Comprehensive 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 Parameters
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Item |
Discreption |
Usage |
| CP020028 |
D55A |
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| CPO20029 |
D90A |
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Our collection incubator is meticulously crafted through forty precise processes, adhering strictly to ISO9001 quality and ISO14001 environmental system standards. Every single unit undergoes a rigorous integrity test, ensuring unparalleled quality traceability and continuous enhancement. Tailored to meet the diverse testing needs of various dosage and packaging forms, an extensive range of cups, filter materials, and compatible needles are selected. We proudly design and develop versatile collection incubators to fulfill diverse sterilization test requirements, embodying excellence and precision.
Sterility Testing of Product Rinse
Combination Product: The product rinse sterility test is specifically designed for items with hollow tubes, such as infusion and infusion sets. It is unsuitable for soaking and requires the fluid channel to be sterile. This straightforward method involves modifying FTM media with liquid D to rinse products, followed by membrane filtration of the eluate, which is then cultured in FTM and SCDM. Although effective, this method is typically reserved for specific scenarios.
Bulk Pharmaceuticals / Biopharmaceutical Products
Bulk drugs (API) are thoroughly sterilized in accordance with USP 71 standards before being released into the manufacturing process, ensuring safety and efficacy.
Bulk biologics undergo stringent sterility testing as per 21 CFR 610.12. This requires using a medium (FTM) with specified sample test sizes outlined in the documentation, ensuring a minimum capacity of 10 ml to guarantee thorough testing.
Decoding Sterility Test Results
Technicians engaged in the cultivation process must be proficient in growth testing methodologies. Growth is observed through a medium that remains generally clear and transparent against the light source, with any turbid area indicating microbial presence. Upon detecting growth, the suspect container undergoes further testing to ascertain if the turbidity is due to microbial activity rather than sample decomposition. Occasionally, cloudiness may result from particle shedding or chemical reactions with the medium. Post-testing, the samples are returned to the incubator for the remaining incubation period. Turbid samples are transferred and monitored over four days, culminating on the 14th day of the test for conclusive results.
Product Tags:
Advanced Laboratory Petri Dish
Bulk Purchase of Cell Culture Dishes
Petri Dish Product Collection
Durable Plastic Petri Dish
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