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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Crafted with precision and dedication, the collection incubator undergoes a rigorous manufacturing process involving forty distinct stages. Each stage is meticulously aligned with the ISO9001 quality management and ISO14001 environmental management standards, ensuring excellence at every step. Every single product passes through a stringent integrity test, guaranteeing consistent quality traceability and continual enhancements. Tailored to meet varying test requirements across diverse dosage and packaging formats, an array of cups, filter materials, and specialized needles are carefully selected. This meticulous design and development process ensures that every collection incubator is fully equipped to cater to a wide spectrum of sterilization test needs.
Product Rinse Sterility Test
For products featuring hollow tubes, such as infusion and transfusion sets where fluid channels are marked sterile, the Product Rinse Sterility Test is the ideal solution. Though not suitable for soaking, this method is praised for its simplicity. It involves the modification of FTM media with Liquid D rinse products. The process begins with membrane filtering of the eluate, followed by placement in FTM and SCDM. While typically not the go-to method, it remains a viable, efficient option under specific conditions.
Bulk Drugs / Biopharmaceuticals
Bulk drugs, or Active Pharmaceutical Ingredients (APIs), undergo rigorous sterilization in accordance with USP 71 standards before they are deemed ready for the manufacturing process. This ensures the highest level of safety and efficacy in pharmaceutical production.
Bulk biologics undergo stringent sterility testing as mandated by 21 CFR 610.12. This requires the use of a specialized medium known as FTM, with precise sample test sizes detailed in the accompanying documentation, each with a minimum capacity of 10 ml.10. This meticulous testing ensures biopharmaceuticals meet the highest standards of sterility and safety.
Interpretation of Sterility Test Results
Technicians play a pivotal role in accurately interpreting sterility test results. Trained thoroughly in growth testing methods, they observe the medium's transparency against a light source, identifying any turbid areas as potential microbial growth. When growth is detected, suspect containers undergo further testing to ascertain whether turbidity results from microbial presence or sample decomposition. Occasionally, turbidity arises from particle shedding or chemical reactions with the medium. Post-testing, samples are returned to the incubator for the remainder of the incubation period. On the 14th day of testing, samples displaying turbidity are transferred for examination, providing crucial insights into sterility.
Tag:
Laboratory Petri Dish
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Plastic Petri Dish
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