Detailed 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 |
Parameter
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Item |
Discreption |
Usage |
| CP020028 |
D55A |
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| CPO20029 |
D90A |
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The exemplary collection incubator is crafted with precision through a meticulous forty-step process, adhering strictly to the ISO9001 quality system and ISO14001 environmental system standards. Each product undergoes a rigorous integrity test, ensuring 100% compliance and setting a benchmark for continuous quality improvement and traceability. Tailored to meet varying testing requirements across different dosage forms and packaging styles, an assortment of cups, filter materials, and compatible needles are selected to design and develop diverse collection incubators. These are engineered meticulously to cater to a multitude of sterilization testing needs.
Product Rinse Sterility Test
Combination Product: The product rinse sterility test is specifically designed for products featuring hollow tubes, such as infusion and infusion sets that are unsuitable for soaking. These fluid channels, marked as sterile, benefit from this user-friendly method, necessitating minor modifications of FTM media with liquid D rinse products. The eluate is membrane-filtered and subsequently placed in FTM and SCDM, though its use is typically limited.
Bulk Drugs / Biopharmaceuticals
Bulk drugs (API) are meticulously sterilized in adherence to USP 71 standards before their release into the manufacturing process, ensuring uncompromising quality.
Bulk biologics undergo stringent sterility testing as per 21 CFR 610.12, mandating the use of a medium (FTM) with specified sample test sizes detailed in the accompanying documentation, and a minimum capacity of 10 ml.
Interpretation of Sterility Test Results
To ensure precision in growth testing during the cultivation process, technicians receive specialized training. Growth is identified by the observation of a medium, generally clear when viewed against a light source, with any turbid areas indicating microbial presence. Upon detection of growth, the suspect container is re-examined to verify that turbidity is microbial rather than sample decomposition. Occasionally, cloudiness results from particle shedding or chemical interaction with the medium. After testing, samples are returned to the incubator for the remainder of the incubation period, with turbid samples being transferred and exhibited on the 14th day, over a four-day display period.
Tag:
Laboratory Petri Dish
Cell Culture Dish Bulkbuy
Petri Dish Products
Plastic Petri Dish
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