty-step process, adhering strictly to the ISO9001 quality system alongside ISO14001 environmental standards. We proudly achieve a 100% pass rate in the integrity tests, constantly refining our quality traceability. Tailored to accommodate the testing requirements of diverse dosage and packaging forms, our selection includes a variety of cups, filter materials, and compatible needles. This enables us to innovate and develop collection incubators that fulfill all needs for a multitude of sterilization tests.
Rinse Sterility Test for Products
Integrated Product: The product rinse sterility test is specifically designed for items featuring hollow tubes, such as infusion and infusion sets. It is unsuitable for soaking, and the fluid channel is marked sterile. This user-friendly method involves altering the FTM media with liquid D rinse products. Following filtration of the eluate via a membrane, it is placed in FTM and SCDM. Note that this method is generally reserved for specific scenarios.
Active Pharmaceutical Ingredients / Biopharmaceuticals
Active Pharmaceutical Ingredients (API) are thoroughly sterilized as per USP 71 standards before they proceed to the manufacturing phase, ensuring quality and safety.
In accordance with 21 CFR 610.12, bulk biologics undergo rigorous sterility testing. This process mandates the use of a specific medium (FTM) with test sample sizes outlined in official documentation and a minimum medium capacity of 10 ml.
Understanding Sterility Test Outcomes
It is essential for technicians to be proficient in growth testing procedures during cultivation. Growth is verified by examining a medium's transparency against a light source; any turbidity indicates microbial growth. Upon detection, the suspect container undergoes testing to establish whether the observed turbidity is microbial or a result of sample decomposition. Occasionally, cloudiness arises from particle shedding or chemical reactions with the medium. Post-testing, samples are returned to the incubator for the reminder of the period. Turbid samples are transferred and observed for four days by the 14th day of testing.
Category:
Laboratory Petri Dish
Bulk Purchase of Cell Culture Dishes
Range of Petri Dish Products
Durable Plastic Petri Dish
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