Exquisite 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 forty exacting processes, each aligned with ISO9001 quality assurance and ISO14001 environmental standards. Every product passes a rigorous integrity test, ensuring unparalleled quality and traceability. With the varied testing needs of different dosage and packaging forms in mind, we have selected an array of cups, filter materials, and matching needles, ingeniously designing a suite of collection incubators to fulfill diverse sterilization testing requirements.
Sterility Testing via Product Rinse
Combination Testing Approach: Our product rinse sterility test is tailored for items with hollow tubes, like infusion sets, where traditional soaking isn't feasible and sterile fluid channels are indicated. This straightforward method involves adjusting FTM media with liquid D to rinse products, followed by membrane filtration of the eluate, which is then cultured in FTM and SCDM. Typically, this method is reserved for specific scenarios.
Bulk Pharmaceuticals / Biologics
Our bulk drugs (Active Pharmaceutical Ingredients) are meticulously sterilized in adherence with the stringent USP 71 protocol before proceeding to manufacturing, ensuring impeccable quality and safety.
Sterility assessments for bulk biologics are conducted as per the rigorous 21 CFR 610.12 standard, necessitating a specific medium (FTM) with carefully defined sample sizes and a minimum volume of 10 ml.
Understanding Sterility Test Outcomes
Technicians engaged in cultivation processes receive comprehensive training in growth testing methods. Microbial growth is detected by examining a medium that appears generally clear against a light source; turbidity indicates microbial presence. Once observed, verification tests ensure that turbidity is microbial in origin, rather than due to sample degradation. In instances of particle shedding or chemical interaction causing cloudiness, further investigation ensues. After initial testing, samples return to incubation for the remaining period. Turbid samples are transferred for continued observation over a 14-day span.
Label:
Research-Grade Petri Dish
Bulk Purchase of Cell Culture Dishes
Comprehensive Petri Dish Portfolio
Durable Plastic Petri Dish
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