Exquisite 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 |
Specifications and Features
| Products code |
Item |
Discreption |
Usage |
| CP020028 |
D55A |
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| CPO20029 |
D90A |
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Our meticulously crafted collection incubators, produced through forty precise processes, adhere rigorously to ISO9001 and ISO14001 standards. Every product proudly passes our thorough integrity tests, ensuring supreme quality traceability and continuous enhancement. Tailored to meet the stringent testing needs across diverse dosage and packaging forms, we offer a variety of cups, filter materials, and compatible needles, meticulously designed to fulfill all sterilization test requirements.
Innovative Product Rinse Sterility Test
Combination Product Insight: Our product rinse sterility test is exclusively designed for items featuring hollow tubes, such as infusion and infusion sets, where soaking isn't feasible, and sterile fluid channels are marked clearly. This user-friendly method involves adjusting FTM media with liquid D rinse products. The eluate undergoes membrane filtration and is then placed in both FTM and SCDM for analysis. Though highly effective, this method is traditionally reserved for specific applications.
Bulk Drugs & Biopharmaceuticals Revolution
Bulk drugs (APIs) undergo strict sterilization processes conforming to USP 71 standards before being released for manufacturing, ensuring the highest level of safety and efficacy.
In the realm of bulk biologics, we adhere to 21 CFR 610.12 for sterility testing, which mandates the use of a medium (FTM) and requires sample sizes with a minimum capacity of 10 ml, ensuring comprehensive quality assurance.
Guidance on Sterility Test Results Interpretation
Technicians undergo rigorous training in growth testing methodologies during the cultivation process. Growth determination involves examining a typically clear medium against a light source, where any turbidity indicates microbial presence. Upon detection, suspect containers undergo confirmation testing to ascertain microbial-induced turbidity rather than sample decomposition. Occasionally, cloudiness may result from particle shedding or chemical reactions. Post-testing, samples return to the incubator for the remaining incubation duration, with turbid samples assessed and showcased on the 14th day of testing.
Category:
Premium Laboratory Petri Dishes
Cell Culture Dish Bulk Purchase
Comprehensive Petri Dish Collection
Durable Plastic Petri Dish
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