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
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Item |
Discreption |
Usage |
| CP020028 |
D55A |
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| CPO20029 |
D90A |
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Crafted with meticulous precision, our collection incubator undergoes a rigorous 40-step manufacturing process, adhering to the highest standards of the ISO9001 quality system and ISO14001 environmental protocols. With a 100% integrity pass rate, our products exemplify exemplary quality traceability and enhancement. Tailored to meet the diverse testing needs of different dosage and packaging forms, we select specialized cups, high-grade filter materials, and compatible needles. Furthermore, our innovative designs of various collection incubators are purpose-built to meet the diverse demands of sterilization testing.
Sterility Test for Product Rinse
Combination Product Insight: The product rinse sterility test is meticulously designed for items with hollow tubes, such as infusion and transfusion sets, marked with sterile fluid channels. Ideal for scenarios unsuitable for soaking, this user-friendly method involves modifying FTM media with liquid D rinse products. The resultant eluate undergoes membrane filtration and is placed in both FTM and SCDM, although it is commonly less utilized.
Active Pharmaceutical Ingredients / Biopharmaceuticals
Before being integrated into the manufacturing process, bulk drugs (API) undergo sterilization in strict accordance with USP 71 standards.
Bulk biologics are subjected to rigorous sterility testing per 21 CFR 610.12, mandating the use of a medium (FTM) with sample test sizes precisely defined in the documentation, and a minimum volume of 10 ml.
Understanding Sterility Test Outcomes
Technicians undergo comprehensive training in growth testing methodologies during the cultivation process. The growth is identified by analyzing a generally clear medium against a light source, where any turbidity signifies microorganism proliferation. Upon detecting growth, further testing of the suspected container confirms microbial presence rather than sample decomposition; occasional sample cloudiness may result from particle shedding or chemical reactions with the medium. Post-testing, the sample returns to the incubator for the remaining incubation period, with turbid samples being monitored for an additional four days on the 14th day of testing.
Tags:
Laboratory-Grade Petri Dish
Cell Culture Dishes Available in Bulk
Range of Petri Dish Products
Durable Plastic Petri Dish
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